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Risk for Preterm Birth Stops Maternal RSV Vaccine Trial
A phase 3 trial of a maternal vaccine candidate for respiratory syncytial virus (RSV) has been stopped early because the risk for preterm births is higher in the candidate vaccine group than in the placebo group.
By the time enrollment was stopped on February 25, 2022 because of the safety signal of preterm birth, 5328 pregnant women had been vaccinated, about half of the intended 10,000 enrollees. Of these, 3557 received the candidate vaccine RSV prefusion F protein–based maternal vaccine, and another 1771 received a placebo.
Data from the trial, sponsored by GSK, were immediately made available when recruitment and vaccination were stopped, and investigation of the preterm birth risk followed. Results of that analysis, led by Ilse Dieussaert, IR, vice president for vaccine development at GSK in Wavre, Belgium, are published online on March 13 in The New England Journal of Medicine.
“We have discontinued our work on this RSV maternal candidate vaccine, and we are closing out all ongoing trials with the exception of the MAT-015 follow-on study to monitor subsequent pregnancies,” a GSK spokesperson said in an interview.
The trial was conducted in pregnant women aged 18-49 years to assess the efficacy and safety of the vaccine. The women were randomly assigned 2:1 to receive the candidate vaccine or placebo between 24 and 34 weeks’ gestation.
Preterm Births
The primary outcomes were any or severe medically assessed RSV-associated lower respiratory tract infection in infants from birth to 6 months and safety in infants from birth to 12 months.
According to the data, preterm birth occurred in 6.8% of the infants in the vaccine group and in 4.9% of those in the placebo group (relative risk [RR], 1.37; 95% CI, 1.08-1.74; P = .01). Neonatal death occurred in 0.4% in the vaccine group and 0.2% in the placebo group (RR, 2.16; 95% CI, 0.62-7.56; P = .23).
To date, only one RSV vaccine (Abrysvo, Pfizer) has been approved for use during pregnancy to protect infants from RSV-associated lower respiratory tract infection.
“It was a very big deal that this trial was stopped, and the new candidate won’t get approval.” said Aaron E. Glatt, MD, chair of the Department of Medicine and chief of Infectious Diseases and Hospital Epidemiologist at Mount Sinai South Nassau in Oceanside, New York.
Only One RSV Vaccine Approved in Pregnancy
Dr. Glatt pointed out the GSK vaccine is like the maternal vaccine that did get approved. “The data clearly show that there was a slight but increased risk in preterm labor,” Dr. Glatt said, “and while not as clearly shown, there was an increase in neonatal death in the group of very small numbers, but any neonatal death is of concern.”
The implications were disturbing, he added, “You’re giving this vaccine to prevent neonatal death.” Though the Pfizer vaccine that was granted approval had a very slight increase in premature birth, the risk wasn’t statistically significant, he pointed out, “and it showed similar benefits in preventing neonatal illness, which can be fatal.”
Dr. Glatt said that there is still a lingering concern with the approved vaccine, and he explained that most clinicians will give it closer to the end of the recommended time window of 34 weeks. “This way, even if there is a slight increase in premature term labor, you’re probably not going to have a serious outcome because the baby will be far enough along.”
A difference in the incidence of preterm birth between the experimental vaccine and placebo groups was predominantly found in low- and middle-income countries, according to Dieussaert’s team, “where approximately 50% of the trial population was enrolled and where the medical need for maternal RSV vaccines is the greatest.”
The RR was 1.56 (95% CI, 1.17-2.10) for low- and middle-income countries and 1.04 (95% CI, 0.68-1.58) for high-income countries.
“If a smaller percentage of participants from low- and middle-income countries had been enrolled in our trial, the RR for preterm birth in the vaccine group as compared with the placebo group might have been reduced in the overall trial population,” they reported.
The authors explained that the data do not reveal the cause of the higher risk for preterm birth in the vaccine group.
“We do not know what caused the signal,” the company’s spokesperson added. “GSK completed all the necessary steps of product development including preclinical toxicology studies and clinical studies in nonpregnant women prior to starting the studies in pregnant women. There were no safety signals identified in any of the earlier parts of the clinical testing. There have been no safety signals identified in the other phase 3 trials for this vaccine candidate.”
Researchers did not find a correlation between preterm births in the treatment vs control groups with gestational age at the time of vaccination or with particular vaccine clinical trial material lots, race, ethnicity, maternal smoking, alcohol consumption, body mass index, or time between study vaccination and delivery, the GSK spokesperson said.
The spokesperson noted that the halted vaccine is different from GSK’s currently approved adjuvanted RSV vaccine (Arexvy) for adults aged 60 years or older.
What’s Next for Other Vaccines
Maternal vaccines have been effective in preventing other diseases in infants, such as tetanus, influenza, and pertussis, but RSV is a very hard virus to make a vaccine for, Dr. Glatt shared.
The need is great to have more than one option for a maternal RSV vaccine, he added, to address any potential supply concerns.
“People have to realize how serious RSV can be in infants,” he said. “It can be a fatal disease. This can be a serious illness even in healthy children.”
A version of this article appeared on Medscape.com.
A phase 3 trial of a maternal vaccine candidate for respiratory syncytial virus (RSV) has been stopped early because the risk for preterm births is higher in the candidate vaccine group than in the placebo group.
By the time enrollment was stopped on February 25, 2022 because of the safety signal of preterm birth, 5328 pregnant women had been vaccinated, about half of the intended 10,000 enrollees. Of these, 3557 received the candidate vaccine RSV prefusion F protein–based maternal vaccine, and another 1771 received a placebo.
Data from the trial, sponsored by GSK, were immediately made available when recruitment and vaccination were stopped, and investigation of the preterm birth risk followed. Results of that analysis, led by Ilse Dieussaert, IR, vice president for vaccine development at GSK in Wavre, Belgium, are published online on March 13 in The New England Journal of Medicine.
“We have discontinued our work on this RSV maternal candidate vaccine, and we are closing out all ongoing trials with the exception of the MAT-015 follow-on study to monitor subsequent pregnancies,” a GSK spokesperson said in an interview.
The trial was conducted in pregnant women aged 18-49 years to assess the efficacy and safety of the vaccine. The women were randomly assigned 2:1 to receive the candidate vaccine or placebo between 24 and 34 weeks’ gestation.
Preterm Births
The primary outcomes were any or severe medically assessed RSV-associated lower respiratory tract infection in infants from birth to 6 months and safety in infants from birth to 12 months.
According to the data, preterm birth occurred in 6.8% of the infants in the vaccine group and in 4.9% of those in the placebo group (relative risk [RR], 1.37; 95% CI, 1.08-1.74; P = .01). Neonatal death occurred in 0.4% in the vaccine group and 0.2% in the placebo group (RR, 2.16; 95% CI, 0.62-7.56; P = .23).
To date, only one RSV vaccine (Abrysvo, Pfizer) has been approved for use during pregnancy to protect infants from RSV-associated lower respiratory tract infection.
“It was a very big deal that this trial was stopped, and the new candidate won’t get approval.” said Aaron E. Glatt, MD, chair of the Department of Medicine and chief of Infectious Diseases and Hospital Epidemiologist at Mount Sinai South Nassau in Oceanside, New York.
Only One RSV Vaccine Approved in Pregnancy
Dr. Glatt pointed out the GSK vaccine is like the maternal vaccine that did get approved. “The data clearly show that there was a slight but increased risk in preterm labor,” Dr. Glatt said, “and while not as clearly shown, there was an increase in neonatal death in the group of very small numbers, but any neonatal death is of concern.”
The implications were disturbing, he added, “You’re giving this vaccine to prevent neonatal death.” Though the Pfizer vaccine that was granted approval had a very slight increase in premature birth, the risk wasn’t statistically significant, he pointed out, “and it showed similar benefits in preventing neonatal illness, which can be fatal.”
Dr. Glatt said that there is still a lingering concern with the approved vaccine, and he explained that most clinicians will give it closer to the end of the recommended time window of 34 weeks. “This way, even if there is a slight increase in premature term labor, you’re probably not going to have a serious outcome because the baby will be far enough along.”
A difference in the incidence of preterm birth between the experimental vaccine and placebo groups was predominantly found in low- and middle-income countries, according to Dieussaert’s team, “where approximately 50% of the trial population was enrolled and where the medical need for maternal RSV vaccines is the greatest.”
The RR was 1.56 (95% CI, 1.17-2.10) for low- and middle-income countries and 1.04 (95% CI, 0.68-1.58) for high-income countries.
“If a smaller percentage of participants from low- and middle-income countries had been enrolled in our trial, the RR for preterm birth in the vaccine group as compared with the placebo group might have been reduced in the overall trial population,” they reported.
The authors explained that the data do not reveal the cause of the higher risk for preterm birth in the vaccine group.
“We do not know what caused the signal,” the company’s spokesperson added. “GSK completed all the necessary steps of product development including preclinical toxicology studies and clinical studies in nonpregnant women prior to starting the studies in pregnant women. There were no safety signals identified in any of the earlier parts of the clinical testing. There have been no safety signals identified in the other phase 3 trials for this vaccine candidate.”
Researchers did not find a correlation between preterm births in the treatment vs control groups with gestational age at the time of vaccination or with particular vaccine clinical trial material lots, race, ethnicity, maternal smoking, alcohol consumption, body mass index, or time between study vaccination and delivery, the GSK spokesperson said.
The spokesperson noted that the halted vaccine is different from GSK’s currently approved adjuvanted RSV vaccine (Arexvy) for adults aged 60 years or older.
What’s Next for Other Vaccines
Maternal vaccines have been effective in preventing other diseases in infants, such as tetanus, influenza, and pertussis, but RSV is a very hard virus to make a vaccine for, Dr. Glatt shared.
The need is great to have more than one option for a maternal RSV vaccine, he added, to address any potential supply concerns.
“People have to realize how serious RSV can be in infants,” he said. “It can be a fatal disease. This can be a serious illness even in healthy children.”
A version of this article appeared on Medscape.com.
A phase 3 trial of a maternal vaccine candidate for respiratory syncytial virus (RSV) has been stopped early because the risk for preterm births is higher in the candidate vaccine group than in the placebo group.
By the time enrollment was stopped on February 25, 2022 because of the safety signal of preterm birth, 5328 pregnant women had been vaccinated, about half of the intended 10,000 enrollees. Of these, 3557 received the candidate vaccine RSV prefusion F protein–based maternal vaccine, and another 1771 received a placebo.
Data from the trial, sponsored by GSK, were immediately made available when recruitment and vaccination were stopped, and investigation of the preterm birth risk followed. Results of that analysis, led by Ilse Dieussaert, IR, vice president for vaccine development at GSK in Wavre, Belgium, are published online on March 13 in The New England Journal of Medicine.
“We have discontinued our work on this RSV maternal candidate vaccine, and we are closing out all ongoing trials with the exception of the MAT-015 follow-on study to monitor subsequent pregnancies,” a GSK spokesperson said in an interview.
The trial was conducted in pregnant women aged 18-49 years to assess the efficacy and safety of the vaccine. The women were randomly assigned 2:1 to receive the candidate vaccine or placebo between 24 and 34 weeks’ gestation.
Preterm Births
The primary outcomes were any or severe medically assessed RSV-associated lower respiratory tract infection in infants from birth to 6 months and safety in infants from birth to 12 months.
According to the data, preterm birth occurred in 6.8% of the infants in the vaccine group and in 4.9% of those in the placebo group (relative risk [RR], 1.37; 95% CI, 1.08-1.74; P = .01). Neonatal death occurred in 0.4% in the vaccine group and 0.2% in the placebo group (RR, 2.16; 95% CI, 0.62-7.56; P = .23).
To date, only one RSV vaccine (Abrysvo, Pfizer) has been approved for use during pregnancy to protect infants from RSV-associated lower respiratory tract infection.
“It was a very big deal that this trial was stopped, and the new candidate won’t get approval.” said Aaron E. Glatt, MD, chair of the Department of Medicine and chief of Infectious Diseases and Hospital Epidemiologist at Mount Sinai South Nassau in Oceanside, New York.
Only One RSV Vaccine Approved in Pregnancy
Dr. Glatt pointed out the GSK vaccine is like the maternal vaccine that did get approved. “The data clearly show that there was a slight but increased risk in preterm labor,” Dr. Glatt said, “and while not as clearly shown, there was an increase in neonatal death in the group of very small numbers, but any neonatal death is of concern.”
The implications were disturbing, he added, “You’re giving this vaccine to prevent neonatal death.” Though the Pfizer vaccine that was granted approval had a very slight increase in premature birth, the risk wasn’t statistically significant, he pointed out, “and it showed similar benefits in preventing neonatal illness, which can be fatal.”
Dr. Glatt said that there is still a lingering concern with the approved vaccine, and he explained that most clinicians will give it closer to the end of the recommended time window of 34 weeks. “This way, even if there is a slight increase in premature term labor, you’re probably not going to have a serious outcome because the baby will be far enough along.”
A difference in the incidence of preterm birth between the experimental vaccine and placebo groups was predominantly found in low- and middle-income countries, according to Dieussaert’s team, “where approximately 50% of the trial population was enrolled and where the medical need for maternal RSV vaccines is the greatest.”
The RR was 1.56 (95% CI, 1.17-2.10) for low- and middle-income countries and 1.04 (95% CI, 0.68-1.58) for high-income countries.
“If a smaller percentage of participants from low- and middle-income countries had been enrolled in our trial, the RR for preterm birth in the vaccine group as compared with the placebo group might have been reduced in the overall trial population,” they reported.
The authors explained that the data do not reveal the cause of the higher risk for preterm birth in the vaccine group.
“We do not know what caused the signal,” the company’s spokesperson added. “GSK completed all the necessary steps of product development including preclinical toxicology studies and clinical studies in nonpregnant women prior to starting the studies in pregnant women. There were no safety signals identified in any of the earlier parts of the clinical testing. There have been no safety signals identified in the other phase 3 trials for this vaccine candidate.”
Researchers did not find a correlation between preterm births in the treatment vs control groups with gestational age at the time of vaccination or with particular vaccine clinical trial material lots, race, ethnicity, maternal smoking, alcohol consumption, body mass index, or time between study vaccination and delivery, the GSK spokesperson said.
The spokesperson noted that the halted vaccine is different from GSK’s currently approved adjuvanted RSV vaccine (Arexvy) for adults aged 60 years or older.
What’s Next for Other Vaccines
Maternal vaccines have been effective in preventing other diseases in infants, such as tetanus, influenza, and pertussis, but RSV is a very hard virus to make a vaccine for, Dr. Glatt shared.
The need is great to have more than one option for a maternal RSV vaccine, he added, to address any potential supply concerns.
“People have to realize how serious RSV can be in infants,” he said. “It can be a fatal disease. This can be a serious illness even in healthy children.”
A version of this article appeared on Medscape.com.
What’s Next for the World’s First HIV Vaccine?
