Bringing a glimmer of hope to a world ravaged by the coronavirus pandemic, biotech giant Moderna announced on Monday that its COVID-19 vaccine has shown to be 94.5 per cent effective.
Cambridge, Massachusetts-based Moderna's announcement comes just a week after Pfizer and Biontech said their COVID-19 vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19 in participants.
Moderna said the independent National Institutes of Health-appointed Data Safety Monitoring Board for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, found the vaccine to have an efficacy of 94.5 per cent.
"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 Stephane Bancel, Chief Executive Officer of Moderna.
Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorisation with the US 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 authorisations to global regulatory agencies.
Bancel said the company is looking forward to the 'next milestones' of submitting for an emergency use authorisation in the US, 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".
By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the US. The company remains on track to manufacture 500 million to 1 billion doses globally in 2021.
The announcements about the vaccines and their potential availability for use among the general population in the coming weeks and months has offered hope to millions around the world in a year that has seen the COVID-19 pandemic devastate lives and economies and still showing no signs of abating.
So far the coronavirus has infected more than 54 million people around the world and killed more than 1.3 million people even as governments implemented strict lockdowns and restrictions to slow the spread of the virus that originated in the Chinese city of Wuhan.
A second wave of infections is threatening to derail economies and impact lives again as countries have gradually begun to ease restrictions and open up.
Moderna said its 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, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, 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.
"This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001)," it said.
A secondary endpoint analysed severe cases of COVID-19 and included 11 severe cases. 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, 4 Black or African Americans, 3 Asian Americans and 1 multiracial).
A review of solicited adverse effects indicated that the vaccine was generally well tolerated. Volunteers reported mild to moderate side-effects, including pain at injection site pain, fatigue, headache and redness at the injection site. These adverse events were generally short-lived, the company said.
"Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups," Moderna said.
Moderna is working with the US Centers for Disease Control and Prevention, Operation Warp Speed and McKesson, a COVID-19 vaccine distributor contracted by the US 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 authorisations.
The Phase 3 COVE study was designed in collaboration with the FDA and NIH to evaluate Americans at risk of severe COVID-19 disease and completed enrollment of 30,000 participants ages 18 and older in the US on October 22, including those at high risk of the severe complications of COVID-19 disease.
The COVE study includes more than 7,000 Americans over the age of 65. It also includes more than 5,000 Americans who are under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease.
These medically high-risk groups represent 42 per cent of the total participants in the Phase 3 COVE study.
