Moderna filing today for FDA emergency authorization

Biotechnology company, Moderna, announced today it would be applying for emergency use authorization with the U.S. Food and Drug Administration (FDA) for its novel coronavirus (COVID-19) vaccination, mRNA-1273, according to a statement made by the Cambridge, Massachusetts-based firm this morning.

The company will ask the FDA to review a more comprehensive data set showing the vaccine is 94.1 percent effective at preventing COVID-19, a slight difference from earlier data indicating 94.5 percent efficacy, the statement said. Additionally, the current data found the vaccine candidate was 100 percent effective at preventing severe cases of the disease.

The ongoing clinical trial, known as the COVE study, enrolled more than 30,000 participants in the United States. The results are based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. Vaccine efficacy was demonstrated at the first interim analysis with a total of 95 cases.

The primary analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1 percent, according to the statement. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group, the company said.

Moderna will be the second company to apply for emergency use authorization with the FDA. Pharmaceutical companies Pfizer and BioNTech submitted its request on November 20 with a similar efficacy rate. Both requests will be reviewed by an FDA advisory committee in December, with Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, noting he expects the first vaccinations in the U.S. to take place in the latter part of the month.  

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