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Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration.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.
The rollout of updated Covid vaccines for healthy children and adults this fall is likely to be delayed after the FDA said it will require another clinical trial.
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,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.
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Live Science on MSN2-in-1 COVID-flu vaccine looks promising in trial — but experts say approval may be delayedLate-stage trial data suggest that a new COVID-flu vaccine offers good protection against both infections, but experts expect the shot's approval may be delayed.
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MySuncoast.com on MSNNew Novavax Covid -19 vaccine tailored for patients 65 and olderAfter a six-week long delay, The Food and Drug Administration (FDA) has finally approved a more traditional protein-based covid vaccine produced by pharmaceutical giant Novavax.