Cold feet at FDA over Cervarix approval?

The prospect of approving Cervarix for a broad audience in the U.S. may be leading to a bad case of cold feet at the FDA. The agency's Office of Vaccine Research & Review deputy director Florence Houn has expressed her own concerns that the agency doesn't fully understand the mechanism of adjuvants in immune response. But Houn has also pointed out the FDA's growing interest in risk management plans, pointing out that Acambis' smallpox vaccine comes with a full RiskMap program even though it is being restricted to a military population. A similar approach to Cervarix in a broad population may be expensive, but necessary to gain approval.

- read the story in In Vivo

ALSO: Sanofi Pasteur has been pitching European investors on the notion that Gardasil is more effective than Cervarix. Didier Hoch, head of a joint venture between Sanofi-Aventis and Merck, has dismissed Glaxo's head-to-head comparison study as "a marketing gimmick." Report

PLUS: Sanofi has released new data covering 20,000 women involved in Phase II/III trials for Gardasil. Researchers say that the vaccine has sustained efficacy in preventing precancerous cervical lesions in 98 percent to 100 percent of the women involved. Report

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.