The FDA wants influenza-vaccine manufacturers to accelerate the development of new vaccines for seasonal and pandemic viruses. In an effort to help move the process forward, the agency has issued a set of recommendations. The draft documents provide manufacturers with guidelines on developing and submitting clinical data to demonstrate safety and effectiveness for new vaccines.
One document is geared toward seasonal-fluvaccine makers, and the other document is aimed at developing a vaccine for pandemic influenza. The FDA documents inform manufacturers that already have a license to sell seasonal vaccines to submit a supplemental license for a pandemic vaccine. Companies that already manufacture a seasonal vaccine could take a pandemic strain and basically substitute that into a seasonal vaccine, explained Jesse Goodman, MD, the FDA's director of the Center for Biologics Evaluation and Research.
The documents also detail the process for the FDA's accelerated-review practice. A faster review process can cut 1 to 2 years off the vaccine development and approval process. Dr. Goodman said that the process permits companies to submit clinical data demonstrating that patients developed an immune response to the vaccine, rather than waiting for clinical data to indicate that the vaccine actually prevents the flu. The flu-prevention data would still be mandatory; however, the data could be submitted after the vaccine is already on the market. Currently, seasonal-influenza-vaccine makers are working on vaccines based on the H5N1 avian-flu strain in the event that the virus mutates and begins spreading among humans.
One study linked multiple pregnancies to an increased risk of developing atrial fibrillation later in life, and another investigated the association between premature delivery and cardiovascular disease.
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