- For immediate release:
Today, the U.S. The Food and Drug Administration has issued the first Emergency Use Authorization (EUA) vaccine for the prevention of coronavirus disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-Covi-2) years and older. Authorization for emergency use The Pfizer-Bioentech COVID-19 vaccine has been approved by the U.S. Allow to be distributed in
“The FDA’s authorization for emergency use of the first Covid-19 vaccine is a significant milestone in the fight against this devastating epidemic that has affected many families in the United States and around the world,” said FDA Commissioner Stephen M. Han, MDA said. The action follows an open and transparent review process that involves the input of independent scientists and public health experts, and the agency’s career scientists to meet the standards for product quality required to support the FDA’s strict, safety, effectiveness, and emergency use of the vaccine. Includes a thorough evaluation to make sure it does. Authenticity. This novel is a true testament to the relentless work to develop a new vaccine to prevent the emergence of a serious and life-threatening disease in the short term, global scientific innovation and public-private collaboration around the world. ”
The FDA has determined that the Pfizer-Bioentech COVID-19 vaccine meets the legal criteria for issuing an EUA. The completeness of the available data provides clear evidence that the Pfizer-Bioentech COVID-19 vaccine may be effective in preventing COVID-19. The data also confirms that the known and potential benefits outweigh the known and potential risks, including the use of the vaccine in millions of people 16 years of age or older, including healthy individuals. 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.
The Pfizer-Bioentech COVID-19 vaccine contains messenger RNA (mRNA), which is a genetic material. The vaccine contains a small fragment of the mRNA of the SARS-Cavi-2 virus that instructs the body’s cells to make a specific “spike” protein for the virus. When a person receives this vaccine, his or her body produces copies of the spike protein, which is not the cause of the disease, but stimulates the immune system to learn to respond protectively, producing an immune response against SARS-Covy-2.
“The authorization of the current emergency use of the Pfizer-bayonet tech CO Weed-19 vaccine without FDA approval promises to change the course of this epidemic in the United States,” said PD Marks, MD, PhD, director. FDA Center for Biological Evaluation and Research. “Science guides us in our decision-making, available safety and efficacy data supporting the authenticity of the Pfizer-Bioentech COVID-19 vaccine because the known and potential benefits of the vaccine clearly outweigh its known and potential risks. The data provided by the sponsor met the FDA’s expectations as stated in our June and October guide documents. Efforts to accelerate vaccine development have not met scientific standards or the integrity of our vaccine evaluation process. The FDA’s review process includes a public and independent review of the agency’s vaccine and related biological products advisory committee members. Today’s achievement is ultimately the commitment of our career scientists and physicians, who worked tirelessly to fully evaluate the data and information for this vaccine. “
FDA evaluation of available security data
The Pfizer Bionettech Covid-19 vaccine is given as a two-dose series, in addition to three weeks. 37,586 participants enrolled in an ongoing randomized, placebo-controlled international study in the safety data available to support the EU. Participants are included, most of whom are U.S. citizens. There are participants. These participants, of whom 18,801 were vaccinated and 18,785 of whom received saline placebo, were followed for an average of two months after receiving the second dose. Side effects, usually lasting several days, were pain, fatigue, headache, muscle aches, colds, joint pain, and fever at the injection site. 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.
Pfizer Inc. And vaccination providers are required to report the following anti-vaccine event reporting system (VARS) to the Pfizer-Bionettech Covid-19 vaccine: all errors in vaccine administration, serious adverse events, cases of multisystem inflammatory syndrome (MIS). , And cases of COVID-19 that result in hospitalization or death.
FDA evaluation of available effectiveness data
Effectiveness data to support the EU included an analysis of 36,523 participants in an ongoing randomized, placebo-controlled international study, most of them US participants who had no evidence of SARS-Co-2 infection after another seven days. Dosage. Of these participants, 18,198 received the vaccine and 18,325 received the placebo. The vaccine was 95% effective in preventing Covid-19 disease in eight COVD-19 cases in the group and 162 patients in the placebo group among the participants in this clinical trial. Of these 170 covid-19 cases, one in the vaccine group and three in the placebo group have been classified as severe. At this time, there is no data available to make a decision about how long the vaccine will protect, or there is no evidence that the vaccine prevents transmission from one person to another.
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 affects national security or the health and safety of United States citizens living abroad. , And then declarations are issued that justify the emergency use of disapproved products in the circumstances, the FDA, the EU may issue accredited medical products or use the disapproved use 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 (license). In determining whether to issue an EUA for a product, the FDA evaluates the available evidence and evaluates any known or potential risks and any known or potential benefits, and if the benefit-risk assessment is favorable, the product is made available during an emergency. . Once the manufacturer submits the 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 available for the vaccine. The FDA.
The EUA also requires fact sheets that will be made available to vaccination providers and vaccinators providing dosing instructions and important information about the benefits and risks of the Pfizer-Bionettech COVID-19 vaccine.
The company has submitted a pharmacovillance plan to the FDA to monitor the safety of the Pfizer-Bioentech 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 aimed at monitoring the safety profile of the Pfizer-Bioentech COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.
The FDA also expects that COVID-19 vaccines are authorized under the EUA to continue their clinical trials in order to obtain authorized safety and efficacy information and obtain a license.
The EUA for the Pfizer-Biontech COVID-19 vaccine was issued to Pfizer Inc. U.A. The declaration of will be effective as long as the circumstances do not exist. And may be amended or revoked if it is determined that the EU 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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