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Today, the United States Food and Drug Administration approved the first COVID-19 vaccine. The vaccine was known as the Pfizer-BioNTech COVID-19 vaccine and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in people aged 16 years and older. The vaccine also continues to be available under emergency use authorization (EUA), including for people ages 12 to 15 and for administration of a third dose in certain immunocompromised people.

“FDA approval of this vaccine is an important milestone as we continue to fight the COVID-19 pandemic. Although this vaccine and others have passed the FDA’s rigorous scientific standards for emergency use authorization, as the first COVID-19 vaccine approved by the FDA, the public can be very confident that this vaccine meets high standards of safety, efficiency and manufacturing quality. FDA requires an approved product,” said Acting FDA Commissioner Janet Woodcock, MD “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine can now inspire additional confidence to get vaccinated. Today’s milestone brings us one step closer to changing the course of this pandemic in the United States”

As of December 11, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under EUA in individuals ages 16 and older, and the authorization was expanded to include individuals ages 12-15 on May 10, 2021. EUAs may be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating disease, provided the FDA determines that the known and potential benefits of a product , when used to prevent, diagnose or treat disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety, and efficacy of medical products. For all vaccines, the FDA evaluates the data and information included in the manufacturer’s submission of a Biologics License Application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA relies on the extensive data and information previously submitted in support of the EUA, such as preclinical and clinical data and information, as well as manufacturing process details, vaccine test results to ensure vaccine quality and site inspections. where the vaccine is made. The agency performs its own analyzes of the information in the BLA to ensure that the vaccine is safe and effective and meets FDA approval standards.

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to mimic one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will eventually react defensively to the virus that causes COVID-19. Comirnaty mRNA is only present in the body for a short time and is not incorporated into – or altering – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is given as a series of two doses, three weeks apart.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We have evaluated the scientific data and information included in hundreds of thousands of pages, performed our own analyzes of Comirnaty’s safety and effectiveness, and performed a detailed evaluation of manufacturing processes, including inspections of manufacturing facilities” , said Peter Marks, MD, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the public health crisis of COVID-19 continues in the United States and that the public relies on safe and effective vaccines. The public and the medical community can be confident that although we approved this vaccine quickly, it fully met our existing high standards for vaccines in the United States. »

FDA Evaluation of Safety and Efficacy Data for Approval for Ages 16 and Older

The first EUA, released Dec. 11, for the Pfizer-BioNTech COVID-19 vaccine for people 16 years of age and older was based on safety and efficacy data from a randomized, controlled, clinical trial. blind in progress on thousands of people.

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

Specifically, during the FDA approval review, the agency analyzed efficacy data from approximately 20,000 vaccines and 20,000 placebo recipients ages 16 and older who had no evidence. infection with the COVID-19 virus within a week of receiving the second dose. The safety of Comirnaty has been evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo aged 16 and over.

According to the results of the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

More than half of clinical trial participants were followed for safety results for at least four months after the second dose. In total, approximately 12,000 beneficiaries were followed 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 consequences, including hospitalization and death.

Additionally, the FDA conducted a rigorous evaluation of post-authorization safety surveillance data regarding myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 vaccine and determined that the data demonstrate increased risks, especially within seven days of the second dose. The observed risk is higher in men under 40 than in women and older men. The observed risk is highest in men aged 12 to 17. Available short-term follow-up data suggests that most individuals have had resolution of symptoms. However, some people needed intensive care. No information is yet available on potential long-term health effects. Comirnaty’s prescribing information includes a warning about these risks.

Continuous security monitoring

The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety issues continue to be identified and assessed in a timely manner. Additionally, the FDA requires the company to conduct post-marketing studies to further assess the risks of myocarditis and pericarditis after vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes in people who develop myocarditis after vaccination with Comirnaty. Additionally, although not an FDA requirement, the company is committed to performing additional post-marketing safety studies, including conducting a pregnancy registry study to assess the results of the pregnancy and infant after receiving Comirnaty during pregnancy.

The FDA granted this application priority review. Approval was granted to BioNTech Manufacturing GmbH.

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.