FDA, COVID
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In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people getting the shot each year. “There may even be a ripple effect: public trust in vaccination in general has declined,” it says.
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.
Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.
The FDA has approved the Novavax COVID-19 vaccine, called Nuvaxovid, mainly for adults 65 or older, but people ages 12 to 64 with medical conditions that increase their risk of serious illness from COVID can also get the shot.
The U.S. Food and Drug Administration approved Novavax's COVIDd-19 vaccine with age restrictions after a six-week delay.
Key Takeaways Novavax received Food and Drug Administration approval for its new, protein-based COVID-19 vaccine.The shot, Nuvaxovid, is designed for older adults and those between the ages of 12 and 64 who have underlying conditions that puts them at higher risk from the disease.
Top officials in the Trump administration on Tuesday announced they will limit the approval of new COVID-19 vaccines to adults over 65 and people who are high risk. The move is a significant shift
Top officials for the FDA laid out new requirements limiting access to yearly COVID shots for healthy younger adults and children. Annual […]
In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the Center for Biologics Evaluation and research at the FDA, and Dr. Martin Makary, FDA commissioner, explained their plan for how the FDA will evaluate and recommend COVID-19 vaccines going forward.
Novavax shares surged more than 17% before the bell on Monday, following the long-delayed approval of its COVID-19 vaccine from the U.S. health regulator, albeit with new conditions.
WASHINGTON — 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.