Novavax Wins Limited FDA Nod For COVID Shot—Cleared Only For Seniors, High-Risk Groups Amid Safety Scrutiny

The U.S. Food and Drug Administration has granted limited approval to Novavax Inc.’s NVAX COVID-19 vaccine, restricting its use to people 65 and older and those 12 and up with underlying health conditions that increase the risk of severe illness.

What Happened: The decision follows a six-week delay during which regulators sought additional data about the protein-based vaccine, which differs from the mRNA technology used by Pfizer Inc. PFE and BioNTech SE BNTX, reported CNN.

“This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option,” Novavax President and CEO John Jacobs said in a statement Saturday.

The FDA is requiring Novavax to conduct postmarketing studies examining the risk of myocarditis and pericarditis—heart inflammation conditions rarely reported after COVID-19 vaccination. While a handful of cases were reported in trials, the CDC maintains that vaccination benefits outweigh these rare risks.

Why It Matters: The approval comes amid shifting political winds at the FDA, where Commissioner Marty Makary previously characterized updated COVID vaccines as “new products” requiring fresh clinical trials. In April, Makary tweeted: “Under this administration, we are prioritizing the Gold Standard of Science—not what saves pharma.”

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President Donald Trump administration appointees had directed a pause on Novavax’s application despite it being on track for approval by April 1, according to the Associated Press.

Earlier studies showed Novavax’s 2024-2025 formula targeting the JN.1 strain produced fewer and less severe side effects compared to mRNA alternatives. In the SHIELD-Utah study, Novavax recipients experienced 1.7 symptoms on average versus 2.8 symptoms for Pfizer-BioNTech recipients.

The CDC’s vaccine advisers are currently considering changes to guidance for annual COVID-19 shots, potentially focusing recommendations on older adults, immunocompromised individuals, and those with higher exposure risks, the report noted.

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