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Moderna submits vaccine to FDA for emergency use authorization

Now the second vaccine to have reached this point in development, Moderna's product will now be reviewed by the FDA, a process which could take just over a month.

Leonardo Briceno The Post Millennial
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Moderna submitted its candidate for a COVID-19 vaccine to the United States Food and Drug Administration on Monday for emergency use authorization. Now the second vaccine to have reached this point in development, Moderna's product will now be reviewed by the FDA, a process which could take just over a month.

The biotech firm, one of the many participants in the Trump administration’s Operation Warp Speed, reports a 94.1 percent success rate against the virus after having completed phase three testing, according to NBC News.

Stéphane Bancel, the Chief executive at Moderna, said that he expects the vaccine to serve as an effective weapon in the fight against COVID-19.

"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," Bancel said.

If a review by the FDA goes favorably, a meeting could be set up as soon as December 17 to discuss the findings. NPR reports that a green light could then be provided for the vaccine's use.

With over $2.84 billion dollars of federal investment behind it, Moderna is on the frontlines of vaccine development. Pfizer, who submitted their candidate on November 20, is the only other vaccine developer to have reached this stage of the approval process with the FDA.

Pfizer's vaccine is also pending the FDA's approval. Astrazeneca, in partnership with Oxford University, is a third vaccine development team to have reached phase three testing. At this time, Astrazeneca has not submitted its product for review due to some discrepancies in its testing results.

Already, Moderna’s vaccine has sparked international demand. The UK has preemptively purchased seven million doses of the vaccine and is likely to continue to up its numbers if the candidate receives approval.

The company's latest findings come after a testing process which included over 30,000 participants in the late-stage trials. Of 196 confirmed Covid cases, 185 were in the placebo group versus 11 in the vaccine group. From those numbers, testing indicated the vaccine had achieved a success rate above 94 percent.

Bancel knows there has been a lot of questions about how a vaccine would be distributed and whether or not the public would embrace one even if it were provided to them.

"As you know a lot of people have been reluctant in surveys to take a vaccine because I think we're worried about the politicization of a vaccine, they're worried about what you get with a flu shot you know 50% to 60% efficacy," Bancel said.

He believes that the 94 percent success rate behind Moderna's candidate will be a great cause for relief once the vaccine is distributed.

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