Novavax’s Vaccine Switched Manufacturing Facilities Multiple Times Prior To EUA
One switch raised questions, but by the time the COVID-19 vaccine reached commercial scale, the changes were considered minor.
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CBER’s Marks said US FDA is working with Novavax on manufacturing to allow its protein-based vaccine to be ready for a fall roll-out. After some concerns about international coordination, multiple regulators seem to be settling on a monovalent approach for fall vaccinations.
But agency assessors also said there did not appear to be a biological reason for the vaccine to cause depression when granting the emergency use authorization for use of the Novavax vaccine in 12- to 17-year-olds.
Providers will have to look up the expiration date for vials of the protein-based vaccine on a website because it is not printed on the carton or packaging; omission sparks ACIP members’ frustrations with FDA and manufacturers about inadequate packaging for some other recently authorized vaccines.