Pfizer, BioNTech Announce Data for mRNA-Based Combination Vaccine Program

Pfizer and BioNtech have announced positive topline data from a vaccine phase 1/2 study (NCT0T05596734), demonstrating immune response to influenza A, influenza B, and SARS-CoV-2 strains.

The study evaluated the safety, tolerability, and immunogenicity of mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults aged 18 to 64 years. The vaccine candidates were compared to a licensed influenza vaccine and Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same visit.

“We are encouraged by these early results in our Phase 1/2 study of our combination vaccine candidates against influenza and COVID-19,” said Annaliesa Anderson, PhD, FAAM, senior vice president and head, Vaccine Research and Development at Pfizer, in a statement. “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. mRNA-based vaccines have demonstrated their ability to induce robust antibody and T-cell responses, and we look forward to starting Phase 3 clinical development. Today’s results are an important achievement towards our ambition of providing a broad portfolio of respiratory combination vaccines.”

Back in December 2022, the companies received FDA Fast Track Designation for the single-dose combination vaccine candidate against COVID-19 and influenza. Fast Track Designation from the FDA aims to facilitate the development and expedite the review of new drugs and vaccines, with the intention of treating and preventing serious conditions and address unmet medical needs.

SARS-CoV-2 led to a global pandemic, resulting in more than 6.5 million deaths and a high socioeconomic burden worldwide. A combination vaccine has the potential to simplify the immunization process against these severe respiratory diseases caused by evolving viruses that require vaccine adaptation.

The results of the ongoing trial showed that the combination formulations evaluated had a safety profile in line with the safety profile of the companies’ COVID-19 vaccine. Furthermore, immunogenicity results induced by lead formulations in the phase 1/2 trial showed point estimates for geometric mean titer (GMT) ratios that were consistent with regulatory approved vaccines against the respective influenza and SARS-CoV-2 strains. These point estimates for GMT ratios for all matched influenza and vaccine strains with lead formulations were relative (>1) to a licensed quadrivalent influenza vaccine (QIV) given simultaneously with the Pfizer-BioNTech COVID-19 vaccine.

The companies plan to begin a pivotal Phase 3 trial in the coming months to evaluate these lead formulations.

“Studies of confirmed viral infections suggest that COVID-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory diseases,” said Ugur Sahin, MD, CEO and cofounder of BioNTech, in a statement. “Co-infections as well as consecutive respiratory infection during this period can further increase the risk of severe illness. 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.”

References

1. Pfizer and BioNTech announce positive topline data for mRNA-based combination vaccine program against influenza and COVID-19. Business Wire. October 26, 2023. Accessed November 2, 2023. https://www.businesswire.com/news/home/20231026448732/en/.

2. Pfizer and BioNTech receive U.S. FDA Fast Track designation for single-dose mRNA-based vaccine candidate against COVID-19 and influenza. Pfizer. December 9, 2022. Accessed November 2, 2023. https://www.pfizer.com/news/announcements/pfizer-and-biontech-receive-us-fda-fast-track-designation-single-dose-mrna-based.