US EditionFDA approves Novavax COVID-19 shot but with unusual restrictions
- The FDA approved Novavax's Covid-19 vaccine late Friday for people 65 and older and those 12 to 64 with high-risk conditions.
- This approval follows a six-week delay and an April 1 missed deadline as the FDA sought more data and faced internal skepticism.
- Novavax’s vaccine, a protein-based alternative to mRNA vaccines from Pfizer and Moderna, was tested in a 30,000-person trial demonstrating safety and effectiveness.
- The FDA imposed restrictions not placed on competitors and required postmarketing studies to examine rare heart inflammation risks after vaccination.
- The approval marks a key step for Novavax toward expanding vaccine options for populations most likely to seek seasonal Covid-19 vaccination.
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"Today's approval consolidates the access of Americans aged 65 and over, and those aged 12 to 64 and suffering from co-morbidity exposing them to a high risk of serious Covid-19, to a vaccine (...) without mRNA," says Novavax president, the pharmaceutical laboratory developing the vaccine.
FDA's Approval of Novavax's COVID Vaccine Has a Lot of Caveats
This weekend, the FDA released its recommendation for Novavax, a vaccine designed to combat COVID-19. That in itself is not unusual; with this approval, Novavax joins the likes of vaccines from Pfizer and Moderna that have a similar purpose. As the Associated Press’s Lauran Neergaard reported, this particular vaccine approval comes with a lot more caveats than its peers.As the Associated Press noted, this approval replaces the emergency authoriz…
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FDA Gives Full OK to Novavax COVID Shot for High-Risk Groups
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