Coronavirus: FDA grants Moderna vaccine EUA

Moderna’s COVID-19 coronavirus vaccine candidate, mRNA-1273, was granted an emergency use authorization late last evening paving the way for wide distribution.

In a Dec. 18 news release, Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, MD, applauded what the EUA means for a public battered by the COVID-19 pandemic.

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” he said in the release. “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”

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 Dec. 17 Vaccines and Related Biological Products Advisory 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.

Moderna now joins 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 was 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.