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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41 Articles
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After delay, FDA approves Novavax’s Covid-19 vaccine, but only for older people and those at high risk | News Channel 3-12
By Katherine Dillinger, CNN (CNN) — After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter from the agency, but only for people 65 and older and those 12 and up who have at least one underlying condition that puts them at higher risk of severe illness. “Market research and US C.D.C. statistics indicate that older individuals and those with underlying conditions are the populatio…
After delay, FDA approves Novavax’s Covid-19 vaccine, but only for older people and those at high risk
By Katherine Dillinger, CNN (CNN) — After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter from the agency, but only for people 65 and older and those 12 and up who have at least one underlying condition that puts them at higher risk of severe illness. “Market research and US C.D.C. statistics indicate that older individuals and those with underlying conditions are the populatio…
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