When the world needed a COVID vaccine, leading HIV investigators answered the call to intervene in the coronavirus pandemic. Now, efforts to discover the world’s first HIV vaccine are revitalized.
“The body is capable of making antibodies to protect us from HIV,” says Yunda Huang, PhD, from the Fred Hutchinson Cancer Center in Seattle, Washington, who sat down with me before her talk today at the Conference on Retroviruses & Opportunistic Infections.
Dr. Huang spoke about the path forward for neutralizing antibody protection after the last attempt in a generation of HIV vaccine development ended in disappointment.
The past two decades marked the rise in HIV broadly neutralizing antibodies, with vaccine strategies to induce them. Promising advances include germline approaches, mRNA, and nanoparticle technologies.
The PrEP vaccine trial testing two experimental prevention regimens in Africa was stopped after investigators reported there is “little to no chance” the trial will show the vaccines are effective.
A Shape-Shifting Virus
HIV has been called the shape-shifting virus because it disguises itself so that even when people are able to make antibodies to it, the virus changes to escape.
But Dr. Huang and others are optimistic that an effective vaccine is still possible.
“We cannot and will not lose hope that the world will have an effective HIV vaccine that is accessible by all who need it, anywhere,” International AIDS Society (IAS) Executive Director Birgit Poniatowski said in a statement in December, when the trial was stopped.
HIV is a still persistent problem in the United States, according to the Centers for Disease Control and Prevention that reports it has affected an estimated 1.2 million people.
With new people infected every day around the globe, Dr. Huang says she feels a sense of urgency to help. “I think about all the people around the globe and the large number of young girls being hurt and I know our big pool of talent can intervene to change what we see happening.”
Dr. Huang says the clinical trial failures we’ve seen so far will help guide next steps in HIV research as much as successes typically do.
Advances in the Field
With significant advances in protein nanoparticle science, mRNA technology, adjuvant development, and B-cell and antibody analyses, a new wave of clinical trials are on the way.
And with so many new approaches in the works, the HIV Vaccine Trials Network is retooling how it operates to navigate a burgeoning field and identify the most promising regimens.
A new Discovery Medicine Program will help the network assess new vaccine candidates. It will also aim to rule out others earlier on.
For COVID-19 and the flu, multimeric nanoparticles are an important alternative under investigation that could also be adapted for HIV.
Dr. Huang says she is particularly excited to watch the progress in cocktails of combination monoclonals. “I’ve been working in this field for 20 years now and there is a misconception that with pre-exposure prophylaxis, our job is done, but HIV is so far from away from being solved.”
But you just never know, Dr. Huang says. With new research, “we could bump on something at any point that changes everything.”
A version of this article appeared on Medscape.com.
When the world needed a COVID vaccine, leading HIV investigators answered the call to intervene in the coronavirus pandemic. Now, efforts to discover the world’s first HIV vaccine are revitalized.
“The body is capable of making antibodies to protect us from HIV,” says Yunda Huang, PhD, from the Fred Hutchinson Cancer Center in Seattle, Washington, who sat down with me before her talk today at the Conference on Retroviruses & Opportunistic Infections.
Dr. Huang spoke about the path forward for neutralizing antibody protection after the last attempt in a generation of HIV vaccine development ended in disappointment.
The past two decades marked the rise in HIV broadly neutralizing antibodies, with vaccine strategies to induce them. Promising advances include germline approaches, mRNA, and nanoparticle technologies.
The PrEP vaccine trial testing two experimental prevention regimens in Africa was stopped after investigators reported there is “little to no chance” the trial will show the vaccines are effective.
A Shape-Shifting Virus
HIV has been called the shape-shifting virus because it disguises itself so that even when people are able to make antibodies to it, the virus changes to escape.
But Dr. Huang and others are optimistic that an effective vaccine is still possible.
“We cannot and will not lose hope that the world will have an effective HIV vaccine that is accessible by all who need it, anywhere,” International AIDS Society (IAS) Executive Director Birgit Poniatowski said in a statement in December, when the trial was stopped.
HIV is a still persistent problem in the United States, according to the Centers for Disease Control and Prevention that reports it has affected an estimated 1.2 million people.
With new people infected every day around the globe, Dr. Huang says she feels a sense of urgency to help. “I think about all the people around the globe and the large number of young girls being hurt and I know our big pool of talent can intervene to change what we see happening.”
Dr. Huang says the clinical trial failures we’ve seen so far will help guide next steps in HIV research as much as successes typically do.
Advances in the Field
With significant advances in protein nanoparticle science, mRNA technology, adjuvant development, and B-cell and antibody analyses, a new wave of clinical trials are on the way.
And with so many new approaches in the works, the HIV Vaccine Trials Network is retooling how it operates to navigate a burgeoning field and identify the most promising regimens.
A new Discovery Medicine Program will help the network assess new vaccine candidates. It will also aim to rule out others earlier on.
For COVID-19 and the flu, multimeric nanoparticles are an important alternative under investigation that could also be adapted for HIV.
Dr. Huang says she is particularly excited to watch the progress in cocktails of combination monoclonals. “I’ve been working in this field for 20 years now and there is a misconception that with pre-exposure prophylaxis, our job is done, but HIV is so far from away from being solved.”
But you just never know, Dr. Huang says. With new research, “we could bump on something at any point that changes everything.”
A version of this article appeared on Medscape.com.
When the world needed a COVID vaccine, leading HIV investigators answered the call to intervene in the coronavirus pandemic. Now, efforts to discover the world’s first HIV vaccine are revitalized.
“The body is capable of making antibodies to protect us from HIV,” says Yunda Huang, PhD, from the Fred Hutchinson Cancer Center in Seattle, Washington, who sat down with me before her talk today at the Conference on Retroviruses & Opportunistic Infections.
Dr. Huang spoke about the path forward for neutralizing antibody protection after the last attempt in a generation of HIV vaccine development ended in disappointment.
The past two decades marked the rise in HIV broadly neutralizing antibodies, with vaccine strategies to induce them. Promising advances include germline approaches, mRNA, and nanoparticle technologies.
The PrEP vaccine trial testing two experimental prevention regimens in Africa was stopped after investigators reported there is “little to no chance” the trial will show the vaccines are effective.
A Shape-Shifting Virus
HIV has been called the shape-shifting virus because it disguises itself so that even when people are able to make antibodies to it, the virus changes to escape.
But Dr. Huang and others are optimistic that an effective vaccine is still possible.
“We cannot and will not lose hope that the world will have an effective HIV vaccine that is accessible by all who need it, anywhere,” International AIDS Society (IAS) Executive Director Birgit Poniatowski said in a statement in December, when the trial was stopped.
HIV is a still persistent problem in the United States, according to the Centers for Disease Control and Prevention that reports it has affected an estimated 1.2 million people.
With new people infected every day around the globe, Dr. Huang says she feels a sense of urgency to help. “I think about all the people around the globe and the large number of young girls being hurt and I know our big pool of talent can intervene to change what we see happening.”
Dr. Huang says the clinical trial failures we’ve seen so far will help guide next steps in HIV research as much as successes typically do.
Advances in the Field
With significant advances in protein nanoparticle science, mRNA technology, adjuvant development, and B-cell and antibody analyses, a new wave of clinical trials are on the way.
And with so many new approaches in the works, the HIV Vaccine Trials Network is retooling how it operates to navigate a burgeoning field and identify the most promising regimens.
A new Discovery Medicine Program will help the network assess new vaccine candidates. It will also aim to rule out others earlier on.
For COVID-19 and the flu, multimeric nanoparticles are an important alternative under investigation that could also be adapted for HIV.
Dr. Huang says she is particularly excited to watch the progress in cocktails of combination monoclonals. “I’ve been working in this field for 20 years now and there is a misconception that with pre-exposure prophylaxis, our job is done, but HIV is so far from away from being solved.”
But you just never know, Dr. Huang says. With new research, “we could bump on something at any point that changes everything.”
A version of this article appeared on Medscape.com.
FROM CROI 2024
Midwife’s Fake Vaccinations Deserve Harsh Punishment: Ethicist
This transcript has been edited for clarity.
Hi. I’m Art Caplan, at the Division of Medical Ethics at New York University’s Grossman School of Medicine.
Very recently, a homeopathic midwife in New York was fined $300,000 for giving out phony injections for kids who were looking to get immunized in order to go to school. She gave pellets, which are sometimes called nosodes, I believe, with homeopathic ingredients, meaning next to nothing in them, and then basically certified that these children — and there were over 1500 of them — were compliant with New York State requirements to be vaccinated to go to school.
However, homeopathy is straight-up bunk. We have seen it again and again discredited as just something that doesn’t work. It has a tradition, but it’s basically nonsense. It certainly doesn’t work as a way to vaccinate anybody.
This midwife basically lied and gave phony certification to the parents of these kids. I’m not talking about the COVID-19 vaccine. I’m talking measles, mumps, rubella, flu, and polio — the childhood immunization schedule. For whatever reason, they put their faith in her and she went along with this fraud.
I think the fine is appropriate, but I think she should be penalized further. Why? When you send 1500 kids to school, mostly in Long Island, New York, but to schools all over the place, you are setting up conditions to bring back epidemic diseases like measles.
We’re already seeing measles outbreaks. At least five states have them. There’s a significant measles outbreak in Philadelphia. Although I can’t say for sure, I believe those outbreaks are directly linked to parents, post–COVID-19, becoming vaccine hesitant and either not vaccinating and lying or going to alternative practitioners like this midwife and claiming that they have been vaccinated.
You’re doing harm not only to the children who you allow to go to school under phony pretenses, but also you’re putting their classmates at risk. We all know that measles is very, very contagious. You’re risking the return of a disease that leads to hospitalization and sometimes even death. That is basically unconscionable.
I think her license should be taken away and she should not be practicing anymore. I believe that anyone who is involved in this kind of phony, dangerous, fraudulent practice ought to be severely punished.
Pre–COVID-19, we had just about gotten rid of measles and mumps. We didn’t see these diseases. Sometimes parents got a bit lazy in childhood vaccination basically because we had used immunization to get rid of the diseases.
Going to alternative healers and allowing people to get away with fraudulent nonsense risks bringing back disabling and deadly killers is not fair to you, me, and other people who are put at risk. It’s not fair to the kids who go to school with other kids who they think are vaccinated but aren’t.
I’m Art Caplan, at the Division of Medical Ethics at the New York University Grossman School of Medicine. Thanks for watching.
Arthur L. Caplan, PhD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position); serves as a contributing author and adviser for Medscape.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan, at the Division of Medical Ethics at New York University’s Grossman School of Medicine.
Very recently, a homeopathic midwife in New York was fined $300,000 for giving out phony injections for kids who were looking to get immunized in order to go to school. She gave pellets, which are sometimes called nosodes, I believe, with homeopathic ingredients, meaning next to nothing in them, and then basically certified that these children — and there were over 1500 of them — were compliant with New York State requirements to be vaccinated to go to school.
However, homeopathy is straight-up bunk. We have seen it again and again discredited as just something that doesn’t work. It has a tradition, but it’s basically nonsense. It certainly doesn’t work as a way to vaccinate anybody.
This midwife basically lied and gave phony certification to the parents of these kids. I’m not talking about the COVID-19 vaccine. I’m talking measles, mumps, rubella, flu, and polio — the childhood immunization schedule. For whatever reason, they put their faith in her and she went along with this fraud.
I think the fine is appropriate, but I think she should be penalized further. Why? When you send 1500 kids to school, mostly in Long Island, New York, but to schools all over the place, you are setting up conditions to bring back epidemic diseases like measles.
We’re already seeing measles outbreaks. At least five states have them. There’s a significant measles outbreak in Philadelphia. Although I can’t say for sure, I believe those outbreaks are directly linked to parents, post–COVID-19, becoming vaccine hesitant and either not vaccinating and lying or going to alternative practitioners like this midwife and claiming that they have been vaccinated.
You’re doing harm not only to the children who you allow to go to school under phony pretenses, but also you’re putting their classmates at risk. We all know that measles is very, very contagious. You’re risking the return of a disease that leads to hospitalization and sometimes even death. That is basically unconscionable.
I think her license should be taken away and she should not be practicing anymore. I believe that anyone who is involved in this kind of phony, dangerous, fraudulent practice ought to be severely punished.
Pre–COVID-19, we had just about gotten rid of measles and mumps. We didn’t see these diseases. Sometimes parents got a bit lazy in childhood vaccination basically because we had used immunization to get rid of the diseases.
Going to alternative healers and allowing people to get away with fraudulent nonsense risks bringing back disabling and deadly killers is not fair to you, me, and other people who are put at risk. It’s not fair to the kids who go to school with other kids who they think are vaccinated but aren’t.
I’m Art Caplan, at the Division of Medical Ethics at the New York University Grossman School of Medicine. Thanks for watching.
Arthur L. Caplan, PhD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position); serves as a contributing author and adviser for Medscape.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan, at the Division of Medical Ethics at New York University’s Grossman School of Medicine.
Very recently, a homeopathic midwife in New York was fined $300,000 for giving out phony injections for kids who were looking to get immunized in order to go to school. She gave pellets, which are sometimes called nosodes, I believe, with homeopathic ingredients, meaning next to nothing in them, and then basically certified that these children — and there were over 1500 of them — were compliant with New York State requirements to be vaccinated to go to school.
However, homeopathy is straight-up bunk. We have seen it again and again discredited as just something that doesn’t work. It has a tradition, but it’s basically nonsense. It certainly doesn’t work as a way to vaccinate anybody.
This midwife basically lied and gave phony certification to the parents of these kids. I’m not talking about the COVID-19 vaccine. I’m talking measles, mumps, rubella, flu, and polio — the childhood immunization schedule. For whatever reason, they put their faith in her and she went along with this fraud.
I think the fine is appropriate, but I think she should be penalized further. Why? When you send 1500 kids to school, mostly in Long Island, New York, but to schools all over the place, you are setting up conditions to bring back epidemic diseases like measles.
We’re already seeing measles outbreaks. At least five states have them. There’s a significant measles outbreak in Philadelphia. Although I can’t say for sure, I believe those outbreaks are directly linked to parents, post–COVID-19, becoming vaccine hesitant and either not vaccinating and lying or going to alternative practitioners like this midwife and claiming that they have been vaccinated.
You’re doing harm not only to the children who you allow to go to school under phony pretenses, but also you’re putting their classmates at risk. We all know that measles is very, very contagious. You’re risking the return of a disease that leads to hospitalization and sometimes even death. That is basically unconscionable.
I think her license should be taken away and she should not be practicing anymore. I believe that anyone who is involved in this kind of phony, dangerous, fraudulent practice ought to be severely punished.
Pre–COVID-19, we had just about gotten rid of measles and mumps. We didn’t see these diseases. Sometimes parents got a bit lazy in childhood vaccination basically because we had used immunization to get rid of the diseases.
Going to alternative healers and allowing people to get away with fraudulent nonsense risks bringing back disabling and deadly killers is not fair to you, me, and other people who are put at risk. It’s not fair to the kids who go to school with other kids who they think are vaccinated but aren’t.
