Pfizer and BioNTech have commenced a Phase I clinical trial of a messenger ribonucleic acid (mRNA)-based combination vaccine candidate for influenza and Covid-19.

The companies have dosed the first subject in the trial.

Sponsored by BioNTech, the randomised trial will assess the safety, immunogenicity, and ideal dosage of the nucleoside-modified RNA (modRNA)-based combination vaccine strategy.

Being carried out in the US, the trial intends to enrol 180 healthy subjects aged 18 to 64 years. 

The combination vaccine combines the quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), of Pfizer, along with Pfizer-BioNTech’s Omicron-adapted bivalent Covid-19 BNT162b2 (Original/Omicron BA.4/BA.5) vaccine.

qIRV (22/23) is presently being analysed in a Phase III trial.

Both vaccines leverage the mRNA platform technology of BioNTech. 

This new development programme is based on the success of the companies in the development of the first approved mRNA vaccine for Covid-19. 

The development cost of the new programme will be shared by both Pfizer and BioNTech.

BioNTech CEO and co-founder professor Ugur Sahin 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 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.” 

The bivalent Covid-19 vaccine received Emergency Use Authorisation (EUA) from the Food and Drug Administration for usage in people aged five years and above as a single booster dose.

In October this year, the companies reported positive early data from a Phase II/III trial of their vaccine in individuals aged 18 years and above.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

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