For immediate posting:

Spanish

Today, the US Food and Drug Administration approved the first vaccine for COVID-19. The vaccine is known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), to prevent COVID-19 disease in individuals 16 years of age and older. The vaccine is also still available under an Emergency Use Authorization (EUA), including for individuals 12 to 15 years of age and for administration of a third dose in certain immunocompromised individuals.

The FDA approval of this vaccine is a milestone as we continue to fight the COVID-19 pandemic. While this and other vaccines have met the FDA’s stringent scientific criteria for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets high standards for safety. Efficacy and manufacturing quality While millions of people have already received COVID-19 vaccines safely, we recognize that for some, FDA approval of a vaccine may now instill additional confidence to get vaccinated, said Janet Woodcock, acting commissioner of the US Food and Drug Administration. Today’s mark puts us another step closer to changing the course of this pandemic in the United States.”

Since December 11, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under the EUA to individuals 16 years of age and older, and authorization has been expanded to those 12 to 15 years of age on May 10, 2021. EUAs can be used by the Food Administration and drug (FDA) during public health emergencies to provide access to medicinal products that may be effective in preventing, diagnosing, or treating disease, provided the Food and Drug Administration determines that the known and potential benefits of the product, when used for prevention, outweigh the disease diagnosis or treatment known risks and potential of the product.

FDA-approved vaccines go through an agency standard process to review the quality, safety, and efficacy of medicinal products. For all vaccines, the U.S. Food and Drug Administration evaluates the data and information contained in the manufacturer’s Biological Materials Authorization Application (BLA) submission. The BLA is a comprehensive document submitted to the agency that provides very specific requirements. For Comirnaty, the BLA relies on comprehensive data and information previously provided that support the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine test results to ensure vaccine quality, and site inspections where the vaccine is made. The agency conducts its own analyzes of the information contained in the Drug Control Act (BLA) to ensure that the vaccine is safe, effective, and meets Food and Drug Administration (FDA) standards for approval.

Comirnaty contains messenger RNA (mRNA), which is a type of genetic material. The body uses mRNA to mimic one of the proteins in the virus that causes COVID-19. The consequence of a person receiving this vaccine is that their immune system will eventually react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – and does not alter – the genetic material of the individual. Comirnaty has the same composition as the EUA vaccine and is given as a series of two doses, three weeks apart.

“Our scientific and medical experts have conducted an incredibly comprehensive and thoughtful evaluation of this vaccine. We have evaluated the scientific data and information included in hundreds of thousands of pages, conducted our own analyzes of Comirnaty’s safety and efficacy, and conducted a detailed evaluation of manufacturing processes, including inspections of manufacturing facilities.” Director of the Food and Drug Administration’s Center for Evaluation and Research of Biology. “We have not forgotten that the COVID-19 public health crisis continues in the United States and that the public is dependent on safe and effective vaccines. The public and the medical community can trust that although we have approved this vaccine promptly, it is fully compliant with the current high standards for vaccines in the United States.”

FDA evaluation of safety and efficacy data for approval of 16 years of age and older

Released on December 11, the first EUA, the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older, was based on safety and efficacy data from a randomized, controlled, blinded clinical trial of thousands of individuals.

To support today’s FDA approval decision, the FDA reviewed updated data from the clinical trial that supported the EUA and included a longer duration of follow-up in a larger set of clinical trials.

Specifically, in its FDA review of approval, the agency analyzed efficacy data for nearly 20,000 vaccines and 20,000 placebo recipients aged 16 and older who had no evidence of COVID-19 infection within a week of receiving the second dose. Comirnaty’s safety has been evaluated in nearly 22,000 people who received the vaccine and 22,000 people who received placebo aged 16 years and older.

Based on clinical trial results, the vaccine was 91% effective in preventing COVID-19 disease.

More than half of clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients were followed up for at least 6 months.

The most common side effects reported by clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

In addition, the Food and Drug Administration (FDA) has rigorously evaluated the post-licensing safety monitoring data related to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 vaccine and determined that the data show an increased risk, particularly within the seven days following the second day dose. . The observed risk is higher among males under 40 years of age than in older females and males. The observed risk is higher in males between 12 and 17 years of age. Available data from short-term follow-up indicate that most individuals have resolved symptoms. However, some individuals require intensive care support. Information is not yet available about possible long-term health outcomes. Comirnaty’s prescribing information includes a warning about these risks.

Continuous safety monitoring

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the Food and Drug Administration (FDA) is requiring the company to conduct postmarketing studies to assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include evaluating long-term outcomes among individuals who develop myocarditis after vaccination with Kommernate. In addition, although not required by the US Food and Drug Administration, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receiving Comirnaty during pregnancy.

The Food and Drug Administration has given this app priority review. Approval has been given to BioNTech Manufacturing GmbH.

Related information

###

boiler

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.