FDA grants full approval to the Pfizer/BioNTech COVID-19 vaccine

Photo: Kathrin Ziegler/Getty Images

The U.S. Food and Drug Administration said Monday it has given full approval to the first COVID-19 vaccine, with the Pfizer/BioNTech offering getting the nod, and the vaccine will now be marketed as Comirnaty. The vaccine has been approved for the prevention of COVID-19 for those 16 years old and older.

The vaccine also continues to be available under emergency use authorization, including for those 12 to 15, and for the administration of a third dose in certain immunocompromised patients.

According to CNN, out of about 170 million Americans who are fully vaccinated against the coronavirus, more than 92 million have received the Pfizer/BioNTech vaccine.

WHAT'S THE IMPACT?

Leading up to final approval, 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 about 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. The safety of Comirnaty was evaluated in roughly 22,000 people who received the vaccine and 22,000 people 16 years old or older who received a placebo.

Based on results from 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 outcomes for at least four months after the second dose. Overall, about 12,000 recipients have been followed for at least six months.

The most commonly reported side effects by those 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 the FDA's evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the vaccine, the data demonstrated increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years old compared to females and older males, and is highest in males 12 through 17.

Available data from a short-term follow-up suggests that most people have had resolution of symptoms, although some required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.

The FDA and Centers for Disease Control and Prevention will be monitoring for safety concerns, and the former is requiring Pfizer/BioNTech to conduct postmarketing 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.

In addition, although not required by the FDA, 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.

Final approval may sway some Americans to get the vaccine. According to a Kaiser Family Foundation survey from July, among the one-third of surveyed adults who were not vaccinated, 16% said the vaccine was too new or not tested enough, and some said they wouldn't get a vaccine unless it was required.

THE LARGER TREND

Since December 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years old and older, and the authorization was expanded to include those 12 through 15 on May 10, 2021. 

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 a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the 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 effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer's submission of a biologics license application, or BLA. A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. 

For Comirnaty, the BLA builds on the data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure quality, and inspections of the sites at which the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA's standards for approval.

Comirnaty contains messenger RNA, or mRNA, which is a kind 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 the vaccine is that their immune system will ultimately 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 – nor does it alter – an individual's genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.

ON THE RECORD

"The FDA's approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," said Acting FDA Commissioner Dr. Janet Woodcock. "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."

"Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine," said Dr. Peter Marks, director of FDA's Center for Biologics Evaluation and Research. "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."
 

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com