COVID, Moderna and FDA
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Moderna on Thursday pushed back the time frame for likely approval of a combination vaccine meant to protect against both COVID-19 and influenza, but said exchanges with U.S. drug regulators have remained constructive under Health Secretary and vaccine skeptic Robert F.
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 isn’t giving up on the combo shot entirely—it plans to resubmit later this year after it collects more data from its Phase III trials, which test how well a new treatment works compared to existing options.
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration.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,
Infectious disease experts say mRNA vaccines have been studied for decades, they are safe and effective, and were instrumental in saving lives during the COVID pandemic.
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Moderna has withdrawn the Biologics License Application (BLA) for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after
In terms of liquidity and interest, the mean open interest for Moderna options trades today is 1389.55 with a total volume of 16,975.00.
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