ACIP Recommends Newly Licensed PCV13

ATLANTA — Recommendations for routine use of the newly licensed 13-valent pneumococcal conjugate vaccine in children should provide a smooth transition from the current 7-valent vaccine.

Licensure of the 13-valent pneumococcal conjugate vaccine (PCV13), Pfizer's Prevnar 13, was announced by a representative from the Food and Drug Administration at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. The vaccine was approved for use in children aged 6 weeks through 5 years of age and is indicated for the prevention of invasive pneumococcal disease caused by all of its 13 serotypes and for prevention of otitis media caused by the serotypes in the 7-valent vaccine (the FDA's Dr. Wellington Sun said.

Following the announcement, the committee then voted on recommendations for routine use of the 13-valent vaccine in previously unvaccinated children aged 2–59 months of age—with the routine primary series given at 2, 4, 6, and 12–15 months of age—and in high-risk children aged 60–71 months, as well as on guidelines for transitioning to PCV13 in children who previously received one or more doses of PCV7.

Children who previously received one or more doses of PCV7 should complete the series with PCV13. Children aged 14–59 months who were completely vaccinated with four doses of PCV7 should receive a single “supplemental” dose of PCV13, but this can occur at the next regularly scheduled office visit, said Dr. Pekka Nuorti of the CDC's respiratory diseases branch.

A supplemental PCV13 dose should also be given to children with underlying medical conditions through 71 months of age, including those who previously received the 23-valent pneumococcal polysaccharide vaccine. Vaccination with a single dose of PCV13 also may be considered for high-risk children aged 6 through 18 years, although such use would be off label, Dr. Nuorti said.

When published in the CDC's Morbidity and Mortality Weekly Report, the guidelines will contain detailed charts for transitioning children from PCV7 to PCV13 based on age and how many doses of PCV7 they have already received. Dosage intervals also will be included, Dr. Nuorti noted.

Dr. Joseph A. Bocchini, the liaison to ACIP from the American Academy of Pediatrics, said that the academy is likely to support the ACIP recommendations. “The recommendations line up with what we consider appropriate use of the vaccine. … I think it will be easy for people to make the [PCV7 to PCV13] transition,” Dr. Bocchini of Louisiana State University, Shreveport, said in an interview at the meeting.

Disclosures: Dr. Nuorti and Dr. Bocchini said they had no conflicts of interest.

'The [committee's] recommendations line up with what we consider appropriate use of the vaccine.'

Source DR. BOCCHINI

My Take

Transition Should be 'Pretty Smooth'

I don't think the American Academy of Family Physicians will have any trouble with these recommendations, and I don't think family physicians will have any trouble implementing them, because they're already doing pretty well with PCV7 and this is just going to substitute.

It's a good move for Pfizer Inc. to issue credit to providers for unused doses of PCV7. There was a lingering question about what we were going to do with the current PCV7 supplies. If they weren't going to buy them back, the tendency would be to continue to use them. Now that they're going to buy back, the transition should be pretty smooth.

ATLANTA — Recommendations for routine use of the newly licensed 13-valent pneumococcal conjugate vaccine in children should provide a smooth transition from the current 7-valent vaccine.

Licensure of the 13-valent pneumococcal conjugate vaccine (PCV13), Pfizer's Prevnar 13, was announced by a representative from the Food and Drug Administration at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. The vaccine was approved for use in children aged 6 weeks through 5 years of age and is indicated for the prevention of invasive pneumococcal disease caused by all of its 13 serotypes and for prevention of otitis media caused by the serotypes in the 7-valent vaccine (the FDA's Dr. Wellington Sun said.

Following the announcement, the committee then voted on recommendations for routine use of the 13-valent vaccine in previously unvaccinated children aged 2–59 months of age—with the routine primary series given at 2, 4, 6, and 12–15 months of age—and in high-risk children aged 60–71 months, as well as on guidelines for transitioning to PCV13 in children who previously received one or more doses of PCV7.

Children who previously received one or more doses of PCV7 should complete the series with PCV13. Children aged 14–59 months who were completely vaccinated with four doses of PCV7 should receive a single “supplemental” dose of PCV13, but this can occur at the next regularly scheduled office visit, said Dr. Pekka Nuorti of the CDC's respiratory diseases branch.

A supplemental PCV13 dose should also be given to children with underlying medical conditions through 71 months of age, including those who previously received the 23-valent pneumococcal polysaccharide vaccine. Vaccination with a single dose of PCV13 also may be considered for high-risk children aged 6 through 18 years, although such use would be off label, Dr. Nuorti said.

