Moderna to ask FDA for emergency use authorization

All Patriot NewsNovember 30, 20204min

Moderna announced that it would seek an emergency use authorization, or EUA, from the Food and Drug Administration on Monday after its phase three study found its coronavirus vaccine candidate to be 94{3c673d3ab703a335aa2de9fb6bc2c1f473b2ba555cfc5936ab3ce7b22bef001e} effective.

Moderna said its vaccine was 100{3c673d3ab703a335aa2de9fb6bc2c1f473b2ba555cfc5936ab3ce7b22bef001e} effective at preventing severe cases of COVID-19.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1{3c673d3ab703a335aa2de9fb6bc2c1f473b2ba555cfc5936ab3ce7b22bef001e} 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,” said Moderna CEO Stephane Bancel. “We will file today for an Emergency Use Authorization from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe.”

The drug-maker will submit the data from its phase three study, which involved 30,000 participants and was conducted in collaboration with the National Institute of Allergy and Infectious Diseases, to a peer-reviewed publication.

At the conclusion of the study, participants reported 196 cases of COVID-19. According to analysis, 185 of those cases were participants who received a placebo, while 11 cases were participants who received the vaccine candidate. The trial also reported 33 severe cases of COVID-19, all of which were found in participants who had been given a placebo. There was one reported death in the placebo group.

In addition to the EUA, Moderna will submit an application for Conditional Marketing Authorization with the European Medicines Agency and has already begun the review processes for authorization in the United Kingdom, Canada, Israel, and Singapore. Moderna will seek prequalification and/or emergency use listing with the World Health Organization.

Moderna’s hearing with the FDA will likely be on Dec. 17, one week after Pfizer has a hearing for its EUA application. Pfizer announced earlier this month that its vaccine candidate was 95{3c673d3ab703a335aa2de9fb6bc2c1f473b2ba555cfc5936ab3ce7b22bef001e} effective at preventing COVID-19.

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Source : Moderna to ask FDA for emergency use authorization