Moderna says its COVID-19 vaccine candidate has 94.5% efficacy

This positive interim analysis from Phase 3 study has given the first clinical validation that the vaccine can prevent COVID-19, including its severe form, the company says

The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine, said Moderna. Photo: iStock

After Pfizer claimed its COVID vaccine candidate had over 90 per cent effectiveness in studies, US biotech firm Moderna on Monday (November 16) said its vaccine efficacy is 94.5% in the ongoing Phase 3 trial involving more than 30,000 participants in America.

“…the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%,” Moderna said in a press release.

“This study, known as the COVE study, enrolled more than 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,” it said.

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“This is a pivotal moment in the development of our COVID-19 vaccine candidate…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,” said Stephane Bancel, Chief Executive Officer of Moderna.

The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus five cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5%, it said.

A secondary endpoint analysed 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.

“Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups. 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,” the company said.

By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the US. The company said it remains on track to manufacture 500 million to 1 billion doses globally in 2021.

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