- Pfizer and BioNTech report Phase 3 results for combined mRNA flu and COVID-19 vaccine, showing strong responses against influenza A and SARS-CoV-2.
- The combination vaccine outperformed a licensed flu vaccine for influenza A but showed lower responses for influenza B; COVID-19 responses were comparable to the existing vaccine.
Pfizer and BioNTech announced top-line results from their Phase 3 trial of a combined mRNA vaccine for influenza and COVID-19 in healthy adults aged 18-64.
In this clinical trial, Pfizer’s mRNA-based influenza vaccine candidate was compared to a licensed influenza vaccine and the companies’ licensed COVID-19 vaccine given at the same visit.
The Phase 3 trial assessed two primary immunogenicity goals: one for SARS-CoV-2 and another for influenza A and B. This observer-blinded study involved over 8,000 adults aged 18-64 to evaluate the safety, tolerability, and effectiveness of a single-dose combination vaccine for influenza and COVID-19.
The main objectives were to show that the combination vaccine's antibody responses to influenza (measured by hemagglutination inhibition, “HAI”) and SARS-CoV-2 (measured by neutralizing titer, “NT”) were at least as good as those from the standard vaccines.
The combination vaccine generated strong immune responses against influenza A, with better results than a licensed flu vaccine, but had lower responses against influenza B.
Additionally, the responses against SARS-CoV-2 were similar to those from the licensed COVID-19 vaccine. No safety issues have been found so far, and participants who received the combination shot also demonstrated strong immune responses without any reported safety concerns.
“We remain optimistic about our combination COVID-19 and influenza program, for which we are evaluating the next steps,” said Annaliesa Anderson, Pfizer's head of vaccine research and development.
The companies are now exploring changes to the combination vaccine to boost immune responses against influenza B and will consult with healthcare authorities on the next steps.
Edited by Harshajit Sarmah
