Pfizer and BioNTech have reported encouraging results from their Phase 1/2 clinical trial, which evaluated the safety, tolerability, and immunogenicity of mRNA-based combination vaccines targeting influenza and COVID-19 in healthy adults aged 18 to 64. The study compared the vaccine candidates to a licensed influenza vaccine and the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine administered at the same visit. The data revealed robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains in the lead formulations of the mRNA-based combination vaccines.
These findings represent a significant step forward in the development of combination vaccines that could protect against multiple respiratory diseases with a single injection. Such vaccines have the potential to simplify vaccination procedures for healthcare providers, patients, and healthcare systems globally. mRNA-based vaccines have previously demonstrated their capacity to elicit strong antibody and T-cell responses.
The combination formulations’ safety profiles in the Phase 1/2 trial were consistent with the safety profiles of Pfizer and BioNTech’s COVID-19 vaccine. Immunogenicity results indicated that the lead formulations induced immune responses in line with the criteria applied to regulatory-approved vaccines against influenza and SARS-CoV-2 strains.
The upcoming pivotal Phase 3 trial will evaluate these lead formulations, to initiate the trial in the coming months. The data from the Phase 1/2 trial will also be published in a peer-reviewed journal.
Both companies aim to create a broad portfolio of respiratory combination vaccines, and this latest achievement brings them closer to their goal of delivering innovative solutions to protect against a range of respiratory diseases. The seasonal nature of COVID-19 and the potential for co-infections or consecutive respiratory illnesses underscore the importance of combination vaccines, particularly for high-risk populations who may be more susceptible to severe illness.
It is worth noting that the mRNA-based combination vaccine candidate for influenza and COVID-19 previously received Fast Track Designation from the U.S. Food and Drug Administration (FDA), indicating the significance and urgency of this development in addressing respiratory diseases. The results from this study could have broad implications for simplifying and enhancing respiratory disease vaccination strategies, and they align with the companies’ mission to make significant contributions to public health.
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