I’m Art Caplan, at the Division of Medical Ethics at the New York University Grossman School of Medicine. Thanks for watching.
Arthur L. Caplan, PhD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position); serves as a contributing author and adviser for Medscape.
A version of this article appeared on Medscape.com.
AAP Updates Guidance on Vaccine Communication and Hesitancy
The measles outbreak in Florida, occurring just as health officials announced an official end to Philadelphia’s measles outbreak and rising global cases, has cast attention once again on concerns about vaccine hesitancy. In the midst of Florida’s surgeon general avoiding measles vaccination recommendations for parents, the American Academy of Pediatrics has updated its clinical guidance on vaccine communication.
“Disruption to routine pediatric vaccination during the COVID-19 pandemic has left many children vulnerable to vaccine-preventable diseases and more locations susceptible to outbreaks in the United States and around the world,” Sean T. O’Leary, MD, MPH, a pediatric infectious diseases specialist and associate professor of pediatrics at the University of Colorado in Aurora, and his colleagues, wrote in the new report, published in the March issue of Pediatrics. “Geographic clustering of vaccine refusal further increases the risk of communicable disease outbreaks in certain communities even when vaccination rates at a state or national level remain high overall.”
The authors note that disease resurgence may bolster vaccine uptake, with media coverage of recent outbreaks linked to more pro-vaccine discussions and attitudes among parents. But the evidence on that remains inconclusive, and the authors point out the slow uptake in COVID-19 vaccination as parents navigate ongoing spread of both the disease and vaccine misinformation.
Conflicting Evidence on Postpandemic Attitudes
It remains unclear how parent attitudes toward vaccines have shifted, if at all, since the pandemic. A study published in Pediatrics from October 2023, which Dr. O’Leary also coauthored, analyzed data from an online survey of Colorado mothers between 2018 and 2021 and found no significant difference in vaccine hesitancy during the pandemic compared with pre-pandemic.
Among 3,553 respondents, 1 in 5 (20.4%) were vaccine hesitant overall. Though parents were twice as likely to feel uncertain in trusting vaccine information after the COVID-19 vaccines were authorized (adjusted odds ratio [aOR] 2.14), they were half as likely to be unsure about hesitancy toward childhood vaccines (aOR 0.48).
Another study in Pediatrics from October 2023 found that common concerns about COVID-19 vaccines among parents included infertility, long-term effects from the vaccines, and effects on preexisting medical conditions. But even then, participants in focus groups “expressed that they would listen to their doctor for information about COVID-19 vaccines,” wrote Aubree Honcoop, MPS, of the University of Nebraska Medical Center in Omaha, and her colleagues.
“I think what we’re seeing, very importantly, is that physicians seem to be the source people rely on,” said Walter Orenstein, MD, professor of medicine and associate director of the Emory Vaccine Center at Emory University in Atlanta. “But we need to give the physicians time and incentives to spend time with families,” such as a billing code for vaccine counseling, he said.
Dr. Orenstein was surprised to see the results from Colorado, but he noted they were from a small survey in a single state. He pointed to other findings, such as those from the University of Pennsylvania’s Annenberg Public Policy Center in November 2023, that found lower confidence overall among Americans toward vaccines.
Paul Offit, MD, director of the Vaccine Education Center and an attending infectious disease physician at Children’s Hospital of Philadelphia, where the city’s measles outbreak began, is similarly skeptical about the Colorado study’s findings that parent vaccine attitudes have changed little since the pandemic. At the AAP’s annual conference in October 2023, Dr. Offit asked pediatricians about their experiences while he signed books.
“I would ask, ‘So what’s it like out there? Are we winning or losing?’ ” he said. “I would say, to a person, everyone said they felt things were much worse now than they ever have been before.”
Clinical Guidance
The new report reviews previously published evidence on the spectrum of parental vaccine acceptance — from supporters and “go along to get along” parents to cautious acceptors and fence sitters to vaccine refusers — and the determinants that contribute to hesitancy. They also noted the social inequities that have played a role in vaccine uptake disparities.
“Distrust of health systems based on historic and ongoing discrimination and inequitable access to care are intertwined challenges that contribute to racial and ethnic disparities in vaccine uptake,” the authors wrote. “Although there has been progress in reducing racial, ethnic, and socioeconomic disparities in childhood vaccination coverage, the COVID-19 pandemic made clear how much work is yet to be done.”
The report also reviewed the societal, individual, payer and pediatric practice costs of vaccine refusal. The 1-year cost to taxpayers from the measles outbreak in New York City in 2018-2019, for example, was $8.4 million, excluding vaccination programs.
The report provides background information to equip pediatricians for conversations with parents about vaccines. Since safety is the top concern for vaccine hesitancy among parents, the authors advised pediatricians to be familiar with the process of vaccine testing, emergency use authorization, licensure, approval, recommendations, and safety monitoring, including the Vaccine Safety Datalink, the Vaccine Adverse Event Reporting System (VAERS), the FDA’s Biologics Effectiveness and Safety (BEST) system, and the CDC’s Clinical Immunization Safety Assessment Project (CISA).
“Because vaccines are generally given to healthy individuals to prevent disease, they are held to a higher safety standard than other medications,” the authors wrote before providing a summary of the process for physicians to reference. The report also includes information on vaccine ingredients and a chart of common misconceptions about vaccines with the corresponding facts.
Overcoming Hesitancy
Evidence-based strategies for increasing childhood vaccine uptake begin with a strong vaccine recommendation using a presumptive rather than participatory approach, the authors wrote. “A presumptive format is one in which the clinician asserts a position regarding vaccines using a closed-ended statement, such as ‘Sara is due for several vaccines today’ or ‘Well, we have to do some shots,’ ” the authors wrote. “This strategy is in contrast to a participatory format, in which an open-ended question is used to more explicitly invite the parent to voice an opinion, such as ‘How do you feel about vaccines today?’ ” The presumptive format and a strong recommendation are both associated with greater uptake, evidence shows.
For parents who express hesitancy, the authors provide a summary of additional evidence-based communication strategies, starting with motivational interviewing. Two other strategies they highlight include using language to re-emphasize the importance of adhering to the CDC recommended schedule — “He really needs these shots” — and bundling discussion of all recommended vaccines for a visit at once.
“Finally, clinicians can emphasize their own experiences when discussing the need for vaccination, including personal experience with vaccine-preventable diseases and the fact that they and their families are vaccinated because of their confidence in the safety and efficacy of the vaccines,” the authors wrote.
For families who refuse or delay vaccines, the authors reviewed the “ethical arguments both in favor of and against dismissal policies,” noting that nearly all pediatricians who report dismissing families who refuse vaccination are in private practice, since large systems are often unable to dismiss patients. They also point out that fewer pediatricians dismiss families for spreading out vaccines than outright refusing all vaccines.
”Dismissal of child patients of vaccine-refusing parents can be a difficult decision arrived at after considering multiple factors and documented attempts to counsel vaccine-refusing families,” they wrote. “However, if repeated attempts to help understand and address parental values and vaccine concerns fails to engender trust, move parents toward vaccine acceptance, or strengthen the therapeutic alliance, dismissal can be an acceptable option.”
Finally, the authors reminded pediatricians “that vaccine-hesitant parents are a heterogeneous group and that specific parental vaccine concerns need to be individually identified and addressed.” Working with families to discuss their questions and concerns is an opportunity to “build rapport and trust with a family,” they wrote, ”and, ultimately, protect their children from the scourge of vaccine-preventable diseases.”
The focus groups study was funded by the National Institutes of Health, and the authors reported having no disclosures. The Colorado attitudes study used no external funding, and the authors reported no disclosures. The new clinical report used no external funding, and the authors reported no disclosures. Dr. Orenstein is an uncompensated member of the Moderna Scientific Advisory Board. Dr. Offit codeveloped a licensed rotavirus vaccine, but he does not receive any royalties or own a patent for that.
The measles outbreak in Florida, occurring just as health officials announced an official end to Philadelphia’s measles outbreak and rising global cases, has cast attention once again on concerns about vaccine hesitancy. In the midst of Florida’s surgeon general avoiding measles vaccination recommendations for parents, the American Academy of Pediatrics has updated its clinical guidance on vaccine communication.
“Disruption to routine pediatric vaccination during the COVID-19 pandemic has left many children vulnerable to vaccine-preventable diseases and more locations susceptible to outbreaks in the United States and around the world,” Sean T. O’Leary, MD, MPH, a pediatric infectious diseases specialist and associate professor of pediatrics at the University of Colorado in Aurora, and his colleagues, wrote in the new report, published in the March issue of Pediatrics. “Geographic clustering of vaccine refusal further increases the risk of communicable disease outbreaks in certain communities even when vaccination rates at a state or national level remain high overall.”
The authors note that disease resurgence may bolster vaccine uptake, with media coverage of recent outbreaks linked to more pro-vaccine discussions and attitudes among parents. But the evidence on that remains inconclusive, and the authors point out the slow uptake in COVID-19 vaccination as parents navigate ongoing spread of both the disease and vaccine misinformation.
Conflicting Evidence on Postpandemic Attitudes
It remains unclear how parent attitudes toward vaccines have shifted, if at all, since the pandemic. A study published in Pediatrics from October 2023, which Dr. O’Leary also coauthored, analyzed data from an online survey of Colorado mothers between 2018 and 2021 and found no significant difference in vaccine hesitancy during the pandemic compared with pre-pandemic.
Among 3,553 respondents, 1 in 5 (20.4%) were vaccine hesitant overall. Though parents were twice as likely to feel uncertain in trusting vaccine information after the COVID-19 vaccines were authorized (adjusted odds ratio [aOR] 2.14), they were half as likely to be unsure about hesitancy toward childhood vaccines (aOR 0.48).
Another study in Pediatrics from October 2023 found that common concerns about COVID-19 vaccines among parents included infertility, long-term effects from the vaccines, and effects on preexisting medical conditions. But even then, participants in focus groups “expressed that they would listen to their doctor for information about COVID-19 vaccines,” wrote Aubree Honcoop, MPS, of the University of Nebraska Medical Center in Omaha, and her colleagues.
“I think what we’re seeing, very importantly, is that physicians seem to be the source people rely on,” said Walter Orenstein, MD, professor of medicine and associate director of the Emory Vaccine Center at Emory University in Atlanta. “But we need to give the physicians time and incentives to spend time with families,” such as a billing code for vaccine counseling, he said.
Dr. Orenstein was surprised to see the results from Colorado, but he noted they were from a small survey in a single state. He pointed to other findings, such as those from the University of Pennsylvania’s Annenberg Public Policy Center in November 2023, that found lower confidence overall among Americans toward vaccines.
Paul Offit, MD, director of the Vaccine Education Center and an attending infectious disease physician at Children’s Hospital of Philadelphia, where the city’s measles outbreak began, is similarly skeptical about the Colorado study’s findings that parent vaccine attitudes have changed little since the pandemic. At the AAP’s annual conference in October 2023, Dr. Offit asked pediatricians about their experiences while he signed books.
“I would ask, ‘So what’s it like out there? Are we winning or losing?’ ” he said. “I would say, to a person, everyone said they felt things were much worse now than they ever have been before.”
Clinical Guidance
The new report reviews previously published evidence on the spectrum of parental vaccine acceptance — from supporters and “go along to get along” parents to cautious acceptors and fence sitters to vaccine refusers — and the determinants that contribute to hesitancy. They also noted the social inequities that have played a role in vaccine uptake disparities.
“Distrust of health systems based on historic and ongoing discrimination and inequitable access to care are intertwined challenges that contribute to racial and ethnic disparities in vaccine uptake,” the authors wrote. “Although there has been progress in reducing racial, ethnic, and socioeconomic disparities in childhood vaccination coverage, the COVID-19 pandemic made clear how much work is yet to be done.”
The report also reviewed the societal, individual, payer and pediatric practice costs of vaccine refusal. The 1-year cost to taxpayers from the measles outbreak in New York City in 2018-2019, for example, was $8.4 million, excluding vaccination programs.
The report provides background information to equip pediatricians for conversations with parents about vaccines. Since safety is the top concern for vaccine hesitancy among parents, the authors advised pediatricians to be familiar with the process of vaccine testing, emergency use authorization, licensure, approval, recommendations, and safety monitoring, including the Vaccine Safety Datalink, the Vaccine Adverse Event Reporting System (VAERS), the FDA’s Biologics Effectiveness and Safety (BEST) system, and the CDC’s Clinical Immunization Safety Assessment Project (CISA).
“Because vaccines are generally given to healthy individuals to prevent disease, they are held to a higher safety standard than other medications,” the authors wrote before providing a summary of the process for physicians to reference. The report also includes information on vaccine ingredients and a chart of common misconceptions about vaccines with the corresponding facts.
Overcoming Hesitancy
Evidence-based strategies for increasing childhood vaccine uptake begin with a strong vaccine recommendation using a presumptive rather than participatory approach, the authors wrote. “A presumptive format is one in which the clinician asserts a position regarding vaccines using a closed-ended statement, such as ‘Sara is due for several vaccines today’ or ‘Well, we have to do some shots,’ ” the authors wrote. “This strategy is in contrast to a participatory format, in which an open-ended question is used to more explicitly invite the parent to voice an opinion, such as ‘How do you feel about vaccines today?’ ” The presumptive format and a strong recommendation are both associated with greater uptake, evidence shows.
For parents who express hesitancy, the authors provide a summary of additional evidence-based communication strategies, starting with motivational interviewing. Two other strategies they highlight include using language to re-emphasize the importance of adhering to the CDC recommended schedule — “He really needs these shots” — and bundling discussion of all recommended vaccines for a visit at once.
“Finally, clinicians can emphasize their own experiences when discussing the need for vaccination, including personal experience with vaccine-preventable diseases and the fact that they and their families are vaccinated because of their confidence in the safety and efficacy of the vaccines,” the authors wrote.
For families who refuse or delay vaccines, the authors reviewed the “ethical arguments both in favor of and against dismissal policies,” noting that nearly all pediatricians who report dismissing families who refuse vaccination are in private practice, since large systems are often unable to dismiss patients. They also point out that fewer pediatricians dismiss families for spreading out vaccines than outright refusing all vaccines.
”Dismissal of child patients of vaccine-refusing parents can be a difficult decision arrived at after considering multiple factors and documented attempts to counsel vaccine-refusing families,” they wrote. “However, if repeated attempts to help understand and address parental values and vaccine concerns fails to engender trust, move parents toward vaccine acceptance, or strengthen the therapeutic alliance, dismissal can be an acceptable option.”
Finally, the authors reminded pediatricians “that vaccine-hesitant parents are a heterogeneous group and that specific parental vaccine concerns need to be individually identified and addressed.” Working with families to discuss their questions and concerns is an opportunity to “build rapport and trust with a family,” they wrote, ”and, ultimately, protect their children from the scourge of vaccine-preventable diseases.”
