Pfizer, BioNTech Release Positive Topline Data for Combination … – Drug Topics

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

Vaccine candidates were compared to a licensed influenza vaccine and the companies own Omicron BA.4/BA/5-adapted bivalent COVID-10 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 vaccines 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 at >1 relative to a licensed quadrivalent influenza vaccine administered 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

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 fluwhich accounts for 1 billion infections, 5 million hospitalizations, and 650,000 deaths worldwide each year.

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.

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Pfizer, BioNTech Release Positive Topline Data for Combination ... - Drug Topics