Federal health experts have backed an updated version of Pfizer’s best-selling anti-infection vaccine. It is safe and effective for infants and babies despite company studies which failed to achieve certain goals.
The Food and Drug Administration’s (FDA) panel with experts has voted 10-1 in the favor of the drug produced by Pfizer. Prevnar 13 protects against pneumococcal disease.
The FDA is not required to follow the advice of the panel but it usually does. The recommendation made by the panel has brought the company closer to expanding the use of a treatment which created up to $2.7 billion in sales last year.
Dr. Emilio Emini, Pfizer's chief of vaccine research said, “We're very gratified to have achieved a positive recommendation from the committee.”
The decision of approval is expected to be made by December 30.
The enhanced new vaccine lessens the risk of infection from 13 different diseases which further lead to varied cases of ear infections, meningitis and pneumonia each year. The new version adds protection from six more strains in addition to the seven covered by the present vaccine.
Prevnar 13 has recently been given positive review from a committee of European regulators enhancing its chances to get approval across the European Union.
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