The focus groups study was funded by the National Institutes of Health, and the authors reported having no disclosures. The Colorado attitudes study used no external funding, and the authors reported no disclosures. The new clinical report used no external funding, and the authors reported no disclosures. Dr. Orenstein is an uncompensated member of the Moderna Scientific Advisory Board. Dr. Offit codeveloped a licensed rotavirus vaccine, but he does not receive any royalties or own a patent for that.
The measles outbreak in Florida, occurring just as health officials announced an official end to Philadelphia’s measles outbreak and rising global cases, has cast attention once again on concerns about vaccine hesitancy. In the midst of Florida’s surgeon general avoiding measles vaccination recommendations for parents, the American Academy of Pediatrics has updated its clinical guidance on vaccine communication.
“Disruption to routine pediatric vaccination during the COVID-19 pandemic has left many children vulnerable to vaccine-preventable diseases and more locations susceptible to outbreaks in the United States and around the world,” Sean T. O’Leary, MD, MPH, a pediatric infectious diseases specialist and associate professor of pediatrics at the University of Colorado in Aurora, and his colleagues, wrote in the new report, published in the March issue of Pediatrics. “Geographic clustering of vaccine refusal further increases the risk of communicable disease outbreaks in certain communities even when vaccination rates at a state or national level remain high overall.”
The authors note that disease resurgence may bolster vaccine uptake, with media coverage of recent outbreaks linked to more pro-vaccine discussions and attitudes among parents. But the evidence on that remains inconclusive, and the authors point out the slow uptake in COVID-19 vaccination as parents navigate ongoing spread of both the disease and vaccine misinformation.
Conflicting Evidence on Postpandemic Attitudes
It remains unclear how parent attitudes toward vaccines have shifted, if at all, since the pandemic. A study published in Pediatrics from October 2023, which Dr. O’Leary also coauthored, analyzed data from an online survey of Colorado mothers between 2018 and 2021 and found no significant difference in vaccine hesitancy during the pandemic compared with pre-pandemic.
Among 3,553 respondents, 1 in 5 (20.4%) were vaccine hesitant overall. Though parents were twice as likely to feel uncertain in trusting vaccine information after the COVID-19 vaccines were authorized (adjusted odds ratio [aOR] 2.14), they were half as likely to be unsure about hesitancy toward childhood vaccines (aOR 0.48).
Another study in Pediatrics from October 2023 found that common concerns about COVID-19 vaccines among parents included infertility, long-term effects from the vaccines, and effects on preexisting medical conditions. But even then, participants in focus groups “expressed that they would listen to their doctor for information about COVID-19 vaccines,” wrote Aubree Honcoop, MPS, of the University of Nebraska Medical Center in Omaha, and her colleagues.
“I think what we’re seeing, very importantly, is that physicians seem to be the source people rely on,” said Walter Orenstein, MD, professor of medicine and associate director of the Emory Vaccine Center at Emory University in Atlanta. “But we need to give the physicians time and incentives to spend time with families,” such as a billing code for vaccine counseling, he said.
Dr. Orenstein was surprised to see the results from Colorado, but he noted they were from a small survey in a single state. He pointed to other findings, such as those from the University of Pennsylvania’s Annenberg Public Policy Center in November 2023, that found lower confidence overall among Americans toward vaccines.
Paul Offit, MD, director of the Vaccine Education Center and an attending infectious disease physician at Children’s Hospital of Philadelphia, where the city’s measles outbreak began, is similarly skeptical about the Colorado study’s findings that parent vaccine attitudes have changed little since the pandemic. At the AAP’s annual conference in October 2023, Dr. Offit asked pediatricians about their experiences while he signed books.
“I would ask, ‘So what’s it like out there? Are we winning or losing?’ ” he said. “I would say, to a person, everyone said they felt things were much worse now than they ever have been before.”
Clinical Guidance
The new report reviews previously published evidence on the spectrum of parental vaccine acceptance — from supporters and “go along to get along” parents to cautious acceptors and fence sitters to vaccine refusers — and the determinants that contribute to hesitancy. They also noted the social inequities that have played a role in vaccine uptake disparities.
“Distrust of health systems based on historic and ongoing discrimination and inequitable access to care are intertwined challenges that contribute to racial and ethnic disparities in vaccine uptake,” the authors wrote. “Although there has been progress in reducing racial, ethnic, and socioeconomic disparities in childhood vaccination coverage, the COVID-19 pandemic made clear how much work is yet to be done.”
The report also reviewed the societal, individual, payer and pediatric practice costs of vaccine refusal. The 1-year cost to taxpayers from the measles outbreak in New York City in 2018-2019, for example, was $8.4 million, excluding vaccination programs.
The report provides background information to equip pediatricians for conversations with parents about vaccines. Since safety is the top concern for vaccine hesitancy among parents, the authors advised pediatricians to be familiar with the process of vaccine testing, emergency use authorization, licensure, approval, recommendations, and safety monitoring, including the Vaccine Safety Datalink, the Vaccine Adverse Event Reporting System (VAERS), the FDA’s Biologics Effectiveness and Safety (BEST) system, and the CDC’s Clinical Immunization Safety Assessment Project (CISA).
“Because vaccines are generally given to healthy individuals to prevent disease, they are held to a higher safety standard than other medications,” the authors wrote before providing a summary of the process for physicians to reference. The report also includes information on vaccine ingredients and a chart of common misconceptions about vaccines with the corresponding facts.
Overcoming Hesitancy
Evidence-based strategies for increasing childhood vaccine uptake begin with a strong vaccine recommendation using a presumptive rather than participatory approach, the authors wrote. “A presumptive format is one in which the clinician asserts a position regarding vaccines using a closed-ended statement, such as ‘Sara is due for several vaccines today’ or ‘Well, we have to do some shots,’ ” the authors wrote. “This strategy is in contrast to a participatory format, in which an open-ended question is used to more explicitly invite the parent to voice an opinion, such as ‘How do you feel about vaccines today?’ ” The presumptive format and a strong recommendation are both associated with greater uptake, evidence shows.
For parents who express hesitancy, the authors provide a summary of additional evidence-based communication strategies, starting with motivational interviewing. Two other strategies they highlight include using language to re-emphasize the importance of adhering to the CDC recommended schedule — “He really needs these shots” — and bundling discussion of all recommended vaccines for a visit at once.
“Finally, clinicians can emphasize their own experiences when discussing the need for vaccination, including personal experience with vaccine-preventable diseases and the fact that they and their families are vaccinated because of their confidence in the safety and efficacy of the vaccines,” the authors wrote.
For families who refuse or delay vaccines, the authors reviewed the “ethical arguments both in favor of and against dismissal policies,” noting that nearly all pediatricians who report dismissing families who refuse vaccination are in private practice, since large systems are often unable to dismiss patients. They also point out that fewer pediatricians dismiss families for spreading out vaccines than outright refusing all vaccines.
”Dismissal of child patients of vaccine-refusing parents can be a difficult decision arrived at after considering multiple factors and documented attempts to counsel vaccine-refusing families,” they wrote. “However, if repeated attempts to help understand and address parental values and vaccine concerns fails to engender trust, move parents toward vaccine acceptance, or strengthen the therapeutic alliance, dismissal can be an acceptable option.”
Finally, the authors reminded pediatricians “that vaccine-hesitant parents are a heterogeneous group and that specific parental vaccine concerns need to be individually identified and addressed.” Working with families to discuss their questions and concerns is an opportunity to “build rapport and trust with a family,” they wrote, ”and, ultimately, protect their children from the scourge of vaccine-preventable diseases.”
The focus groups study was funded by the National Institutes of Health, and the authors reported having no disclosures. The Colorado attitudes study used no external funding, and the authors reported no disclosures. The new clinical report used no external funding, and the authors reported no disclosures. Dr. Orenstein is an uncompensated member of the Moderna Scientific Advisory Board. Dr. Offit codeveloped a licensed rotavirus vaccine, but he does not receive any royalties or own a patent for that.
FROM PEDIATRICS
Do Kids With an October Birthday Have Protection From Flu?
TOPLINE:
A new study shows young children with October birthdays may have better protection against flu.
METHODOLOGY:
- Researchers analyzed data from the MarketScan Research Database between 2011 and 2018.
- They focused on 819,223 children aged 2-5 years who were vaccinated against influenza between August 1 and January 31 and whose birthdays fell during that window.
TAKEAWAY:
- Children born in October had the lowest rate of influenza diagnosis, with an average diagnosis rate of 2.7%, whereas those born in August had a diagnosis rate of 3%.
- Compared with children born in August, the adjusted odds ratio for influenza diagnosis in children born in October was 0.88 (95% CI, 0.85-0.92).
IN PRACTICE:
“The findings support current recommendations that children be vaccinated in October preceding a typical influenza season,” the authors of the study wrote.
SOURCE:
Anupam B. Jena, MD, PhD, with Harvard Medical School and Massachusetts General Hospital in Boston, Massachusetts, was the corresponding author on the study. The research was published online in BMJ .
LIMITATIONS:
The availability of the influenza vaccine and the peak of seasonal flu infections vary by year and region.
DISCLOSURES:
Researchers disclosed consulting fees from pharmaceutical and healthcare companies unrelated to the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
TOPLINE:
A new study shows young children with October birthdays may have better protection against flu.
METHODOLOGY:
- Researchers analyzed data from the MarketScan Research Database between 2011 and 2018.
- They focused on 819,223 children aged 2-5 years who were vaccinated against influenza between August 1 and January 31 and whose birthdays fell during that window.
TAKEAWAY:
- Children born in October had the lowest rate of influenza diagnosis, with an average diagnosis rate of 2.7%, whereas those born in August had a diagnosis rate of 3%.
- Compared with children born in August, the adjusted odds ratio for influenza diagnosis in children born in October was 0.88 (95% CI, 0.85-0.92).
IN PRACTICE:
“The findings support current recommendations that children be vaccinated in October preceding a typical influenza season,” the authors of the study wrote.
SOURCE:
Anupam B. Jena, MD, PhD, with Harvard Medical School and Massachusetts General Hospital in Boston, Massachusetts, was the corresponding author on the study. The research was published online in BMJ .
LIMITATIONS:
The availability of the influenza vaccine and the peak of seasonal flu infections vary by year and region.
DISCLOSURES:
Researchers disclosed consulting fees from pharmaceutical and healthcare companies unrelated to the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
TOPLINE:
A new study shows young children with October birthdays may have better protection against flu.
METHODOLOGY:
- Researchers analyzed data from the MarketScan Research Database between 2011 and 2018.
- They focused on 819,223 children aged 2-5 years who were vaccinated against influenza between August 1 and January 31 and whose birthdays fell during that window.
TAKEAWAY:
- Children born in October had the lowest rate of influenza diagnosis, with an average diagnosis rate of 2.7%, whereas those born in August had a diagnosis rate of 3%.
- Compared with children born in August, the adjusted odds ratio for influenza diagnosis in children born in October was 0.88 (95% CI, 0.85-0.92).
IN PRACTICE:
“The findings support current recommendations that children be vaccinated in October preceding a typical influenza season,” the authors of the study wrote.
SOURCE:
Anupam B. Jena, MD, PhD, with Harvard Medical School and Massachusetts General Hospital in Boston, Massachusetts, was the corresponding author on the study. The research was published online in BMJ .
LIMITATIONS:
The availability of the influenza vaccine and the peak of seasonal flu infections vary by year and region.
DISCLOSURES:
Researchers disclosed consulting fees from pharmaceutical and healthcare companies unrelated to the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
Ebola Vaccine Saves Lives Even After Exposure
The Ervebo vaccine not only reduces the risk for Ebola infection but also halves mortality rates. This is the result of a study published in The Lancet Infectious Diseases.
Rebecca Coulborn, an epidemiologist at Epicentre in Paris, France, and colleagues analyzed data collected during the 10th Ebola epidemic in the Democratic Republic of the Congo. Their analysis revealed that among the 2279 patients with confirmed Ebola who were admitted to an Ebola health facility between July 27, 2018, and April 27, 2020, the mortality risk was 56% for unvaccinated patients. In vaccinated patients, however, it was only 25%. The reduced mortality applied to all patients, regardless of age and gender.
The study was funded by Doctors Without Borders. For data collection, Epicentre, the epidemiological division of Doctors Without Borders, collaborated with the Institut National de Recherche Biomédicale and the Ministry of Health of the Democratic Republic of the Congo.
The study authors focused on the Ervebo vaccine, which is approved for use against Zaire ebolavirus in the European Union, the United States, and some African countries, among others. It is the only Ebola vaccine currently recommended for use during an epidemic. It is administered intramuscularly as a single dose and is approved for adults aged 18 years and older.
The vaccine is primarily recommended for ring vaccination of individuals at a high risk for infection during an epidemic. In studies, the vaccine has been used for ring vaccinations among contacts of diagnosed cases since the end of the Ebola outbreak in West Africa in 2014 and 2015 and since 2018 in the Democratic Republic of the Congo.
The preliminary estimated vaccine effectiveness 10 days after vaccination is 97.5%-100%. The duration of protection is unknown. Individuals who became ill despite vaccination typically experienced a milder course of illness.
Although people should be vaccinated as early as possible during Ebola outbreaks, the results of the Epicentre study showed that the vaccine still protects against the risk for infection even when administered after exposure to the virus.
Furthermore, Dr. Coulborn and her team found no antagonistic effect between vaccination and Ebola treatment in their analysis. “Vaccination following exposure to a person infected with Ebola still provides significant protection against death, even if administered shortly before the onset of symptoms,” said study author Dr. Coulborn in a press release from Doctors Without Borders.
This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The Ervebo vaccine not only reduces the risk for Ebola infection but also halves mortality rates. This is the result of a study published in The Lancet Infectious Diseases.
Rebecca Coulborn, an epidemiologist at Epicentre in Paris, France, and colleagues analyzed data collected during the 10th Ebola epidemic in the Democratic Republic of the Congo. Their analysis revealed that among the 2279 patients with confirmed Ebola who were admitted to an Ebola health facility between July 27, 2018, and April 27, 2020, the mortality risk was 56% for unvaccinated patients. In vaccinated patients, however, it was only 25%. The reduced mortality applied to all patients, regardless of age and gender.
The study was funded by Doctors Without Borders. For data collection, Epicentre, the epidemiological division of Doctors Without Borders, collaborated with the Institut National de Recherche Biomédicale and the Ministry of Health of the Democratic Republic of the Congo.
The study authors focused on the Ervebo vaccine, which is approved for use against Zaire ebolavirus in the European Union, the United States, and some African countries, among others. It is the only Ebola vaccine currently recommended for use during an epidemic. It is administered intramuscularly as a single dose and is approved for adults aged 18 years and older.
The vaccine is primarily recommended for ring vaccination of individuals at a high risk for infection during an epidemic. In studies, the vaccine has been used for ring vaccinations among contacts of diagnosed cases since the end of the Ebola outbreak in West Africa in 2014 and 2015 and since 2018 in the Democratic Republic of the Congo.
