Moderna Inc. said Monday that its COVID-19 vaccine candidate met its primary endpoint in a Phase 3 trial, demonstrating 94.5% efficacy, a far higher rate than originally expected, sparking a broad-based market rally.
The news was shared in a release and has not yet been published as a preprint or in a peer-reviewed medical journal. It comes a week after Pfizer Inc. PFE, +2.85% and partner BioNTech SE BNTX, +4.30% said their COVID-19 vaccine candidate had achieved 90% efficacy in a similar late-stage trial, news that also sent the broad market, and pandemic-decimated sectors notably, sharply higher.
It comes as the U.S. continues to set records for new cases of COVID-19 and hospitalizations and as health-care systems in states including the Dakotas and Wisconsin are close to full hospital capacity. The U.S. leads the world by case numbers at 11 million and deaths at 246,224, according to data aggregated by Johns Hopkins University. In each case, it is about a fifth of the global tally.
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Cambridge, Mass.–based Moderna MRNA, +1.79% said it plans to submit an emergency-use-authorization application with the U.S. Food and Drug Administration for the vaccine, which is named mRNA-1273, in the coming weeks and expects it to be based on the final analysis of 151 cases and a median follow-up of more than two months. The FDA has said it would require a coronavirus vaccine to be at least 50% effective to win approval.
The Phase 3 trial enrolled more than 30,000 participants in the U.S. and is being conducted 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 U.S. Department of Health and Human Services.
Moderna said the primary endpoint of the Phase 3 trial is based on the analysis of COVID-19 cases starting two weeks after the second dose of vaccine. The first analysis was based on 95 cases with 90 cases in the placebo group and five in the mRNA-1273 group.
The 95 cases were in older adults, aged 65 and up, with 20 participants identifying as coming from diverse communities. Twelve were Hispanic or Latinx, four were Black or African-American, three were Asian Americans and one was multiracial person. Including diverse patients in trials is important as Black and Asian people are at greater risk statistically of contracting the virus and developing severe cases of COVID-19. The trial did not report any significant safety concerns.
Separately, Moderna said mRNA-1273 now remains stable at refrigerated temperatures for longer times. Specifically, the vaccine can remain stable at 2 degrees to 8 degrees Celsius (36 degrees to 46 degrees Fahrenheit), which is the temperature of a standard home refrigerator, for 30 days, an extension from an earlier estimate of seven days.
At negative 20 degrees Celsius (negative 4 degrees Fahrenheit), mRNA-1273 can remain stable for up to six months. It can remain stable at room temperature for up to 12 hours.
The vaccine won’t require dilution or special handling, which means vaccination can be made in a range of settings, including pharmacies and physicians’ offices, said Moderna.
Like the Pfizer-BioNTech vaccine, two doses of the Moderna vaccine are required.
“We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval,” said Moderna’s Chief Technical Operations and Quality Officer Juan Andres. “The ability to store our vaccine for up to six months at [-20 degrees Celsius] including up to 30 days at normal refrigerator conditions after thawing is an important development and would enable simpler distribution and more flexibility to facilitate wider-scale vaccination in the United States and other parts of the world.”
Medical experts cautioned last week that the Pfizer/BioNTech vaccine may prove to be less effective in the real world than in the lab, as MarketWatch’s Jaimy Lee reported.
“In the clinical trial, you select the patients that you like, and you follow them very closely,” said Mizuho Securities analyst Difei Yang. “In the real world, there’s all kinds of ages, and everyone has different underlying health conditions.”