When published in the CDC's Morbidity and Mortality Weekly Report, the guidelines will contain detailed charts for transitioning children from PCV7 to PCV13 based on age and how many doses of PCV7 they have already received. Dosage intervals also will be included, Dr. Nuorti noted.

Dr. Joseph A. Bocchini, the liaison to ACIP from the American Academy of Pediatrics, said that the academy is likely to support the ACIP recommendations. “The recommendations line up with what we consider appropriate use of the vaccine. … I think it will be easy for people to make the [PCV7 to PCV13] transition,” Dr. Bocchini of Louisiana State University, Shreveport, said in an interview at the meeting.

Disclosures: Dr. Nuorti and Dr. Bocchini said they had no conflicts of interest.

'The [committee's] recommendations line up with what we consider appropriate use of the vaccine.'

Source DR. BOCCHINI

My Take

Transition Should be 'Pretty Smooth'

I don't think the American Academy of Family Physicians will have any trouble with these recommendations, and I don't think family physicians will have any trouble implementing them, because they're already doing pretty well with PCV7 and this is just going to substitute.

It's a good move for Pfizer Inc. to issue credit to providers for unused doses of PCV7. There was a lingering question about what we were going to do with the current PCV7 supplies. If they weren't going to buy them back, the tendency would be to continue to use them. Now that they're going to buy back, the transition should be pretty smooth.

ATLANTA — Recommendations for routine use of the newly licensed 13-valent pneumococcal conjugate vaccine in children should provide a smooth transition from the current 7-valent vaccine.

Licensure of the 13-valent pneumococcal conjugate vaccine (PCV13), Pfizer's Prevnar 13, was announced by a representative from the Food and Drug Administration at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. The vaccine was approved for use in children aged 6 weeks through 5 years of age and is indicated for the prevention of invasive pneumococcal disease caused by all of its 13 serotypes and for prevention of otitis media caused by the serotypes in the 7-valent vaccine (the FDA's Dr. Wellington Sun said.

Following the announcement, the committee then voted on recommendations for routine use of the 13-valent vaccine in previously unvaccinated children aged 2–59 months of age—with the routine primary series given at 2, 4, 6, and 12–15 months of age—and in high-risk children aged 60–71 months, as well as on guidelines for transitioning to PCV13 in children who previously received one or more doses of PCV7.

Children who previously received one or more doses of PCV7 should complete the series with PCV13. Children aged 14–59 months who were completely vaccinated with four doses of PCV7 should receive a single “supplemental” dose of PCV13, but this can occur at the next regularly scheduled office visit, said Dr. Pekka Nuorti of the CDC's respiratory diseases branch.

A supplemental PCV13 dose should also be given to children with underlying medical conditions through 71 months of age, including those who previously received the 23-valent pneumococcal polysaccharide vaccine. Vaccination with a single dose of PCV13 also may be considered for high-risk children aged 6 through 18 years, although such use would be off label, Dr. Nuorti said.

When published in the CDC's Morbidity and Mortality Weekly Report, the guidelines will contain detailed charts for transitioning children from PCV7 to PCV13 based on age and how many doses of PCV7 they have already received. Dosage intervals also will be included, Dr. Nuorti noted.

Dr. Joseph A. Bocchini, the liaison to ACIP from the American Academy of Pediatrics, said that the academy is likely to support the ACIP recommendations. “The recommendations line up with what we consider appropriate use of the vaccine. … I think it will be easy for people to make the [PCV7 to PCV13] transition,” Dr. Bocchini of Louisiana State University, Shreveport, said in an interview at the meeting.

Disclosures: Dr. Nuorti and Dr. Bocchini said they had no conflicts of interest.

'The [committee's] recommendations line up with what we consider appropriate use of the vaccine.'

Source DR. BOCCHINI

My Take

Transition Should be 'Pretty Smooth'

I don't think the American Academy of Family Physicians will have any trouble with these recommendations, and I don't think family physicians will have any trouble implementing them, because they're already doing pretty well with PCV7 and this is just going to substitute.

It's a good move for Pfizer Inc. to issue credit to providers for unused doses of PCV7. There was a lingering question about what we were going to do with the current PCV7 supplies. If they weren't going to buy them back, the tendency would be to continue to use them. Now that they're going to buy back, the transition should be pretty smooth.