Coronavirus: Moderna vaccine clears EUA hurdle

December 18, 2020
Keith A. Reynolds

A regulatory panel has given the vaccine approval leaving only the official EUA approval before distribution.

Another COVID-19 coronavirus preventative will soon be available to the public as the Vaccines and Related Biological Products Advisory Committee approved Moderna’s vaccine candidate, mRNA-1273, bringing it one step away from distribution.

In a Dec. 17 news release, Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, MD, and Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the agency will continue their rapid pace toward granting the drug an emergency use authorization (EUA).

“Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” they say in the release. “The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.”

The vaccine showed an efficacy of 94.1 percent with 100 percent efficacy against severe COVID-19 and low frequency of serious adverse events, according to documents released by the FDA in advance of the committee meeting.

Previously, Moderna reported that they expect to have 20 million doses available by the end of the year and a further 500 million to one billion doses in 2021.

If the EUA is granted, Moderna will join Pfizer and BioNTech in supplying the drugs to the U.S. government. Pfizer’s EUA was granted late Dec. 11 after President Donald J. Trump’s staff ordered FDA Commissioner Steven M. Hahn, MD, to get the EUA approved on that day or start looking for a new job, according to a report from The New York Times.

It is unclear if the same pressure campaign is being used for the Moderna vaccine.

The public seems ready for a vaccine to finally bring the COVID-19 coronavirus pandemic to an end as a recent survey from the Kaiser Family Foundation found that 71 percent of respondents say they would definitely or probably get a COVID-19 vaccine if it was deemed safe by scientists and was available for free on demand. This is up from 63 percent reported in a September survey and is an increase across racial and ethnic groups, as well as among Democrats and Republicans.

Frontline healthcare workers in America began receiving the Pfizer vaccine Dec. 14, the Times reports.