CDC ACIP 2904-12

ATLANTA – A federal vaccine advisory panel is considering options for ensuring that health care personnel who were vaccinated against hepatitis B in the remote past are currently protected.

Increasing proportions of health care personnel were vaccinated against hepatitis B in infancy, or as a catch-up during adolescence. An estimated 90%-95% of healthy adults aged 40 years and younger achieve a protective antibody titer (defined as anti–hepatitis B surface antigen concentrations of 10 mIU/mL or greater) after receiving the three-dose series (MMWR 2011;60[RR07]:1-45).

However, there is currently no recommendation for postvaccination serologic testing to ensure protection, and records may no longer be available for some people who did have such testing earlier in their careers. Health care schools and other institutions are now seeking guidance to ensure hepatitis B protection for students and workers, said Dr. Sarah Schillie of the Centers for Disease Control and Prevention.

Current CDC recommendations for immunization of health care providers call for all unvaccinated individuals whose activities involve "reasonably anticipated risk for exposure to blood or other infectious body fluid" to be vaccinated with the complete three-dose hepatitis B vaccine series prior to contact with blood. Postvaccination serologic testing (at 1-2 months after the last dose) is recommended for all providers at high risk for occupational exposure to blood or body fluids. Revaccination is recommended for those with hepatitis B surface antigen (anti-HBs) concentrations less than 10 mIU/mL.

However, anti-HBs levels wane over time following vaccination, and an anti-HBs level of less than 10 mIU/mL years after vaccination doesn’t distinguish between people who responded initially and are still protected, those who have a delayed response and would likely respond to a second series of three additional doses, and nonresponders who would be susceptible to infection even after six doses (or who might have past or chronic HBV infection), Dr. Schillie explained.

The following three options are currently under consideration by the CDC’s Advisory Committee on Immunization Practices (ACIP):

• No action unless exposed. This strategy relies on the provider’s timely reporting of a percutaneous or mucosal exposure to blood or body fluids. The individual is then assessed for both hepatitis B vaccination history and serologic anti-HBs testing, and the source patient is tested for anti-HBs. The decision to give hepatitis B vaccination (HBV) and/or hepatitis B immune globulin is based on the results.

• Pre-exposure anti-HBs. If the level is above 10 mIU/mL, no further action is needed. If the anti-HBs level is less than 10 mIU/mL, one dose of HBV is given and the individual is retested 1-2 months later. If the anti-HBs level is still less than 10 mIU/mL, current recommendations for revaccination and retesting should be followed.

• Challenge dose of HBV. One dose is given at the time of school matriculation or hiring, and the anti-HBs level is measured 1-2 months later. If the level is more than 10 mIU/mL, no further action is needed. If it’s less than 10 mIU/mL, then current recommendations for revaccination and retesting should be followed.

Many health care systems in the United States are already using one of these options, Dr. Schillie noted.

Dr. Mark H. Sawyer, chair of the ACIP hepatitis B working group, said that a cost-effectiveness analysis of the three options will be presented to the ACIP at its June 2012 meeting, and a vote could be taken at its October 2012 meeting.

Dr. Sawyer and Dr. Schillie have no relevant disclosures.

ATLANTA – A federal vaccine advisory panel is considering options for ensuring that health care personnel who were vaccinated against hepatitis B in the remote past are currently protected.

Increasing proportions of health care personnel were vaccinated against hepatitis B in infancy, or as a catch-up during adolescence. An estimated 90%-95% of healthy adults aged 40 years and younger achieve a protective antibody titer (defined as anti–hepatitis B surface antigen concentrations of 10 mIU/mL or greater) after receiving the three-dose series (MMWR 2011;60[RR07]:1-45).

However, there is currently no recommendation for postvaccination serologic testing to ensure protection, and records may no longer be available for some people who did have such testing earlier in their careers. Health care schools and other institutions are now seeking guidance to ensure hepatitis B protection for students and workers, said Dr. Sarah Schillie of the Centers for Disease Control and Prevention.

