Novavax’s Vaccine Switched Manufacturing Facilities Multiple Times Prior To EUA
Executive Summary
One switch raised questions, but by the time the COVID-19 vaccine reached commercial scale, the changes were considered minor.
You may also be interested in...
Novavax Readying Multiple COVID-19 Vaccine Candidates To Ensure Fall Availability
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.
Depression And COVID-19 Vaccines: US FDA Notes ‘Imbalance’ In Novavax Trial For Adolescents
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.
ACIP Nod For Novavax’s COVID Vaccine Comes With Criticism On Lack Of Expiration Date Packaging
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.