The messenger RNA technology that Pfizer and BioNTech used to successfully develop a Covid-19 vaccine is the basis of a new alliance that brings the two companies working together to develop a shingles vaccine – the third partnership between the companies. When their Covid-19 alliance started in 2020, the two companies had already been collaborating on a flu vaccine since 2018.
Pfizer brought its vaccine expertise and significant money to these alliances, but with the new collaboration in shingles, it brings something more. The shingles vaccine will be based on proprietary antigen sequences identified by Pfizer. Under the agreement, Pfizer BioNTech will pay $ 225 million in advance to launch the new partnership, the companies announced Wednesday. This payment is divided into $ 75 million in cash and a $ 150 million equity investment. BioNTech will pay Pfizer $ 25 million in advance for the pharmaceutical giant’s antigen sequences. Expenses for vaccine development will be shared; a clinical trial is expected to begin in the second half of this year.
Shingles is a viral infection caused by the same virus that causes chickenpox. After chickenpox infection, the virus remains dormant in nerve tissue, but can be reactivated later in a person’s life due to triggers such as stress or a weakened immune system. Reactivation can trigger nerve pain; in rare cases, it leads to facial paralysis, deafness and blindness.
Vaccines against shingles have already been developed, but they have limitations and safety risks. Merck’s Zostavax, made from a live but attenuated form of varicella zoster virus that causes shingles, was approved by the FDA in 2006 for the prevention of shingles in those 50 and older. However, the vaccine lasts only about five years, so the Centers for Disease Control and Prevention’s advisory committee on vaccines recommended that the shot be given to those 60 years and older, giving people protection in the age group where the risk of shingles and its complications is greatest. . Label updates in 2019 marked the rare side effects of Guillain Barré syndrome, in which the immune system damages the nerves as well as facial paralysis.
In 2020, Merck stopped selling Zostavax in the United States. The company said in a letter to clinicians that the decision was not due to any safety or production issues. Zostavax’s exit left the US shingles market for GlaxoSmithKline’s Shingrix, which received FDA approval in 2017. Unlike the Merck vaccine, Shingrix is not made from a live virus, but rather a recombinant vaccine containing antigens that elicit an immune response. The two-shot GSK regimen showed higher efficacy results than Merck’s single-shot vaccine. But Guillain Barré is also at risk for the GSK vaccine.
An mRNA shingles vaccine with efficacy and tolerability better than or at least comparable to Shingrix would position Pfizer and BioNTech to steal market share from their rivals blockbuster product. GSK reported £ 502 million in global sales in the third quarter of 2021 for Shingrix, a 34% increase over the third quarter of 2020. In the nine months ending September 30, the vaccine accounted for £ 1.1 billion in revenue. That’s a 16% drop from the same period in 2020, a change that the company attributed to the priorities that governments have placed on Covid-19 vaccination programs during the pandemic.
If Pfizer and the BioNTech vaccine succeed in securing regulatory approvals for an mRNA shingles vaccine, commercialization will be shared between the two companies. Pfizer has the right to market the shingles vaccine globally, with the exception of Germany, Turkey and certain unspecified developing countries where BioNTech has commercialization rights. The gross profit from the sale of the shingles vaccine will be shared. BioNTech would also be eligible for regulatory and sales milestone payments that could reach $ 200 million.
“The collaboration aims to develop a new mRNA-based vaccine against shingles that leverages both companies’ expertise and resources,” said Ugur Sahin, BioNTech co-founder and CEO in a prepared statement. “Adults aged 50 and over as well as vulnerable populations such as cancer patients have an increased risk of shingles. Our goal is to develop an mRNA vaccine with a favorable safety profile and high efficiency, which is also more easily scalable to support global access.”
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