Current CDC recommendations for immunization of health care providers call for all unvaccinated individuals whose activities involve "reasonably anticipated risk for exposure to blood or other infectious body fluid" to be vaccinated with the complete three-dose hepatitis B vaccine series prior to contact with blood. Postvaccination serologic testing (at 1-2 months after the last dose) is recommended for all providers at high risk for occupational exposure to blood or body fluids. Revaccination is recommended for those with hepatitis B surface antigen (anti-HBs) concentrations less than 10 mIU/mL.

However, anti-HBs levels wane over time following vaccination, and an anti-HBs level of less than 10 mIU/mL years after vaccination doesn’t distinguish between people who responded initially and are still protected, those who have a delayed response and would likely respond to a second series of three additional doses, and nonresponders who would be susceptible to infection even after six doses (or who might have past or chronic HBV infection), Dr. Schillie explained.

The following three options are currently under consideration by the CDC’s Advisory Committee on Immunization Practices (ACIP):

• No action unless exposed. This strategy relies on the provider’s timely reporting of a percutaneous or mucosal exposure to blood or body fluids. The individual is then assessed for both hepatitis B vaccination history and serologic anti-HBs testing, and the source patient is tested for anti-HBs. The decision to give hepatitis B vaccination (HBV) and/or hepatitis B immune globulin is based on the results.

• Pre-exposure anti-HBs. If the level is above 10 mIU/mL, no further action is needed. If the anti-HBs level is less than 10 mIU/mL, one dose of HBV is given and the individual is retested 1-2 months later. If the anti-HBs level is still less than 10 mIU/mL, current recommendations for revaccination and retesting should be followed.

• Challenge dose of HBV. One dose is given at the time of school matriculation or hiring, and the anti-HBs level is measured 1-2 months later. If the level is more than 10 mIU/mL, no further action is needed. If it’s less than 10 mIU/mL, then current recommendations for revaccination and retesting should be followed.

Many health care systems in the United States are already using one of these options, Dr. Schillie noted.

Dr. Mark H. Sawyer, chair of the ACIP hepatitis B working group, said that a cost-effectiveness analysis of the three options will be presented to the ACIP at its June 2012 meeting, and a vote could be taken at its October 2012 meeting.

Dr. Sawyer and Dr. Schillie have no relevant disclosures.

ATLANTA – A federal vaccine advisory panel is considering options for ensuring that health care personnel who were vaccinated against hepatitis B in the remote past are currently protected.

Increasing proportions of health care personnel were vaccinated against hepatitis B in infancy, or as a catch-up during adolescence. An estimated 90%-95% of healthy adults aged 40 years and younger achieve a protective antibody titer (defined as anti–hepatitis B surface antigen concentrations of 10 mIU/mL or greater) after receiving the three-dose series (MMWR 2011;60[RR07]:1-45).

However, there is currently no recommendation for postvaccination serologic testing to ensure protection, and records may no longer be available for some people who did have such testing earlier in their careers. Health care schools and other institutions are now seeking guidance to ensure hepatitis B protection for students and workers, said Dr. Sarah Schillie of the Centers for Disease Control and Prevention.

Current CDC recommendations for immunization of health care providers call for all unvaccinated individuals whose activities involve "reasonably anticipated risk for exposure to blood or other infectious body fluid" to be vaccinated with the complete three-dose hepatitis B vaccine series prior to contact with blood. Postvaccination serologic testing (at 1-2 months after the last dose) is recommended for all providers at high risk for occupational exposure to blood or body fluids. Revaccination is recommended for those with hepatitis B surface antigen (anti-HBs) concentrations less than 10 mIU/mL.

However, anti-HBs levels wane over time following vaccination, and an anti-HBs level of less than 10 mIU/mL years after vaccination doesn’t distinguish between people who responded initially and are still protected, those who have a delayed response and would likely respond to a second series of three additional doses, and nonresponders who would be susceptible to infection even after six doses (or who might have past or chronic HBV infection), Dr. Schillie explained.

