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Moderna Files For Emergency FDA Approval

By 12/01/2020 6:30 PMNo CommentsBy YidInfo Staff

On Monday, Moderna submitted it’s 94% efficacious vaccine candidate for approval from the Food and Drug Administration, in anticipation of an emergency use authorization from the agency. 

A week after the Massachusetts biotech firm reported the findings of its Phase 3 trials to be 94.1 percent effective against Covid-19 and 100 percent effective at preventing severe cases of the disease, Moderna officially filed for emergency use authorization yesterday, passing another major milestone in the run for the coronavirus vaccine. 

Source: The Seattle Times

Moderna said it expects the FDA’s Vaccines and Related Biological Products Advisory Committee to convene on Dec. 17 to discuss its submission. That is a week after the FDA is expected to discuss another candidate, developed by the U.S. pharma giant Pfizer and its German partner BioNTech, which has also applied for regulatory approval having observed a similar level of efficacy, standing at 95%. 

To understand the fast approval better, the emergency use authorization (EUA) is a mechanism that allows drugs, vaccines, and other medical interventions to come to market much quicker than they normally would. According to the FDA, “Under a EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.”

Source: TrialSite News

This being said, both Pfizer and Moderna have made vaccines that feature the use of the mRNA being injected into the body. An mRNA-based drug has ever won approval before, which might make it crucial for the approval to be a well-deliberated one. 

In a statement announcing the application on Monday, Moderna CEO Stéphane Bancel said, “This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death.”

If the EUA is approved by the 17th of December, up to 20 million doses could be administered across the US by the end of December. The deployment will first be made to the front-line medical workers and at-risk citizens, including senior citizens. Moderna says it expects to manufacture 500 million to 1 billion doses of its vaccine globally in 2021.



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