FDA Experts Back Pfizer’s Enhanced Vaccine For Children
Despite, the failure of Pfizer's in-house studies to meet set goals, the US Food and Drug Administration's (FDA) panel of vaccine experts voting 10-1 in favour of the company's Prevnar 13, have given their seal of approval to Pfizer's updated version of a popular anti-infection vaccine Wednesday, recommending it to be safe, effective and offering protection against pneumococcal disease, such as pneumonia, meningitis and other diseases caused by pneumococcus bacteria in both infants and toddlers.
FDA is not required to follow the panel's advice; however, its recommendation offers Pfizer an opportunity to expand the use of a treatment that raked in over $2.7-billion in sales last year, as the world's best-selling vaccine.
The FDA is expected to come to a decision by 30th December.
The new vaccine is believed to reduce the risk of infection and fight 13-different varieties of a bacterium called streptococcus pneumoniae or pneumococcus, which causes thousands of cases of ear infection, meningitis and pneumonia every year. While, the current vaccine protects against seven strains of the disease, the new version offers protection against six additional strains.
According to FDA, 60% of pneumococcal infections in children under-5 in the USA are due to the new strains.
The use of Prevnar 13, Pfizer estimates may help prevent 9,800-deaths and 160,000-hospitalizations due to pneumonia over a period of 10-years.
In competition with rivals GlaxoSmithKline and Merck, Pfizer is trying to carve a niche for itself in the global vaccine marketplace. GlaxoSmithKline is already marketing its Synflorix vaccine, approved for use in children is Europe, whilst Merck markets Pneumovax 23 targeted for use in adults, offering protection against pneumococcal disease.
A slowdown in prescription medications sales, including intense competition from generic drugs, has drug manufacturers viewing vaccines, as critical to their growth.
In their review, FDA's panel of experts noted, for Pfizer's in-house studies failed to meet pre-selected goals for 3-types of pneumococcal disease. On their part, Pfizer scientists argued missed statistical targets were due to comparisons between the new vaccine and the original Prevnar, which has been on the market for over 9-years and is sold in 95-countries.
Requiring a series of four injections, generally given at 2, 4 and 6-months old and then between 12 and 15-months old, Prevnar 13 was recently positively reviewed by a committee of European regulators, setting the stage for its approval across the European Union.
The FDA panel has recommended long-term safety tracking for the new vaccine and Pfizer has agreed to a 43,000-patient follow-up study.
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