Researchers assess the safety, tolerability, and immunogenicity of a single combination dose to evaluate its immunogenicity against SARS-CoV-2 and influenza.
Pfizer Inc and BioNTech SE announced positive results from their phase 3 clinical trial that assessed a combined mRNA vaccine candidate to protect against influenza and COVID-19 among healthy individuals aged 18 to 64 years. According to study authors, the combination includes Pfizer’s mRNA-based influenza vaccine with the licensed COVID-19 vaccine.1
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“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,” Annaliesa Anderson, PhD, senior vice president and head of vaccine research and development at Pfizer, said in a news release.1
Influenza is reported to cause around 140,000 to 710,00 hospitalizations and 12,000 to 52,000 deaths in the US each year.1 The virus contains 4 types of infection, including A, B, C, and D; however A and B cause the seasonal epidemics of the disease, recognized as flu season. Study authors noted that influenza A viruses are separated into subtypes based on 2 proteins on the exterior of the virus—hemagglutinin (H) and neuraminidase (N), with 18 different H subtypes and 11 different N subtypes.2
Individuals 65 years and older face an increased risk of hospitalization and death caused from influenza, despite receiving a vaccine that matches the circulating strain. Study authors noted that available influenza vaccines provide 40% to 60% protection annually and is decreasing protection in years with poor corresponding of strains.1
However, because influenza strains change within the seasons, researchers noted that it becomes difficult to match the vaccine for the upcoming epidemics, which are typically chosen more than 6 months before the next season. mRNA technology could solve this issue due to its prompt manufacturing, allowing for a more accurate strain match.1
Researchers assessed the safety, tolerability, and immunogenicity of a single combination dose to evaluate its immunogenicity against SARS-CoV-2 and influenza A and B, in a phase 3 randomized, observer-blinded study (NCT06178991). The study included more than 8000 individuals aged 18 to 64, aiming to demonstrate if the antibody responses to influenza and SARS-CoV-2 were non-inferior to standard of care, according to study authors.1
Trial Name: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza
ClinicalTrials.gov: NCT06178991
Sponsor: BioNTech SE
Completion Date (Estimated): November 2024
The results found that the trivalent combination displayed higher influenza A responses compared to a licensed influenza vaccine while showing lower geometric mean titers and seroconversion against influenza B, according to the results. Additionally, the combination displayed similar results to protect against SARS-CoV-2, compared to the COVID-19 vaccine. However, the study authors noted that the trial did not meet one of primary immunogenicity objectives of non-inferiority against the influenza B strain.1
“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,” said Anderson in a news release.1
The study authors noted that no new safety signals were found among individuals that received the combination vaccine.1
“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,” Ugur Sahin, MD, CEO and co-founder of BioNTech, said in a news release. “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.”1
