Early Analysis Finds Moderna’s COVID-19 Vaccine Is 95% Effective

November 16, 2020 - Moderna recently announced that its mRNA COVID-19 vaccine candidate proved 95 percent effective in a Phase 3 clinical trial. 

The candidate, mRNA-1273, met statistical criteria pre-specified in the study protocol for efficacy in a majority of US participants. 

The primary endpoint of the trial, referred to as COVE, was based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks after the second dose of the vaccine, Moderna explained in the announcement.

The first analysis was based on 95 cases and showed a point estimate of vaccine efficacy of 94.5 percent. The second endpoint analyzed was severe COVID-19 cases; there were11 severe cases. All 11 cases occurred in the placebo group and not in the group that received the mRNA-1273 injections. 

“This is a pivotal moment in the development of our COVID-19 vaccine candidate. 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,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement.

Researchers said that the minor adverse events found in the trial indicated that the vaccine was generally well tolerated among all patients.

Specifically, Grade 3 events greater than two percent in frequency after the first dose included injection site pain (2.7 percent), fatigue (9.7 percent) myalgia (8.9 percent), arthralgia (5.2 percent), headache (4.5 percent), and pain (4.1 percent).

Notably, the minor adverse events were short-lived, but data is subject to change based on further analysis of the vaccine candidate in the COVE trial, Moderna stipulated.

The company also stated that it will request an emergency use authorization (EUA) from the FDA in the coming weeks, when it anticipates it will have the final safety and efficacy data for the EUA.

“We look forward to the next milestones of submitting for an EUA in the U.S., and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic,” Bancel said.

Current trials of mRNA-1273 are being conducted in collaboration with the National Institutes of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of HHS.

By the end of 2020, Moderna expects to have nearly 20 million doses of mRNA-1273 ready to ship in the US. So far, the company is on track to manufacture 500 million to 1 billion doses globally by next year.

In mid-August, HHS and the Department of Defense (DoD), announced an agreement with Moderna to manufacture and deliver 100 million doses of mRNA-1273.

Under the agreement, Moderna will manufacture the vaccine doses while clinical trials are underway. 

Additionally, the federal government will own the doses and will be able to acquire up to an additional 400 million doses of mRNA-1273.

Manufacturing in parallel with clinical trials increases the speed of vaccine development and furthers the government’s Operation Warp Speed goal of delivering safe and effective vaccines to Americans by the end of 2020, HHS said in the August announcement. 

HHS Secretary Alex Azar issued the following statement after Moderna announced the positive results from its Phase 3 trial.  

“The Moderna/NIH vaccine candidate is now the second vaccine to show the potential for very high efficacy in Phase 3 trials. Operation Warp Speed has provided about $2 billion in funding and operational support for development, manufacturing, and eventual potential delivery of the Moderna/NIH vaccine,” Azar said.

“This news is another stunning result of President Trump’s leadership and his unwavering support for Operation Warp Speed, an incredible tribute to American scientists and innovators, and one more reminder that there is light at the end of the tunnel,” he concluded.