US FDA Wants Global COVID-19 Vaccine Update System, But Says May Not Be Possible
The agency’s Vaccines and Related Biological Products Advisory Committee will consider simplifying and harmonizing the vaccine composition, as well as formalizing a system for likely annual US updates.
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A Milestone Meeting For US FDA: Vaccine Reviews After COVID
The tandem reviews by a US FDA advisory committee of two RSV vaccine candidates from Pfizer and GSK is a milestone event for the agency. They are the first non-COVID vaccine BLAs to go to committee since the pandemic began – and the debut of the new vaccine office leadership at FDA.
US FDA Investigating Concomitant Flu, COVID Vaccine Link To Stroke Safety Signal
No stroke risk has been identified, but FDA and CDC officials want to investigate whether concomitant administration of influenza and COVID-19 vaccines are related to the issue.
FDA’s Cell, Gene Therapy Office Head Wilson Bryan Set To Retire
OTAT Director Bryan, who has worked at the FDA for more than 20 years, will depart by the end of March as the agency’s cell and gene therapy operations are poised for a major overhaul and a large number of new hires.