FDA, COVID-19 and Vaccine
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Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration.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,
U.S. health officials knew about the risks of myocarditis from COVID-19 vaccines but downplayed the concern and delayed informing the public about the risks of taking the jab, according to a new Senate report released by Sen.
The mRNA vaccines were developed using novel technology that was approved for the first time for public use during the COVID-19 pandemic.
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,
Federal health agencies were alerted in February 2021 to "large reports of myocarditis" in young people who received the Pfizer vaccine, but waited until late June to adjust the vaccine labels to make that side effect known.
On May 20, U.S. Food and Drug Administration (FDA) officials announced that Covid-19 vaccines will no longer be available to everyone. Instead, annual boosters will be limited to people ages 65 and older, and those with certain medical conditions that put them at high risk for severe infection.