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.
The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration.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,
Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter.
The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from yesterday.
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,
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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.