Uncertainty about Novavax vaccine approval due to new FDA rules.
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The Trump administration wants new rules for Novavax's COVID-19 vaccine. This is causing worry about other vaccine updates, too. Novavax said the FDA wants a new trial after giving full approval, which might not be possible before fall.
An FDA commissioner talked about needing a new trial for yearly updates. Experts worry this means constant trials and outdated vaccines. A former FDA vaccine chief thinks strain changes shouldn't make a vaccine a 'new product'.
These changes at the FDA came after the vaccine chief was forced out. This happened because of disagreements with Health Secretary Robert F. Kennedy Jr. Kennedy promised not to change the vaccine schedule, but he's also questioning vaccine safety.
The Novavax vaccine is currently used under emergency approval. Other vaccines from Pfizer and Moderna have full approval for some groups. Vaccine makers usually change their recipes yearly to target new strains, like with flu vaccines.
The FDA was going to fully approve Novavax, but Trump officials paused the decision. Now, the FDA is discussing new requirements for approval. Experts say the FDA could be sued if it skips steps or adds rules for political reasons.
Questions
What does the Trump administration want for Novavax's COVID-19 vaccine?
The Trump administration wants new rules for Novavax's COVID-19 vaccine.
Why are experts worried about the new trial for yearly updates?
Experts worry this means constant trials and outdated vaccines.
What is the current status of the Novavax vaccine?
The Novavax vaccine is currently used under emergency approval.
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