FDA Proposes New Vaccine Approval Process for Pandemics

Due to concerns about the H5N1 avian virus, which has been shown to spread to humans, the U.S. Food and Drug Administration (FDA) has proposed a new approach to pandemic vaccines.
At the Vaccines and Related Biological Products Advisory Committee meeting on Thursday, Jerry Weir, director of the FDA’s Division of Viral Products, asked the 11 committee members to discuss changes to the influenza vaccine strain change process.
Under the current plan, vaccines would be developed before a pandemic to target specific high-risk viruses.
These vaccines can be released if a pandemic occurs, assuming they are safe because they follow established manufacturing processes. New seasonal influenza vaccines have an established manufacturing process of being produced in eggs or in cell lines….