FDA issues EUA for Moderna COVID vaccine

Regulatory NewsRegulatory News | 18 December 2020 |  By 

The US Food and Drug Administration (FDA) on Friday authorized Moderna’s mRNA-based COVID-19 vaccine for emergency use in individuals 18 and older, just a day after its Vaccines and Related Biological Products Advisory Committee (VBRPAC) voted 20-0 with one abstention in favor of the vaccine’s use.
The emergency use authorization (EUA) is the second to be issued by FDA after its EUA for Pfizer and BioNTech’s mRNA vaccine last week and the first authorization for Moderna’s vaccine globally. (RELATED: VRBPAC: Another thumbs up, this time for Moderna's COVID vaccine, Regulatory Focus 17 December 2020; FDA authorizes Pfizer-BioNTech vaccine for emergency use, Regulatory Focus 11 December 2020).

“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,” said FDA Commissioner Stephen M. Hahn, MD, announcing the EUA for the Moderna vaccine. “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 US has so far agreed to purchase 200 million doses of the Moderna vaccine, which was developed in partnership with the National Institutes of Health, enough to vaccinate 100 million people. The first 6 million doses are set to be delivered within days with 20 million doses expected to be distributed by the end of the year. Another 80 million doses are expected in Q1 2021, with the remaining 100 million doses anticipated in Q2.
The authorization is based on data from a 30,000 participant Phase 3 randomized placebo-controlled trial that found the vaccine to be 94.1% effective and raised no safety issues that FDA said would preclude issuance of an EUA. FDA’s review of the safety data from the trial found that mild to moderate adverse reactions such as injection site pain, fatigue and headache were common and were reported to be more severe after the second dose.
While both the Pfizer and Moderna vaccines are based on the same underlying technology and require cold transport and storage, Moderna has said its vaccine remains stable for up to 30 days at normal refrigerator temperatures of 2-8°C, whereas Pfizer’s vaccine requires ultra-cold temperatures of -70°C during transport and storage. Moderna also says its vaccine can be stored for up to six months at -20°C.
Both vaccines require two doses, though Moderna’s is administered 28 days apart compared to 21 days for the Pfizer-BioNTech vaccine. Moderna’s vaccine can be shipped in smaller quantities than Pfizer’s—as few as 100 doses per container—which combined with its less demanding storage requirements, could make it more accessible in many parts of the country.


© 2023 Regulatory Affairs Professionals Society.

Tags: coronavirus, FDA, US

Discover more of what matters to you

No taxonomy