mRNA-Based Influenza and COVID-19 Combo Vaccine Candidate Launches Study

Global leaders in vaccine innovation today announced the advancement of an mRNA-based vaccine candidate preventing both influenza and COVID-19 to a Phase 1 clinical trial.

The Pfizer Inc. and BioNTech SE vaccine candidate aims to address these severe respiratory diseases with one vaccine.

The vaccine candidate combines Pfizer's quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinical development, and Pfizer and BioNTech's authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) vaccine.

This innovation is based on BioNTech's proprietary mRNA platform technology. 

Annaliesa Anderson, Ph.D., SVP and Chief Scientific Officer, Vaccine Research and Development, Pfizer, commented in a press release on November 3, 2022, "Even with existing seasonal influenza vaccines, the burden of this virus is severe across the world, causing thousands of deaths and hospitalizations every year."

"This is an exciting step in our ongoing journey with BioNTech as we collectively look to transform the prevention of infectious diseases around the world."

The BioNTech-sponsored, randomized Phase 1 study is designed to evaluate the safety, immunogenicity, and optimal dose level of a combined vaccine candidate against COVID-19 and influenza and is being conducted in the U.S., aiming to enroll 180 healthy volunteers 18 through 64 years of age.

The follow-up period for each participant will be a total of six months. 

The vaccine candidate contains mRNA strands encoding the wild-type spike protein of the SARS-CoV-2 coronavirus and the spike protein of the Omicron BA.4/BA.5 subvariants, as well as mRNA strands encoding the hemagglutinin of four different influenza strains, recommended for the Northern Hemisphere 2022/23 by the World Health Organization (WHO).

Hemagglutinin is a surface protein of the influenza virus which plays a role in the initiation of infection.

The influenza virus is subject to constant mutations to evade the host immune response, causing a seasonal variation in circulating strains.

The WHO recommended on October 31, 2022, countries should monitor the co-circulation of influenza and SARS-CoV-2 viruses.

And they are encouraged to enhance integrated surveillance. Clinicians should consider influenza in differential diagnosis, especially for high-risk groups for influenza, and test and treat according to national guidance.

The new combo vaccine development program builds on the companies' success in developing the first approved and most widely used mRNA vaccine to help prevent COVID-19.

This is the fourth collaboration between Pfizer and BioNTech in the infectious diseases field, following the influenza vaccine collaboration initiated in 2018, the COVID-19 vaccine collaboration started in 2020, and the shingles vaccine collaboration initiated in 2022.

Additionally, with the flexibility and versatility of mRNA technology, vaccine candidates can potentially be adjusted rapidly to virus variants and aim to offer a valuable solution in the race against virus mutations in both COVID-19 and influenza.

Other flu shot news for 2022 is posted at PrecisionVaccinations.com/Flu.

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