The preliminary estimated vaccine effectiveness 10 days after vaccination is 97.5%-100%. The duration of protection is unknown. Individuals who became ill despite vaccination typically experienced a milder course of illness.
Although people should be vaccinated as early as possible during Ebola outbreaks, the results of the Epicentre study showed that the vaccine still protects against the risk for infection even when administered after exposure to the virus.
Furthermore, Dr. Coulborn and her team found no antagonistic effect between vaccination and Ebola treatment in their analysis. “Vaccination following exposure to a person infected with Ebola still provides significant protection against death, even if administered shortly before the onset of symptoms,” said study author Dr. Coulborn in a press release from Doctors Without Borders.
This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The Ervebo vaccine not only reduces the risk for Ebola infection but also halves mortality rates. This is the result of a study published in The Lancet Infectious Diseases.
Rebecca Coulborn, an epidemiologist at Epicentre in Paris, France, and colleagues analyzed data collected during the 10th Ebola epidemic in the Democratic Republic of the Congo. Their analysis revealed that among the 2279 patients with confirmed Ebola who were admitted to an Ebola health facility between July 27, 2018, and April 27, 2020, the mortality risk was 56% for unvaccinated patients. In vaccinated patients, however, it was only 25%. The reduced mortality applied to all patients, regardless of age and gender.
The study was funded by Doctors Without Borders. For data collection, Epicentre, the epidemiological division of Doctors Without Borders, collaborated with the Institut National de Recherche Biomédicale and the Ministry of Health of the Democratic Republic of the Congo.
The study authors focused on the Ervebo vaccine, which is approved for use against Zaire ebolavirus in the European Union, the United States, and some African countries, among others. It is the only Ebola vaccine currently recommended for use during an epidemic. It is administered intramuscularly as a single dose and is approved for adults aged 18 years and older.
The vaccine is primarily recommended for ring vaccination of individuals at a high risk for infection during an epidemic. In studies, the vaccine has been used for ring vaccinations among contacts of diagnosed cases since the end of the Ebola outbreak in West Africa in 2014 and 2015 and since 2018 in the Democratic Republic of the Congo.
The preliminary estimated vaccine effectiveness 10 days after vaccination is 97.5%-100%. The duration of protection is unknown. Individuals who became ill despite vaccination typically experienced a milder course of illness.
Although people should be vaccinated as early as possible during Ebola outbreaks, the results of the Epicentre study showed that the vaccine still protects against the risk for infection even when administered after exposure to the virus.
Furthermore, Dr. Coulborn and her team found no antagonistic effect between vaccination and Ebola treatment in their analysis. “Vaccination following exposure to a person infected with Ebola still provides significant protection against death, even if administered shortly before the onset of symptoms,” said study author Dr. Coulborn in a press release from Doctors Without Borders.
This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
FROM THE LANCET INFECTIOUS DISEASES
Florida’s Stance on Measles Upends Expert Guidance
Amid an ongoing measles outbreak in Florida possibly sparked by vaccine hesitancy, the state’s surgeon general Joseph Ladapo, MD, is contradicting public health guidance of encouraging quarantine of unvaccinated children.
Rather than requesting that parents keep children unvaccinated against measles home from school or to get their children vaccinated, both critical tools in containing an outbreak, Dr. Ladapo has advised parents to do whatever they think is best. Pediatricians and infectious disease specialists fear a free-for-all will fuel the spread of the highly infectious virus, including in their own clinics.
The outbreak has been traced to an elementary school in Weston and has so far sickened at least eight children, one of whom is younger than 5 years. According to the Centers for Disease Control and Prevention, roughly 91% of the 230,000-odd kindergarteners in Florida had received the requisite doses of the MMR vaccine, which also protects against mumps and rubella, for the 2022-2023 school year, below the 95% vaccination level which public health authorities believes confers herd immunity against measles. An estimated 4.5% of kindergarteners in the state have received an exemption for the vaccine, which prevents measles in 97% of the people who get the shots, for a lifetime. The first dose is given around age 13 months and the second when people are age 4 or 5 years and soon to enter school.
“If you’re vaccinated you have a very slim chance of getting the virus,” said Rana Alissa, MD, a pediatrician at University of Florida Health in Jacksonville.
An unvaccinated child has no protection against measles, and could spread it to others merely by sneezing or touching a surface. In a school setting, infection could spread to a teacher who cannot receive the measles vaccine due to a weakened immune system, or the unvaccinated child could spread the virus at a pediatric clinic or hospital when seeking care for measles unless the clinic staff takes rigorous steps to separate the child from other children. Some children at the clinic won’t be able to get the measles vaccine either because of immunodeficiency or perhaps having had a bone marrow transplant.
Assuming the unvaccinated child is healthy, the measles infection will run its course, and the child will then be immune to the disease, Dr. Alissa said. But meanwhile, the child could pose a significant risk to others.
“We’re not worried about the unvaccinated kids who are very healthy. We’re worried about the adults who did not get vaccinated and who are very sick,” said Dr. Alissa, vice president of the Florida chapter of the American Academy of Pediatrics (AAP). “We’re worried about the little kids who are less than 13 months old. We’re worried about the kids with immunodeficiency disorders.” The Florida chapter of the AAP encourages parents to get their children vaccinated against measles amid the ongoing outbreak.
“I wish our surgeon general was on the same page as us,” Dr. Alissa added, noting that she thinks misplaced vaccine hesitancy has caused some parents to forego a safe and effective vaccine for their children.
Never Too Late to Vaxx
Measles symptoms appear 10-14 days after exposure and can include sore throat, cough, runny nose, inflamed eyes, fever, and blotchy skin rashes. According to the Centers for Disease Control and Prevention (CDC), 20% of people who are unvaccinated against measles will be hospitalized for the virus if they contract it.
Given the incubation period for the virus, clinicians and public health officials recommend unvaccinated children isolate for 21 days after being exposed to measles at school. The advice applies to any unvaccinated child, whether because their parent opted against the vaccine or because they cannot safely receive the immunization.
This is the guidance that Surgeon General Ladapo is flouting.
“We have a public health system. They’re awesome. They’re the experts. Let’s use them,” Dr. Alissa noted. “Their recommendation is to keep the unvaccinated kids at home for 21 days when you have an outbreak.”
“We’re not calling him doctor anymore,” said Andrew Pavia, MD, chief of the Division of Pediatric Infectious Diseases at the University of Utah in Salt Lake City.
“Getting your kids immunized before they enter school is so critical,” added Dr. Pavia, because the 21-day quarantine period is onerous for children and parents alike.
In a February 26 statement, Marcus Plescia, MD, MPH, chief medical officer of the Association of State and Territorial Health Officials, said “well-established public health practice recommends that unvaccinated persons exposed to measles stay home for at least 21 days to prevent further growth of the outbreak. While this is undoubtedly disruptive to the persons impacted, imagine how much more disruptive it would be if measles takes hold again in the United States, spreading widely, and impacting children and communities across the entire nation.”
During an outbreak, it’s still possible to give a measles vaccine to a child who has not yet received the shots, Dr. Pavia stressed. But time is of the essence: Vaccination should occur within 72 hours of the first known measles case in a school.
“It’s not perfect, they may still get measles, but it will greatly decrease the severity,” Dr. Pavia said.
If some children won’t get vaccinated during an outbreak, their parents may call a pediatrician or hospital staff for help as measles symptoms take hold. Clinicians should advise everyone in the home who is older than 2 years to begin wearing N95 masks and gloves, Dr. Alissa said. And when the child comes into the clinic he or she should be examined in a separate room, ideally one with negative air pressure and frequent filtration, Dr. Alissa added. If not, any private room will do if nobody else uses the room for at least 2 hours afterward.
“Measles is phenomenally transmissible,” Dr. Pavia said. A person with the virus can infect 12 to 18 others who are not protected against the pathogen.
Someone with a severe reaction to measles could get an injection of intramuscular immunoglobulin, Dr. Pavia said, although this tends to be uncomfortable and expensive.
“The vaccine works. We almost got rid of measles,” Dr. Alissa said, although parents who choose to send their unvaccinated children to school can do so if they choose to.
“The fear of every pediatrician is to have a child die from this,” she said. “People who are sick, please stay at home.”
Dr. Pavia reported an advisory relationship with Sanofi Pasteur regarding an RSV vaccine. Dr. Alissa reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
Amid an ongoing measles outbreak in Florida possibly sparked by vaccine hesitancy, the state’s surgeon general Joseph Ladapo, MD, is contradicting public health guidance of encouraging quarantine of unvaccinated children.
Rather than requesting that parents keep children unvaccinated against measles home from school or to get their children vaccinated, both critical tools in containing an outbreak, Dr. Ladapo has advised parents to do whatever they think is best. Pediatricians and infectious disease specialists fear a free-for-all will fuel the spread of the highly infectious virus, including in their own clinics.
The outbreak has been traced to an elementary school in Weston and has so far sickened at least eight children, one of whom is younger than 5 years. According to the Centers for Disease Control and Prevention, roughly 91% of the 230,000-odd kindergarteners in Florida had received the requisite doses of the MMR vaccine, which also protects against mumps and rubella, for the 2022-2023 school year, below the 95% vaccination level which public health authorities believes confers herd immunity against measles. An estimated 4.5% of kindergarteners in the state have received an exemption for the vaccine, which prevents measles in 97% of the people who get the shots, for a lifetime. The first dose is given around age 13 months and the second when people are age 4 or 5 years and soon to enter school.
“If you’re vaccinated you have a very slim chance of getting the virus,” said Rana Alissa, MD, a pediatrician at University of Florida Health in Jacksonville.
An unvaccinated child has no protection against measles, and could spread it to others merely by sneezing or touching a surface. In a school setting, infection could spread to a teacher who cannot receive the measles vaccine due to a weakened immune system, or the unvaccinated child could spread the virus at a pediatric clinic or hospital when seeking care for measles unless the clinic staff takes rigorous steps to separate the child from other children. Some children at the clinic won’t be able to get the measles vaccine either because of immunodeficiency or perhaps having had a bone marrow transplant.
Assuming the unvaccinated child is healthy, the measles infection will run its course, and the child will then be immune to the disease, Dr. Alissa said. But meanwhile, the child could pose a significant risk to others.
“We’re not worried about the unvaccinated kids who are very healthy. We’re worried about the adults who did not get vaccinated and who are very sick,” said Dr. Alissa, vice president of the Florida chapter of the American Academy of Pediatrics (AAP). “We’re worried about the little kids who are less than 13 months old. We’re worried about the kids with immunodeficiency disorders.” The Florida chapter of the AAP encourages parents to get their children vaccinated against measles amid the ongoing outbreak.
“I wish our surgeon general was on the same page as us,” Dr. Alissa added, noting that she thinks misplaced vaccine hesitancy has caused some parents to forego a safe and effective vaccine for their children.
Never Too Late to Vaxx
Measles symptoms appear 10-14 days after exposure and can include sore throat, cough, runny nose, inflamed eyes, fever, and blotchy skin rashes. According to the Centers for Disease Control and Prevention (CDC), 20% of people who are unvaccinated against measles will be hospitalized for the virus if they contract it.
Given the incubation period for the virus, clinicians and public health officials recommend unvaccinated children isolate for 21 days after being exposed to measles at school. The advice applies to any unvaccinated child, whether because their parent opted against the vaccine or because they cannot safely receive the immunization.
This is the guidance that Surgeon General Ladapo is flouting.
“We have a public health system. They’re awesome. They’re the experts. Let’s use them,” Dr. Alissa noted. “Their recommendation is to keep the unvaccinated kids at home for 21 days when you have an outbreak.”
“We’re not calling him doctor anymore,” said Andrew Pavia, MD, chief of the Division of Pediatric Infectious Diseases at the University of Utah in Salt Lake City.
“Getting your kids immunized before they enter school is so critical,” added Dr. Pavia, because the 21-day quarantine period is onerous for children and parents alike.
In a February 26 statement, Marcus Plescia, MD, MPH, chief medical officer of the Association of State and Territorial Health Officials, said “well-established public health practice recommends that unvaccinated persons exposed to measles stay home for at least 21 days to prevent further growth of the outbreak. While this is undoubtedly disruptive to the persons impacted, imagine how much more disruptive it would be if measles takes hold again in the United States, spreading widely, and impacting children and communities across the entire nation.”
During an outbreak, it’s still possible to give a measles vaccine to a child who has not yet received the shots, Dr. Pavia stressed. But time is of the essence: Vaccination should occur within 72 hours of the first known measles case in a school.
“It’s not perfect, they may still get measles, but it will greatly decrease the severity,” Dr. Pavia said.
If some children won’t get vaccinated during an outbreak, their parents may call a pediatrician or hospital staff for help as measles symptoms take hold. Clinicians should advise everyone in the home who is older than 2 years to begin wearing N95 masks and gloves, Dr. Alissa said. And when the child comes into the clinic he or she should be examined in a separate room, ideally one with negative air pressure and frequent filtration, Dr. Alissa added. If not, any private room will do if nobody else uses the room for at least 2 hours afterward.
“Measles is phenomenally transmissible,” Dr. Pavia said. A person with the virus can infect 12 to 18 others who are not protected against the pathogen.
Someone with a severe reaction to measles could get an injection of intramuscular immunoglobulin, Dr. Pavia said, although this tends to be uncomfortable and expensive.
“The vaccine works. We almost got rid of measles,” Dr. Alissa said, although parents who choose to send their unvaccinated children to school can do so if they choose to.
“The fear of every pediatrician is to have a child die from this,” she said. “People who are sick, please stay at home.”
Dr. Pavia reported an advisory relationship with Sanofi Pasteur regarding an RSV vaccine. Dr. Alissa reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
Amid an ongoing measles outbreak in Florida possibly sparked by vaccine hesitancy, the state’s surgeon general Joseph Ladapo, MD, is contradicting public health guidance of encouraging quarantine of unvaccinated children.
Rather than requesting that parents keep children unvaccinated against measles home from school or to get their children vaccinated, both critical tools in containing an outbreak, Dr. Ladapo has advised parents to do whatever they think is best. Pediatricians and infectious disease specialists fear a free-for-all will fuel the spread of the highly infectious virus, including in their own clinics.
The outbreak has been traced to an elementary school in Weston and has so far sickened at least eight children, one of whom is younger than 5 years. According to the Centers for Disease Control and Prevention, roughly 91% of the 230,000-odd kindergarteners in Florida had received the requisite doses of the MMR vaccine, which also protects against mumps and rubella, for the 2022-2023 school year, below the 95% vaccination level which public health authorities believes confers herd immunity against measles. An estimated 4.5% of kindergarteners in the state have received an exemption for the vaccine, which prevents measles in 97% of the people who get the shots, for a lifetime. The first dose is given around age 13 months and the second when people are age 4 or 5 years and soon to enter school.
“If you’re vaccinated you have a very slim chance of getting the virus,” said Rana Alissa, MD, a pediatrician at University of Florida Health in Jacksonville.
