Pfizer/BioNTech Ready for Omicron, Eye Shingles

11.01.2022 - Pfizer and BioNTech expect to have a modified version of their mRNA-based Covid-19 vaccine ready to tackle the Omicron variant by March, Pfizer CEO Albert Bourla said on Jan. 10. The partners already have begun manufacturing trial doses at their own risk, he said, but did not disclose where they will be sold, only that the doses will be available for countries that need them quickly.

Though targeted at Omicron, the Pfizer chief said the reformulated vaccine should also be able to deal with other variants in circulation, noting additionally that it is not yet clear how much protection those who have received three doses of the Comirnaty-branded vaccine already have against the variant and whether they will need another shot.

A recent real-world study from the UK Health Security Agency showed that two doses of either of the mRNA vaccines, including Moderna’s Spikevax, to be only around 10% effective at preventing symptomatic infection from Omicron. While the original two doses nevertheless offered good protection against severe illness, the study did not look at the effect of a third, or booster, dose.

Comirnaty Partners to Develop First mRNA-Shingles Vaccine

Moving beyond Covid-19, BioNTech and Pfizer said last week they had agreed a new R&D and commercialization collaboration to develop the first mRNA-based vaccine targeted at preventing herpes zoster, popularly known as shingles. It will be their third cooperation in the infectious diseases field, following the influenza vaccine collaboration initiated in 2018 and the Covid vaccine collaboration initiated in 2020.

The companies plan to leverage a proprietary antigen technology identified by Pfizer’s scientists, together with BioNTech's proprietary mRNA platform technology used in the Covid vaccine. Clinical trials are planned to start in the second half of 2022, and the parties will share development costs as well as gross profits from commercialization of any product.

Similar to the arrangement for Covid, Pfizer will have rights to commercialize the potential shingles vaccine on a global basis, with the exception of Germany, Turkey and certain developing countries where BioNTech will have commercialization rights.

Under the financial terms, Pfizer will pay BioNTech $225 million upfront, including a cash payment of $75 million and an equity investment of $150 million. BioNTech will be eligible to receive future regulatory and sales milestone payments of up to $200 million. The German company also will pay Pfizer $25 million for the US company’s proprietary antigen technology.

Commenting on the new partnership, Ugur Sahin, CEO and co-founder of BioNTech together with his wife Özlem Türeci, said the collaboration will leverage the expertise and resources of both companies toward developing an mRNA shingles vaccine with a favorable safety profile and high efficacy. Compared with the vaccines currently on the market, the new vaccine should also be more easily scalable in order to support global access, he said.

Shingles (HZV) is a chronic form of the varicella zoster virus (VZV), which causes an initial chickenpox infection. After chickenpox, the virus remains dormant in human nerve cells and can reactivate later in life. As Sahin explained, adults aged older than 50 as well as vulnerable populations such as cancer patients are at increased risk of contracting the painful infection characterized by potentially disfiguring patches.

Although there are shingles vaccines already approved, a new product would be welcome news for the market as older products have faced issues. Merck & Co has fought lawsuits from patients who charged its Zostavax gave them a persistent strain of the disease it purported to treat. Less severe tolerability issues have been seen by the newer vaccine made by Glaxo SmithKline, Shingrix, but the drugmaker has had intermittent production problems.

While Shingrix is on the market in the UK, the US and Canada, it has not yet emerged from the European Medicines Agency’s approval pipeline.

Author: Dede Williams, Freelance Journalist