If granted an EUA by the FDA, mRNA-1273 would become the second COVID-19 vaccine to receive the designation.
This article was updated December 17, 2020 with additional information.
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 were grateful for the opportunity to present the clinical data package for our mRNA vaccine against COVID-19 to the FDA’s advisory committee today. We thank the committee for their review and for their positive recommendation in support of [EUA],” said Stéphane Bancel, CEO of Moderna, in a prepared statement released Thursday. “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.”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
In a statement issued Thursday night, FDA Commissioner Stephen M. Hahn, MD, and Peter Marks, MD, PhD, director, Center for Biologics Evaluation and Research, said the FDA will rapidly work toward finalization and issuance of an EUA for mRNA-1273. According to Hahn and Marks, FDA officials have also notified the CDC and Operation Warp Speed of their work towards EUA for mRNA-1273, for which they can execute plans for vaccine distribution.4
If granted an EUA by the FDA, mRNA-1273 would become the second COVID-19 vaccine to receive the designation. On December 11, 2020, the FDA approved an EUA application for vaccine BNT162b2, jointly developed by Pfizer and BioNTech, which was the first COVID-19 vaccine authorized for use in the United States. Administration of BNT162b2 began on Monday with the initial wave of recipients.3,5
Neither vaccine has been granted FDA approval; however, EUA designation allows these vaccines to be used in addressing a public health emergency.
According to Moderna, the VRBPAC based its recommendation on the totality of scientific evidence shared by the company, which includes a data analysis from the phase 3 COVE study for mRNA-1273.1 The primary efficacy analysis of this clinical trial was conducted on 196 cases and confirms the high efficacy observed at the first interim analysis.3,6 The data analysis indicates a vaccine efficacy of 94.1%. Safety data continue to accrue and the study continues to be monitored by an independent, National Institutes of Health (NIH)-appointed Data Safety Monitoring Board (DSMB).5
According to Moderna, the COVE study enrolled more than 30,000 participants in the United States and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.6
The primary endpoint of the phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting 2 weeks following the second dose of vaccine. Vaccine efficacy has been demonstrated at the first interim analysis with a total of 95 cases based on the pre-specified success criterion on efficacy.6
The primary analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases in this analysis. All 30 cases occurred in the placebo group and there were no cases in the mRNA-1273 vaccinated group. There was 1 COVID-19-related death in the study, as of November 30, 2020, which occurred in the placebo group.6
Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 adults, aged 65 years and older; and 42 participants identifying as being from diverse communities, including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans, and 3 multiracial participants.6
Data released by the FDA on Tuesday suggest that Moderna’s vaccine candidate may also prevent the spread of COVID-19, with asymptomatic infection reduced by 63% following administration of the first dose; however, the FDA may require 2 doses of the vaccine for maximum protection.3,7
According to Moderna, all participants in the COVE study will be monitored for 2 years after their second dose to assess long-term protection and safety.1