Moderna’s COVID-19 Vaccine Receives FDA Committee Recommendation for Emergency Use

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

REFERENCES

1. Moderna Receives FDA Advisory Committee Vote Supporting Emergency Use for Moderna’s Vaccine Against COVID-19 in the United States [news release]. Cambridge, MA; December 17, 2020: Moderna. Accessed December 17, 2020. https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-advisory-committee-vote-supporting
2. FDA Briefing Document: Moderna COVID-19 Vaccine. FDA Vaccines and Related Biological Products Advisory Committee. Published December 15, 2020. Accessed December 17, 2020. https://www.fda.gov/media/144434/download
3. Moderna COVID-19 Vaccine Shows High Efficacy, Clearing Path for EUA. Pharmacy Times®. Published December 15, 2020. Accessed December 17, 2020. https://www.pharmacytimes.com/news/moderna-covid-19-vaccine-shows-high-efficacy-clearing-path-for-eua
4. FDA Grants Historic Emergency Use Authorization to COVID-19 Vaccine From Pfizer and BioNTech. Pharmacy Times. Published December 12, 2020. Accessed December 18, 2020. https://www.pharmacytimes.com/news/fda-grants-historic-emergency-use-authorization-to-covid-19-vaccine-from-pfizer-and-biontech
5. European Commission exercises option for additional 80 million doses of Moderna’s COVID-19 vaccine candidate [news release]. Cambridge, MA; December 18, 2020: Moderna. Accessed December 18, 2020. https://investors.modernatx.com/news-releases/news-release-details/european-commission-exercises-option-additional-80-million-doses