FDA will limit approval for seasonal COVID vaccines
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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.
A day after the FDA tightened the restrictions for winning vaccine approvals, Moderna Inc. is pulling its application for approval of its flu-Covid combination vaccine.
The article summarizes recent health news, highlighting Mexico's suspension of poultry imports from Brazil due to bird flu, FDA's conditions on the Novavax COVID vaccine, and the approval of Amneal’s migraine treatment.
Former government health officials fear the Trump administration ... it responded to an earlier FDA request to commit to providing more data on the vaccine if approved — a standard practice.
FRIDAY, April 25, 2025 (HealthDay News) — Novavax’s COVID-19 vaccine could soon receive full approval from the U.S. Food and Drug Administration (FDA), the ... much like how flu shots are ...