Pfizer, BioNTech report positive topline results from phase 1/2 study of mRNA-based combination vaccine program against influenza and Covid-19

Pfizer Inc. and BioNTech SE announced positive topline results from a phase 1/2 study (NCT05596734) 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. 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.

“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. “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.”

“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 Prof. Ugur Sahin, MD, CEO and co-founder of BioNTech. “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.”

The topline 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.

Pfizer and BioNTech previously announced that their mRNA-based combination vaccine candidate for influenza and Covid-19 received Fast Track Designation from the US Food and Drug Administration (FDA).

SARS-CoV-2 led to a global pandemic with more than 6.5 million deaths and a severe socio-economic burden worldwide. While vaccinations can help address the disease, Covid-19 is expected to remain a circulating, severe respiratory disease, requiring adjustments of vaccines to variants of concern. This is reminiscent of influenza, another respiratory disease that requires repeated vaccinations due to its genomic instability resulting in modifications of the surface protein hemagglutinin. Each year, influenza results in up to one billion infections, five million hospitalizations, and 650,000 deaths worldwide.

COMIRNATY (Covid-19 Vaccine, mRNA) is a vaccine for use in people 12 years of age and older to protect against coronavirus disease 2019 (Covid-19).

Pfizer-BioNTech Covid-19 Vaccine (2023-2024 Formula) is FDA authorized under Emergency Use Authorization (EUA) to prevent coronavirus disease 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months through 11 years of age.

Pfizer-BioNTech Covid-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (Covid-19) for use in individuals aged 6 months through 11 years of age. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)?(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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