Aug. 24, 2021, 10:25 a.m. News Staff — On Aug. 23, the FDA granted full approval to the Pfizer-BioNTech vaccine for the prevention of COVID-19 in individuals age 16 and older. The vaccine will be marketed under the name Comirnaty (pronounced “koe-MIR-na-tee”), and is the first such vaccine in the United States to receive full licensure from the agency.
Previously, the Pfizer-BioNTech vaccine was available under an emergency use authorization that had been in effect since Dec. 11, 2020. The EUA was expanded on May 10, 2021, to allow for administration of the vaccine to individuals ages 12 to 15.
The FDA also stated in a press release that under the EUA, the vaccine will continue to be available to those ages 12 to 15. In addition, administration of a third dose will be available to individuals with certain immunocompromising conditions.
“Today we applaud full FDA approval of the Pfizer-BioNTech COVID-19 vaccine in individuals 16 years of age and older following a rigorous review of the quality, safety and effectiveness of the vaccine,” AAFP President Ada Stewart, M.D., said in a statement. “We are optimistic that full approval will improve patients’ confidence in the safety, effectiveness and quality of the COVID-19 vaccine and help them decide to get vaccinated.”
News of the vaccine’s approval comes at a time of increasing concern about the delta variant of SARS-CoV-2, the virus that causes COVID-19. In addition to showing the effect of the delta variant on infection and hospitalization rates, recently published research also has shown that all three of the COVID-19 vaccines currently available in the United States remain highly effective in reducing the incidence of negative health outcomes, and that they continue to provide substantial protection against hospitalization and severe disease from the delta variant. However, there is an increased risk of transmission of the delta variant by fully vaccinated individuals.
The news also comes amid encouraging signs that more Americans are taking the pandemic seriously. On Aug. 19, a White House official announced that more than 1 million doses of COVID-19 vaccine had been administered in the prior 24 hours, marking the first time in nearly two months that the number of doses administered in a 24-hour period had surpassed 1 million.
According to the CDC’s COVID Data Tracker, as of Aug. 24 nearly 202 million Americans have received at least one dose of a COVID-19 vaccine, and more than 171 million have been fully vaccinated. As impressive as those number may sound, it means that only 60.3% of all individuals 12 and older in the United States are fully vaccinated.
As such, it remains crucial that all individuals who are eligible to receive the COVID-19 vaccine consult with their family physician to address any questions or concerns and to get vaccinated.
For those who are not eligible to receive the vaccine, such as children younger than 12, it is important to recognize the effectiveness of public health measures such as wearing masks and social distancing to reduce the spread of the virus where possible. The AAFP encourages the FDA to prioritize the review of data to facilitate an EUA for children under 12.
AAFP expert staff remain committed to updating content and resources on the AAFP website and familydoctor.org to keep members informed as new information becomes available. Visit the Academy’s COVID-19 and COVID-19 Vaccine pages to find the latest on COVID-19 vaccine data, meetings of the FDA and the Advisory Committee on Immunization Practices, educational resources, advocacy and more.