Moderna to seek FDA approval for COVID-19 vaccine

Nov. 30 (UPI) -- U.S. biotech firm Moderna said Monday it will seek an emergency use authorization from U.S. regulators for its COVID-19 vaccine candidate after further clinical trials confirmed it is 94% effective.

Moderna plans to request an "EUA" from the U.S. Food and Drug Administration and conditional approval from the European Medicines Agency after the latest positive results, company officials said in a press release.

"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," CEO Stéphane Bancel said.

"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," he said.

With the expected FDA approval, the first doses of Moderna's "mRNA-1273" vaccine could become available within weeks. The company is the second drugmaker to seek an emergency use authorization from the FDA. The team of Pfizer and BioNTech sought the same authorization on Nov. 20.

The FDA's Vaccines and Related Biological Products Advisory Committee will meet Dec. 10 to review Pfizer's vaccine and recommend whether it should be cleared for use in health workers and other vulnerable populations. A review of Moderna's data is set for a week later.

Moderna announced interim results from its late-stage, 30,000-participant "COVE" study earlier this month, indicating the vaccine is 94.5% effective in preventing infection, and those results were largely confirmed Monday using a bigger sample size.

The primary analysis found that in 196 confirmed COVID-19 case among participants in the COVE study, 185 were in a group receiving a placebo group while just 11 cases were seen in the mRNA-1273 group, resulting in an vaccine efficacy of 94.1%.

The result "confirms the high efficacy observed at the first interim analysis," Bancel said.

Moderna's announcement comes as the total global death toll from COVID-19 reached 1.46 million with new cases growing by 1 million every two days, mainly in Europe and the United States, according to Johns Hopkins University.