The new Pfizer-Wyeth got good news Wednesday after an FDA panel determined that the company's updated version of childhood vaccine Prevnar is safe and effective.
In a 10-1 vote, the FDA's Vaccines and Related Biological Products Advisory Committee recommended Prevnar-13 as a safe, effective measure against diseases caused by the streptococcus pneumonia bacteria, including ear infections and pneumonia, according to Reuters. This updated Prevnar is designed to protect against six additional forms of the bacteria--up from the seven included in the original vaccine, which was approved in February 2000. An FDA decision on whether to approve the vaccine is expected by Dec. 30.
Prior to the vote, the FDA had questioned the updated vaccine's effectiveness in briefing documents, pointing out that the vaccine missed primary noninferiority immunogenicity criteria for serotypes 6B, 9V and 3 in the pivotal U.S. study.
The committee's decision comes a couple of weeks after Dutch authorities pulled a batch of Prevnar following the deaths of three infants.
- read the Reuters story
- check out the FDA's briefing documents