The US Food and Drug Administration (FDA) is taking major action in the fight against COVID-19 by issuing an emergency use authorization for the first COVID-19 vaccine

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The US Food and Drug Administration today issued the first Emergency Use Authorization (EUA) for a vaccine to prevent severe acute respiratory syndrome coronavirus disease 2019 (COVID-19) 2 (SARS-CoV-2) in individuals 16 years of age and older. The Emergency Use Permit allows distribution of the Pfizer-BioNTech COVID-19 vaccine in the United States

Today, the procedure follows an open and transparent review process that included input from independent science and public health experts and a comprehensive evaluation by the agency’s professional scientists to ensure that this vaccine meets stringent scientific standards for safety, efficacy, and manufacturing quality necessary,” FDA Commissioner Stephen M. Hahn, MD, said today. To support emergency use authorization. The tireless work to develop a new vaccine to prevent this new, dangerous and life-threatening disease in a rapid time frame after its emergence is a true testament to scientific innovation and collaboration between the public and private sectors around the world.”

The US Food and Drug Administration (FDA) has determined that the Pfizer-BioNTech COVID-19 vaccine has met the legal criteria for an EUA release. The total available data provides clear evidence that the Pfizer-BioNTech COVID-19 vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting 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 reassure the public and the medical community that it has conducted a comprehensive evaluation of the available safety, efficacy, and manufacturing quality information.

The Pfizer-BioNTech COVID-19 vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the mRNA of the SARS-CoV-2 virus that instructs cells in the body to make the virus’ signature “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but rather stimulates the immune system to learn how to react defensively, producing an immune response against SARS-CoV-2.

said Peter Marks, MD, PhD, director of the Food and Drug Administration’s Center for Biology Evaluation and Research. “With the science that guides our decision-making, the available safety and efficacy data support authorization for use of the Pfizer-BioNTech COVID-19 vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks. The data provided by the sponsor met the expectations of the U.S. Food and Drug Administration as reported in Guidance documents for June and October Efforts to expedite vaccine development did not sacrifice scientific standards or the integrity of our vaccine evaluation process The FDA’s review process also included a public, independent review from members of the Agency’s Vaccines and Biological Products Advisory Committee Today’s achievement is in The end is a testament to the commitment of our scientists and medical professionals, who have worked tirelessly to conduct a comprehensive assessment of the data and information for this vaccine.”

Food and Drug Administration assessment of available safety data

The Pfizer BioNTech COVID-19 vaccine is given as two doses, three weeks apart. The safety data available to support the EUA includes 37586 participants enrolled in an ongoing randomized, placebo-controlled international study, the majority of whom were from the United States. These participants, 18,801 of whom received the vaccine and 18,785 of whom received a placebo, were followed for an average of two months after receiving the second dose. The most common side effects reported, which usually lasted several days, were injection site pain, fatigue, headache, muscle aches, chills, joint pain, and fever. It should be noted that more people experienced these side effects after the second dose than after the first dose, so it is important for vaccinators and recipients to expect some side effects to occur after either dose, but more so after the second dose.

Pfizer Inc. must Vaccination Providers will report the following to the Pfizer-BioNTech COVID-19 Vaccine Adverse Event Reporting System (VAERS): All vaccine administration errors, serious adverse events, multisystem inflammatory syndrome (MIS) cases, and COVID-19 cases resulting in hospitalization or death.

FDA evaluation of available efficacy data

Efficacy data to support the EUA includes an analysis of 36,523 participants in the ongoing international randomized placebo-controlled study, mostly US participants, who had no evidence of SARS-CoV-2 infection within seven days after the second. dose. Of these participants, 18,198 received the vaccine and 18,325 received a placebo. The vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight cases of COVID-19 in the vaccine group and 162 in the placebo group. Of the 170 COVID-19 cases, one in the vaccine group and three in the placebo group were classified as severe. Currently, data is not available to determine how long a vaccine will provide protection, and there is no evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

USA operation

Based on the decision of the Secretary of Health and Human Services on February 4, 2020, that a public health emergency has significant potential to affect the national security or the health and security of United States citizens living abroad, and thus make declarations that circumstances exist that justify authorizing the emergency use of unapproved products , the Food and Drug Administration (FDA) may issue an EUA to allow the emergency use of unapproved medicinal products or unapproved uses of approved medicinal products for the diagnosis, treatment, or prevention of COVID-19 in the absence of appropriate, approved and available alternatives.

An EUA release is different from Food and Drug Administration (FDA) approval (authorization) for a vaccine. In deciding whether to issue an EUA for a product, the FDA evaluates the available evidence, assesses any known or potential risks and any known or potential benefits, and if the benefit risk assessment is appropriate, the product will be made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the Food and Drug Administration, the agency then evaluates the request and determines whether the relevant legal criteria are met, taking into account the entirety of scientific evidence about the vaccine available to the FDA.

EUA law also requires that fact sheets providing important information, including dosing instructions, and information about the benefits and risks of the Pfizer-BioNTech COVID-19 vaccine be available to vaccination providers and vaccine recipients.

The company has submitted a pharmacovigilance plan to the FDA to monitor the safety of the Pfizer-BioNTech COVID-19 vaccine. The pharmacovigilance plan includes a plan to complete 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 the Pfizer-BioNTech COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines have been licensed under the European Union Agreement (EUA) to continue their clinical trials to obtain additional information on safety and efficacy and to pursue approval (licensing).

The EUA has been issued to the Pfizer-BioNTech COVID-19 vaccine for Pfizer Inc. The EUA will be in effect until conditions are declared that justify authorization of emergency use of medicines and biological preparations for the prevention and treatment of COVID-19, and may be revised or rescinded if it is determined that the EUA no longer meets the legal criteria for issuance.

The Food and Drug Administration, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary medicines, vaccines, and other biological products for human use and medical devices. The agency is also responsible for the safety and security of our nation’s food, cosmetics, and dietary supplement supplies, products that emit electronic radiation, and for regulating tobacco products.

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