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Q&A about the Full FDA Approval of the Pfizer-BioNTech COVID-19 Vaccine

When did the FDA grant full approval of the Pfizer-BioNTech COVID-19 vaccine?

Aug. 23, 2021

What kind of approval did the Pfizer-BioNTech COVID-19 vaccine have before this?

  • Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under emergency use authorization (EUA) for individuals 16 years of age and older.
  • The authorization of the Pfizer-BioNTech COVID-19 vaccine was expanded to include those 12 to 15 years of age on May 10, 2021.
  • The Pfizer-BioNTech COVID-19 vaccine continues to be available under EUA for individuals 12 to 15 years of age and for the administration of a third dose for certain immunocompromised individuals.

What is the difference between an EUA and full approval?

  • EUA allows the FDA to authorize use of vaccines and drugs that do not yet have full approval when there are no other options to treat life-threatening conditions and if there is strong evidence of benefit.
  • In addition to the review and testing process for EUA, full FDA approval requires a rigorous review of even more data from clinical trials and real-world information over longer periods of time.

Is there a new name for the Pfizer-BioNTech COVID-19 vaccine?

Yes, the new name is Comirnaty (koe-mir’-na-tee).

What were the findings of the rigorous review for full approval?

This review found that:

  • The Pfizer-BioNTech COVID-19 vaccine is safe and effective, and can be manufactured reliably.
  • The Pfizer-BioNTech COVID-19 vaccine is effective in preventing COVID-19 and potentially serious outcomes from the disease, including hospitalization and death.
  • 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.

What about the risk of myocarditis and pericarditis?

  • The FDA conducted a rigorous evaluation of the post-authorization safety surveillance data regarding cases of myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 vaccine. It has determined that the data demonstrate very rare but increased risks, particularly within the seven days following the second dose.
    • The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age.
    • Most patients with myocarditis or pericarditis who received care responded well to medicine and rest and felt better quickly.
    • Patients can usually return to their normal daily activities after their symptoms improve. Those who have been diagnosed with myocarditis should consult with their cardiologist (heart doctor) about return to exercise or sports. More information will be shared as it becomes available.
    • The known risks of COVID-19 illness and its related, possibly severe complications, such as long-term health problems, hospitalization, and even death, far outweigh the potential risks of having a rare adverse reaction to vaccination, including the possible risk of myocarditis or pericarditis.
    • Information is not yet available about potential long-term health outcomes of those who developed myocarditis or pericarditis following vaccination.
    • The Comirnaty prescribing information includes a warning about these risks.

Is there a preferred COVID-19 vaccine?

  • Even though one COVID-19 vaccine has received full FDA approval, each of the three COVID-19 vaccines authorized or approved in the United States are extremely safe and effective, based on extensive clinical trial data and the evidence that nearly 200 million Americans have safely received at least one shot.
  • Unvaccinated individuals should get the vaccine that is most accessible to them to protect themselves and their families, especially because of the recent surge of COVID-19 infections due to the delta variant.

Should health care providers consider using Comirnaty for off-label purposes such as vaccinating children younger than 12 years of age?

  • The FDA, CDC, and American Academy of Pediatrics (AAP) all advise against off-label use.
  • The FDA and CDC provide specific advice:
    • Vaccine providers must adhere to requirements of the CDC, the Advisory Committee on Immunization Practices, and the FDA. The FDA licensed the vaccine as a two-dose series for people ages 16 years and older. It also can be used for adolescents as young as 12 years under the EUA. Some people ages 12 years and older who are immunocompromised are eligible for a third dose.
    • If vaccine providers use the vaccine off-label, negative consequences will ensue. Providers could lose immunity from claims, eligibility for federal compensation after an adverse event, eligibility to provide COVID-19 vaccines, and/or payment.
  • The AAP has made a statement about off-label administration of the vaccine to children:
    • “We do not want individual physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients,” Yvonne A. Maldonado, MD, chair of the AAP’s Committee on Infectious Diseases, said in a statement. “We should do this based on all of the evidence for each age group, and for that we need the trials to be completed. I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials.”

Updated on September 16, 2021