mRNA-1273 is an mRNA vaccine candidate against COVID-19, which encodes a pre-fusion stabilized form of the spike (S) protein. It is administered in two doses. mRNA-1273 was jointly developed by Moderna and researchers at the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID), Maryland, USA, which is part of the National Institutes of Health (NIH).
Moderna announced that the initial results of their Phase 3 study with mRNA-1273 show a vaccine efficacy of 94.5%. More than 30,000 people participated in their study in the USA. More than 7,000 Americans were over the age of 65. More than 5,000 Americans were under the age of 65 with high-risk chronic diseases that put them at increased risk for serious COVID-19 disorders, including diabetes, severe obesity, and heart disease.
The primary endpoint of the Phase 3 study is based on the analysis of COVID-19 cases confirmed and adjudicated two weeks after the second vaccine dose. This first interim analysis was based on 95 cases. 90 of these were observed in the placebo group and 5 in the mRNA-1273 group. The 95 COVID-19 cases included 15 adults above 65 and 20 participants who identified themselves as coming from different communities, e.g., Hispanic, Black, Asian American. A secondary endpoint analyzed severe cases of COVID-19. 11 cases were defined in the study protocol. They all occurred in the placebo group, according to the press release.
Moderna reports that the vaccine was generally well-tolerated, and no significant safety concerns were found. The company says that the vaccine remains stable for one month in conventional refrigerators and six months in ordinary freezers. The Pfizer BioNTech vaccine, whose first Phase 3 study results were reported six days ago, must be stored at -70 °C. Moderna announced to send data from the full Phase 3 study to a peer-reviewed publication.
The phase 3 study continues. Based on these preliminary safety and efficacy data, Moderna intends to submit an Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) in the coming weeks. The company also plans to submit applications for regulatory approval to global regulatory authorities. It expects to have approximately 20 million doses of mRNA-1273 ready for shipment in the US by the end of 2020. By 2021, it plans to produce 500 million to 1 billion doses worldwide.
The study is conducted in collaboration with the NIAID and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services.
- Moderna, Inc., Cambridge, MA, USA
Also of Interest
- Collection: SARS-CoV-2 Virus
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