Pfizer and BioNTech Announce Positive Phase 2 Results for Second-Generation Trivalent mRNA Influenza Vaccine

Aug 17, 2024 07:31 CST Updated 07:31

BioNTech

Developer of Novel Biologics

Pfizer

Pharmaceutical R&D Developer

▎WuXiEdited by Kant Content Team

Today, Pfizer and BioNTech announced the latest progress of their second-generation trivalent (tIRV) influenza mRNA vaccine in a Phase 2 trial, which showed encouraging data.Compared with the standard influenza vaccine, this vaccine has shown strong immunogenicity against all virus strains.

Influenza causes about 140,000 to 710,000 hospitalizations and 12,000 to 52,000 deaths annually in the United States.Elderly individuals aged 65 and above are at higher risk of severe influenza complications, including hospitalization and death.Even when the vaccine matches the circulating strains well, the current flu vaccines typically offer only 40-60% protection each year, and in years with a poor strain match, the protection rate is even lower.

Due to the constant changes in influenza virus strains, global health experts face significant challenges in predicting the optimal matching strain for the next season's vaccine, as these strains are selected more than six months before the target flu season begins.The flexibility of mRNA technology and its rapid manufacturing capabilities may enable better strain matching in the coming years, and in the event of an influenza pandemic, mRNA technology can facilitate swift, large-scale vaccine production.

Pfizer launched a Phase 2 clinical trial for its second-generation flu candidate vaccine earlier this year. The trial aims to evaluate the efficacy of this mRNA vaccine against influenza and has recruited 450 participants aged 18-64. They were randomly assigned to receive either the investigational mRNA-based flu vaccine or an already approved flu vaccine.

Pfizer, Inc. previously announced positive top-line results from the Phase 3 trial of its first-generation quadrivalent (qIRV) candidate vaccine, with analysis showing thatmRNAEffectiveness of the vaccine in subjects aged 18-64. However, this first-generation qIRV candidate vaccine did not meet the primary endpoint in adults aged 65 and above. Compared with the approved influenza vaccines, the first-generation qIRV vaccine did not achieve non-inferiority in relative vaccine efficacy (rVE). Pfizer further developed a second-generation candidate vaccine aimed at enhancing immunogenicity and potential protection coverage, including adopting a new tIRV formulation in line with the latest recommendations from the World Health Organization (WHO) and the US FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC).The tIRV formulation elicited robust immune responses against both influenza A and influenza B, with the influenza A immune response showing a sustained upward trend compared to approved influenza vaccines.

So far, no safety signals regarding the vaccine have been reported. Detailed phase 2 trial data for adults aged 65 and above will be released later.

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References:

[1] Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age. Retrieved August 16, 2024 from https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-provide-update-mrna-based-combination

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