FDA 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.
116 Articles
116 Articles
FDA Approves Novavax COVID-19 Shot with Restrictions
The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions.Novavax makes the nation’s only traditional protein-based coronavirus vaccine – and until now it had emergency authorization from FDA for use in anyone 12 and older.But late Friday, the FDA granted the company full approval for its vaccine for use only in adults 65 and older – or those 12 to 64 who have at least one hea…
"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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