Pfizer and BioNTech Receive FDA Approval for Latest COVID-19 Vaccine
New vaccine is tailored to the KP.2 strain, based on regulatory guidance for upcoming fall and winter season.
The FDA has approved and granted emergency use authorization (EUA) for Pfizer and BioNTech’s latest COVID-19 vaccine. This new formula for the 2024-2025 fall and winter season includes a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of COVID-19.1
"Vaccination continues to be the cornerstone of COVID-19 prevention," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research said in a press release. "These updated vaccines meet the agency's rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants."
The development of Pfizer and BioNTech’s latest COVID-19 vaccine is based on earlier guidance from the FDA in June which advised manufacturers of licensed and authorized COVID-19 vaccines that their vaccines for 2024-2025should be monovalent JN.1 vaccines.
Earlier in August, Pfizer and BioNTech provided an update with trial results from its vaccine development program against COVID-19 and influenza. In a Phase III randomized, observer-blinded study (NCT06178991), Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives.2
“We are encouraged by the robust immunogenicity we saw with our combination vaccine against influenza A, which was similar to what we had seen for our initial quadrivalent influenza vaccine where we saw superior relative vaccine efficacy against a comparator flu vaccine,” Annaliesa Anderson, PhD, senior vice president and head, vaccine research and development at Pfizer said in a press release. “We are committed to developing vaccines that will reduce the burden of respiratory diseases and believe that combination vaccines are the most efficient way to do this. Today’s results provide insight and direction towards achieving this goal, and we remain optimistic about our combination COVID-19 and influenza program, for which we are evaluating the next steps.”
Professor Ugur Sahin, MD, CEO and co-founder of BioNTech added, “We are dedicated to developing combination vaccines which provide broader protection against multiple respiratory diseases. The insights gained from this combination vaccine trial are highly valuable and will play a crucial role in guiding the further development of Pfizer’s and our combination vaccine program against influenza and COVID-19. We are committed to drawing on our experience in developing mRNA-based vaccine candidates against multiple antigens and believe we can successfully accomplish this task in collaboration with our partner Pfizer.”
In a sperate Phase II study (NCT06436703) evaluating second-generation trivalent influenza mRNA vaccine candidates, Pfizer has seen encouraging data which show a robust immunogenicity against all strains compared to a standard of care influenza vaccine.
References
1. FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants. News release. FDA. August 22, 2024. Accessed August 26, 2024. https://www.prnewswire.com/news-releases/fda-approves-and-authorizes-updated-mrna-covid-19-vaccines-to-better-protect-against-currently-circulating-variants-302228899.html
2. Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age. News release. Pfizer/BioNTech. August 16, 2024. Accessed August 26, 2024. https://www.businesswire.com/news/home/20240816872017/en/Pfizer-and-BioNTech-Provide-Update-on-mRNA-based-Combination-Vaccine-Program-Against-Influenza-and-COVID-19-in-Individuals-18-64-Years-of-Age
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