Coronavirus: Moderna to seek EUA for vaccine candidate

Moderna says it will seek emergency use authorization (EUA) for their COVID-19 coronavirus vaccine candidate from the U.S. Food and Drug Administration (FDA).

According to a news release, in the primary efficacy analysis of the phase 3 COVE study of the vaccine candidate, mRNA-1273, showed an efficacy of 94.1 percent against COVID-19, and 100 percent against severe COVID-19 infection. It has been generally well tolerated and no serious safety concerns have been identified to date.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1 (percent) efficacy and importantly, the ability to prevent severe COVID-19 disease. 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,” Stéphane Bancel, CEO of Moderna, says in the release.

The company is currently working with the federal government as well as a vaccine distributor to prepare for release of the candidate should it be accepted. 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 waiting for an EUA for a COVID-19 vaccine.

Previously, Pfizer announced their intent to seek EUA for COVID-19 coronavirus vaccine candidate BNT162b2 and have already initiated rolling submissions in Australia, Canada, Europe, and Japan for authorization. The plan is to produce 50 million doses of the drug by the end of the year and up to an additional 1.3 billion doses by the end of 2021.

In July, the U.S. Department of Health and Human Services placed an initial order for 100 million doses of BNT162b2 for $1.95 billion after it is manufactured and either obtains approval or emergency use authorization from the FDA. The federal government will also be able to acquire up to an additional 500 million doses and American patients will receive the vaccine free.