For immediate release: December 11, 2020 Today, the U.S. Food and Drug Administration released the first Emergency Use Approval (EUA) vaccine for the prevention of corona virus disease 2019 (COVID-19) caused by acute respiratory coronavirus 2 (SARS). -CoV-2) In persons 16 years of age and older. Emergency Application Credit Allows Distribution of Pfizer-Bioentech Covit-19 Vaccine in the United States M. Han said, “Today’s action follows an open and transparent review process, which includes input from independent scientific and public health professionals and a thorough evaluation of the company’s industry scientists to confirm this vaccine to support the FDA’s rigorous, scientific approach to safety, performance and product quality required to support authorization. Met standards. This novel is a true testament to the tireless work, scientific discovery and public-private collaboration around the world to develop a new vaccine to prevent serious and life-threatening disease in its short time. The FDA has determined that the Pfizer-Bioentech Covit-19 vaccine meets the legal criteria for issuing an EU. The Pfizer-Bioendech COVID-19 vaccine provides conclusive evidence of the total available data on its effectiveness in preventing COVID-19. The data also support the fact that the known and potential benefits outweigh the known and potential risks, and support the use of the vaccine in millions of people aged 16 and over, including healthy individuals. In making this decision, the FDA can guarantee that it has fully evaluated the safety, performance and product quality information available to the general and medical community. The Pfizer-Bioentech Covit-19 vaccine contains messenger RNA, a genetic material. The vaccine contains a small portion of the mRNA of the SARS-CoV-2 virus, which prompts cells in the body to develop the virus’s unique “spike” protein. When a person receives this vaccine, their body makes copies of the spike protein, which does not cause disease, but stimulates the immune system to learn to function defensively, building up immunity against SARS-CoV-2. “Although not approved by the FDA, today’s emergency use of the Pfizer-BioTech Covit-19 vaccine is a pledge to reverse the trend in the United States,” said Peter Marx, MD, Ph.D., Director, FDA. Center for Biological Assessment and Research. “As science leads to our decision-making, the available safety and efficacy data support the recognition of the Pfizer-Bioendech Covit-19 vaccine because the known and potential benefits of the vaccine outweigh its known and potential risks. Avin has lived up to expectations: Attempts to accelerate vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process, including industry and independent review of information from members of the Agency’s Immunization and Related Biological Products Advisory Board in the FDA’s review process. It is a testament to the dedication of our industry scientists and physicians who have worked tirelessly to fully evaluate. ”Available The FDA rating of the Dia Safety Data Pfizer Bioentech Covit-19 vaccine is administered in a series of two doses at three-week intervals. Of the available security data to support the EUA, 37,586 participants were included in a series of randomized, placebo-controlled international surveys, most of them U.S. participants. These participants, 18,801 of whom were vaccinated, 18,785 of whom received salivary placebo, were followed up between two months after receiving the second dose. Side effects that usually last for several days include injection site pain, fatigue, headache, muscle aches, cold, joint pain and fever. It is noteworthy that more people experienced these side effects after the first dose than after the second dose, so it is important that vaccine providers and recipients expect some side effects to occur after a single dose, but not after a second dose. Pfizer Inc. and vaccine providers are required to report to the Vaccine Adverse Event Reporting System (VAERS) for the Pfizer-BioTech Covid-19 Vaccine: All vaccine management errors, severe adverse events, multicast inflammatory disease syndrome (MIS), or COVID-19 hospitalization . FDA rating of available performance data Performance data to support the EUA include analysis of 36,523 participants in a consistently randomized, placebo-controlled international study, most of whom had no evidence of SARS-CoV-2 infection within seven days after the second dose. Of these participants, 18,198 were vaccinated and 18,325 received placebo. The vaccine was 95% effective in preventing COVID-19 disease among participants in this clinical trial, with eight COVID-19 cases in the vaccine group and 162 in the placebo group. Of these 170 COVID-19 cases, one in the vaccine group and three cases in the placebo group were classified as severe. At this time, no data are available to determine how long the vaccine will provide protection, or there is no evidence that the vaccine prevents the spread of SARS-CoV-2 from person to person. EU Process Based on a resolution of the Secretary of the Department of Health and Human Services dated February 4, 2020, there is a public health emergency that has significant potential to affect national security or the health and safety of the United States. Citizens living abroad may then issue notices that there are circumstances justifying the authorization of emergency use of unauthorized products, and the FDA may issue an EUA to allow the emergency detection, treatment, and use of unauthorized medical products or unauthorized use of approved medical products. Or prevent COVID-19 when there are no adequate, approved and available alternatives. The EUA issuance is different than the FDA approval (license) of a vaccine. In determining whether a product can be awarded an EUA, the FDA evaluates available resources and evaluates known or potential risks and known or potential benefits, and if the benefit-risk assessment is positive, the product is available in an emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the company evaluates that request and determines whether the relevant legal criteria are met, taking into account the total amount of scientific evidence about the vaccine. The EUA requests that vaccine providers and vaccinators be provided with fact sheets that provide vital information, including stimulant guidelines, and information on the benefits and risks of the Pfizer-Biotech Covit-19 vaccine. The company has submitted a pharmaceutical plan to the FDA to monitor the safety of the Pfizer-Bioentech Covit-19 vaccine. The Pharmaceutical Awareness Program includes a program to complete long-term safety follow-up for participants enrolled in current clinical trials. Other activities aimed at monitoring the safety profile of the Pfizer-Bioentech Covit-19 vaccine are included in the pharmaceutical awareness program, ensuring that any safety concerns are identified and evaluated in a timely manner. The FDA also expects EUA-approved manufacturers of COVID-19 vaccines to continue their clinical trials for additional safety and efficacy information and approval (licensing). Pfizer-Bioentech awarded to EUA Pfizer Inc. for COVID-19 vaccine. The EUA will remain effective until it declares that there are circumstances justifying the authorization of emergency use of drugs and biologics for the prevention and treatment of COVID-19. It may be amended or revoked if it is determined that the EUA no longer meets the legal criteria for issuance. The FDA, within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products and medical devices for human use. This company is responsible for the safety and security of our country’s food supply, cosmetics, food products, electronic radiation products and tobacco products. ### Related information