On Wednesday, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of a single booster dose, to be administered at least six months after completion of the primary series in:
- Individuals 65 years of age and older
- Individuals 18 through 64 years of age at high risk of severe COVID-19
- Individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of severe complications of COVID-19, including severe COVID-19
Officials said Wednesday’s authorization applies only to the Pfizer-BioNTech COVID-19 Vaccine.
“Wednesday’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic.
After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in specific populations such as health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” said Acting FDA Commissioner Janet Woodcock, M.D.
“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness 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 evaluate the rapidly changing science and keep the public informed.”
Officials said the booster was safety evaluated in 306 participants 18 through 55 years of age and 12 participants 65 years of age and older who were followed for an average of over two months.
The most commonly reported side effects by the clinical trial participants who received the booster dose of the vaccine were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain and chills.
Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.
Since December 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA for individuals 16 years of age and older.
The authorization was expanded on May 20, 2021, to include those 12 through 15 years of age, and again on August 12, to include the use of a third dose of a three-dose primary series in specific immunocompromised individuals 12 years of age and older.
The FDA can use eUAs 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 avoid, diagnose, or treat the 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.
“We’re grateful for the advice of the doctors, scientists, and leading vaccine experts on our advisory committee and the vital role they have played in ensuring transparent discussions about COVID-19 vaccines.
We appreciate the robust discussion, including the vote regarding individuals over 65 years of age and individuals at high risk for severe disease, as well as the committee’s views regarding the use of a booster dose for those with institutional or occupational exposure to SARS-CoV-2,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research.