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Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,
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.
Dr. Peter McCullough testified Thursday at a Senate hearing on "The Corruption of Science and Federal Health Agencies: How Health Officials Downplayed and Hid Myocarditis and Other Adverse Events Associated with the COVID-19 Vaccines.
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration.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 FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.
The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from yesterday.
The question weighing on Moderna and other Covid-19 vaccine stocks in recent weeks has been whether the FDA will require drugmakers to run a new randomized, controlled trial befor