The Food and Drug Administration (FDA) has granted Fast Track designation to Pfizer-BioNTech’s mRNA-based combination vaccine candidate for the prevention of influenza and COVID-19 with a single injection.

The vaccine candidate utilizes BioNTech’s mRNA technology to combine Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), and Pfizer-BioNTech’s authorized Omicron-adapted bivalent COVID-19 vaccine. 

The formulation contains mRNA strands encoding the original strain of the SARS-CoV-2 virus and a strain from Omicron sublineages BA.4/BA.5, as well as the hemagglutinin of 4 different influenza strains, recommended for the Northern Hemisphere 2022/23 by the World Health Organization.

Pfizer and BioNTech have initiated a phase 1 trial (ClinicalTrials.gov Identifier: NCT05596734) to investigate the immunogenicity and safety of the vaccine candidate in healthy adults. The US-based study will include 180 participants 18 to 64 years of age.

References

  1. Pfizer and BioNTech receive US FDA Fast Track designation for single-dose mRNA-based vaccine candidate against COVID-19 and influenza. News release. Pfizer and BioNTech. Accessed December 9, 2022. https://www.globenewswire.com/news-release/2022/12/09/2570906/0/en/Pfizer-and-BioNTech-Receive-U-S-FDA-Fast-Track-Designation-for-Single-Dose-mRNA-Based-Vaccine-Candidate-Against-COVID-19-and-Influenza.html.
  2. Pfizer and BioNTech initiate phase 1 study of single dose mRNA-based combination vaccine candidate for influenza and COVID-19. News release. Pfizer and BioNTech. November 3, 2022. Accessed December 9, 2022. https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-initiate-phase-1-study-single-dose-mrna.