A vaccine candidate jointly developed by Moderna and the National Institutes of Health (NIH) has been shown in early results to be 94.5 percent effective.
Biotech company Moderna said in a statement on Nov. 16 that an analysis of its clinical trial by an independent data and safety monitoring board shows that its experimental vaccine is highly effective at preventing infection by the CCP virus.
NIH said in a separate release that “the findings are statistically significant, meaning they are likely not due to chance. This interim review of the data suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults.”
The vaccine trial enrolled more than 30,000 participants in the United States, with half of the study subjects receiving two doses of the vaccine 28 days apart and the other half receiving two shots of a placebo.
The vaccine combines Moderna’s messenger RNA delivery platform with the stabilized SARS-CoV-2 spike immunogen developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), which is part of NIH.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” said Stéphane Bancel, chief executive officer of Moderna, in a statement.
“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,” Bancel said. “This milestone is only possible because of the hard work and sacrifices of so many.”
The study is being done in collaboration with NIH, NIAID, and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Department of Health and Human Services.
“I want to thank our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point,” Bancel said, referring to the Trump administration’s effort to accelerate the development, manufacturing, and distribution of a COVID-19 vaccine, therapeutics, and diagnostics.
Moderna said it plans to file an application for emergency use authorization of its vaccine with the Food and Drug Administration sometime “in the coming weeks.”
“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,” Bancel said. “We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”
The company said it expects to be able to ship around 20 million doses of its vaccine in the United States by the end of 2020 and that next year, it expects to be able to make between 500 million and 1 billion doses available around the world.
Together with Pfizer’s vaccine, which appears to be more than 90 percent effective, the United States could have two vaccines authorized for emergency use in December, with as many as 60 million doses of vaccine available this year.
A key advantage of Moderna’s vaccine is that, unlike Pfizer’s, it doesn’t need to be stored at very low temperatures, making it easier to distribute.
Virus cases topped 11 million in the United States over the weekend, with 1 million of them recorded in just the past week.