Pfizer and BioNTech Kickstart Trial For Combination Vaccine for Influenza and COVID-19

On November 3, Pfizer and BioNTech jointly announced the advancement of an mRNA-based combination vaccine candidate for influenza and COVID-19 to a Phase 1 clinical trial, with the target of providing adequate protection against these two severe respiratory diseases with a single dose of vaccine. The first participant has been dosed in the trial evaluating the safety, tolerability, and immunogenicity of this novel combination vaccine.

Related Article: Pfizer Doses First Patients with an Influenza Vaccine in a Phase 3 Clinical Trial

Protection Against Two Diseases with One Vaccine

As one of the top players in the vaccines industry, Pfizer reported vaccine revenues of $25.4 billion in the first half of 2022. Since being granted FDA emergency use approval for COVID-19 prevention in individuals age 12 and older in August 2021, the company’s BioNTech-partnered vaccine (marketed under the brand name Comirnaty) has risen to prominence as one of the most widely used COVID-19 vaccines worldwide. As of October 2022, the Pfizer-BioNTech mRNA vaccine has been adopted in 165 countries, with more than 380 million doses administered in the United States alone.

Based on the companies’ previous success in vaccine development, the duo recently launched a new program of developing a nucleoside-modified RNA (modRNA)-based combination vaccine approach with BioNTech’s proprietary mRNA platform technology, with the aim of achieving vaccination against COVID-19 and influenza in a single dose. The vaccine candidates involved in this project include Pfizer’s quadrivalent modRNA-based influenza vaccine which is being clinically tested in a pivotal Phase 3 study, together with an Omicron-adapted version (original/Omicron BA.4/BA.5) of the Pfizer-BioNTech mRNA vaccine. 

The Phase 1 Study Initiated This Month

The BioNTech-sponsored, randomized Phase 1 study is designed to evaluate the safety, immunogenicity, and optimal dose level of the combination vaccine against COVID-19 and influenza and is being conducted in the United States, aiming to enroll 180 healthy volunteers 18 through 64 years of age with the first participant dosed this week. The follow-up period for each participant will be a total of six months.

Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer at Pfizer, believes that the flexibility and manufacturing speed of the mRNA technology can be well utilized for vaccine development against respiratory diseases other than COVID-19. The company is aiming to simplify immunization practices against these two respiratory pathogens, potentially leading to better vaccine uptake for both COVID-19 and influenza. 

According to Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech, the data collected in the coming clinical trials will provide more insights on the potential of mRNA vaccines addressing multiple pathogens, which will be beneficial for the future development of the company’s infectious disease pipeline. 

Author

Richard Chau