Well, that could have been embarrassing. Pfizer
Prevnar 13 covers -- you guessed it -- 13 different types of pneumococcal disease, six more than the original. In order to gain approval, Wyeth tested the new vaccine against the old version, but Prevnar 13 failed to show that it was as good as the original for three of the strains in some patients.
The FDA asked a panel of experts for their opinion on how important the failure was. But they shrugged it off at a meeting yesterday, voting 10-1 that the vaccine is safe and effective.
Now the ball is back in the FDA's hands. The agency doesn't have to follow the committee's advice, but I have a hard time imagining that it won't approve the vaccine, given such resounding support. The PDUFA date for the vaccine is Dec. 30, so perhaps an early Christmas present is in order.
Pfizer is competing globally against rival Synflorix from GlaxoSmithKline
I liked Pfizer's move into immunizations with its acquisition of Wyeth. As Glaxo, Novartis