- For immediate release:
Today, the U.S. The Food and Drug Administration has issued an Emergency Use Author Theory (EUA) for a second vaccine to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Emergency use authorization allows the delivery of the Moderna COVID-19 vaccine in the US for individuals 18 years of age or older.
“Now with the availability of two vaccines to prevent covid-1, the FDA has taken another decisive step in the fight against this global epidemic, which causes a large number of hospitalizations and deaths every day in the United States,” the FDA commissioner said. . Stephen M. Hein, MD “Two COVID-19 vaccines have been authorized in a timely manner by the FDA through an open and transparent scientific review process, while adhering to strict standards for product quality required to support the safety, effectiveness and validity of emergency use. These standards and our review process, similar to the one we used in the first COVID-19 vaccine review and any other COVID-19 vaccine intended to include the input of independent scientists and public health experts, as well as a thorough analysis. Data from the agency’s career staff. “
The FDA has determined that the Moderna KVID-19 vaccine meets the EU’s legal criteria for issuance. The completeness of the available data provides 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 – the company has supported the request for vaccine use in people 18 years of age or older. In making this decision, the FDA can assure the public and medical community that it has thoroughly evaluated the available safety, effectiveness, and product quality information.
Messenger RNA in the modern COVID-19 vaccine. (MRNA), which is the genetic material. The vaccine contains a small fraction of the mRNA of the SARS-Cavi-2 virus that instructs the body’s cells to make a specific “spike” protein for the virus. After a person receives this vaccine, his or her body produces copies of the spike protein, which does not cause disease, but stimulates the immune system to learn to respond protectively, producing an immune response against SARS-CoV-2.
“Guided by science and data, the agency’s career staff has determined that the known and potential benefits of the vaccine outweigh its known and potential risks, and despite FDA approval, the FDA’s expectations described in our June and October guide documents have been met. Peter Marcus, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Today’s authorization demonstrates our unwavering commitment to the health of the American people, with the assurance that our scientific standards and the integrity of our review process are maintained. This achievement is another testament to the dedication of the FDA’s career of scientists and physicians, who are urgently working to expand and rigorously evaluate the data submitted for vaccines to prevent COVID-19. “
FDA evaluation of available security data
The Moderna COVID-19 vaccine is given as a two-dose series, in addition to one month. In the security data available to support the EU, the U.S. The ongoing randomized, placebo-controlled study conducted in included an analysis of 30,351 participants enrolled in these participants, of whom 15,185 received the vaccine and 15,166 of whom received saline placebo, were followed for the mediator more than two months after receiving the second dose. Side effects that usually last for several days, such as pain at the injection site, fatigue, headache, muscle aches, colds, joint pain, swollen lymph nodes, which were like injections, ause bruising and otitis media and fever. Notably, more people experienced these side effects after the first dose than the second dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more after the second dose.
ModernaTX, Inc. And vaccine providers are required to report the following anti-vaccine event reporting system (VAERS) for the Moderna COVID-19 vaccine: all errors in vaccine administration, serious adverse events, cases of multisystem inflammatory syndrome (MIS), and cases of COVID-19 Resulting in hospitalization or death.
FDA evaluation of available effectiveness data
Ongoing randomized, placebo-controlled U.S. in efficacy data to support the EU. The study included an analysis of 28,207 participants who did not have evidence of having a SARS-CoV-2 infection prior to the first dose of the vaccine. Of these participants, 14,134 received the vaccine and 14,073 received the placebo. The vaccine was 94.1% effective in preventing Covid-19 disease in 11 of the covid group in the vaccine group and 185 cases in the placebo group among the clinical trial participants. At the time of analysis of these 196 COVID-19 cases, none in the vaccine group and 30 in the placebo group were not classified as severe. After the completion of the analysis of these 196 cases, a serious case has been identified in the vaccine group and is awaiting confirmation. At this time, data are not available to determine how long the vaccine will provide protection, or there is no evidence that the vaccine prevents the transmission of SARS-COV-2 from person to person.
EU process
As determined by the Secretary of the Department of Health and Human Services on February 4, 2020, there is a public health crisis that is likely to affect national security or affect the health and safety of citizens of the United States. Issued declarations that exist abroad and in the circumstances of authorizing the emergency use of rejected products, the FDA, E.O.A. May use unapproved medical products or unrecognized uses of accredited medical products to diagnose, treat or prevent in an emergency. -19 When there are not enough, valid and available options.
The EUA’s introduction differs from the vaccine’s FDA approval (licensor) in that the vaccine available under the EUA is not approved. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence as to whether the product may be effective and also evaluates the known or potential risks and any known or potential benefits. If the product meets the standard of effectiveness and the benefit-risk assessment is favorable, the product is made available during the crisis. Once a manufacturer submits an EUA request for the COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant legal criteria are met, taking into account the completeness of the scientific evidence about the vaccine. The FDA.
The EUA also requires fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Moderna COVID-19 vaccine, to vaccine providers and vaccinators.
ModernaTX, Inc. A has submitted a pharmacovillance plan to the FDA to monitor the safety of the Moderna COVID-19 vaccine. The PharmacoVillance plan includes a plan to complete long-term safety follow-up for participants enrolled in ongoing clinical trials. The PharmacoVillance plan includes other activities to monitor the safety profile of the Moderna CO COVID-19 vaccine and to ensure that any safety issues are identified and evaluated in a timely manner.
The FDA also expects that COVID-19 vaccines are authorized under EUA to continue their clinical trials in order to obtain authorized safety and efficacy information and obtain a license.
The EUA for Moderna COVID-19 vaccine was issued to ModernaTX, Inc. This approval will not be effective as long as the circumstances exist, the use of drugs and biological elements for the prevention and treatment of COVID-19 can be recognized. The EUA for the Moderna COVID-19 vaccine may be amended or revoked if it is determined that the EUA will not meet the legal criteria for issuing.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, 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, dietary supplements, electronic radiation products, and the regulation of tobacco products.
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