Pfizer Vaccine Missed Some Goals: FDA Review

In advance of an FDA meeting this week to review Pfizer's Prevnar 13 vaccine for pneumococcal disease, agency reviewers write that criteria for fighting infection from three of 13 strains was missed,Reuters reports. Pfizer, however, maintains overall data shows the vaccine was more effective than the original Prevnar.

The new version would immunize infants and toddlers against 13 forms of pneumococcal disease, the new service notes, adding that Prevnar 13 is one of the most important products in the pipeline that Pfizer acquired from Wyeth this year. The original Prevnar vaccine has annual sales of about $3 billion and fights seven strains of pneumoccocal disease.

Wyeth studied whether levels of antibodies that fight infection were equivalent, or "non-inferior," between Prevnar and Prevnar 13, Reuters writes. For three of the types, "the non-inferiority criterion was not met" for some people in the study, FDA reviewers wrote in their analysis. In its own summary, Pfizer said the vaccine provides a substantial benefit to "elicit immune responses" to all 13 strains.

Emilio Emini, Pfizer's chief scientific officer for vaccine research, noted this is the same data that was reviewed by the European Medicines Agency, which recommended approval of the vaccine in Europe, although a final decision from the European Commission is still pending, Reuters reminds us. Pfizer, by the way, plans to seek regulatory approval next year to market the vaccine for treating adults.