Pfizer and BioNTech have announced top-line results from a late-stage study of their mRNA-based combination vaccine for influenza and COVID-19.
The partners have been evaluating the candidate against a licensed flu vaccine and their own licensed COVID-19 vaccine given at the same visit in more than 8,000 healthy adults aged 18 to 64 years.
The trial met one of its two primary immunogenicity endpoints, with a single dose of the combination candidate demonstrating comparable responses against SARS-CoV-2 versus the companies’ COVID-19 vaccine.
Despite eliciting higher influenza A immune responses compared to the standard flu vaccine comparator, the combination candidate showed weaker results against the influenza B strain.
The companies said they are now evaluating adjustments to the vaccine aimed at improving immune responses against influenza B and will discuss next steps with health authorities.
The combined vaccine approach could alleviate the impact of both COVID-19 and flu while offering a combined administration, potentially simplifying immunisation practices for healthcare providers and patients.
Annaliesa Anderson, senior vice president and head, vaccine research and development at Pfizer, said: “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.
“[These] results provide insight and direction towards achieving this goal, and we remain optimistic about our combination COVID-19 and influenza programme, for which we are evaluating the next steps.”
Ugur Sahin, chief executive officer and co-founder of BioNTech, added: “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 programme against influenza and COVID-19.”
The announcement comes just two months after Moderna shared positive phase 3 results for its own flu/COVID-19 combination vaccine candidate.
The immune responses from a single dose of mRNA-1083 were found to be non-inferior to the flu and COVID-19 vaccine comparators co-administered in the study, with the candidate also demonstrating statistically significantly higher immune responses against three influenza virus strains and against SARS-CoV-2.