An unvaccinated child has no protection against measles, and could spread it to others merely by sneezing or touching a surface. In a school setting, infection could spread to a teacher who cannot receive the measles vaccine due to a weakened immune system, or the unvaccinated child could spread the virus at a pediatric clinic or hospital when seeking care for measles unless the clinic staff takes rigorous steps to separate the child from other children. Some children at the clinic won’t be able to get the measles vaccine either because of immunodeficiency or perhaps having had a bone marrow transplant.
Assuming the unvaccinated child is healthy, the measles infection will run its course, and the child will then be immune to the disease, Dr. Alissa said. But meanwhile, the child could pose a significant risk to others.
“We’re not worried about the unvaccinated kids who are very healthy. We’re worried about the adults who did not get vaccinated and who are very sick,” said Dr. Alissa, vice president of the Florida chapter of the American Academy of Pediatrics (AAP). “We’re worried about the little kids who are less than 13 months old. We’re worried about the kids with immunodeficiency disorders.” The Florida chapter of the AAP encourages parents to get their children vaccinated against measles amid the ongoing outbreak.
“I wish our surgeon general was on the same page as us,” Dr. Alissa added, noting that she thinks misplaced vaccine hesitancy has caused some parents to forego a safe and effective vaccine for their children.
Never Too Late to Vaxx
Measles symptoms appear 10-14 days after exposure and can include sore throat, cough, runny nose, inflamed eyes, fever, and blotchy skin rashes. According to the Centers for Disease Control and Prevention (CDC), 20% of people who are unvaccinated against measles will be hospitalized for the virus if they contract it.
Given the incubation period for the virus, clinicians and public health officials recommend unvaccinated children isolate for 21 days after being exposed to measles at school. The advice applies to any unvaccinated child, whether because their parent opted against the vaccine or because they cannot safely receive the immunization.
This is the guidance that Surgeon General Ladapo is flouting.
“We have a public health system. They’re awesome. They’re the experts. Let’s use them,” Dr. Alissa noted. “Their recommendation is to keep the unvaccinated kids at home for 21 days when you have an outbreak.”
“We’re not calling him doctor anymore,” said Andrew Pavia, MD, chief of the Division of Pediatric Infectious Diseases at the University of Utah in Salt Lake City.
“Getting your kids immunized before they enter school is so critical,” added Dr. Pavia, because the 21-day quarantine period is onerous for children and parents alike.
In a February 26 statement, Marcus Plescia, MD, MPH, chief medical officer of the Association of State and Territorial Health Officials, said “well-established public health practice recommends that unvaccinated persons exposed to measles stay home for at least 21 days to prevent further growth of the outbreak. While this is undoubtedly disruptive to the persons impacted, imagine how much more disruptive it would be if measles takes hold again in the United States, spreading widely, and impacting children and communities across the entire nation.”
During an outbreak, it’s still possible to give a measles vaccine to a child who has not yet received the shots, Dr. Pavia stressed. But time is of the essence: Vaccination should occur within 72 hours of the first known measles case in a school.
“It’s not perfect, they may still get measles, but it will greatly decrease the severity,” Dr. Pavia said.
If some children won’t get vaccinated during an outbreak, their parents may call a pediatrician or hospital staff for help as measles symptoms take hold. Clinicians should advise everyone in the home who is older than 2 years to begin wearing N95 masks and gloves, Dr. Alissa said. And when the child comes into the clinic he or she should be examined in a separate room, ideally one with negative air pressure and frequent filtration, Dr. Alissa added. If not, any private room will do if nobody else uses the room for at least 2 hours afterward.
“Measles is phenomenally transmissible,” Dr. Pavia said. A person with the virus can infect 12 to 18 others who are not protected against the pathogen.
Someone with a severe reaction to measles could get an injection of intramuscular immunoglobulin, Dr. Pavia said, although this tends to be uncomfortable and expensive.
“The vaccine works. We almost got rid of measles,” Dr. Alissa said, although parents who choose to send their unvaccinated children to school can do so if they choose to.
“The fear of every pediatrician is to have a child die from this,” she said. “People who are sick, please stay at home.”
Dr. Pavia reported an advisory relationship with Sanofi Pasteur regarding an RSV vaccine. Dr. Alissa reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
Reduced-Dose Vaccines Protect Patients With HIV Against Mpox
The smallpox vaccine effectively induces immunity against mpox virus infection (formerly simian smallpox) in patients with human immunodeficiency virus (HIV) infection, although patients with lymphocyte counts below 500 cells/mm3 require booster doses, according to data from a study published in the Journal of Medical Virology.
The data come from the prospective observational study conducted by researchers at the Infection Biology Laboratory of the Department of Medicine and Life Sciences at Pompeu Fabra University and the HIV Unit of the Hospital del Mar Medical Research Institute in Barcelona, Spain. The investigators analyzed T-cell responses induced by vaccination with JYNNEOS.
Despite the substantial decrease in the reporting frequency of mpox cases from the global peak in August 2022 (30,894 cases) to 804 monthly cases in the last six months of 2023, mpox continues to circulate, and there is no specific vaccine. The JYNNEOS vaccine, with protective cross-reactivity against orthopoxviruses, is approved by the US Food and Drug Administration and the European Medicines Agency for the prevention of smallpox and mpox in adults at high risk for infection.
During the 2022 outbreak in the United States and Europe, vaccine shortages led to the emergency use authorization of a lower intradermal dose. This strategy was aimed at increasing vaccine supply up to fivefold.
Further clinical trials are needed to evaluate responses to JYNNEOS vaccination and compare different administration routes in patients with HIV infection. Protecting this population against mpox is a priority because people with high viral loads or loCD4+ T-lymphocyte counts are especially susceptible to severe disease.
Vaccination Responses
The study assessed the immune response to the JYNNEOS vaccine in patients with HIV who were receiving antiretroviral therapy as outpatients at the Infectious Diseases Unit of Hospital del Mar in Barcelona, Spain. Participants had viral loads controlled by antiretroviral therapy and CD4+ T-lymphocyte counts ≤ 500/mm3 (loCD4 group) or ≥ 500/mm3 (hiCD4 group) in blood. Vaccine responses were compared with those of vaccinated controls without the disease. The study included cases that received the standard subcutaneous vaccine (before August 2022) or the emergency dose-saving intradermal vaccine after its approval in August 2022.
The results demonstrated that the intradermal dose-saving vaccination route is preferable to the subcutaneous route and that patients in the loCD4 group may require at least one booster to generate an efficient response of specific T cells for mpox, wrote the authors.
“This study has two relevant points,” study author Robert Güerri-Fernandez, MD, PhD, head of infectious diseases at the Hospital del Mar Medical Research Institute, told this news organization. “In the subgroup of patients with HIV with effective treatment but without an immune response (ie, loCD4), the vaccine response is worse than in people who have recovered immunity or do not have HIV. Therefore, they need a booster dose.
“The second point is that the intradermal route with one-fifth of the standard subcutaneous dose has a better immune response than the standard subcutaneous route.” He added that it was a good strategy to save doses and be able to vaccinate many more people when vaccine shortages occurred.
“A general conclusion cannot be drawn,” he said. “It needs to be validated with many more subjects, of course, but in some way, it reinforced our confidence in the strategy of health authorities to promote intradermal vaccination. There we had evidence that the patients we were vaccinating intradermally were responding well.”
In Spain, although there is no shortage of vaccines today, they continue to be administered intradermally with a fractionated dose equivalent to one fifth of a standard dose, said Dr. Güerri-Fernandez.
However, in his opinion, observations regarding the two administration routes signal a need for further research. The main message should be that for patients with HIV infection who do not have an immune response, the vaccine response is incomplete, and they need booster doses as well as monitoring of the vaccine immune response, said Dr. Güerri-Fernandez.
More Studies Required
The research, which prospectively collected data and blood samples from patients with HIV who received the JYNNEOS vaccine, is small and included only 24 patients with HIV infection, with seven hospital workers who also received the vaccine and seven unvaccinated individuals as controls. “I am one of the control subjects of the study, and intradermal vaccination is not especially pleasant,” said Dr. Güerri-Fernandez. “It is a very innervated area, and the moment of introducing the liquid is uncomfortable. But it is perfectly bearable.”
Outpatient HIV-infected patients from the Infectious Diseases Unit of Hospital del Mar on antiretroviral therapy and with undetectable viral loads were grouped according to their CD4+ T-lymphocyte counts. Those with CD4+ T-lymphocyte counts ≤ 500/mm3 required at least one booster vaccine to exhibit efficient virus-specific T-lymphocyte responses. The magnitude of the T-cell response after this booster correlated directly with the CD4+ T-lymphocyte count of those vaccinated.
For Argentine infectious disease specialist Julián García, MD, clinical researcher at the Huésped Foundation in Buenos Aires, Argentina, who did not participate in the study, it is always productive to know that T-cell responses develop in patients with HIV infection, with CD4+ T-lymphocyte counts > and < 500/mm3, through an intradermal administration route.
Dr. García emphasized that the most novel aspect is that the JYNNEOS vaccine induces a specific T-cell response in patients with HIV infection that increases with higher CD4+ T-lymphocyte levels. However, he noted that the number of patients was less than 10 in most study groups, and the control group had only intradermal administration, which limits the interpretation of the results. “It will be necessary to verify this in studies with larger groups with control groups from all routes and with a correlate of protection.”
Dr. García referred to this latter point as a significant source of uncertainty. “The study is fundamentally based on the cellular response, but nowadays, there is no immune correlate of real-life protection.” He concluded that the study builds knowledge, which is essential for a vaccine that began to be used for mpox and the effectiveness of which is based on estimates.
Dr. Güerri-Fernandez and Dr. Garcia declared no relevant financial conflicts of interest.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The smallpox vaccine effectively induces immunity against mpox virus infection (formerly simian smallpox) in patients with human immunodeficiency virus (HIV) infection, although patients with lymphocyte counts below 500 cells/mm3 require booster doses, according to data from a study published in the Journal of Medical Virology.
The data come from the prospective observational study conducted by researchers at the Infection Biology Laboratory of the Department of Medicine and Life Sciences at Pompeu Fabra University and the HIV Unit of the Hospital del Mar Medical Research Institute in Barcelona, Spain. The investigators analyzed T-cell responses induced by vaccination with JYNNEOS.
Despite the substantial decrease in the reporting frequency of mpox cases from the global peak in August 2022 (30,894 cases) to 804 monthly cases in the last six months of 2023, mpox continues to circulate, and there is no specific vaccine. The JYNNEOS vaccine, with protective cross-reactivity against orthopoxviruses, is approved by the US Food and Drug Administration and the European Medicines Agency for the prevention of smallpox and mpox in adults at high risk for infection.
During the 2022 outbreak in the United States and Europe, vaccine shortages led to the emergency use authorization of a lower intradermal dose. This strategy was aimed at increasing vaccine supply up to fivefold.
Further clinical trials are needed to evaluate responses to JYNNEOS vaccination and compare different administration routes in patients with HIV infection. Protecting this population against mpox is a priority because people with high viral loads or loCD4+ T-lymphocyte counts are especially susceptible to severe disease.
Vaccination Responses
The study assessed the immune response to the JYNNEOS vaccine in patients with HIV who were receiving antiretroviral therapy as outpatients at the Infectious Diseases Unit of Hospital del Mar in Barcelona, Spain. Participants had viral loads controlled by antiretroviral therapy and CD4+ T-lymphocyte counts ≤ 500/mm3 (loCD4 group) or ≥ 500/mm3 (hiCD4 group) in blood. Vaccine responses were compared with those of vaccinated controls without the disease. The study included cases that received the standard subcutaneous vaccine (before August 2022) or the emergency dose-saving intradermal vaccine after its approval in August 2022.
The results demonstrated that the intradermal dose-saving vaccination route is preferable to the subcutaneous route and that patients in the loCD4 group may require at least one booster to generate an efficient response of specific T cells for mpox, wrote the authors.
“This study has two relevant points,” study author Robert Güerri-Fernandez, MD, PhD, head of infectious diseases at the Hospital del Mar Medical Research Institute, told this news organization. “In the subgroup of patients with HIV with effective treatment but without an immune response (ie, loCD4), the vaccine response is worse than in people who have recovered immunity or do not have HIV. Therefore, they need a booster dose.
“The second point is that the intradermal route with one-fifth of the standard subcutaneous dose has a better immune response than the standard subcutaneous route.” He added that it was a good strategy to save doses and be able to vaccinate many more people when vaccine shortages occurred.
“A general conclusion cannot be drawn,” he said. “It needs to be validated with many more subjects, of course, but in some way, it reinforced our confidence in the strategy of health authorities to promote intradermal vaccination. There we had evidence that the patients we were vaccinating intradermally were responding well.”
In Spain, although there is no shortage of vaccines today, they continue to be administered intradermally with a fractionated dose equivalent to one fifth of a standard dose, said Dr. Güerri-Fernandez.
However, in his opinion, observations regarding the two administration routes signal a need for further research. The main message should be that for patients with HIV infection who do not have an immune response, the vaccine response is incomplete, and they need booster doses as well as monitoring of the vaccine immune response, said Dr. Güerri-Fernandez.
More Studies Required
The research, which prospectively collected data and blood samples from patients with HIV who received the JYNNEOS vaccine, is small and included only 24 patients with HIV infection, with seven hospital workers who also received the vaccine and seven unvaccinated individuals as controls. “I am one of the control subjects of the study, and intradermal vaccination is not especially pleasant,” said Dr. Güerri-Fernandez. “It is a very innervated area, and the moment of introducing the liquid is uncomfortable. But it is perfectly bearable.”
Outpatient HIV-infected patients from the Infectious Diseases Unit of Hospital del Mar on antiretroviral therapy and with undetectable viral loads were grouped according to their CD4+ T-lymphocyte counts. Those with CD4+ T-lymphocyte counts ≤ 500/mm3 required at least one booster vaccine to exhibit efficient virus-specific T-lymphocyte responses. The magnitude of the T-cell response after this booster correlated directly with the CD4+ T-lymphocyte count of those vaccinated.
For Argentine infectious disease specialist Julián García, MD, clinical researcher at the Huésped Foundation in Buenos Aires, Argentina, who did not participate in the study, it is always productive to know that T-cell responses develop in patients with HIV infection, with CD4+ T-lymphocyte counts > and < 500/mm3, through an intradermal administration route.
Dr. García emphasized that the most novel aspect is that the JYNNEOS vaccine induces a specific T-cell response in patients with HIV infection that increases with higher CD4+ T-lymphocyte levels. However, he noted that the number of patients was less than 10 in most study groups, and the control group had only intradermal administration, which limits the interpretation of the results. “It will be necessary to verify this in studies with larger groups with control groups from all routes and with a correlate of protection.”