The following three options are currently under consideration by the CDC’s Advisory Committee on Immunization Practices (ACIP):

• No action unless exposed. This strategy relies on the provider’s timely reporting of a percutaneous or mucosal exposure to blood or body fluids. The individual is then assessed for both hepatitis B vaccination history and serologic anti-HBs testing, and the source patient is tested for anti-HBs. The decision to give hepatitis B vaccination (HBV) and/or hepatitis B immune globulin is based on the results.

• Pre-exposure anti-HBs. If the level is above 10 mIU/mL, no further action is needed. If the anti-HBs level is less than 10 mIU/mL, one dose of HBV is given and the individual is retested 1-2 months later. If the anti-HBs level is still less than 10 mIU/mL, current recommendations for revaccination and retesting should be followed.

• Challenge dose of HBV. One dose is given at the time of school matriculation or hiring, and the anti-HBs level is measured 1-2 months later. If the level is more than 10 mIU/mL, no further action is needed. If it’s less than 10 mIU/mL, then current recommendations for revaccination and retesting should be followed.

Many health care systems in the United States are already using one of these options, Dr. Schillie noted.

Dr. Mark H. Sawyer, chair of the ACIP hepatitis B working group, said that a cost-effectiveness analysis of the three options will be presented to the ACIP at its June 2012 meeting, and a vote could be taken at its October 2012 meeting.

Dr. Sawyer and Dr. Schillie have no relevant disclosures.

ATLANTA – The Centers for Disease Control and Prevention’s vaccine advisory panel is holding off on a recommendation for use of the 13-valent conjugate pneumococcal vaccine in adults, despite its December 2011 licensure for those aged 50 years and older.

At its February 2012 meeting, the Advisory Committee on Immunization Practices reviewed the evidence for the use of PCV13 in adults aged 65 years and older and in immunocompromised adults. The full committee agreed with a prior recommendation from its Pneumococcal Vaccines Work Group that there is insufficient evidence at this time to determine the value of immunizing adults with PCV13. Currently missing are data on efficacy, expected to be available in 2013 from an ongoing Dutch trial, and information about the indirect impact of the current routine use of PCV13 in children on herd immunity in adults, work group chair Dr. Nancy M. Bennett said.

In contrast to ACIP’s evidence-based approach, the Food and Drug Administration based its adult approval of PCV13 (Pfizer’s Prevnar 13) on noninferiority, compared with the 23-valent pneumococcal polysaccharide (PPSV23) vaccine, and on safety, explained Dr. Bennett, professor of medicine and community and preventive medicine at the University of Rochester (N.Y.).

PCV13 "is very promising in the prevention of pneumococcal disease in all age groups. ... The ACIP was asked to consider all of the evidence related to the use of the vaccine in adults. At this time, we are not prepared to make a recommendation. We are in the process of reevaluating all the evidence that’s available. The important thing to realize is that there’s a difference between licensure by the FDA and a recommendation from the ACIP," she said in an interview.

The current plan – subject to revision – is for ACIP to vote at its June 2012 meeting on use of PCV13 in immunocompromised adults (for whom the data in favor of PCV13 use are stronger) and to review data from the CDC’s Active Bacterial Core surveillance to see whether routine use of PCV13 in children indirectly reduces the rates of disease in adults, as occurred with the previous 7-valent pneumococcal conjugate vaccine (J. Infect. Dis. 2010;201:32-41)

In 2013, ACIP is expected to review data from the Community Acquired Pneumonia Immunization Trial in Adults (CAPITA), a randomized, placebo-controlled trial involving 85,000 community-dwelling, pneumococcal vaccine–naive adults aged 65 years and older being conducted in the Netherlands. The study’s primary objective is to determine the efficacy of PCV13 against vaccine-serotype community-acquired pneumonia (CAP). Secondary objectives are to evaluate efficacy against nonbacteremic vaccine-type CAP and vaccine-type invasive pneumococcal disease, all pneumococcal CAP, and death (Neth. J. Med. 2008;66:378-83).

