USA – Pfizer Inc and BioNTech SE have announced a new research, development, and commercialization collaboration to create the world’s first mRNA-based vaccine for shingles prevention.
The agreement is Pfizer and BioNTech’s third in the field of infectious diseases, following influenza and COVID-19 vaccine collaborations launched in 2018 and 2020, respectively.
The parties will split the costs of development. Clinical trials are set to begin in the second half of 2022.
Pfizer will have the global commercialization rights to the potential vaccine, with the exception of Germany, Turkey, and a few developing countries where BioNTech will have the rights.
The companies will split the gross profits from any product’s commercialization. Pfizer will pay BioNTech US$225 million in upfront payments, including a US$75 million cash payment and a US$150 million equity investment, according to the terms of the agreement.
Future regulatory and sales milestone payments of up to US$200 million are possible for BioNTech. Pfizer will pay BioNTech US$25 million for Pfizer’s proprietary antigen technology.
BioNTech and Pfizer have entered one of the most potentially lucrative vaccine markets, while also posing a direct challenge to older vaccine technologies and developers.
Without vaccination, approximately one in every three Americans will develop shingles, a disease that, while not life-threatening, can cause chronic and debilitating pain.
When GlaxoSmithKline launched Shingrix, a protein-based shingles vaccine, in 2018, to replace Merck’s decades-old live virus shot, the company faced “unprecedented” demand, resulting in shortages and waiting lists. Analysts predicted that eventual sales would be around US$2 billion per year.
Pfizer and BioNTech will now attempt to counteract it with an mRNA shot that they presumably believe will be more effective or last longer.
It’s another challenge for GSK, which dragged its feet and lost the Covid vaccine race, and now faces a broad threat to its long-standing vaccine business.
Nonetheless, the stakes for Pfizer and BioNTech will be high. Shingrix is already 90 percent effective at shingles prevention. And, as Moderna’s flu efforts demonstrated, making a vaccine out of mRNA does not guarantee that it will be more effective, as Endpoints News reports.
According to Moderna’s data, its flu shot, like its Covid-19 vaccine, caused more adverse reactions than protein-based or live virus vaccines.
An mRNA version of the existing flu shots could still be useful and offer a few advantages, but they also have their own set of often overlooked flaws.
The shot’s reactogenicity, or tendency to cause significant headaches, fever, and other unpleasant side effects in the days following inoculation, is one of them.