Pfizer signs mRNA flu vaccine deal with BioNTech

Pfizer has teamed up with German biotech BioNTech to develop a new generation of influenza vaccines that can be made quicker and more cheaply than current products.

The US pharma giant has just signed a front-loaded deal with BioNTech – with $120m in upfront and near-term payments and another $305m in the offing tied to development, regulatory and commercial milestones – for the development of vaccines based on messenger RNA.

The deal marks something of a departure for BioNTech, whose R&D pipeline is currently populated solely by mRNA and other candidates for cancer, and the German company’s CEO Ugur Sahin said it is “one of a number of steps that we are taking to rapidly build a sustainable R&D presence in infectious disease”.

Using mRNA is an attractive proposition for flu vaccine development because its can be sued to code for “any protein or multiple proteins, and the potential to manufacture higher potency flu vaccines more rapidly and at a lower cost than contemporary flu vaccines”, said Katrin Jansen, who heads up Pfizer’s vaccines R&D unit.

New flu vaccines are needed to provide improved protection against seasonal flu, and to respond rapidly and in quantity to emerging influenza strains that could lead to a pandemic, she added.

Under the terms of the deal the two partners will collaborate on early-stage R&D on flu vaccines, and Pfizer will take on development and commercial responsibility for candidates once they pass the phase I first-in-human clinical trial stage.

mRNA vaccines have long been held up as a promising alternative to conventional vaccines, but until latterly progress has been held back by difficulties associated with delivering them efficiently and in stable form into the body. Technological improvements have improved the delivery of mRNA and its ability to translate proteins in vivo, and potent immune responses have been achieved using the approach in animal models of a number of diseases, including Zika and rabies.

Last year, a research team from the University of Munich’s Department of Infectious Diseases and Tropical Medicine moved a rabies vaccine developed by CureVac into what it said was the first human trial of a freeze-dried mRNA vaccine candidate. The scientists said that CV7201 induced functional antibodies against rabies antigens and appeared to be safe and well-tolerated.

Interestingly, that study showed a response with a needle-free delivery device but not with conventional syringe delivery, leading the researchers to suggest that the needle-free administration could be “more efficient at recruiting immunocompetent cells at the injection site or enable more efficient cellular uptake” of the vaccine.