The FDA issued an emergency use authorization for the second coronavirus 2019 disease vaccine, Moderna COVID-19 Vaccine, to be distributed in the U.S. for use in individuals 18 years of age and older.
The FDA issued an emergency use authorization (EUA) to Moderna COVID-19 Vaccine, the second coronavirus 2019 disease (COVID-19) vaccine to prevent disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The EUA authorizes the vaccine’s distribution in the U.S. for use in individuals 18 years of age and older.
“With the availability of 2 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,” FDA Commissioner Stephen M. Hahn, MD, said in a press release issued by the agency. “Through the FDA’s open and transparent scientific review process, 2 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.”
Moderna COVID-19 Vaccine is administered as a series of two doses, one month apart.
The FDA determined Moderna COVID-19 Vaccine met the statutory criteria for issuance of an EUA, given totality of the available data that provided clear evidence of efficacy in preventing COVID-19. Such data demonstrated that known and potential benefits outweighed the known and potential risks.
“In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information,” the agency stated.
For safety analysis, the agency based its authorization on available safety data that included an analysis of 30,351 participants enrolled in an ongoing randomized, placebo-controlled study conducted in the U.S.
In total, 15,185 participants received the vaccine, while 15,166 were administered saline placebo. Participants were followed for a median of more than 2 months after receiving the second dose.
The most commonly reported adverse events (AEs), lasting typically for only several days, included 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. Patients experienced AEs following the second dose of the vaccine, “so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose,” the FDA warned.
For efficacy, the agency based its decision on data from an analysis of 28,207 participants in the ongoing randomized, placebo-controlled U.S. study who did not have evidence of SARS-CoV-2 infection prior to the first dose of vaccine. In total, 14,134 participants received the vaccine and 14,073 received placebo.
Moderna COVID-19 Vaccine was 94.1% effective in preventing COVID-19 disease, with 11 cases of COVID-19 in the vaccine group and 185 in the placebo group. At the time of analysis, no case in the vaccine group and 30 in the placebo group were classified as severe. Following the analysis, 1 severe case in the vaccine group was identified and is awaiting confirmation.
Similar to BNT162b2, which was approved just 1 week ago, Moderna COVID-19 Vaccine targets the SARS-CoV-2 – the virus that causes COVID-19 – spike glycoprotein (S) antigen that is encoded by RNA and formulated in lipid nanoparticles (LNPs). The vaccine contains a small piece of the SARS-CoV-2 virus’s messenger RNA that instructs cells in the body to make the virus’s distinctive “spike” protein. “After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2,” the FDA reported. In addition, the agency noted, data are not available to determine how long the vaccine will provide protection, and these is no evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.
“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,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “Today’s authorization demonstrates our steadfast commitment to the health of the American people, with the assurance that our scientific standards and the integrity of our review process have been maintained. This achievement is yet another testament to the dedication of FDA’s career scientists and physicians, who have been working urgently to conduct comprehensive and rigorous evaluations of the data submitted for vaccines to prevent COVID-19.”
FDA. FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine. Published: December 18, 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid?utm_medium=email&utm_source=govdelivery. Accessed: December 18, 2020.