Depending on when those data become available, a vote on the use of PCV13 in adults aged 65 and older (the age group currently targeted for PPSV23) could take place in February or June 2013, Dr. Bennett said.

Of course, PCV13 is licensed for adults aged 50 years and older, so physicians are able to use the vaccine in those individuals if they so choose. In an interview, Dr. William Schaffner, a member of the pneumococcal work group, said that he has received numerous questions from physicians about use of PCV13 in adults. For example, they want to know if patients who are already immunized with PPSV23 might benefit from receiving a dose of PCV13 since it provides better immunogenicity, better boosting, and unlike PPSV23, is likely to eliminate pneumococcal carriage.

Moreover, physicians have asked him whether new patients who are eligible for pneumococcal vaccine should be given PCV13, PPSV23, or perhaps both (to obtain both the presumed advantages of PCV13 along with protection against the extra 10 serotypes from PPSV23). And if they should be given both, can the two vaccines be administered simultaneously or must they be given in sequence? And if in sequence, which vaccine should be given first and what should be the interval in between?

Those questions have not been answered as yet, but, Dr. Schaffner said in an interview, "If I have a 67-year-old patient who is overweight, has diabetes, and has smoked – not an unusual combination – I want to do everything I can to make this specific patient who is sitting in front of me have the maximum protection. [Then] there may be a clinical reason to use this vaccine. Sometimes the public health decision may be different from an individualized clinical decision."

Dr. Schaffner, chair of the department of preventive medicine at Vanderbilt University in Nashville, Tenn., said data suggest that such a patient would likely receive maximal protection with a dose of PCV13 first, followed by a PPSV23 dose 6-8 weeks later. He acknowledged that this might be impractical for a variety of reasons. For one thing, although Medicare is expected to cover PCV13 under Part B, it is not clear whether it would cover both vaccines given in sequence. Thus, he said, "at the moment I would say to physicians, ‘Keep doing what you’re doing, and stay tuned.’ "

Dr. Bennett stated that she has no disclosures. Dr. Schaffner serves on the data safety monitoring board for Sanofi-Pasteur and Merck, and is an occasional consultant for Novartis, GlaxoSmithKline, and Pfizer.

ATLANTA – The Centers for Disease Control and Prevention’s vaccine advisory panel is holding off on a recommendation for use of the 13-valent conjugate pneumococcal vaccine in adults, despite its December 2011 licensure for those aged 50 years and older.

At its February 2012 meeting, the Advisory Committee on Immunization Practices reviewed the evidence for the use of PCV13 in adults aged 65 years and older and in immunocompromised adults. The full committee agreed with a prior recommendation from its Pneumococcal Vaccines Work Group that there is insufficient evidence at this time to determine the value of immunizing adults with PCV13. Currently missing are data on efficacy, expected to be available in 2013 from an ongoing Dutch trial, and information about the indirect impact of the current routine use of PCV13 in children on herd immunity in adults, work group chair Dr. Nancy M. Bennett said.

In contrast to ACIP’s evidence-based approach, the Food and Drug Administration based its adult approval of PCV13 (Pfizer’s Prevnar 13) on noninferiority, compared with the 23-valent pneumococcal polysaccharide (PPSV23) vaccine, and on safety, explained Dr. Bennett, professor of medicine and community and preventive medicine at the University of Rochester (N.Y.).

PCV13 "is very promising in the prevention of pneumococcal disease in all age groups. ... The ACIP was asked to consider all of the evidence related to the use of the vaccine in adults. At this time, we are not prepared to make a recommendation. We are in the process of reevaluating all the evidence that’s available. The important thing to realize is that there’s a difference between licensure by the FDA and a recommendation from the ACIP," she said in an interview.

