BioNTech and Pfizer have announced that they are initiating a phase 1 study to evaluate a single dose mRNA-based combination vaccine candidate against influenza and COVID-19 – a novel combination approach to help protect individuals against two severe respiratory viral diseases in one dose.
Based in the US, the study will include 180 participants aged between 18 to 64 years of age. The first participant was dosed this week. The follow-up period for each participant will be a total of six months.
The randomised, phase 1 study will evaluate the safety, tolerability, and immunogenicity of the nucleoside-modified RNA (modRNA)based combination vaccine, which combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, gIRV (22/23) – currently in phase 3 clinical development – with the Pfizer/BioNTech Omicron-adapted bivalent COVID-19 vaccine, BNT162b2 (Original/Omicron BA.4/BA.5). Both were based on BioNTech’s proprietary mRNA platform technology.
Senior vice president and chief scientific officer of vaccine research and development at Pfizer, Annaliesa Anderson, PhD, said: “The flexibility and manufacturing speed of the mRNA technology has demonstrated that it is well-suited for other respiratory diseases. […] Even with existing seasonal influenza vaccines, the burden of this virus is severe across the world, causing thousands of deaths and hospitalisations every year.”
CEO and co-founder of BioNTech, Professor Ugur Sahin, MD, said: “By combining both indications in one vaccine approach, we aim to provide individuals with an efficient way to receive immunisation against two severe respiratory diseases with evolving viruses that require vaccine adaptation.”
The influenza virus is subject to constant mutations to evade host immune response, and this causes the seasonal variation in circulating strains. Pfizer’s gIRV encodes the haemagglutinin – the surface protein of the influenza virus that plays a role in the initiation of infection – of four different influenza strains and is recommended for the Northern Hemisphere 2022/23 by the World Health Organization.
Professor Sahin added: “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.”
Pfizer and BioNTech will share the development costs in what is the fourth collaboration between the companies in the infectious diseases field, after an influenza vaccine collaboration initiated in 2018, the COVID-19 vaccine collaboration begun in 2020, and the shingles vaccine collaboration of this year.
Recently, a backlash ensued after it was revealed that Pfizer/BioNTech plans to charge as much as $130 for the Covid vaccine, Comirnaty, once Covid vaccines and therapeutics are moved onto commercial health platforms in the US.
More positively, Pfizer/BioNTech’s vaccine was cleared for children aged five through 11 last month, having been authorised by the FDA for the over 12s in August.
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