FDA sets advisory meeting date to discuss Moderna COVID-19 vaccine

By The Science Advisory Board staff writers

December 1, 2020 -- The U.S. Food and Drug Administration (FDA) has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for December 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine candidate from Moderna.

The committee will discuss the safety and effectiveness data provided by Moderna. The company submitted its EUA request for the messenger RNA (mRNA)-1273 vaccine candidate on November 30.

The agency plans to make background materials available to the public, including the agenda and committee roster. The committee will be composed of a chair, members with scientific and public health expertise, consumer and industry representatives, and potentially a patient representative. The committee will advise the agency, however the final decision on whether to authorize the vaccine for emergency use will be made by the FDA.

The FDA will livestream the VRBPAC meeting on its YouTube, Facebook, and Twitter channels, as well as from the FDA website.

Moderna to file COVID-19 vaccine EUA request
Moderna said it plans to request on November 30 an emergency use authorization (EUA) from the U.S. Food and Drug Administration and conditional marketing...
Moderna expands COVID-19 vaccine supply agreement with U.K.
Moderna has announced a supply agreement with the U.K. government for an additional 2 million doses of messenger RNA (mRNA)-1273, the company's...
EC secures 80M doses of Moderna COVID-19 vaccine
Moderna has announced that the European Commission (EC) has agreed to secure 80 million doses of its COVID-19 vaccine messenger RNA (mRNA)-1273.
Moderna reports EMA review of COVID-19 vaccine candidate, U.K. supply deal
Moderna said that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use has initiated a rolling review of the firm's messenger...
Moderna reports 94.5% efficacy for COVID-19 vaccine
A COVID-19 vaccine under development by Moderna had 94.5% efficacy in a phase III clinical trial, according to an independent data safety monitoring board...

Copyright © 2020 scienceboard.net


Register below for our weekly Letter from the Editor to receive the latest Science news and insights.
Email
Connect
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter