Pfizer and BioNTech Join Forces to Develop Combination Influenza and COVID-19 Vaccine
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have 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 data showed that the companies’ lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains.
Annaliesa Anderson, PhD, FAAM, Senior Vice President and Head, Vaccine Research and Development at Pfizer, said, “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.”
Prof. Ugur Sahin, MD, CEO and Co-founder of BioNTech, said, “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. Data from the Phase 1/2 trial will be published in a peer-reviewed journal.
A pivotal Phase 3 trial evaluating these lead formulations is expected to be initiated in the coming months.
Pfizer and BioNTech previously announced that their mRNA-based combination vaccine candidate for influenza and COVID-19 received Fast Track Designation from the U.S. Food and Drug Administration (FDA).
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Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Regeneron, Sanofi and Pfizer. For more information, please visit www.BioNTech.com.