New Delhi (NVI): Moderna today said it will request emergency clearance from the Food and Drug Administration (FDA) for its coronavirus vaccine after new data confirms the vaccine is more than 94 per cent effective in preventing Covid-19 and was safe.
Moderna is the second drugmaker to seek emergency use from the FDA after Pfizer applied for the same authorization on November 20.
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 new analysis from Moderna in the Phase 3 COVE study for mRNA-1273, evaluated 196 confirmed Covid infections among the late-stage trial’s 30,000 participants.
The company said 185 cases of Covid were observed in the placebo group versus 11 cases observed in the group that received its vaccine. That resulted in an estimated vaccine efficacy of 94.1 per cent, the company said.
It also appears to prevent volunteers from getting severely sick from the virus. Of the 30 severe cases of Covid-19 in the trial, none were in the group that received the vaccine, Moderna said. Additionally, there was one Covid-19 related death in the study that occurred in the placebo group, according to the company.
The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose, the statement read.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” Moderna CEO Stephane Bancel said in a statement.
Moderna said the vaccine’s effectiveness was consistent across age, race and gender. The 196 confirmed cases included 33 adults over the age of 65 and 42 people from Black, Latino and other “diverse” communities.
The vaccine was also well tolerated with the most common side effects being fatigue, muscle pain, headache and pain at the injection site, the company said.
Additionally, FDA’s review of Moderna’s vaccine is expected to take a few weeks. The agency will likely schedule an advisory committee meeting to review the vaccine on Dec. 17, Moderna said. It has already initiated rolling submissions with several regulatory agencies around the world, including the European Medicines Agency.