The current plan – subject to revision – is for ACIP to vote at its June 2012 meeting on use of PCV13 in immunocompromised adults (for whom the data in favor of PCV13 use are stronger) and to review data from the CDC’s Active Bacterial Core surveillance to see whether routine use of PCV13 in children indirectly reduces the rates of disease in adults, as occurred with the previous 7-valent pneumococcal conjugate vaccine (J. Infect. Dis. 2010;201:32-41)

In 2013, ACIP is expected to review data from the Community Acquired Pneumonia Immunization Trial in Adults (CAPITA), a randomized, placebo-controlled trial involving 85,000 community-dwelling, pneumococcal vaccine–naive adults aged 65 years and older being conducted in the Netherlands. The study’s primary objective is to determine the efficacy of PCV13 against vaccine-serotype community-acquired pneumonia (CAP). Secondary objectives are to evaluate efficacy against nonbacteremic vaccine-type CAP and vaccine-type invasive pneumococcal disease, all pneumococcal CAP, and death (Neth. J. Med. 2008;66:378-83).

Depending on when those data become available, a vote on the use of PCV13 in adults aged 65 and older (the age group currently targeted for PPSV23) could take place in February or June 2013, Dr. Bennett said.

Of course, PCV13 is licensed for adults aged 50 years and older, so physicians are able to use the vaccine in those individuals if they so choose. In an interview, Dr. William Schaffner, a member of the pneumococcal work group, said that he has received numerous questions from physicians about use of PCV13 in adults. For example, they want to know if patients who are already immunized with PPSV23 might benefit from receiving a dose of PCV13 since it provides better immunogenicity, better boosting, and unlike PPSV23, is likely to eliminate pneumococcal carriage.

Moreover, physicians have asked him whether new patients who are eligible for pneumococcal vaccine should be given PCV13, PPSV23, or perhaps both (to obtain both the presumed advantages of PCV13 along with protection against the extra 10 serotypes from PPSV23). And if they should be given both, can the two vaccines be administered simultaneously or must they be given in sequence? And if in sequence, which vaccine should be given first and what should be the interval in between?

Those questions have not been answered as yet, but, Dr. Schaffner said in an interview, "If I have a 67-year-old patient who is overweight, has diabetes, and has smoked – not an unusual combination – I want to do everything I can to make this specific patient who is sitting in front of me have the maximum protection. [Then] there may be a clinical reason to use this vaccine. Sometimes the public health decision may be different from an individualized clinical decision."

Dr. Schaffner, chair of the department of preventive medicine at Vanderbilt University in Nashville, Tenn., said data suggest that such a patient would likely receive maximal protection with a dose of PCV13 first, followed by a PPSV23 dose 6-8 weeks later. He acknowledged that this might be impractical for a variety of reasons. For one thing, although Medicare is expected to cover PCV13 under Part B, it is not clear whether it would cover both vaccines given in sequence. Thus, he said, "at the moment I would say to physicians, ‘Keep doing what you’re doing, and stay tuned.’ "

Dr. Bennett stated that she has no disclosures. Dr. Schaffner serves on the data safety monitoring board for Sanofi-Pasteur and Merck, and is an occasional consultant for Novartis, GlaxoSmithKline, and Pfizer.

ATLANTA – The Centers for Disease Control and Prevention’s vaccine advisory panel is holding off on a recommendation for use of the 13-valent conjugate pneumococcal vaccine in adults, despite its December 2011 licensure for those aged 50 years and older.

At its February 2012 meeting, the Advisory Committee on Immunization Practices reviewed the evidence for the use of PCV13 in adults aged 65 years and older and in immunocompromised adults. The full committee agreed with a prior recommendation from its Pneumococcal Vaccines Work Group that there is insufficient evidence at this time to determine the value of immunizing adults with PCV13. Currently missing are data on efficacy, expected to be available in 2013 from an ongoing Dutch trial, and information about the indirect impact of the current routine use of PCV13 in children on herd immunity in adults, work group chair Dr. Nancy M. Bennett said.

