Combination influenza and COVID-19 vaccine program demonstrates positive phase ½ results | Image Credit: © Kathy images- © Kathy images - stock.adobe.com.
- Positive topline data reported from Pfizer and BioNTech's phase ½ study on mRNA-based combination vaccines for influenza and COVID-19.
- Trial assessed safety, immunogenicity, and tolerability in healthy adults aged 18 to 64, showing consistent safety profile with Pfizer’s COVID-19 vaccine.
- Lead formulations induced robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains.
- Point estimates for Geometric Mean Titer (GMT) ratios consistent with criteria for approved vaccines against influenza and SARS-CoV-2 strains.
- Combination vaccine has potential to simplify immunization practices, offering robust antibody and T-cell responses; phase 3 clinical development expected to start soon.
Positive, topline data has been reported from a phase ½ study evaluating mRNA-based combination vaccines for influenza and COVID-19, according to a press release from Pfizer and BioNTech.
The phase ½ trial (NCT05596734) evaluated the safety, immunogenicity, and tolerability of the combination vaccine candidates in healthy adults aged 18 to 64 years. The ongoing trial demonstrated that the combination formulations had a consistent safety profile with Pfizer’s COVID-19 vaccine.
In the trial, immunogenicity results were induced by lead formulations. These results revealed point estimates for Geometric Mean Titer (GMT) ratios consistent with criteria applied to regulatory approved vaccines against influenza and SARS-CoV-2 strains, respectively. The companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine was compared to the vaccine candidates given at the same visit during the clinical trial.
According to Pfizer, “the data from the trial showed that the companies’ lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains.”
This vaccine has the potential to lessen the impact of  respiratory diseases with a single injection and may simplify immunization practices for providers, patients, and healthcare systems all over the world,” said Annaliesa Anderson, PhD, FAAM, senior vice president and head, vaccine research and development, Pfizer. “mRNA-based vaccines have demonstrated their ability to induce robust antibody and T-cell responses, and we look forward to starting phase 3 clinical development. Today’s results are an important achievement towards our ambition of providing a broad portfolio of respiratory combination vaccines.”
Point estimates for GMT ratios for all matching influenza vaccine strains with lead formulations were greater than 1 relative to a licensed quadrivalent influenza vaccine (QIV), given concomitantly with the Pfizer-BioNTech COVID-19 vaccine, the release stated.
The combination vaccine candidate for influenza and COVID-19 previously received Fast Track Designation from the FDA. In the coming months, a pivotal phase 3 trial evaluating the lead formulations is expected to be initiated.
Pfizer and BioNTech announce positive topline data for mRNA-based combination vaccine program against influenza and COVID-19. Pfizer. Press release. October 26, 2023. Accessed October 26, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-data-mrna?cid=em_PfizerNewsroomAlert&ttype=em