ASGCT News   |   President's Message

Second mRNA Vaccine for COVID-19 Approved in the U.S.

Stephen J. Russell, M.D., Ph.D. - December 18, 2020

ASGCT President Stephen J. Russell, M.D., Ph.D. reacts to today's FDA approval of the second COVID-19 vaccine authorized for use in the U.S.

One week after the historic approval of the first mRNA vaccine for COVID-19, the FDA approved a second mRNA-based vaccine made by Moderna, confirming that gene therapy is a safe, effective, and valid strategy to fight against the virus.

The authorization for emergency use on Friday capped off the same week that health care workers began to administer the first vaccine, BNT162b2 from Pfizer and BioNTech, to hospital employees.

Data reviewed by the FDA showed that the Moderna vaccine, mRNA-1273, has an efficacy rate of 94.1% in a trial of 30,000 people. The FDA said its analysis supported a favorable safety profile with no specific concerns. Side effects including fever, headache, and fatigue were common but not dangerous.

Like the Pfizer-BioNTech vaccine, the Moderna vaccine is based on the virus’ genetic instructions for building the spike protein. Both vaccines use mRNA to program a person's cells to produce many copies of a fragment of the SARS-CoV-2 virus. The fragment then educates the immune system to attack if the real virus tries to invade the body. Both the Pfizer-BioNTech and Moderna vaccines require two doses, administered three weeks and one month apart, respectively.

During ASGCT’s COVID-19 Symposium in September, attendees heard from Kizzmekia Corbett, Ph.D., a research fellow in the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID). Dr. Corbett talked about the VRC’s collaboration with Moderna on this vaccine, adding that the extensive work the team did around MERS coronavirus fueled the rapid development of mRNA-1273. You can watch her presentation below.

Distribution of about six million doses of the Moderna vaccine could begin next week. Both vaccines will be provided free of charge.

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