The new version of Prevnar, an anti-infection vaccine is safe and effective for infants and toddlers, according to an advisory board to the FDA. This report comes despite the fact that the drug failed to meet certain goals in company studies.
The Food and Drug Administration's panel of vaccine experts voted 10-1 in favor of acceptance of Pfizer's Prevnar 13 to protect against pneumococcal disease. It should be noted that the FDA is not required to follow the recommendation.
Some complained, however. Data from clinical trials showed that the new vaccine had not proved more effective than the original Prevnar vaccine in fighting two of the original strains of pneumococcal disease and one new strain.
Prevnar 13 reduces the risk of infection from 13 varieties of the disease. Pneumococcal straings cause thousands of cases of ear infection, meningitis and pneumonia each year. Reportedly, the newer version of the vaccine adds protection against six additional strains in addition the seven covered by the current vaccine (hence the 13 part of the name).
The original Prevnar vaccine was developed by Wyeth. The lone vote against Prevnar 13 was Vicky Debold, director of patient safety at the National Vaccine Information Center and the advisory board's consumer representative.
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