CAMBRIDGE, Mass. — Biotech company Moderna announced today that its COVID-19 vaccine is 94.5% effective.
Moderna, a biotechnology company pioneering messenger RNA therapeutics and vaccines to create medicines for patients, said the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.
This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. 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 U.S. Department of Health and Human Services.
- First interim analysis included 95 participants with confirmed cases of COVID-19. The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities (including 12 Hispanic or LatinX, four Black or African Americans, three Asian Americans and one multiracial).
- Phase 3 study met statistical criteria with a vaccine efficacy of 94.5%
- Moderna intends to submit for an emergency use authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than two months
Moderna’s interim analysis included a concurrent review of the available Phase 3 COVE study safety data by the DSMB, which did not report any significant safety concerns. A review of solicited adverse events indicated that the vaccine was generally well tolerated. The majority of adverse events were mild or moderate in severity. Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%). These solicited adverse events were generally short-lived. These data are subject to change based on ongoing analysis of further Phase 3 COVE study data and final analysis.
Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.
As more cases accrue leading up to the final analysis, Moderna expects the point estimate for vaccine efficacy may change. The company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, chief executive officer of Moderna.
Based on these interim safety and efficacy data, Moderna intends to submit for an emergency use authorization (EUA) with the U.S. Food and Drug Administration in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months). Moderna also plans to submit applications for authorizations to global regulatory agencies.
Moderna is working with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson, a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations. By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. Moderna remains on track to manufacture 500 million to 1 billion doses globally in 2021. The company recently announced further progress towards ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure.
To learn more about Moderna’s work on mRNA-1273, visit www.modernatx.com/COVID19.