Here We Go: Pfizer and BioNTech Begin Phase 1 Study of Combined mRNA-Based Vaccine for COVID-19 and Influenza

On Thursday, U.S. pharmaceutical giant Pfizer Inc. and its German partner BioNTech announced the launch of Phase I clinical trial to assess the efficacy of a combination vaccination targeting COVID-19 and influenza.

The single-dose vaccination candidate is a mix of Pfizer’s mRNA-based flu shot, which is now in Phase 3 clinical testing, and the companies’ Omicron-tailored COVID-19 booster shot.

According to its news release, the goal of a new combination vaccine is to prevent people from two extremely dangerous respiratory virus infections.

The study will start early this week in the US, and there will be a total of 180 volunteers ranging in age from 18 to 64 years old.

Read more from the news release:

Pfizer Inc. and BioNTech SE today announced the advancement of an mRNA-based combination vaccine candidate for influenza and COVID-19 to a Phase 1 trial with the aim to address two severe respiratory diseases with one vaccine. The first participant has been dosed in a Phase 1 trial evaluating the safety, tolerability, and immunogenicity of a nucleoside-modified RNA (modRNA)-based combination vaccine approach.

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, each of which is based on BioNTech’s proprietary mRNA platform technology.

“The flexibility and manufacturing speed of the mRNA technology has demonstrated that it is well-suited for other respiratory diseases. 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,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “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.”

“By combining both indications in one vaccine approach, we aim to provide individuals with an efficient way to receive immunization against two severe respiratory diseases with evolving viruses that require vaccine adaptation,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “The data will also provide us with more insights on the potential of mRNA vaccines addressing more than one pathogen. This will help us to further develop our infectious disease pipeline to deliver on patient centric vaccination approaches.”

About the Phase 1 Study 
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 United States, 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 is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 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. 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 new development program builds on the companies’ success in developing the first approved and most widely used mRNA vaccine as of todayi to help prevent COVID-19. The companies will share the development costs. 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 initiated in 2020 and the shingles vaccine collaboration initiated in 2022.

According to Barrons, both Moderna and Novavax have been working on developing combined immunizations against influenza and COVID.

The Gateway Pundit previously reported that a Phase 3 trial of an mRNA influenza vaccine has begun at two major pharmaceutical companies, Moderna and Pfizer.

The physician who invented the mRNA technology contained in COVID vaccines is urging the public not to receive COVID vaccination that could permanently damage the critical organs, reproductive systems, and immune systems, or may cause death.

The public is being misled about the vaccine’s efficacy and effects, warns Dr. Robert Malone, the Chief Medical and Regulatory Officer for The Unity Project who invented messenger mRNA therapeutics in 1988.

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Jim Hᴏft is the founder and editor of The Gateway Pundit, one of the top conservative news outlets in America. Jim was awarded the Reed Irvine Accuracy in Media Award in 2013 and is the proud recipient of the Breitbart Award for Excellence in Online Journalism from the Americans for Prosperity Foundation in May 2016.

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