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FDA Authorizes Booster Dose of Pfizer, BioNTech COVID-19 Vaccine
After approving the COVID-19 vaccine last month, FDA authorized a booster dose six months after completion of the primary vaccination series based on scientific evidence.
FDA recently amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow for a single booster dose six months after completing the primary series.
In December 2020, FDA issued the first emergency use authorization for a COVID-19 vaccine to Pfizer and BioNTech, allowing for distribution across the country. And in August, the agency fully approved the vaccine, now marketed as Comirnaty.
Comirnaty is the first COVID-19 vaccine to be FDA approved.
“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,” Acting FDA Commissioner Janet Woodcock, MD, said in the announcement.
“FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” Woodcock continued.
FDA based its decision on the totality of the available scientific evidence and the deliberations of its advisory committee of scientific and public health experts.
During deliberations, vaccine manufacturers presented information and data in support of the biologics license application. And FDA also presented its analysis of clinical trial data from trials evaluating the safety, efficacy, and immunogenicity of Comirnaty.
For example, in March, Pfizer and BioNTech announced that Comirnaty demonstrated 100 percent efficacy and robust antibody responses in adolescents with or without prior SARS-CoV-2 infection.
Overall, FDA concluded that a booster dose of Comirnaty may be effective in preventing COVID-19. And the known and potential benefits of a booster dose outweigh the known and potential risks.
“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
