FDA wants panel to probe Pfizer vaccine efficacy

WASHINGTON — Pfizer Inc's next-generation Prevnar vaccine missed some of the main goals in a study testing its ability to protect against bacteria that cause ear infections, pneumonia and other diseases, U.S. reviewers said in documents released Nov. 16, Reuters reported.

Pfizer said the overall data showed the experimental Prevnar 13 shot was effective against a wider range of illness than the original vaccine and the company would make that case to an advisory panel that meets on Wednesday.

The new version is designed for immunizing infants and toddlers against 13 forms of a bacterium called streptococcus pneumoniae, or pneumococcus, which cause an array of illnesses.

The vaccine was the most important product in the pipeline of Wyeth, which Pfizer recently acquired. The Food and Drug Administration is weighing whether to approve Prevnar 13 for sale.

The original Prevnar was introduced in 2000 and has annual sales approximately $3 billion. It fights seven pneumococcal types.

Wyeth studied whether levels of antibodies that fight infection were equivalent, or "non-inferior," between Prevnar and Prevnar 13.

For three of the types, "the non-inferiority criterion was not met" for some people in the study, FDA reviewers said in an analysis prepared for an outside advisory committee.

The reviewers said they would ask the advisory panel about the clinical trial findings.

Pfizer, in a separate summary also released by the FDA, said overall results showed Prevnar 13 provided "a real and substantial benefit given its demonstrated ability to elicit immune responses" to each of the 13 types.

The company also said the vaccine was "well tolerated and as safe as Prevnar."

Dr. Emilio Emini, Pfizer's chief scientific officer for vaccine research, said World Health Organization guidelines for testing pneumococcal vaccines state that reaching all of the non-inferiority goals is not a requirement if other measures are achieved.

Emini said the data under FDA review was the same that was scrutinized by the European Medicines Agency, which recommended approval of the vaccine in Europe. A final decision from the European Commission is still pending.

Wyeth had been due to receive a decision in the United States in September, but the company announced in August the review was extended by three months to Dec. 30.

Prevnar 13 also is being studied for potential use in adults, a new indication that could accelerate already booming sales of the franchise.

Wyeth expects to seek regulatory approvals in 2010 to market Prevnar 13 to adults. Pneumonia caused by the pneumococcal organism is one of the biggest causes of death in older individuals and its incidence begins to increase when one is about 50 years old and increases rapidly thereafter as the immune system weakens.

GlaxoSmithKline Plc has a rival vaccine, called Synflorix, that is active against 10 strains. Synflorix is approved in Europe and some other markets, but not the United States.