Pfizer, BioNTech Snag Fast Track for COVID-19-Flu Vaccine Combo

The FDA granted Fast Track Designation to Pfizer and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19. The vaccine aims to help prevent two respiratory diseases with a single injection, the two pharma makers said in a news release.

“A combined influenza and COVID-19 vaccine approach, if successful, has the potential to alleviate the impact of both diseases while simplifying immunization practices for healthcare providers as well as individuals, potentially leading to better uptake,” a Pfizer spokesperson told Formulary Watch.

The solution would be a “logical fit alongside Pfizer’s authorized standalone mRNA COVID-19 vaccine, prospective standalone mRNA influenza vaccine, and other authorized or investigational vaccines across Pfizer’s portfolio and pipeline targeting critical infectious diseases,” the spokesperson added.

The companies began a phase 1 trial to evaluate the safety, immunogenicity, and optimal dose level of a combined vaccine candidate in November 2022. The trial will enroll 180 healthy volunteers and each patient will be followed for six months.

The vaccine candidate is based on BioNTech’s mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the omicron sublineages BA.4/BA.5. It also encodes mRNA strands with the hemagglutinin of four different influenza strains that recommended by the World Health Organization for the Northern Hemisphere 2022 and 2023. Hemagglutinin is a surface protein of the influenza virus that plays a role in the initiation of infection.

“The flexibility and manufacturing speed of the mRNA technology has demonstrated that it is well-suited for other respiratory diseases,” Annaliesa Anderson, Ph.D., senior Vice president and chief scientific officer, Vaccine Research and Development, at Pfizer, said in a press release. “Pfizer is deeply proud of our continued work to explore its potential to protect against influenza and COVID-19 in one combination vaccine, which we think could simplify immunization practices against these two respiratory pathogens, potentially leading to better vaccine uptake for both diseases.”