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FDA Reconsiders Moderna's mRNA Flu Vaccine Approval

2/18/2026

Summary

Story summary

The U.S. Food and Drug Administration (FDA) has reversed its decision and is now considering Moderna, Inc.'s mRNA flu vaccine.
FDA officials, including Commissioner Dr. Marty Makary, say the agency may approve the vaccine later.
The rejection stemmed from concerns about the control product used in trials, which Moderna disputes, claiming FDA agreements supported their plan.
The ongoing dialogue highlights tensions between the agency and Moderna over vaccine approval processes.

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Story summary

The U.S. Food and Drug Administration (FDA) has reversed its decision and is now considering Moderna, Inc.'s mRNA flu vaccine.
FDA officials, including Commissioner Dr. Marty Makary, say the agency may approve the vaccine later.
The rejection stemmed from concerns about the control product used in trials, which Moderna disputes, claiming FDA agreements supported their plan.
The ongoing dialogue highlights tensions between the agency and Moderna over vaccine approval processes.