Dr. García referred to this latter point as a significant source of uncertainty. “The study is fundamentally based on the cellular response, but nowadays, there is no immune correlate of real-life protection.” He concluded that the study builds knowledge, which is essential for a vaccine that began to be used for mpox and the effectiveness of which is based on estimates.
Dr. Güerri-Fernandez and Dr. Garcia declared no relevant financial conflicts of interest.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The smallpox vaccine effectively induces immunity against mpox virus infection (formerly simian smallpox) in patients with human immunodeficiency virus (HIV) infection, although patients with lymphocyte counts below 500 cells/mm3 require booster doses, according to data from a study published in the Journal of Medical Virology.
The data come from the prospective observational study conducted by researchers at the Infection Biology Laboratory of the Department of Medicine and Life Sciences at Pompeu Fabra University and the HIV Unit of the Hospital del Mar Medical Research Institute in Barcelona, Spain. The investigators analyzed T-cell responses induced by vaccination with JYNNEOS.
Despite the substantial decrease in the reporting frequency of mpox cases from the global peak in August 2022 (30,894 cases) to 804 monthly cases in the last six months of 2023, mpox continues to circulate, and there is no specific vaccine. The JYNNEOS vaccine, with protective cross-reactivity against orthopoxviruses, is approved by the US Food and Drug Administration and the European Medicines Agency for the prevention of smallpox and mpox in adults at high risk for infection.
During the 2022 outbreak in the United States and Europe, vaccine shortages led to the emergency use authorization of a lower intradermal dose. This strategy was aimed at increasing vaccine supply up to fivefold.
Further clinical trials are needed to evaluate responses to JYNNEOS vaccination and compare different administration routes in patients with HIV infection. Protecting this population against mpox is a priority because people with high viral loads or loCD4+ T-lymphocyte counts are especially susceptible to severe disease.
Vaccination Responses
The study assessed the immune response to the JYNNEOS vaccine in patients with HIV who were receiving antiretroviral therapy as outpatients at the Infectious Diseases Unit of Hospital del Mar in Barcelona, Spain. Participants had viral loads controlled by antiretroviral therapy and CD4+ T-lymphocyte counts ≤ 500/mm3 (loCD4 group) or ≥ 500/mm3 (hiCD4 group) in blood. Vaccine responses were compared with those of vaccinated controls without the disease. The study included cases that received the standard subcutaneous vaccine (before August 2022) or the emergency dose-saving intradermal vaccine after its approval in August 2022.
The results demonstrated that the intradermal dose-saving vaccination route is preferable to the subcutaneous route and that patients in the loCD4 group may require at least one booster to generate an efficient response of specific T cells for mpox, wrote the authors.
“This study has two relevant points,” study author Robert Güerri-Fernandez, MD, PhD, head of infectious diseases at the Hospital del Mar Medical Research Institute, told this news organization. “In the subgroup of patients with HIV with effective treatment but without an immune response (ie, loCD4), the vaccine response is worse than in people who have recovered immunity or do not have HIV. Therefore, they need a booster dose.
“The second point is that the intradermal route with one-fifth of the standard subcutaneous dose has a better immune response than the standard subcutaneous route.” He added that it was a good strategy to save doses and be able to vaccinate many more people when vaccine shortages occurred.
“A general conclusion cannot be drawn,” he said. “It needs to be validated with many more subjects, of course, but in some way, it reinforced our confidence in the strategy of health authorities to promote intradermal vaccination. There we had evidence that the patients we were vaccinating intradermally were responding well.”
In Spain, although there is no shortage of vaccines today, they continue to be administered intradermally with a fractionated dose equivalent to one fifth of a standard dose, said Dr. Güerri-Fernandez.
However, in his opinion, observations regarding the two administration routes signal a need for further research. The main message should be that for patients with HIV infection who do not have an immune response, the vaccine response is incomplete, and they need booster doses as well as monitoring of the vaccine immune response, said Dr. Güerri-Fernandez.
More Studies Required
The research, which prospectively collected data and blood samples from patients with HIV who received the JYNNEOS vaccine, is small and included only 24 patients with HIV infection, with seven hospital workers who also received the vaccine and seven unvaccinated individuals as controls. “I am one of the control subjects of the study, and intradermal vaccination is not especially pleasant,” said Dr. Güerri-Fernandez. “It is a very innervated area, and the moment of introducing the liquid is uncomfortable. But it is perfectly bearable.”
Outpatient HIV-infected patients from the Infectious Diseases Unit of Hospital del Mar on antiretroviral therapy and with undetectable viral loads were grouped according to their CD4+ T-lymphocyte counts. Those with CD4+ T-lymphocyte counts ≤ 500/mm3 required at least one booster vaccine to exhibit efficient virus-specific T-lymphocyte responses. The magnitude of the T-cell response after this booster correlated directly with the CD4+ T-lymphocyte count of those vaccinated.
For Argentine infectious disease specialist Julián García, MD, clinical researcher at the Huésped Foundation in Buenos Aires, Argentina, who did not participate in the study, it is always productive to know that T-cell responses develop in patients with HIV infection, with CD4+ T-lymphocyte counts > and < 500/mm3, through an intradermal administration route.
Dr. García emphasized that the most novel aspect is that the JYNNEOS vaccine induces a specific T-cell response in patients with HIV infection that increases with higher CD4+ T-lymphocyte levels. However, he noted that the number of patients was less than 10 in most study groups, and the control group had only intradermal administration, which limits the interpretation of the results. “It will be necessary to verify this in studies with larger groups with control groups from all routes and with a correlate of protection.”
Dr. García referred to this latter point as a significant source of uncertainty. “The study is fundamentally based on the cellular response, but nowadays, there is no immune correlate of real-life protection.” He concluded that the study builds knowledge, which is essential for a vaccine that began to be used for mpox and the effectiveness of which is based on estimates.
Dr. Güerri-Fernandez and Dr. Garcia declared no relevant financial conflicts of interest.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Long-Term Follow-Up Emphasizes HPV Vaccination Importance
This transcript has been edited for clarity.
I want to briefly discuss a critically important topic that cannot be overly emphasized. It is the relevance, the importance, the benefits, and the outcome of HPV vaccination.
The paper I’m referring to was published in Pediatrics in October 2023. It’s titled, “Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety.”
Let me emphasize that we’re talking about a 10-year follow-up. In this particular paper and analysis, 301 boys — I emphasize boys — were included and 971 girls at 40 different sites in 13 countries, who received the 9-valent vaccine, which includes HPV 16, 18, and seven other types.
Most importantly, there was not a single case. Not one. Let me repeat this: There was not a single case of high-grade intraepithelial neoplasia, or worse, or condyloma in either males or females. There was not a single case in over 1000 individuals with a follow-up of more than 10 years.
It is difficult to overstate the magnitude of the benefit associated with HPV vaccination for our children and young adults on their risk of developing highly relevant, life-changing, potentially deadly cancers.
For those of you who are interested in this topic — which should include almost all of you, if not all of you — I encourage you to read this very important follow-up paper, again, demonstrating the simple, overwhelming magnitude of the benefit of HPV vaccination. I thank you for your attention.
Dr. Markman is a professor in the department of medical oncology and therapeutics research, City of Hope, Duarte, California, and president of medicine and science, City of Hope Atlanta, Chicago, and Phoenix. He disclosed ties with GlaxoSmithKline; AstraZeneca.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
I want to briefly discuss a critically important topic that cannot be overly emphasized. It is the relevance, the importance, the benefits, and the outcome of HPV vaccination.
The paper I’m referring to was published in Pediatrics in October 2023. It’s titled, “Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety.”
Let me emphasize that we’re talking about a 10-year follow-up. In this particular paper and analysis, 301 boys — I emphasize boys — were included and 971 girls at 40 different sites in 13 countries, who received the 9-valent vaccine, which includes HPV 16, 18, and seven other types.
Most importantly, there was not a single case. Not one. Let me repeat this: There was not a single case of high-grade intraepithelial neoplasia, or worse, or condyloma in either males or females. There was not a single case in over 1000 individuals with a follow-up of more than 10 years.
It is difficult to overstate the magnitude of the benefit associated with HPV vaccination for our children and young adults on their risk of developing highly relevant, life-changing, potentially deadly cancers.
For those of you who are interested in this topic — which should include almost all of you, if not all of you — I encourage you to read this very important follow-up paper, again, demonstrating the simple, overwhelming magnitude of the benefit of HPV vaccination. I thank you for your attention.
Dr. Markman is a professor in the department of medical oncology and therapeutics research, City of Hope, Duarte, California, and president of medicine and science, City of Hope Atlanta, Chicago, and Phoenix. He disclosed ties with GlaxoSmithKline; AstraZeneca.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
I want to briefly discuss a critically important topic that cannot be overly emphasized. It is the relevance, the importance, the benefits, and the outcome of HPV vaccination.
The paper I’m referring to was published in Pediatrics in October 2023. It’s titled, “Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety.”
Let me emphasize that we’re talking about a 10-year follow-up. In this particular paper and analysis, 301 boys — I emphasize boys — were included and 971 girls at 40 different sites in 13 countries, who received the 9-valent vaccine, which includes HPV 16, 18, and seven other types.
Most importantly, there was not a single case. Not one. Let me repeat this: There was not a single case of high-grade intraepithelial neoplasia, or worse, or condyloma in either males or females. There was not a single case in over 1000 individuals with a follow-up of more than 10 years.
It is difficult to overstate the magnitude of the benefit associated with HPV vaccination for our children and young adults on their risk of developing highly relevant, life-changing, potentially deadly cancers.
For those of you who are interested in this topic — which should include almost all of you, if not all of you — I encourage you to read this very important follow-up paper, again, demonstrating the simple, overwhelming magnitude of the benefit of HPV vaccination. I thank you for your attention.
Dr. Markman is a professor in the department of medical oncology and therapeutics research, City of Hope, Duarte, California, and president of medicine and science, City of Hope Atlanta, Chicago, and Phoenix. He disclosed ties with GlaxoSmithKline; AstraZeneca.
A version of this article appeared on Medscape.com.
Virus and Booster Apathy Could Be Fueling Long COVID
A celebrity makeup artist, the 55-year-old New Yorker had been boosted and vaccinated at every opportunity since vaccines were approved at the end of 2020, until the fall of 2023, when she skipped the shot.
“I really started subscribing to the mindset that you have an immune system and your immune system is supposed to work for you,” she said. “That was the stupidest thing I’ve ever done.”
Maio was not the only person to skip the latest booster: A recent study reported that while nearly 80% of adults in the United States said they’d received their first series of vaccines, barely 20% were up to date on boosters. Nor was Maio alone in getting long COVID 4 years after the start of the deadliest pandemic in a century.
It’s tempting, this far out from the shutdowns of 2020, to think the virus is over, that we’re immune, and nobody’s going to get sick anymore. But while fewer people are getting COVID, it is still very much a part of our lives. And as Maio and others are learning the hard way, long COVID is, too — and it can be deadly.
For those who have recently contracted long COVID, it can feel as if the whole world has moved on from the pandemic, and they are being left behind.
Too Easy to Let Our Guard Down
“It’s really difficult to prevent exposure to COVID no matter how careful you are and no matter how many times you are vaccinated,” said Akiko Iwasaki, an immunology professor at Yale School of Medicine, New Haven, Connecticut, and pioneer in long COVID research. Iwasaki was quick to point out that “we should never blame anybody for getting long COVID because there is no bulletproof way of preventing long COVID from happening” — although research shows you can increase your protection through vaccination, masking, and increasing ventilation indoors.
Also, just because you didn’t get long COVID after catching the virus once, doesn’t mean you’ll dodge the bullet if you get sick again, as Maio has now learned twice. She had long COVID in 2022 after her second bout with the virus, with breathing problems and brain fog that lasted for several months.
Subsequent long COVID experiences won’t necessarily mimic previous ones. Although Maio developed brain fog again, this time she didn’t have the breathing problems that plagued her in 2022. Instead, she had headaches so excruciating she thought she was dying of a brain aneurysm.
A Journal of the American Medical Association study released in May identified the 37 most common symptoms of long COVID, including symptom subgroups that occurred in 80% of the nearly 10,000 study participants. But the symptoms that patients with long COVID are experiencing now are slightly different from earlier in the pandemic or at least that’s what doctors are finding at the Post-COVID Recovery Clinic affiliated with the University of Pittsburgh Medical Center.
Michael Risbano, MD, the clinic’s codirector, said fewer patients have pulmonary or lung damage now than in the past, but a steady stream report problems with brain fog, forgetfulness, exercise intolerance (shortness of breath and fatigue with exercise and difficulty performing any kind of exertional activity), and post-exertional malaise (feeling wiped out or fatigued for hours or even days after physical or mental activity).
Long COVID Treatments Showing Improvement — Slowly
“There still isn’t a great way to treat any of this,” said Risbano, whose clinic is involved with the National Institute of Health’s RECOVER-VITAL trial, which is evaluating potential treatments including Paxlovid and exercise to treat autonomic dysfunction with similarities to myalgic encephalomyelitis/chronic fatigue syndrome and POTS, exercise intolerance, and neurocognitive effects such as brain fog.
Risbano and colleagues have found that physical therapy and exercise training have helped patients with exercise intolerance and neurocognitive problems. “It’s not a quick thing where they go through one visit and are better the next day,” he stressed. “It takes a little bit of time, a little bit of effort, a little bit of homework — there are no silver bullets, no magic medications.”
A quick fix was definitely not in the cards for Dean Jones, PhD, who could barely move when he developed long COVID in May 2023. A 74-year-old biochemist and professor of medicine at Emory University in Atlanta, Georgia, he’d recovered fully the first time he had COVID, in August 2022, but had a completely different experience the second time. He had been vaccinated four times when he began experiencing chronic fatigue, intense exertion-induced migraines, severe airway congestion, brain fog, and shortness of breath. The symptoms began after Memorial Day and worsened over the next month.
His resting heart rate began racing even when he was sleeping, jumping from 53 to 70 beats per minute. “It was almost as though the virus had hit my heart rather than the lungs alone,” he said.
Doctors prescribed multiple inhalers and glucocorticoids to calm Jones’s immune system. The worst symptoms began to abate after a few weeks. The bad ones continued for fully 2 months, severely limiting Jones’s activity. Although he no longer slept all day, just walking from one room to another was exhausting. A dedicated scientist who typically worked 10-15 hours a day before getting sick, he was lucky to focus on work-related tasks for a fraction of that time.
Although the migraines went away early on, the headaches remained until well into the fall. Jones’s energy level gradually returned, and by Christmas, he was beginning to feel as healthy as he had before getting COVID in May.
Still, he’s not complaining that it took so long to get better. “At 74, there’s a lot of colleagues who have already passed away,” he said. “I respect the realities of my age. There are so many people who died from COVID that I’m thankful I had those vaccines. I’m thankful that I pulled through it and was able to rebound.”
