December 18, 2020
A day after receiving US Food and Drug Administration (FDA) advisory panel support, the agency announced Friday evening that it has issued emergency use authorization (EUA) for the second vaccine for the prevention of COVID-19 that was created by Moderna. This vaccine will be distributed in the US; it is for patients 18 years of age and older and will be given in two doses, one month apart.
“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, in a press statement.
According to the agency, the vaccine created by Moderna met statutory criteria needed to receive an EUA. The agency explained that the available data shows that the vaccine may be effective in preventing COVID-19. Further, the data also shows that the known and potential benefits outweigh the known and potential risks.
Similar to the vaccine approved recently by Pfizer and BioNTech, Moderna’s vaccine contains the genetic material, messenger RNA (mRNA). Additionally, the vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA. This instructs the cells in the body to create the virus’s distinctive “spike” protein, the agency explained. After receiving the vaccine, the body will produce copies of the spike protein, which does not cause the disease, but rather tell the immune system to react defensively.
“Guided by science and data, the agency’s career staff determined that the vaccine’s known and potential benefits clearly outweigh its known and potential risks, and although not an FDA approval, the FDA’s expectations described in our June and October guidance documents have been met,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research.
The EUA was based on an analysis of 30,351 participants enrolled in an ongoing randomized, placebo-controlled study conducted in the US. Of these participants, 15,185 received the vaccine and 15,166 of whom received saline placebo. The participants were followed for more than two months after receiving the second dose. According to the study findings, the most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever. The FDA noted that more participants experienced side effects after the second dose more so than the first dose.
It is expected that shipment of these vaccines will begin on Sunday. There will be roughly 5.9 million doses that will be shipped. Unlike Pfizer and BioNTech’s vaccine, the Moderna COVID-19 vaccine does not have to be stored in extreme-cold storage. It will also be delivered in smaller batches. Additionally, unlike the vaccine that rolled out earlier this week, the Moderna vaccine deliveries will be managed by the federal government. It is funded by Operation Warp Speed—the program created by the administration to develop and distribute vaccines as fast as possible.
“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,” said Dr Hahn.
“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.”
- US Food and Drug Administration. FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine [press release]. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid. December 18, 2020.
- The New York Times. F.D.A. OKs the Moderna Covid Vaccine, Adding Millions More Doses to the U.S. Supply. https://www.nytimes.com/2020/12/18/health/covid-vaccine-fda-moderna.html. December 18, 2020.