FDA will OK updated COVID vaccines for some
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The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit future shots to older Americans and people at higher risk of serious Covid-19 infection.
19hon MSN
The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the virus, and those older than age 65.
Moderna filed for FDA approval of its mRNA-1083 combination shot last year. The submission put the biotech on track to win approval in adults aged 50 and older in November 2025. However, at the start of May, Moderna pushed back the expected approval date to 2026 after the FDA asked to see phase 3 efficacy before making a decision on authorization.
President Donald Trump’s administration is slated to lay out its approach to Covid vaccination at an event Tuesday that could spell major changes in what is required to get regulatory approval for immunizations.