Pfizer and BioNTech said that their mRNA-based combination vaccine candidates for influenza and Covid-19 have shown strong immune responses to influenza A and B and SARS-CoV-2 strains in a Phase 1/2 study.
The combination vaccine candidates are designed to prevent the two respiratory diseases with a single shot.
The clinical study assessed the safety, tolerability, and immunogenicity of the combination vaccine candidates among healthy individuals aged 18 to 64 years.
In the trial, the candidates were compared against a licensed influenza vaccine and the two firms’ Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine.
According to the results, the safety profile of the combination formulations was consistent with the companies’ Covid-19 vaccine.
Pfizer vaccine research and development senior vice president and head Annaliesa Anderson said: “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 immunisation 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.”
Previously, the combination vaccine candidate secured Fast Track Designation from the US Food and Drug Administration (FDA).
A Phase 3 trial to assess these lead formulations is anticipated to begin in the upcoming months.
BioNTech CEO and co-founder Ugur Sahin said: “Studies of confirmed viral infections suggest that COVID-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory diseases. 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.”
