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Pfizer BioNTech Topline Data Show Robust Immune Response for COVID-19/Influenza Vaccine Combination


The mRNA-based combination vaccine candidate for flu and COVID-19 received Fast Track Designation from the US Food and Drug Administration.

Pfizer and BioNTech announced positive topline results from a phase 1/2 clinical trial of the lead formulations of an mRNA-based combination vaccine for influenza and COVID-19. The vaccine candidates produced robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains in healthy vaccine candidates aged 18 to 64 years.

“We are encouraged by these early results in our Phase 1/2 study of our combination vaccine candidates against influenza and COVID-19. This vaccine has the potential to lessen the impact of two respiratory diseases with a single injection and may simplify immunization practices for providers, patients, and healthcare systems all over the world,” said Annaliesa Anderson, PhD, FAAM, senior vice president and head, vaccine research and development at Pfizer, in a press release­­.1

Pfizer BioNTech Topline Data Show Robust Immune Response for COVID-19/Influenza Vaccine Combination  / image credit flu and C19 viruses ©Kateryna_Kon/stock.adobe.com / image credit flu and C19 viruses ©Kateryna_Kon/stock.adobe.com

Vaccine candidates were compared to a licensed influenza vaccine and the companies’ own Omicron BA.4/BA/5-adapted bivalent COVID-19 vaccine administered at the same visit. Topline results of the ongoing phase 1/2 trial (NCT05596734) demonstrated a consistent safety profile for the mRNA-based combination vaccine that was similar to the companies’ prior COVID-19 vaccine. Further, immunogenicity results of the vaccine’s lead formulations demonstrated point estimates for geometric mean titer (GMT) ratios consistent with criteria applied to approved vaccines against the respective influenza and SARS-CoV-2 strains. GMT ratio point estimates for all matched influenza vaccine strains with lead formulations measured >1 relative to a licensed quadrivalent influenza vaccine administered in tandem with the Pfizer-BioNTech COVID-19 vaccine.

Pfizer and BioNTech expect to begin a pivotal Phase 3 trial in the coming months. This trial will continue evaluation of the lead formulations of their novel combination vaccine. In December 2022, the companies announced that their mRNA-based combination vaccine received Fast Track Designation from the FDA.2

Read more: Pfizer BioNTech Topline Data Show Robust Immune Response for COVID-19/Influenza Vaccine Combination

The prognosis of those infected with the SARS-CoV-2 virus has improved immensely since the onset of the global COVID-19 pandemic, due to the development of a singular vaccine and the implementation of prevention and quarantine strategies. However, the virus is expected to remain a circulating severe respiratory disease in the long-term, similar to the flu—which accounts for 1 billion infections, 5 million hospitalizations, and 650 000 deaths worldwide each year.1

“Studies of confirmed viral infections suggest that COVID-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory diseases. Coinfections, as well as consecutive respiratory infection during this period, can further increase the risk of severe illness,” said Ugur Sahin, MD, ceo and cofounder of BioNTech, in the news release.1 “Combination vaccines have the potential to become a mainstay of routine vaccination against respiratory diseases, especially for the vaccination of populations who have a higher risk of severe illness.”

Pfizer and BioNTech expect their mRNA-based combination vaccine to become a routine part of vaccination regimens against both diseases, hailing its ability to reduce the severity of both illnesses for high-risk individuals as a great potential benefit of the development.1

  1. Pfizer and BioNTech announce positive topline data for mRNA-based combination vaccine program against influenza and COVID-19. News Release. Pfizer. October 26, 2023. Accessed October 30, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-data-mrna
  2. Pfizer and BioNTech received US FDA Fast Track Designation for single-dose mRNA-based vaccine candidate against COVID-19 and influenza. News release. Pfizer. December 9, 2022. Accessed October 31, 2023. https://www.pfizer.com/news/announcements/pfizer-and-biontech-receive-us-fda-fast-track-designation-single-dose-mrna-based

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