Pfizer and BioNTech’s mRNA-Based Combination Vaccine Demonstrates Strong Immune Responses to Influenza A
Results from the joint Phase III clinical trial of the vaccine also demonstrated results comparable to the companies’ licensed COVID-19 vaccine.
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Pfizer and BioNTech announced that their mRNA-based combination vaccine program aimed at combating both influenza and COVID-19 in individuals aged 18-64 has demonstrated strong immune responses to influenza A, meeting one of two primary immunogenicity goals. The vaccine demonstrated lower effectiveness against influenza B compared to a licensed influenza vaccine. Additionally, the combination vaccine's immune response to SARS-CoV-2 was found to be comparable to Pfizer and BioNTech’s licensed COVID-19 vaccine.1
“We are encouraged by the robust immunogenicity we saw with our combination vaccine against influenza A, which was similar to what we had seen for our initial quadrivalent influenza vaccine where we saw superior relative vaccine efficacy against a comparator flu vaccine,” said Annaliesa Anderson, PhD, SVP, head, vaccine research and development, Pfizer, in a press release. “We are committed to developing vaccines that will reduce the burden of respiratory diseases and believe that combination vaccines are the most efficient way to do this. Today’s results provide insight and direction towards achieving this goal, and we remain optimistic about our combination COVID-19 and influenza program, for which we are evaluating the next steps.”
The results came from a Phase III randomized, observer-blinded study (NCT06178991), which enrolled over 8,000 patients between the ages of 18 and 64 years old, aiming to evaluate the safety, tolerability, and immunogenicity of a single dose combination vaccine candidate against influenza and COVID. The vaccine was compared to a previously approved influenza vaccine administered during the same visit. The primary endpoint of the trial was to demonstrate that the antibody responses to influenza and COVID were non-inferior to the current standard of care.
Results found that no new safety signals were identified during the study, with both Pfizer and BioNTech stating that patients who have received the vaccine continue to display robust immune responses against both influenza and COVID. Common adverse events (AEs) associated with the vaccine included both severe and non-severe allergic reactions, tiredness, headache, arm pain, muscle pain, joint pain, fainting, chills, fever, injection site swelling, redness, nausea, swollen lymph nodes, diarrhea, vomiting, dizziness, irritability, and decreased appetite.
In a separate Phase II trial, Pfizer’s standalone trivalent influenza vaccine candidates also demonstrated promise in the same age group. This trial consisted of 450 patients that were randomized to receive investigational mRNA-based influenza vaccines or influenza vaccines approved by the FDA. Results demonstrated that statistical non-inferior relative vaccine efficacy compared to a licensed influenza vaccine was not met based on the number of cases accrued. Full data on the trial is expected to be released at a later date.
According to Pfizer, influenza results in 140,000 to 710,000 hospitalizations, 12,000 to 52,000 deaths, and $25 billion in losses in the United States on a yearly basis. Additionally, patients over the age of 65 years old are considered to be at a higher risk of serious complications from influenza, such as hospitalization and death. Further, influenza has a higher effect on racial and ethnic minority groups, with black Americans being nearly two times more likely than white Americans to be hospitalized for influenza.1
“We are dedicated to developing combination vaccines which provide broader protection against multiple respiratory diseases,” said Ugur Sahin, MD, CEO, co-founder, BioNTech, in the press release. “The insights gained from this combination vaccine trial are highly valuable and will play a crucial role in guiding the further development of Pfizer’s and our combination vaccine program against influenza and COVID-19. We are committed to drawing on our experience in developing mRNA-based vaccine candidates against multiple antigens and believe we can successfully accomplish this task in collaboration with our partner Pfizer.”
Reference
1. Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age. Business Wire. August 16, 2024. Accessed August 16, 2024. https://www.businesswire.com/news/home/20240816872017/en/Pfizer-and-BioNTech-Provide-Update-on-mRNA-based-Combination-Vaccine-Program-Against-Influenza-and-COVID-19-in-Individuals-18-64-Years-of-Age
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