Moderna Applies for Emergency F.D.A. Approval for Its Corona
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Moderna announced highly encouraging results on 30th November showing its vaccine to be 94.1 % effective. They applied to the Food and Drug Administration to authorize the vaccine for emergency use and that if approved, injections for Americans could begin as early as Dec. 21.

Pfizer applied on November 20 with data showing similarly high efficacy. In its Phase 3 clinical trial, the vaccine proved to be 95% effective.

The new data from Moderna show that its study of 30,000 people has met the scientific criteria needed to determine whether the vaccine works. The findings from the full set of data match an analysis of interim data released on Nov. 16.

The vaccines are given in two doses with few weeks gap in between and it might cause side effects such as fever or bodyache. Both Pfizer and Moderna use messenger RNA to elicit an immune response in the human body.

The FDA is scheduled to meet with its Vaccines and Related Biological Products Advisory Committee regarding Pfizer's (Dec 10) and Moderna's (Dec 17) application. Offit, who is a member of that panel, said it will be important to look and see why some people still got Covid-19 even after being vaccinated.

If the emergency use authorization is granted, the next steps would be about who should get the shots first. After the CDC issues those recommendations, shots can go into arms.

By the end of 2020, Moderna expects to have approximately 20 million doses of its vaccine available in the United States, and it's on track to manufacture 500 million to 1 billion doses globally next year.

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Dec 1, 2020Like