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From AP News: 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 health problem that puts them at increased risk from COVID-19.
Vaccines made by Novavax’s competitors Pfizer and Moderna already are fully licensed for use in anyone 12 and older, and also are authorized for use in children as young as 6 months.
“Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option,” Novavax chief executive John C. Jacobs said.
In its Friday approval letter, the FDA failed to provide any explanation for the restrictions. There was some indication in the letter, however, as it referenced skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other officials.
Novavax demonstrated the safety and efficacy of its vaccine in a clinical trial involving 30,000 individuals. According to two individuals with direct knowledge of the matter, who spoke on condition of anonymity to discuss confidential agency matters, the FDA was on track to grant Novavax full approval without any restrictions by its April 1 target date.
Novavax later announced that in a usual move, the FDA had instead requested it to conduct an additional trial following approval. The FDA ordered wants them to examine whether the vaccine may be associated with certain heart conditions. Another required study must assess the benefits of continuing vaccination in individuals aged 50 to 64 who do not have health conditions that increase their risk from COVID-19.
Here’s more about today’s approval of the Novavax vaccine.
In addition to the restrictions now on people 18 to 64, they’re also requesting Novavax do a study of healthy people with a placebo arm. pic.twitter.com/wBFeWZfXDB
— M. Elisabeth (@ChildrenNeedUs_) May 18, 2025
Here’s more about today’s approval of the Novavax vaccine.
In addition to the restrictions now on people 18 to 64, they’re also requesting Novavax do a study of healthy people with a placebo arm. pic.twitter.com/wBFeWZfXDB
— M. Elisabeth (@ChildrenNeedUs_) May 18, 2025
READ MORE at AP News.
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