A new primary analysis shows that Moderna’s COVID-19 vaccine candidate was more than 94% effective in its clinical trial, and the company will seek emergency regulatory approval today in the U.S. and Europe, The Associated Press is reporting.
We just announced the primary efficacy analysis in the Phase 3 COVE study for mRNA-1273, our COVID-19 vaccine candidate and that today, we plan to request an Emergency Use Authorization from the U.S. FDA & conditional approval from the EMA. Read more: https://t.co/90FbcVHdWN pic.twitter.com/36tpY0QeFl
— Moderna (@moderna_tx) November 30, 2020
The biotech company announced the update in a news release early Monday.
“The primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis,” the release said. “The data analysis indicates a vaccine efficacy of 94.1%. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB).”
The release added that Moderna is requesting an emergency use authorization from the U.S. Food and Drug Administration, as well as conditional approval from the European Medicines Agency.
Moderna said the study, known as COVE, enrolled more than 30,000 participants. The monitoring board analyzed 196 COVID-19 infections among the participants and found that 185 occurred in those who received a placebo instead of the real vaccine, the release said. Additionally, all 30 participants who developed severe cases had received the placebo, according to the company.
In addition, the vaccine’s “efficacy was consistent across age, race and ethnicity, and gender demographics,” the release said.
The company said it will submit the data from its trial for publication in a peer-reviewed journal.
Earlier this month, Pfizer and partner BioNTech formally asked the FDA to allow the emergency use of its COVID-19 vaccine, which was 95% effective in a clinical trial, the companies said. Additionally, British drugmaker AstraZeneca said an interim analysis revealed its COVID-19 vaccine was, on average, 70% effective in its clinical trial.
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