CDC Advisory Panel Recommends Use of Newly Approved Pneumococcal Vaccine

From Medscape Medical News
Kathleen Louden

February 25, 2010 — The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted yesterday to recommend the use of a 13-valent pneumococcal conjugate vaccine (PCV13), which provides broader protection for young children against pneumococcal diseases.

The vote, at a meeting in Atlanta, Georgia, came after an announcement that the US Food and Drug Administration had approved the vaccine, marketed as Prevnar 13. The agency approved the vaccine for active immunization of infants and children aged 6 weeks through 5 years against Streptococcus pneumonia–caused invasive pneumococcal diseases, such as pneumonia and meningitis, and against otitis media.

Manufactured by Pfizer subsidiary Wyeth Pharmaceuticals of Collegeville, Pennsylvania, Prevnar 13 will succeed Prevnar, a 7-valent PCV (PCV7). The new version of the vaccine protects against 6 more serotypes of S pneumonia than the original version. Unlike Prevnar, Prevnar 13 includes serotype 19A, which is the most common serotype causing invasive pneumococcal infections in children, according to a study published online February 22 in Pediatrics. In addition to serotype 19A, Prevnar 13 also contains conjugated antigens representing serotypes 1, 3, 4, 5, 6A and B, 7F, 9V, 14, 18C, 19F, and 23F.

"PCV13 will be replacing PCV7," said Jeanne Santoli, MD, MPH, from the Vaccine Supply and Assurance Branch of the CDC's National Center for HIV, Hepatitis, STD, and TB Prevention (NCIRD), after the vote.

Recommendations

The advisory committee approved 5 recommendations that the pneumococcal vaccines work group proposed. The recommendations, presented by Pekka Nuorti, MD, DSc, an epidemiologist with the NCIRD, were as follows:

Unvaccinated infants and children: PCV13 is recommended for all children aged 2 through 59 months. In the United States, infants receive a "3 plus 1" dosing schedule, with doses at 2, 4, and 6 months and a booster dose at 12 to 15 months. Older children will follow the schedule currently recommended for PCV7.
Children incompletely vaccinated with PCV7: Children aged 24 to 59 months who received 1 or more doses of PCV7 should complete their vaccine series with PCV13. The age may be extended to 71 months for children with an underlying medical condition, such as sickle cell disease, HIV, or asplenia.
Children completely vaccinated with PCV7: Those children 14 to 59 months of age who have received all 4 doses of PCV7 should receive a single supplemental dose of PCV13. The age may be extended to 71 months for children with an underlying medical condition.
High-risk children aged 6 years and older: This permissive recommendation for an off-label use states: "Vaccination with a single dose of PCV13 may be appropriate for children 6 through 18 years of age who are at increased risk for pneumococcal disease." Healthy older children should not receive the vaccine.
Additional vaccine for children with underlying medical conditions: Children aged 2 years and older who are at increased risk for invasive pneumococcal disease should receive a 23-valent pneumococcal polysaccharide vaccine after vaccination with PCV13.
The final recommendation is new since the draft recommendations that ACIP made in October 2009, according to Dr. Nuorti.

In discussing the third recommendation, Dr. Nuorti said a supplemental (formerly called catch-up) dose of PCV13 "appears safe, has been shown to elicit antibodies against 6 additional serotypes in children older than 12 months, and has been found to be cost saving."

Transition

The manufacturer expects to start shipping PCV13 the week of March 15 to private buyers. Each dose will cost $108, a company representative said at the meeting.

Once providers have PCV13 in their offices, they should give the new version, not PCV7, to unvaccinated or incompletely vaccinated children, Dr. Santoli stated.

"Pfizer is offering credit for returned unused PCV7" from private stock, she said. Providers with stock through the publicly funded Vaccines for Children Program should use up their PCV7 supplies, she added.

The ACIP recommendations will become official CDC recommendations once the CDC director and the US secretary of health and human services accept them.

Meeting of the Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention, Atlanta, Georgia. Presented February 24, 2010.