Crucial review for new Pfizer vaccine

The U.S. Food and Drug Administration, which granted priority review to the vaccine earlier this year because it appeared to be a significant health advance, posted documents on its Web site in which drug-application reviewers questioned the effectiveness of Prevnar 13 for three types of infections. But the review also noted that "there is no consensus" over whether the criteria accurately assess the effectiveness of Prevnar 13 in preventing these common infections.

The Associated Press said Pfizer, which has research-and-development campuses in Groton and New London, pointed to the World Health Organization's vaccine guidelines stating that meeting such goals is "desirable, but not an absolute requirement."

Prevnar 13 is a follow-up vaccine to Prevnar, which targeted seven common strep bacteria that can lead to ear infections, pneumonia, bloodstream infections and meningitis. Prevnar 13 adds six new bacterial strains to those targeted by the original formulation -- an acknowledgment that these other strains have been on the rise even as those affected by Prevnar were being brought under control, the review said.

Prevnar sales were expected to contribute about $3 billion to Wyeth's bottom line this year, though some of those sales numbers will be reflected in Pfizer's profits now that its $67 billion merger with the New Jersey drug firm has been completed.

Since the introduction of Prevnar in 2000, the rates of invasive pneumococcal disease -- a bacterial infection that can affect various parts of the body -- have declined dramatically, according to the FDA review. And ear infections, another common result of strep bacteria, were cut by about 15 million cases annually over a five-year period, the review said.

The AP reported that Pfizer's top vaccine researcher, Emilio Emini, minimized the review's impact, saying the missed goals did not represent a problem with the vaccine but rather with the way statistics were handled.

"The public health imperative for this vaccine is clearly there," Emini told the AP. "Pneumococcal disease is the No. 1 cause of vaccine-preventable death in the world."

Outside experts will give their opinion Wednesday on the advisability of approving Prevnar 13. The FDA, expected to rule on Prevnar 13's approval next month, usually follows the experts' advice, though it is not required to do so.

Reuters news service reported that Morgan Stanley analyst David Risinger believes the panel of experts will recommend approval of Prevnar 13. He said in a research note that the new drug's effect on a bacterial infection strain known as 19A, which has become the leading U.S. cause of pneumococcal infections, likely will sway the panel, according to Reuters.

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