In contrast to ACIP’s evidence-based approach, the Food and Drug Administration based its adult approval of PCV13 (Pfizer’s Prevnar 13) on noninferiority, compared with the 23-valent pneumococcal polysaccharide (PPSV23) vaccine, and on safety, explained Dr. Bennett, professor of medicine and community and preventive medicine at the University of Rochester (N.Y.).

PCV13 "is very promising in the prevention of pneumococcal disease in all age groups. ... The ACIP was asked to consider all of the evidence related to the use of the vaccine in adults. At this time, we are not prepared to make a recommendation. We are in the process of reevaluating all the evidence that’s available. The important thing to realize is that there’s a difference between licensure by the FDA and a recommendation from the ACIP," she said in an interview.

The current plan – subject to revision – is for ACIP to vote at its June 2012 meeting on use of PCV13 in immunocompromised adults (for whom the data in favor of PCV13 use are stronger) and to review data from the CDC’s Active Bacterial Core surveillance to see whether routine use of PCV13 in children indirectly reduces the rates of disease in adults, as occurred with the previous 7-valent pneumococcal conjugate vaccine (J. Infect. Dis. 2010;201:32-41)

In 2013, ACIP is expected to review data from the Community Acquired Pneumonia Immunization Trial in Adults (CAPITA), a randomized, placebo-controlled trial involving 85,000 community-dwelling, pneumococcal vaccine–naive adults aged 65 years and older being conducted in the Netherlands. The study’s primary objective is to determine the efficacy of PCV13 against vaccine-serotype community-acquired pneumonia (CAP). Secondary objectives are to evaluate efficacy against nonbacteremic vaccine-type CAP and vaccine-type invasive pneumococcal disease, all pneumococcal CAP, and death (Neth. J. Med. 2008;66:378-83).

Depending on when those data become available, a vote on the use of PCV13 in adults aged 65 and older (the age group currently targeted for PPSV23) could take place in February or June 2013, Dr. Bennett said.

Of course, PCV13 is licensed for adults aged 50 years and older, so physicians are able to use the vaccine in those individuals if they so choose. In an interview, Dr. William Schaffner, a member of the pneumococcal work group, said that he has received numerous questions from physicians about use of PCV13 in adults. For example, they want to know if patients who are already immunized with PPSV23 might benefit from receiving a dose of PCV13 since it provides better immunogenicity, better boosting, and unlike PPSV23, is likely to eliminate pneumococcal carriage.

Moreover, physicians have asked him whether new patients who are eligible for pneumococcal vaccine should be given PCV13, PPSV23, or perhaps both (to obtain both the presumed advantages of PCV13 along with protection against the extra 10 serotypes from PPSV23). And if they should be given both, can the two vaccines be administered simultaneously or must they be given in sequence? And if in sequence, which vaccine should be given first and what should be the interval in between?

Those questions have not been answered as yet, but, Dr. Schaffner said in an interview, "If I have a 67-year-old patient who is overweight, has diabetes, and has smoked – not an unusual combination – I want to do everything I can to make this specific patient who is sitting in front of me have the maximum protection. [Then] there may be a clinical reason to use this vaccine. Sometimes the public health decision may be different from an individualized clinical decision."

Dr. Schaffner, chair of the department of preventive medicine at Vanderbilt University in Nashville, Tenn., said data suggest that such a patient would likely receive maximal protection with a dose of PCV13 first, followed by a PPSV23 dose 6-8 weeks later. He acknowledged that this might be impractical for a variety of reasons. For one thing, although Medicare is expected to cover PCV13 under Part B, it is not clear whether it would cover both vaccines given in sequence. Thus, he said, "at the moment I would say to physicians, ‘Keep doing what you’re doing, and stay tuned.’ "

Dr. Bennett stated that she has no disclosures. Dr. Schaffner serves on the data safety monitoring board for Sanofi-Pasteur and Merck, and is an occasional consultant for Novartis, GlaxoSmithKline, and Pfizer.