Pfizer and BioNTech dose first patient in COVID-19/flu combination vaccine study

Pfizer and BioNTech have dosed the first patient in their phase 1 study of an mRNA-based combination vaccine for influenza and COVID-19, the companies announced.

The combined vaccine approach has the potential to alleviate the impact of both diseases while offering a combined administration, potentially simplifying immunisation practices for health care providers as well as patients and leading to higher vaccine uptake.

Additionally, with the flexibility and versatility of mRNA technology, vaccine candidates can potentially be adjusted rapidly to virus variants.

The vaccine combines Pfizer’s quadrivalent modified RNA-based influenza vaccine candidate, currently in phase 3 clinical development, and Pfizer and BioNTech’s authorised Omicron-adapted bivalent COVID-19 vaccine, both of which are based on BioNTech’s proprietary mRNA platform technology.

“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,” said Professor Ugur Sahin, chief executive officer 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,” he added.

The US-based study, which is being sponsored by BioNTech, is designed to evaluate the safety, immunogenicity and optimal dose level of the combination vaccine, and aims to enrol 180 healthy volunteers aged 18 to 64 years. The follow-up period for each participant will be a total of six months, the companies outline in a statement.

COVID-19 is expected to remain a circulating, severe respiratory disease, requiring adjustments of vaccines to variants of concern. This is the same case for influenza, another respiratory disease that requires continuous changes to the strains used in vaccines as circulating viruses keep evolving.

“The flexibility and manufacturing speed of the mRNA technology has demonstrated that it is well-suited for other respiratory diseases,” said Annaliesa Anderson, 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 hospitalisations 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,” she added.