- For immediate release:
Today, the US Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use permit allows the Moderna COVID-19 vaccine to be distributed in the United States for use by persons 18 years of age and older.
“With the availability of two vaccines now to prevent COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing a large number of hospitalizations and deaths in the United States every day,” said FDA Commissioner Stephen M. Hahn, MD “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been approved over an accelerated time frame, while meeting the rigorous safety, efficacy and production quality standards required to support the authorization. emergency use that the American people have come to expect from the FDA. These standards and our review process, which are the same ones we used in the review of the first COVID-19 vaccine and we intend to use for any other COVID-19 vaccines, have included contributions from independent scientific and public health experts, as well as an in-depth analysis of the data of the agency’s career staff. “
The FDA has determined that the Modern COVID-19 vaccine has met the legal criteria for issuing a EUA. All available data provide clear evidence that the Modern COVID-19 vaccine may be effective in preventing COVID-19. The data also show that the known and potential benefits outweigh the known and potential risks – supporting the company’s demand for vaccine use in people aged 18 and over. By making this determination, the FDA can assure the public and the medical community that it has conducted an in-depth evaluation of available information on the safety, efficacy, and quality of production.
The Modern COVID-19 vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of SARS-CoV-2 virus mRNA that instructs cells in the body to produce the distinctive spike virus 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.
“Guided by science and data, the agency’s career staff has established that the known and potential benefits of the vaccine clearly outweigh its known and potential risks and, although not an FDA approval, the FDA expectations described in our June guidance documents and October have been met, “said Peter Marks, MD, Ph.D., director of the FDA’s Center for Biological Evaluation and Research. Today’s authorization demonstrates our strong commitment to the health of the American people, ensuring that our scientific standards and the integrity of our review process have been maintained. This achievement is further evidence of the dedication of scientists and physicians in the FDA’s careers who have worked urgently to conduct comprehensive and rigorous evaluations of data presented for vaccines to prevent COVID-19.
FDA evaluation of available safety data
The Modern COVID-19 vaccine is given as a two-dose series, one month apart. The safety data available to support EUAs include an analysis of 30,351 participants enrolled in an ongoing randomized, placebo-controlled study in the US. These participants, of whom 15,185 received the vaccine and 15,166 of whom received placebo saline, were were followed for a median of more than two months after the second dose. The most commonly reported side effects, which usually lasted for several days, were pain at the injection site, fatigue, headache, muscle aches, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting and fever. Notably, more people experienced these side effects after the second dose than after the first dose, so it is important that vaccination providers and recipients expect that there may be some side effects after either dose, but even more so. long after the second dose.
Mandatory for ModernaTX, Inc. and vaccination providers to report the following information to the Vaccine Adverse Event Reporting System (VAERS) for Modern COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome (MIS), and cases of COVID-19 leading to hospitalization or death.
FDA evaluation of available efficacy data
Efficacy data to support EUAs include an analysis of 28,207 participants in the ongoing, randomized, placebo-controlled study in the United States who had no evidence of SARS-CoV-2 infection prior to the first dose of vaccine. Of these participants, 14,134 received the vaccine and 14,073 received placebo. The vaccine was 94.1% effective in preventing COVID-19 disease among these participants in clinical trials, with 11 cases of COVID-19 in the vaccine group and 185 in the placebo group. At the time of analysis of these 196 COVID-19 cases, none of the vaccine group and 30 of the placebo group were classified as severe. After completing the analysis of these 196 cases, a severe case from the vaccine group has been identified and is awaiting confirmation. At this time, no data are available to determine how long the vaccine will provide protection, nor is there any evidence that the vaccine prevents person-to-person transmission of SARS-CoV-2.
The US trial
Based on the decision by the Secretary of the Department of Health and Human Services of February 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and safety of U.S. citizens living abroad and issued statements that there are circumstances that warrant authorization of the emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no suitable, approved and available alternatives.
The release of an EUA is different from the FDA approval (licensing) of a vaccine, in that a vaccine available under an EUA is not approved. To determine whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits. If the product meets the efficiency standard and the risk-benefit assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA application for a COVID-19 vaccine to the FDA, the agency then evaluates the application and determines whether the relevant statutory criteria are met, taking into account all scientific evidence about the vaccine available to the FDA.
EUA also requests that fact sheets providing important information, including dosing instructions and information on the benefits and risks of the Moderna COVID-19 vaccine, be made available to vaccine suppliers and vaccine recipients.
ModernaTX, Inc. submitted a pharmacovigilance plan to the FDA to monitor the safety of Moderna COVID-19 vaccine. The pharmacovigilance plan includes a plan to complete the long-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of Moderna COVID-19 vaccine and ensuring that any safety issues are identified and assessed in a timely manner.
The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and efficacy information and to obtain approval (licensing).
EUA certificates for the Moderna COVID-19 vaccine have been issued to ModernaTX, Inc. The authorization will be effective until the declaration that there are circumstances justifying the authorization of the emergency use of medicinal products and biological substances for the prevention and treatment of COVID-19. EUA for the Modern COVID-19 vaccine may be reviewed or revoked if it is found that EUA no longer meets the legal criteria for release.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, food supplements, products that emit electronic radiation and for regulating tobacco products.
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