FDA delays decision on Wyeth vaccine

Wyeth late yesterday said the Food and Drug Administration had delayed approval of Prevnar 13, a vaccine that is one of the primary drivers behind the company's anticipated $68 billion merger with Pfizer Inc.

Wyeth said the 90-day delay would have no impact on its acquisition by Pfizer and also said it still expects the FDA to approve Prevnar 13. The agency delayed the approval date from Sept. 30 to Dec. 30 after Wyeth submitted new information about how it was measuring and validating the vaccine's physical and chemical properties.

"This has no bearing on our discussions with Pfizer," Wyeth spokesperson Natalie de Vane said. "The decision has nothing to do with clinical data, nothing to do with safety and efficacy or with manufacturing capabilities."

Pfizer also said the news had no bearing on the merger. Delays in approval are common at the FDA.

An approved version of Prevnar, which protects children against meningitis and other diseases caused by pneumococcal bacteria, accounts for $2.7 billion in yearly sales. Analysts have estimated that figure could soar to $6 billion or $7 billion if Wyeth got FDA approval for a new version, which would expand the number of pneumococcal strains that the vaccine protects against from seven to 13.

Wyeth is based in Madison, N.J., but employs several thousand people in Collegeville and Malvern.

The pharmaceutical industry has refocused efforts on vaccines because they are difficult to manufacture, leaving them less vulnerable to generic competition. That is especially appealing to New York-based Pfizer, which is facing patent expiration on its best-selling cholesterol drug Lipitor.

"Prevnar 13 is a very crucial element in the Pfizer acquisition," said Daniel Hoffman, a Chester County consultant to the pharmaceutical industry.