CAMBRIDGE, Mass. — Biotech company Moderna said an early analysis has revealed that its COVID-19 vaccine candidate was 94.5% effective in its clinical trial, multiple news outlets are reporting.
According to The Associated Press, the company announced the news Monday morning.
We just announced that mRNA-1273, our COVID-19 vaccine candidate, has met its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study.
— Moderna (@moderna_tx) November 16, 2020
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In a news release, Moderna said the independent Data Safety Monitoring Board for the Phase 3 study of its vaccine candidate, mRNA-1273, said the trial “has met the statistical criteria pre-specified in the study protocal for efficacy, with a vaccine efficacy of 94.5%.”
Moderna said the study, known as COVE, enrolled more than 30,000 participants. The monitoring board analyzed 95 COVID-19 infections among the participants and found that 90 occurred in those who received a placebo instead of the real vaccine, the AP reported. Additionally, all 11 participants who developed severe cases had received the placebo, according to the news agency.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” Moderna CEO Stéphane Bancel said in a statement. “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.”
The news comes just one week after a different drugmaker announced positive early data from the clinical trial of another COVID-19 vaccine candidate. On Nov. 9, Pfizer, which partnered with BioNTech to create its candidate, said its vaccine “was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis."
An independent Data Monitoring Committee evaluated 94 confirmed coronavirus cases among 43,500 people enrolled in that study, The Associated Press reported at the time. Pfizer has said it would continue the study until researchers record 164 coronavirus cases among participants, according to the news agency.
“As the study continues, the final vaccine efficacy percentage may vary,” Pfizer said in the news release. “The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.”
As of 7:30 a.m. ET Monday, more than 54 million coronavirus cases and 1.3 million deaths had been reported worldwide, according to data from Johns Hopkins University. The U.S. has reported more than 11 million cases and 246,000 deaths, the university said.
Cox Media Group
