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Tags: Coronavirus | Health Topics | Vaccines | Moderna | Vaccine | BoosterShot | FDA

Moderna Completes Submission to FDA for COVID-19 Booster

Moderna Completes Submission to FDA for COVID-19 Booster
(Joseph Prezioso/AFP via Getty Images)

By    |   Friday, 03 September 2021 04:13 PM

Moderna has completed a submission to the U.S. Food and Drug Administration to evaluate a booster dose of its COVID-19 vaccine, the company announced on Friday.

''We are pleased to announce that today we completed our submission to the U.S. FDA, which we began on Wednesday, for the evaluation of a booster dose of the Moderna COVID-19 vaccine,'' the company tweeted Friday afternoon.

As the company noted, it asked the FDA earlier this week to authorize a 50 microgram dose, which is half the dosage of the first two shots of the Moderna vaccine, according to The Wall Street Journal, which added that sources said that no decisions have been made, as the agency is reviewing data collected in several studies on booster shots.

Moderna CEO Stéphane Bancel said in a statement on Wednesday: ''We are pleased to initiate the submission process for our booster candidate at the 50 µg dose with the FDA. Our submission is supported by data generated with the 50 µg dose of our COVID-19 vaccine, which shows robust antibody responses against the Delta variant.

"We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2. We will continue to generate data and transparently share to support governments and regulators as they make evidence-based decisions regarding future vaccination strategies.''

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Moderna has completed a submission to the U.S. Food and Drug Administration to evaluate a booster dose of its COVID-19 vaccine, the company announced on Friday.
Moderna, Vaccine, BoosterShot, FDA
218
2021-13-03
Friday, 03 September 2021 04:13 PM
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