The US Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc.
Moderna has released a primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. 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, NIH-appointed Data Safety Monitoring Board (DSMB).
Moderna submitted a request for an EUA from the US FDA and conditional approval from the European Medicines Agency (EMA). The company anticipates that the shipping of mRNA-1273 to designated distribution points throughout the US will occur shortly after an Emergency Use Authorization is granted.
The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (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.
The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two 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. Today’s 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 (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.
Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) 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).
The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.
“In keeping with the FDA’s commitment to ensuring full transparency, dialogue and efficiency, the Vaccines and Related Biological Products Advisory Committee, made up of outside scientific and public health experts from around the country, will meet to discuss the totality of the safety and effectiveness data provided by Moderna for their EUA submission,” said FDA Commissioner Stephen M. Hahn, MD. “The FDA understands there is tremendous public interest regarding vaccines for COVID-19. We remain committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, the public and the medical community can have trust and confidence in receiving the vaccine for our families and ourselves.”
Although the VRBPAC members provide advice to the agency, which may include advice on the safety and effectiveness data submitted in the EUA request, final decisions on whether to authorize the vaccine for emergency use are made by the FDA. In terms of timing of the VRBPAC meeting following the submission of the EUA request, this amount of time will allow the FDA to thoroughly evaluate the data and information submitted in the EUA request before the meeting and to be prepared for a robust public discussion with the advisory committee members.
The FDA intends to livestream the VRBPAC meeting on the agency’s YouTube, Facebook and Twitter channels; the meeting will also be webcast from the FDA website.