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January 18, 2022 10:12pm
This new COVID-19 vaccine (mRNA-1273) candidate was deemed highly effective by an FDA advisory committee.
Moderna’s vaccine candidate for the coronavirus disease 2019 (COVID-19) has been recommended for Emergency Use Authorization (EUA) by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), according to the company.1 This new COVID-19 vaccine (mRNA-1273) candidate was deemed highly effective in a filing released by the VRBPAC on Tuesday.2,3
“We have been working with the [CDC] and Operation Warp Speed to prepare for the distribution of mRNA-1273, if the FDA chooses to grant an [EUA]. We look forward to getting our vaccine to people in the US to help address this ongoing public health emergency,” said Stéphane Bancel, CEO of Moderna, in a prepared statement released Thursday.1
On Thursday, 20 VRBPAC members voted in favor of the recommendation with no members voting against it, and 1 member abstained, according to Moderna. Although the VRBPAC’s recommendation is nonbinding, the FDA will take it into consideration in making a final decision on granting an EUA.1
The FDA previously approved an EUA application for the first COVID-19 vaccine to be distributed in the United States. The BNT162b2 vaccine was jointly developed by Pfizer and BioNTech.4
In addition to announcing the VRBPAC's recommendation, Moderna announced Friday a purchase of additional 80 million doses of mRNA-1273 by the European Commission (EC). The additional doses bring the EC’s confirmed order commitment to 160 million doses, which will commence from the company’s dedicated European supply chain, according to Moderna.5