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Moderna requests FDA grant priority review to its COVID-19 vaccine

Stéphane Bancel hospital covid-19 vaccine
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CAMBRIDGE, Mass. - Moderna has passed a major milestone on its path to getting its COVID-19 vaccine fully approved by the U.S.

Food and Drug Administration.The pharmaceutical company announced Wednesday that it completed the rolling submission process for its Biologics License Application.

The BLA, which Moderna began on June 1, involves submitting nonclinical and clinical data to support the licensure of the COVID-19 vaccine.Now that it’s complete, Moderna has asked the FDA for priority review.

Once granted, that would allow the FDA to take action within a six-month window, rather than the typical 10-month time frame.In a news release, Stéphane Bancel, Chief Executive Officer of Moderna, said the company began its BLA process in June.

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United States
Cases: 46 252 513
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Deaths: 459 652
Recovered: 0
Brazil
Brazil
Cases: 21 835 785
Deaths: 608 235
Recovered: 0
United Kingdom
United Kingdom
Cases: 9 215 683
Deaths: 141 607
Recovered: 0
Russia
Russia
Cases: 8 494 589
Deaths: 237 619
Recovered: 0
Detail statistic
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