Pfizer Vaccine FDA Review Incomplete
The U. S. Food and Drug Administration (FDA) continues its review of Prevnar 13, Pfizer Inc.’s children’s vaccine for fighting pneumonia and meningitis past its previous deadline of Wednesday.
Emilio Emini, Pfizer’s Chief Scientific Officer for Vaccine Research is confident of the data submitted in support of Prevnar 13 in the pharmaceutical’s application for approval, will expedite the review process.
Prevnar, a part of Pfizer’s $67-billion acquisition of Wyeth helped the world’s largest drugmaker’s to diversify into vaccines and bio-tech medicines, with analysts estimating Prevnar 13 sales to touch $4-billion a year by 2013.
Pfizer’s latest product offers protection against 13-streptococcus pneumoniae (pneumococcus) serotypes or forms of the bacterium, causing illnesses that range from ear infections to pneumonia, including meningitis.
While, the original Prevnar introduced in 2000 fights seven pneumococcal strains, currently Pfizer has applied for FDA approval, with a U. S. FDA advisory panel voting 10-1 that the drug was safe and effective for infants and toddlers, in November.
As a rule, FDA usually approves advisory committees approved products. Earlier this month, the new form of Prevnar also got the nod from European regulators, and has also been approved in
34-countries.
Synflorix, a rival vaccine from GlaxoSmithKline is said to be active against 10-strains of the bacterium, and while has been approved in Europe and other markets, it has still to be approved for use in the United States.
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