The FDA wants influenza-vaccine manufacturersto accelerate the development of new vaccines forseasonal and pandemic viruses. In an effort to helpmove the process forward, the agency has issueda set of recommendations. The draft documentsprovide manufacturers with guidelines on developingand submitting clinical data to demonstratesafety and effectiveness for new vaccines.
One document is geared toward seasonal-fluvaccinemakers, and the other document isaimed at developing a vaccine for pandemicinfluenza. The FDA documents inform manufacturersthat already have a license to sell seasonalvaccines to submit a supplemental license fora pandemic vaccine. Companies that alreadymanufacture a seasonal vaccine could take apandemic strain and basically substitute thatinto a seasonal vaccine, explained JesseGoodman, MD, the FDA's director of the Centerfor Biologics Evaluation and Research.
The documents also detail the process for theFDA's accelerated-review practice. A fasterreview process can cut 1 to 2 years off the vaccinedevelopment and approval process. Dr.Goodman said that the process permits companiesto submit clinical data demonstrating thatpatients developed an immune response to thevaccine, rather than waiting for clinical data toindicate that the vaccine actually prevents theflu. The flu-prevention data would still bemandatory; however, the data could be submittedafter the vaccine is already on the market.Currently, seasonal-influenza-vaccine makersare working on vaccines based on the H5N1avian-flu strain in the event that the virusmutates and begins spreading among humans.