- For immediate release:
Today, the United States Food and Drug Administration amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow the use of a single booster dose, to be administered at least six months after the end of the primary series in:
- people 65 years of age and over;
- people aged 18 to 64 at high risk of severe COVID-19; and
- people aged 18 to 64 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications from COVID-19, including severe COVID-19.
Today’s authorization only applies to the Pfizer-BioNTech COVID-19 vaccine.
âToday’s action demonstrates that currently available science and data continue to guide FDA decision making for COVID-19 vaccines during this pandemic. After reviewing all of the available scientific evidence and the deliberations of our independent external expert advisory committee, the FDA modified the EUA for Pfizer-BioNTech COVID-19 vaccine to allow a booster dose in certain populations such as than healthcare workers. , teachers and daycare staff, grocers and people in shelters or homeless prisons, among others, âsaid Acting FDA Commissioner Janet Woodcock, MDâ This pandemic is dynamic and in developments, new data on the safety and efficacy of vaccines are becoming available every day. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to assess the rapidly evolving science and hold the informed public. “
The process of evaluating available data
Comirnaty (COVID-19 vaccine, mRNA) was approved by the FDA on August 23 for the prevention of COVID-19 caused by SARS-CoV-2 in people 16 years of age and older. On August 25, 2021, the FDA received a supplement from Pfizer Inc. to its Biologics License Application for Comirnaty seeking approval of a single booster dose to be administered approximately six months after completion of the primary vaccination series. for people aged 16 and over.
As part of the FDA’s commitment to transparency, the agency convened a public meeting of its Advisory Committee on Vaccines and Related Biologics (VRBPAC) on September 17 to solicit input from scientific experts and independent public health authorities on the data submitted in the application. During the meeting, the vaccine manufacturer presented information and data to support their claim. The FDA also presented its analysis of clinical trial data submitted by the vaccine manufacturer. In addition, the public also had the opportunity to comment; and the FDA invited international and US agencies and external groups, including representatives from the Israeli Ministry of Health, University of Bristol, UK, and the Centers for Disease Control and Prevention, to present data recent reports on the use of vaccine boosters, the epidemiology of COVID-19, and actual evidence of vaccine effectiveness.
The FDA reviewed the data submitted by the vaccine manufacturer, the information presented during the VRBPAC meeting and the committee discussion, and determined that based on all of the available scientific evidence, a booster dose of the vaccine Pfizer-BioNTech COVID-19 may be effective in preventing COVID-19 and the known and potential benefits of a booster dose outweigh the known and potential risks in populations approved for use by the FDA. The booster dose is authorized for administration to such persons at least six months after the end of their primary vaccination course and can be given at any time after this date.
It is important to note that the FDA-cleared Pfizer-BioNTech COVID-19 vaccine is the same formulation as the FDA-approved Comirnaty and the vaccines can be used interchangeably.
âWe are grateful for the advice of the doctors, scientists and leading vaccine experts on our advisory committee and the important role they have played in ensuring transparent discussions on COVID-19 vaccines. We appreciate the robust discussion, including the vote regarding people over 65 and those at high risk for serious illness, as well as the committee’s views regarding the use of a booster dose for people with institutional or occupational exposure to SARS-CoV-2, âsaid Peter Marks, MD, Ph.D., director of the Center for Biologics Evaluation and Research at the FDA. âThe FDA has considered the committee’s comments and conducted its own in-depth review of the data submitted to reach today’s decision. We will continue to analyze the data submitted to the FDA regarding the use of COVID-19 vaccine booster doses and make further decisions, as appropriate, based on the data. ”
Data in support of the emergency use authorization
To support the authorization for the emergency use of a single booster dose, the FDA analyzed safety and immune response data from a subset of participants from the original Pfizer-BioNTech vaccine clinical trial. COVID-19. In addition, actual data on the effectiveness of the vaccine over an extended period was considered, provided by US and international sources including the CDC, UK and Israel. The immune responses of approximately 200 participants aged 18 to 55 who received a single booster dose approximately six months after their second dose were assessed. The antibody response against the SARS-CoV-2 virus one month after a booster dose of the vaccine compared to the response one month after the primary two-dose series in the same individuals demonstrated a booster response.
Additional analysis conducted by the manufacturer, as requested by the FDA, compared the levels of COVID-19 accumulated during the current wave of Delta variants among original clinical trial participants who completed the primary vaccination series to two doses at the start of the clinical trial to those who completed a two-dose series later in the study. Analysis submitted by the company showed that during the study period of July and August 2021, the incidence of COVID-19 was higher among participants who completed their primary vaccination series earlier, compared to to participants who completed it later. The FDA has determined that the COVID-19 breakthrough rate reported during this period results in a slight decrease in vaccine effectiveness among those vaccinated earlier.
Safety was evaluated in 306 participants aged 18 to 55 and 12 participants aged 65 and over who were followed for an average of more than two months. The most common side effects reported by clinical trial participants who received the booster dose of the vaccine were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills. Of note, swollen armpit lymph nodes were seen more frequently after the booster dose than after the two-dose primary series.
As of December 11, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under the EUA for people 16 years of age and older. The authorization was extended on May 20, 2021 to include people aged 12 to 15 years, and again on August 12, 2021 to include the use of a third dose of a primary series of three doses in certain immunocompromised people. 12 years old. and older. EUAs can be used by the FDA in 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 disease. product, when used to prevent, diagnose or treat disease, outweigh the known and potential risks of the product.
The amendment to the EUA to include a single booster dose was granted to Pfizer Inc.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.