Moderna submits data to FDA for COVID booster approval

Drug maker second after Pfizer to seek approval for third dose

FILE - In this Tuesday, July 27, 2021 file photo, a medical worker prepares a shot of the Moderna vaccine during a vaccination campaign at Saint Damien Hospital in Port-au-Prince, Haiti. In late June, the international system for sharing coronavirus vaccines sent about 530,000 doses to Britain more than double the amount sent that month to the entire continent of Africa. It was the latest example of how a system that was supposed to guarantee low and middle-income countries vaccines is failing, leaving them at the mercy of haphazard donations from rich countries. (AP Photo/Joseph Odelyn, file) (Joseph Odelyn, Copyright 2021 The Associated Press. All rights reserved)

Moderna submitted data to the U.S. Food and Drug Administration on Wednesday for a booster dose of its COVID-19 vaccine.

This step makes Moderna the second vaccine maker — following Pfizer-BioNTech — to submit an application for a third dose of its vaccine.

In August, the company submitted its application for full approval. Prior to Moderna submitting the application, the company announced its vaccine showed 93% efficacy up to six months after the second dose.

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“We remain committed to staying ahead of the virus and following the evolving epidemiology of COVID-19,” Moderna CEO Stéphane Bancel said.

The company shared data from a Phase 2 study offering a booster to 344 interested people six months after their second dose, saying “the antibodies appeared to be active against variants including beta, gamma and delta.”

About 370 million doses of the COVID-19 vaccine have been given across the U.S. as of Tuesday with an average of 899,000 doses being administered each day.