A US-developed vaccine has been shown to be 94.5% effective at protecting people from COVID-19, according to early trials data.
The announcement follows on the heels of similar news last week from Pfizer’s vaccine trial as pharmaceutical companies across the world race against the clock to find ways to prevent the virus.
Interim data from Moderna suggests its vaccine is highly effective in preventing people getting ill and also works across all age groups, including the elderly.
Both the Pfizer and Moderna vaccines use a technology known as mRNA, which introduces into the body a messenger sequence that contains the genetic instructions for the vaccinated person's own cells to produce the antigens and generate an immune response.
Moderna's interim analysis was based on 95 infections among trial participants who received either a placebo or the vaccine. Of those, 90 had received the placebo and only five the active vaccine, resulting in a point estimate of vaccine efficacy of 94.5%.
A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.
The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities.
As more cases accrue leading up to the final analysis, the Company expects the point estimate for vaccine efficacy may change. The Company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate," said Stéphane Bancel, Chief Executive Officer of Moderna. "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.”
“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."
Moderna also announced that the vaccine can be kept in a conventional freezer (-20C) for up to six months, as opposed to Pfizer's vaccine which requires ultra-cold storage, and that once thawed the vaccine can be kept for up to 30 days at standard refrigerator (2-8C).
Based on the interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data.
Moderna also plans to submit applications for authorizations to global regulatory agencies.
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