Pfizer-BioNTech COVID-19 Vaccine First to be Fully Approved by the FDA

The U.S. Food and Drug Administration announced on Monday it has approved the Pfizer-BioNTech COVID-19 Vaccine. The vaccine which will be sold under the brand name Comirnaty (koe-mir’-na-tee) has set an important milestone as the first COVID-19 vaccine to be fully licensed by the federal agency.

On December 11, 2020, the U.S. Food and Drug Administration issued the first-ever emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease allowing the Pfizer-BioNTech COVID-19 Vaccine to become the first to be distributed in the U.S.

Comirnaty becomes the first FDA-approved COVID-19 vaccine

Now the Pfizer-BioNTech COVID-19 Vaccine has also become the first to be fully licensed for preventing COVID-19 disease in humans aged 16 and over in the U.S under the Comirnaty brand. The vaccine will remain accessible under emergency use authorisation (EUA) for teenagers aged 12 to 15, as well as for administration as a third dose booster for immunocompromised individuals.

Acting FDA Commissioner Janet Woodcock, M.D. stated:

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product. While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

The Pfizer-BioNTech COVID-19 Vaccine has been accessible under EUA  for individuals 16 years of age and older from December 11, 2020, and on May 10, 2021, the authorization was extended to also cover individuals12 to 15 years of age.  

Comirnaty has the same formulation as the EUA the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) 

Comirnaty has the same formulation as the EUA vaccine and is administered in two doses three weeks apart. The vaccine is based on messenger RNA (mRNA), a kind of genetic material. The mRNA creates a copy in the human body of one of the viral proteins that cause COVID-19. A person’s immune system will eventually respond defensively against the virus that causes COVID-19 as a result of getting this mRNA vaccine. Comirnaty’s mRNA is only present in the body for a brief period of time and does not affect an individual’s genetic material.

The FDA can use EUA’s during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating disease, if the FDA determines that the product’s known and potential benefits, when used to prevent, diagnose, or treat disease, outweigh the product’s known and potential risks.

Vaccines that have been authorized by the FDA have gone through the agency’s standard process for verifying product quality, safety, and efficacy. The FDA reviews the entire data and information submitted in a biologics licensing application by the manufacturer (BLA). A BLA is a formal document that is presented to the agency and outlines the specifications in detail.

The BLA for Comirnaty is based on the comprehensive data and information submitted initially to support the EUA  application, involving preclinical and clinical study and quality data, manufacturing processes and production site inspection details. The FDA has run its own evaluations of the data contained in the BLA to confirm that the vaccine is safe and effective and meets the agency’s approval criteria.

Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research said:

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities. We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older

The first EUA for the Pfizer-BioNTech COVID-19 Vaccine was based on safety and efficacy results from a randomized, controlled, blinded clinical study involving thousands of people. To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. 

Comirnaty’s safety was tested in about 22,000 persons 16 years and older who received the vaccination and 22,000 people who received a placebo. The vaccine was shown to be 91 percent effective in preventing COVID-19 illness in a clinical study.

After the second dosage, more than half of the clinical trial participants were followed for at least four months for safety outcomes. A total of 12,000 recipients have been tracked for at least six months.

Discomfort, redness, and swelling at the injection site, tiredness, headache, muscular or joint pain, chills, and fever were the most often reported adverse effects among clinical trial participants who received Comirnaty. The vaccine protects against COVID-19 and its potentially fatal consequences, such as hospitalization and death. Furthermore, the FDA conducted a  review of post-authorization safety surveillance data on myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and confirmed that the data show increased risks, particularly within the first seven days after the second dose. Guys under the age of 40 have a greater risk than females and older males. Males between the ages of 12 and 17 have the highest risk. Short-term follow-up research data suggests that the majority of people have had their symptoms resolved. Some people, however, required intensive care support. Information on potential long-term health effects is currently unavailable. These risks are featured in the Comirnaty Prescribing Information.

Ongoing Safety Monitoring

The FDA and 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 FDA is requiring the company to conduct post-marketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

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