Moderna intends to seek the US FDA’s Emergency Use Authorisation (EUA) based on the interim data analysis of 151 cases
Moderna announced that the Phase 3 study of its investigational Covid-19 vaccine candidate mRNA-1273 has met the primary efficacy endpoint, and showed 94.5% vaccine efficacy in the first interim analysis.
An independent, NIH-appointed Data Safety Monitoring Board (DSMB) analysed the safety and efficacy data from the Phase 3 study, dubbed COVE.
DSMB analysed 95 Covid-19 cases, of which 90 cases were observed in the placebo group, compared to five cases in the mRNA-1273 group, reporting no significant safety concerns.
The 95 Covid-19 cases included 15 older adults, aged 65 years and above, and 20 participants from diverse communities, including 12 Hispanic or LatinX, four Black or African Americans, three Asian Americans and one multiracial.
Moderna chief executive officer Stéphane Bancel said: “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.”
Details of Phase 3 COVE study
Phase 3 COVE study enrolled more than 30,000 participants in the US and is conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH and BARDA.
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.
As defined in the study protocol, the secondary endpoint analysed severe cases of Covid-19, with 11 severe cases in the first interim analysis, with all cases in the placebo group, and no severe case observed in the vaccinated group.
The company said that its vaccine was generally well tolerated, with most of the adverse events were mild or moderate in severity, as per the review of solicited adverse events, and demonstrated a consistent safety and efficacy profile across all evaluated subgroups.
Moderna intends to seek an Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA), based on the interim safety and efficacy data, with plans to file additional applications with global regulatory agencies.
Furthermore, the biotechnology firm is working together with the US Centres for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson, a Covid-19 vaccine distributor contracted by the US government.
Bancel added: “This milestone is only possible because of the hard work and sacrifices of so many. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus.
“We look forward to the next milestones of submitting for an EUA in the U.S., and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the Covid-19 pandemic.”