FDA, COVID and vaccine
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Moderna had designs on releasing a combined influenza and covid-19 vaccine after some promising trials, but this week the drugmaker said it would withdraw its application seeking approval from the U.S.
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration. The company said it would resubmit the application later this year with vaccine efficacy data from a late-stage trial of its experimental seasonal influenza vaccine,
The advisory committee, which met after the agency rolled out new vaccine guidelines, said companies should tailor their booster doses to the “JN.1” coronavirus lineage.
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,
The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from yesterday.
The Trump administration shared the outlines of how it plans to push drug companies to lower their prices in the U.S.