Combo vaccine prompts robust immune responses against influenza A, influenza B, and COVID-19
Viral infections are difficult to treat and several vaccines are being tested for a while in combination. Two pharma giants Pzifer and BioNTech announced positive topline results from a Phase 1/2 study evaluating the safety, tolerability and immunogenicity of mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults 18 to 64 years of age.
The press release by Pzifer on Oct 26th reveals that lead formulations evaluated in the Phase 1/2 study demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains. Safety profile of the mRNA-based combination vaccine candidates consistent with the companies’ COVID-19 vaccine. The companies plan to start a pivotal Phase 3 trial in the coming months.
In the clinical trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same visit. The data from the trial showed that the companies' lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains.
The study reports the following
• The top results of the ongoing trial demonstrated that the combination formulations evaluated had a safety profile consistent with the safety profile of the companies’ COVID-19 vaccine.
• Immunogenicity results induced by lead formulations in the companies’ Phase 1/2 trial showed point estimates for Geometric Mean Titer (GMT) ratios that were consistent with the criteria applied to regulatory approved vaccines against the respective influenza and SARS-CoV-2 strains.
• Point estimates for GMT ratios for all matched influenza vaccine strains with lead formulations were >1 relative to a licensed Quadrivalent Influenza Vaccine (QIV) given concomitantly with the Pfizer-BioNTech COVID-19 vaccine.
• A pivotal Phase 3 trial evaluating these lead formulations is expected to be initiated in the coming months. Data from the Phase 1/2 trial will be published in a peer-reviewed journal.
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, said the authors.
In the press release they added “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.”
