Pfizer receives FDA emergency use authorization for COVID-19 booster
The third Pfizer shot is approved for those 65 and older, individuals at high risk and frontline workers such as clinicians and teachers.
Photo: Longhua Liao/Getty Images
The U.S. Food and Drug Administration has approved emergency use authorization for a booster shot of the Pfizer-BioNTech vaccine to be given at least six months after completion of the second dose for individuals 65 years of age and older, individuals 18 through 64 at high risk of severe COVID-19 and those age 18 through 64 whose occupational exposure places them at high risk of serious complications of COVID-19.
The FDA announced the amended EUA for Pfizer today.
WHY THIS MATTERS
The necessity of a booster shot continues to be debated.
On Tuesday, an 18-member FDA Vaccines and Related Biological Products Advisory Committee overwhelmingly rejected a question of whether to approve a booster for all individuals 16 and older.
Advisory committee members voted unanimously to approve emergency use authorization for a Pfizer vaccine booster for individuals 65 and older and for individuals 16 years and older at high risk of severe COVID-19. Members said healthcare workers and other front-line workers such as teachers should be included in this group.
The FDA includes healthcare and front-line workers in its approval.
Only Pfizer has received emergency use authorization approval for a booster shot.
Studies submitted to the FDA showed that incidence of COVID-19 was higher among participants who completed their primary vaccine series earlier, compared to participants who completed it later. The FDA determined that the rate of breakthrough COVID-19 reported during this time period translated to a modest decrease in the efficacy of the vaccine among those vaccinated earlier.
Safety was 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 more than two months.
The most commonly reported side effects were pain, redness and swelling at the injection site, as well as 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.
THE LARGER TREND
This week, Johnson & Johnson said a second dose of its one-shot vaccine administered eight weeks after the first dose provided 94% protection against COVID-19, which is similar to levels of the two-shot Moderna and Pfizer vaccines.
Pfizer received EUA for its two-dose vaccine in December. It was given full FDA approval on August 23. Two days later, the FDA received a supplement from Pfizer seeking approval of a single booster dose to be administered approximately six months after completion of the primary vaccination series for individuals 16 years of age and older.
ON THE RECORD
"We're 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 about COVID-19 vaccines," said Dr. Peter Marks, director of FDA's Center for Biologics Evaluation and Research. "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. The FDA considered the committee's input and conducted its own thorough review of the submitted data to reach today's decision. We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines and we will make further decisions as appropriate based on the data."
"Today'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," said Acting FDA Commissioner Dr. Janet Woodcock, M.D. "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 certain populations such as healthcare workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others. 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."
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com
