Pfizer and BioNTech that the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend the FDA grant Emergency Use Authorization (EUA) for a booster dose of COMIRNATY® (COVID-19 Vaccine, mRNA) in individuals 65 years of age and older and individuals at high risk of severe COVID-19. The committee recommended that the additional dose be administered at least six months after the two-dose series. The panel also agreed that healthcare workers and others at high risk for occupational exposure should be included in this EUA.
VRBPAC is made up of independent experts who advise the FDA on scientific and regulatory matters, including the evaluation of vaccine safety and efficacy.
At this time, VRBPAC did not vote in favor of approval of a booster dose for the full population for which Pfizer and BioNTech submitted their supplemental Biologics License Application, which was individuals 16 and older. The same data have recently been submitted to the European Medicines Agency (EMA) and will be filed with other regulatory authorities in the coming weeks. The companies remain vigilant and continue to generate relevant COMIRNATY booster dose data for evaluation for future licensure in further groups as well as to address emerging variants of concern.
The FDA is expected to make its decision in the coming days. This decision could allow COMIRNATY to be the first COVID-19 vaccine with a booster authorized in the U.S.
“Today the VRBPAC reviewed data from our clinical program showing a favorable safety profile and strong immune responses against SARS-CoV-2 after a booster dose of our vaccine. These data, and the larger body of scientific evidence presented at the meeting, underscore our belief that boosters can be a critical tool in the ongoing effort to control the spread of this virus,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We thank the committee for their thoughtful review of the data and will work with the FDA following today’s meeting to address the committee’s questions, as we continue to believe in the benefits of a booster dose for a broader population.”
“We are committed to support the ongoing efforts to reduce infections and COVID-19 cases. The data we submitted to the FDA, EMA and other regulatory authorities underline that a booster induces a strong immune response against all tested variants of concern and may contribute to address a public health need,” said Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech.
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