Moderna's Covid-19 vaccine 94% effective, data indicates

Biotechnology company Moderna has announced that its vaccine candidate for Covid-19, mRNA-1273, is up to 94.5% effective according to early data.

Moderna was informed by an independent National Institute of Health (NIH)-appointed Data Safety Monitoring Board (DSMB) that interim data from the company's Phase 3 study of mRNA-1273 indicated an efficacy of 94.5%.

Moderna's COVE study has enrolled over 30,000 participants in the US and is being conducted alongside 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).

The interim analysis of the study was based on 95 cases of participants with Covid-19. However, of these participants, 90 were given a placebo treatment with only five people receiving the vaccine candidate. Moderna states that the 95 Covid-19 cases included 15 adults above 65 years of age, and 20 participants as being from diverse communities. No significant safety concerns were reported by the DSMB.

Moderna now intends to apply for an Emergency Use Authorisation (EUA) with the FDA as well as with other global regulatory agencies for authorised use.

“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.

“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. They are an inspiration to us all. I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of foundational research on potential pandemic threats at the Vaccine Research Center that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others’. I want to thank our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point. Finally, I want to thank the Moderna team, our suppliers and our partners, for their tireless work across research, development and manufacturing of the vaccine. 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.”