Time Helps Healing — But Prompt Care Still Needed
Recovery is the case for most patients with long COVID, said Lisa Sanders, MD, medical director of the Yale New Haven Health Systems Long COVID Consultation Clinic, which opened in March 2023. Although the clinic has a small segment of patients who have had the condition since 2020, “people who recover, who are most people, move on,” she said. “Even the patients who sometimes have to wait a month or so to see me, some of them say, ‘I’m already starting to get better. I wasn’t sure I should come.’”
Maio, too, is recovering but only after multiple visits to the emergency room and a neurologist in late December and early January. The third emergency room trip was prompted after a brief episode in which she lost the feeling in her legs, which began convulsing. A CAT scan showed severely constricted blood vessels in her brain, leading the medical team to speculate she might have reversible cerebral vasoconstriction syndrome (RCVS), which can trigger the thunderclap headaches that had been causing her such misery.
After her third such headache prompted a fourth emergency room visit, further tests confirmed RCVS, which doctors said was related to inflammation caused by COVID. Maio was then admitted to the hospital, where she spent 4 days starting on a regimen of blood pressure medication, magnesium for the headaches, and oxycodone for pain management.
The TV show Maio works on went back into production after the holidays. She went back at the end of January. She’s still having headaches, though they’re less intense, and she’s still taking medication. She was scheduled for another test to look at her blood vessels in February.
Maio has yet to forgive herself for skipping the last booster, even though there’s no guarantee it would have prevented her from getting sick. Her message for others: it’s better to be safe than to be as sorry as she is.
“I’ll never, ever be persuaded by people who don’t believe in vaccines because I believe in science, and I believe in vaccines — that’s why people don’t die at the age of 30 anymore,” she said. “I really think that people need to know about this and what to expect. Because it is horrendous. It is very painful. I would never want anyone to go through this. Ever.”
A version of this article appeared on Medscape.com.
A celebrity makeup artist, the 55-year-old New Yorker had been boosted and vaccinated at every opportunity since vaccines were approved at the end of 2020, until the fall of 2023, when she skipped the shot.
“I really started subscribing to the mindset that you have an immune system and your immune system is supposed to work for you,” she said. “That was the stupidest thing I’ve ever done.”
Maio was not the only person to skip the latest booster: A recent study reported that while nearly 80% of adults in the United States said they’d received their first series of vaccines, barely 20% were up to date on boosters. Nor was Maio alone in getting long COVID 4 years after the start of the deadliest pandemic in a century.
It’s tempting, this far out from the shutdowns of 2020, to think the virus is over, that we’re immune, and nobody’s going to get sick anymore. But while fewer people are getting COVID, it is still very much a part of our lives. And as Maio and others are learning the hard way, long COVID is, too — and it can be deadly.
For those who have recently contracted long COVID, it can feel as if the whole world has moved on from the pandemic, and they are being left behind.
Too Easy to Let Our Guard Down
“It’s really difficult to prevent exposure to COVID no matter how careful you are and no matter how many times you are vaccinated,” said Akiko Iwasaki, an immunology professor at Yale School of Medicine, New Haven, Connecticut, and pioneer in long COVID research. Iwasaki was quick to point out that “we should never blame anybody for getting long COVID because there is no bulletproof way of preventing long COVID from happening” — although research shows you can increase your protection through vaccination, masking, and increasing ventilation indoors.
Also, just because you didn’t get long COVID after catching the virus once, doesn’t mean you’ll dodge the bullet if you get sick again, as Maio has now learned twice. She had long COVID in 2022 after her second bout with the virus, with breathing problems and brain fog that lasted for several months.
Subsequent long COVID experiences won’t necessarily mimic previous ones. Although Maio developed brain fog again, this time she didn’t have the breathing problems that plagued her in 2022. Instead, she had headaches so excruciating she thought she was dying of a brain aneurysm.
A Journal of the American Medical Association study released in May identified the 37 most common symptoms of long COVID, including symptom subgroups that occurred in 80% of the nearly 10,000 study participants. But the symptoms that patients with long COVID are experiencing now are slightly different from earlier in the pandemic or at least that’s what doctors are finding at the Post-COVID Recovery Clinic affiliated with the University of Pittsburgh Medical Center.
Michael Risbano, MD, the clinic’s codirector, said fewer patients have pulmonary or lung damage now than in the past, but a steady stream report problems with brain fog, forgetfulness, exercise intolerance (shortness of breath and fatigue with exercise and difficulty performing any kind of exertional activity), and post-exertional malaise (feeling wiped out or fatigued for hours or even days after physical or mental activity).
Long COVID Treatments Showing Improvement — Slowly
“There still isn’t a great way to treat any of this,” said Risbano, whose clinic is involved with the National Institute of Health’s RECOVER-VITAL trial, which is evaluating potential treatments including Paxlovid and exercise to treat autonomic dysfunction with similarities to myalgic encephalomyelitis/chronic fatigue syndrome and POTS, exercise intolerance, and neurocognitive effects such as brain fog.
Risbano and colleagues have found that physical therapy and exercise training have helped patients with exercise intolerance and neurocognitive problems. “It’s not a quick thing where they go through one visit and are better the next day,” he stressed. “It takes a little bit of time, a little bit of effort, a little bit of homework — there are no silver bullets, no magic medications.”
A quick fix was definitely not in the cards for Dean Jones, PhD, who could barely move when he developed long COVID in May 2023. A 74-year-old biochemist and professor of medicine at Emory University in Atlanta, Georgia, he’d recovered fully the first time he had COVID, in August 2022, but had a completely different experience the second time. He had been vaccinated four times when he began experiencing chronic fatigue, intense exertion-induced migraines, severe airway congestion, brain fog, and shortness of breath. The symptoms began after Memorial Day and worsened over the next month.
His resting heart rate began racing even when he was sleeping, jumping from 53 to 70 beats per minute. “It was almost as though the virus had hit my heart rather than the lungs alone,” he said.
Doctors prescribed multiple inhalers and glucocorticoids to calm Jones’s immune system. The worst symptoms began to abate after a few weeks. The bad ones continued for fully 2 months, severely limiting Jones’s activity. Although he no longer slept all day, just walking from one room to another was exhausting. A dedicated scientist who typically worked 10-15 hours a day before getting sick, he was lucky to focus on work-related tasks for a fraction of that time.
Although the migraines went away early on, the headaches remained until well into the fall. Jones’s energy level gradually returned, and by Christmas, he was beginning to feel as healthy as he had before getting COVID in May.
Still, he’s not complaining that it took so long to get better. “At 74, there’s a lot of colleagues who have already passed away,” he said. “I respect the realities of my age. There are so many people who died from COVID that I’m thankful I had those vaccines. I’m thankful that I pulled through it and was able to rebound.”
Time Helps Healing — But Prompt Care Still Needed
Recovery is the case for most patients with long COVID, said Lisa Sanders, MD, medical director of the Yale New Haven Health Systems Long COVID Consultation Clinic, which opened in March 2023. Although the clinic has a small segment of patients who have had the condition since 2020, “people who recover, who are most people, move on,” she said. “Even the patients who sometimes have to wait a month or so to see me, some of them say, ‘I’m already starting to get better. I wasn’t sure I should come.’”
Maio, too, is recovering but only after multiple visits to the emergency room and a neurologist in late December and early January. The third emergency room trip was prompted after a brief episode in which she lost the feeling in her legs, which began convulsing. A CAT scan showed severely constricted blood vessels in her brain, leading the medical team to speculate she might have reversible cerebral vasoconstriction syndrome (RCVS), which can trigger the thunderclap headaches that had been causing her such misery.
After her third such headache prompted a fourth emergency room visit, further tests confirmed RCVS, which doctors said was related to inflammation caused by COVID. Maio was then admitted to the hospital, where she spent 4 days starting on a regimen of blood pressure medication, magnesium for the headaches, and oxycodone for pain management.
The TV show Maio works on went back into production after the holidays. She went back at the end of January. She’s still having headaches, though they’re less intense, and she’s still taking medication. She was scheduled for another test to look at her blood vessels in February.
Maio has yet to forgive herself for skipping the last booster, even though there’s no guarantee it would have prevented her from getting sick. Her message for others: it’s better to be safe than to be as sorry as she is.
“I’ll never, ever be persuaded by people who don’t believe in vaccines because I believe in science, and I believe in vaccines — that’s why people don’t die at the age of 30 anymore,” she said. “I really think that people need to know about this and what to expect. Because it is horrendous. It is very painful. I would never want anyone to go through this. Ever.”
A version of this article appeared on Medscape.com.
A celebrity makeup artist, the 55-year-old New Yorker had been boosted and vaccinated at every opportunity since vaccines were approved at the end of 2020, until the fall of 2023, when she skipped the shot.
“I really started subscribing to the mindset that you have an immune system and your immune system is supposed to work for you,” she said. “That was the stupidest thing I’ve ever done.”
Maio was not the only person to skip the latest booster: A recent study reported that while nearly 80% of adults in the United States said they’d received their first series of vaccines, barely 20% were up to date on boosters. Nor was Maio alone in getting long COVID 4 years after the start of the deadliest pandemic in a century.
It’s tempting, this far out from the shutdowns of 2020, to think the virus is over, that we’re immune, and nobody’s going to get sick anymore. But while fewer people are getting COVID, it is still very much a part of our lives. And as Maio and others are learning the hard way, long COVID is, too — and it can be deadly.
For those who have recently contracted long COVID, it can feel as if the whole world has moved on from the pandemic, and they are being left behind.
Too Easy to Let Our Guard Down
“It’s really difficult to prevent exposure to COVID no matter how careful you are and no matter how many times you are vaccinated,” said Akiko Iwasaki, an immunology professor at Yale School of Medicine, New Haven, Connecticut, and pioneer in long COVID research. Iwasaki was quick to point out that “we should never blame anybody for getting long COVID because there is no bulletproof way of preventing long COVID from happening” — although research shows you can increase your protection through vaccination, masking, and increasing ventilation indoors.
Also, just because you didn’t get long COVID after catching the virus once, doesn’t mean you’ll dodge the bullet if you get sick again, as Maio has now learned twice. She had long COVID in 2022 after her second bout with the virus, with breathing problems and brain fog that lasted for several months.
Subsequent long COVID experiences won’t necessarily mimic previous ones. Although Maio developed brain fog again, this time she didn’t have the breathing problems that plagued her in 2022. Instead, she had headaches so excruciating she thought she was dying of a brain aneurysm.
A Journal of the American Medical Association study released in May identified the 37 most common symptoms of long COVID, including symptom subgroups that occurred in 80% of the nearly 10,000 study participants. But the symptoms that patients with long COVID are experiencing now are slightly different from earlier in the pandemic or at least that’s what doctors are finding at the Post-COVID Recovery Clinic affiliated with the University of Pittsburgh Medical Center.
Michael Risbano, MD, the clinic’s codirector, said fewer patients have pulmonary or lung damage now than in the past, but a steady stream report problems with brain fog, forgetfulness, exercise intolerance (shortness of breath and fatigue with exercise and difficulty performing any kind of exertional activity), and post-exertional malaise (feeling wiped out or fatigued for hours or even days after physical or mental activity).
Long COVID Treatments Showing Improvement — Slowly
“There still isn’t a great way to treat any of this,” said Risbano, whose clinic is involved with the National Institute of Health’s RECOVER-VITAL trial, which is evaluating potential treatments including Paxlovid and exercise to treat autonomic dysfunction with similarities to myalgic encephalomyelitis/chronic fatigue syndrome and POTS, exercise intolerance, and neurocognitive effects such as brain fog.
Risbano and colleagues have found that physical therapy and exercise training have helped patients with exercise intolerance and neurocognitive problems. “It’s not a quick thing where they go through one visit and are better the next day,” he stressed. “It takes a little bit of time, a little bit of effort, a little bit of homework — there are no silver bullets, no magic medications.”
A quick fix was definitely not in the cards for Dean Jones, PhD, who could barely move when he developed long COVID in May 2023. A 74-year-old biochemist and professor of medicine at Emory University in Atlanta, Georgia, he’d recovered fully the first time he had COVID, in August 2022, but had a completely different experience the second time. He had been vaccinated four times when he began experiencing chronic fatigue, intense exertion-induced migraines, severe airway congestion, brain fog, and shortness of breath. The symptoms began after Memorial Day and worsened over the next month.
His resting heart rate began racing even when he was sleeping, jumping from 53 to 70 beats per minute. “It was almost as though the virus had hit my heart rather than the lungs alone,” he said.
Doctors prescribed multiple inhalers and glucocorticoids to calm Jones’s immune system. The worst symptoms began to abate after a few weeks. The bad ones continued for fully 2 months, severely limiting Jones’s activity. Although he no longer slept all day, just walking from one room to another was exhausting. A dedicated scientist who typically worked 10-15 hours a day before getting sick, he was lucky to focus on work-related tasks for a fraction of that time.
Although the migraines went away early on, the headaches remained until well into the fall. Jones’s energy level gradually returned, and by Christmas, he was beginning to feel as healthy as he had before getting COVID in May.
Still, he’s not complaining that it took so long to get better. “At 74, there’s a lot of colleagues who have already passed away,” he said. “I respect the realities of my age. There are so many people who died from COVID that I’m thankful I had those vaccines. I’m thankful that I pulled through it and was able to rebound.”
Time Helps Healing — But Prompt Care Still Needed
Recovery is the case for most patients with long COVID, said Lisa Sanders, MD, medical director of the Yale New Haven Health Systems Long COVID Consultation Clinic, which opened in March 2023. Although the clinic has a small segment of patients who have had the condition since 2020, “people who recover, who are most people, move on,” she said. “Even the patients who sometimes have to wait a month or so to see me, some of them say, ‘I’m already starting to get better. I wasn’t sure I should come.’”
Maio, too, is recovering but only after multiple visits to the emergency room and a neurologist in late December and early January. The third emergency room trip was prompted after a brief episode in which she lost the feeling in her legs, which began convulsing. A CAT scan showed severely constricted blood vessels in her brain, leading the medical team to speculate she might have reversible cerebral vasoconstriction syndrome (RCVS), which can trigger the thunderclap headaches that had been causing her such misery.
After her third such headache prompted a fourth emergency room visit, further tests confirmed RCVS, which doctors said was related to inflammation caused by COVID. Maio was then admitted to the hospital, where she spent 4 days starting on a regimen of blood pressure medication, magnesium for the headaches, and oxycodone for pain management.
The TV show Maio works on went back into production after the holidays. She went back at the end of January. She’s still having headaches, though they’re less intense, and she’s still taking medication. She was scheduled for another test to look at her blood vessels in February.
Maio has yet to forgive herself for skipping the last booster, even though there’s no guarantee it would have prevented her from getting sick. Her message for others: it’s better to be safe than to be as sorry as she is.
“I’ll never, ever be persuaded by people who don’t believe in vaccines because I believe in science, and I believe in vaccines — that’s why people don’t die at the age of 30 anymore,” she said. “I really think that people need to know about this and what to expect. Because it is horrendous. It is very painful. I would never want anyone to go through this. Ever.”
A version of this article appeared on Medscape.com.