Moderna’s COVID-19 vaccine achieves over 90% efficacy in Phase III trial

pharmafile | January 4, 2021 | News story | Sales and Marketing COVID-19, Moderna 

Moderna’s COVID-19 vaccine has achieved over 90% efficacy in interim safety and primary efficacy results following its Phase III trial.

According to the results published in the New England Journal of Medicine, the two-dose regime of the biotechnology company’s vaccine was given 28 days apart, was well-tolerated, and demonstrated vaccine efficacy of 94.1% against COVID-19.

The primary endpoint of the Phase III study was based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This final analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group compared to 11 cases observed in the Moderna vaccine group – corresponding to a 94.1% vaccine efficacy.

A secondary endpoint analysed severe cases of COVID-19 and included 30 severe cases in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.

The Phase III study enrolled over 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

Safety data on Moderna’s vaccine continues to accrue, and the study continues to be monitored by an independent Data Safety Monitoring Board (DSMB) appointed by the NIH. All participants in the study will be monitored for two years after their second dose, to assess long-term protection and safety.

Additional studies are planned to evaluate the jab in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.

Darcy Jimenez

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