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# Positive Data on Pfizer/BioNTech Combo Vaccine
- URL: https://www.fdaweb.com/positive-data-on-pfizer-biontech-combo-vaccine/
- Published: 2023-10-26T12:00:00.000Z
- Updated: 2026-09-14T14:14:29.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155655

Pfizer and BioNTech have [announced](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-data-mrna?ref=fdaweb.com) “positive topline results” from their Phase 1/2 study ([NCT05596734](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05596734%3Fcond%3Dcovid%2520influenza%26term%3Dpfizer%2520biontech%26rank%3D2&esheet=53688835&newsitemid=20231026448732&lan=en-US&anchor=NCT05596734&index=3&md5=61dbd1b58be2c32a6f78c473e82b8c3c&ref=fdaweb.com)) that is evaluating the safety, tolerability and immunogenicity of mRNA-based combination vaccine candidates for influenza and Covid-19 among healthy adults 18 to 64 years of age. “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,” the companies say. “This vaccine has the potential to lessen the impact of two respiratory diseases with a single injection and may simplify immunization practices for providers, patients, and healthcare systems all over the world.”

Pfizer and BioNTech also say their data demonstrated that the combination formulations had a safety profile consistent with the safety profile of the already-marketed Covid-19 vaccine. “Immunogenicity results induced by lead formulations in the companies’ Phase 1/2 trial showed point estimates for Geometric Mean Titer (GMT) ratios that were consistent with the criteria applied to regulatory approved vaccines against the respective influenza and SARS-CoV-2 strains,” they say.

A pivotal Phase 3 trial evaluating the formulations is expected to be initiated in the coming months, Pfizer and BioNTech note. Data from the Phase 1/2 trial will also be published in a peer-reviewed journal, they add.

The data update comes on the heels of a similar announcement earlier this month from Moderna and its work to develop a combination vaccine against flu and Covid-19\. In that update Moderna said it will start a Phase 3 trial of its investigational mRNA-1083 combination vaccine later this year. The company [said](https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-Positive-Phase-12-Data-from-mRNA-1083-the-Companys-Combination-Vaccine-Against-Influenza-and-COVID-19/default.aspx?ref=fdaweb.com) the decision to open a Phase 3 trial follows interim reports of positive data from a Phase 1/2 trial. Moderna added that it is targeting potential regulatory approval for the combination vaccine in 2025.