BETHESDA, Md. (AP) ¿ Federal health experts said Wednesday an updated version of Pfizer's best-selling anti-infection vaccine is safe and effective for infants and toddlers, despite company studies that failed to meet certain goals.
The Food and Drug Administration's panel of vaccine experts voted 10-1 in favor of Pfizer's Prevnar 13 to protect against pneumococcal disease.
While the FDA is not required to follow the group's advice, its recommendation moves the company closer to expanding the use of a treatment that racked up more than $2.7 billion in sales last year as the world's top-selling vaccine."We're very gratified to have achieved a positive recommendation from the committee," said Dr. Emilio Emini, Pfizer's chief of vaccine research. The FDA is expected to make its approval decision by Dec. 30. The new vaccine reduces risk of infection from 13 varieties of the disease, which causes thousands of cases of ear infection, meningitis and pneumonia each year. The new version adds protection against six additional strains to the seven covered by the current vaccine.