FDA, COVID 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Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration.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,
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.
Preliminary data from researchers in China suggest the NB.1.8.1 variant is not better at evading the immune system compared to other strains on the rise, but it does have a greater ability to bind to human cells, suggesting it could be more transmissible.
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,
Moderna has withdrawn the Biologics License Application (BLA) for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after
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.