Approval Signifies Key Achievement for Public Health

Today, the US 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 individuals aged 16 years and older. The vaccine will also continue to be available under an Emergency Use Authorization (EUA), including for individuals aged 12 to 15 years and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone in our fight against the COVID-19 pandemic. While this and other vaccines meet the FDA’s rigorous scientific standards for emergency use authorization, the public can be the first FDA-approved COVID-19 vaccine to have confidence that this vaccine meets the high standards of safety, effectiveness and manufacturing quality the FDA demands of an approved product,” said Acting FDA Commissioner Janet Woodcock, MD. can arouse to being vaccinated. Today’s milestone brings us one step closer to changing the course of this pandemic in the US.”

As of December 11, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under EUA for individuals aged 16 years and older, and the authorization was extended on May 10, 2021 to include individuals aged 12 to 15 years. EUAs can 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 assessing the quality, safety, and effectiveness of medical products. For all vaccines, the FDA reviews the data and information included in the manufacturer’s submission of a Biologics License Application (BLA). A BLA is a comprehensive document filed with the agency with very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted in support of 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 inspections of vaccine sites. is made. The agency conducts its own analyzes of the information in the BLA to ensure the vaccine is safe, effective and meets FDA standards for approval.

Comirnaty contains messenger RNA (mRNA), a type of genetic material. The mRNA is used by the body to make a mimic of 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 respond 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 – nor does it alter – 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 have evaluated this vaccine incredibly thoroughly and thoughtfully. We reviewed scientific data and information on hundreds of thousands of pages, conducted our own analyzes of Comirnaty’s safety and effectiveness, and conducted a detailed assessment of manufacturing processes, including facility inspections,” said Peter Marks, MD, Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research: “We have not lost sight of the continuing COVID-19 public health crisis in the US and the public’s counting on safe and effective vaccines. The public and the The medical community can be confident that while we approved this vaccine quickly, it was fully consistent with our existing high standards for vaccines in the US.”

FDA Review of Safety and Effectiveness Data for Approval for Ages 16 and Over

The first EUA, issued Dec. 11, for 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 ongoing clinical trial involving thousands of individuals.

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

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

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

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

The most commonly reported side effects by the clinical study 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.

In addition, the FDA has conducted a rigorous review of the post-approval safety surveillance data for myocarditis and pericarditis following the administration of the Pfizer-BioNTech COVID-19 vaccine and determined that the data demonstrate increased risks, particularly within seven days of the second dose. The observed risk is higher in men under 40 years of age than in women and older men. The observed risk is highest in men aged 12 to 17 years. Available data from short-term follow-up suggest that most people have resolved symptoms. However, some individuals required intensive care support. No information is yet available on possible long-term health outcomes. The Comirnaty’s prescribing information contains a warning about these risks.

Continuous security monitoring

The FDA and the Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety issues are identified and evaluated in a timely manner. In addition, the FDA requires the company to conduct post-marketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies included an evaluation of long-term outcomes in individuals who develop myocarditis after vaccination with Comirnaty. In addition, while the company has no FDA requirements, the company has committed to conducting additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receiving Comirnaty during pregnancy.

The FDA has granted this application Priority Review. The approval was given to BioNTech Manufacturing GmbH.

Related information

The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and animal medicines, 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, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.