GlaxoSmithKline has successfully overtaken the shingles vaccine market once owned by Merck, but enter king Pfizer.
The Big Pharma juggernaut has signed a third deal with COVID-19 vaccine partner BioNTech, this time to develop an mRNA-based shingles vaccine, CEO Albert Bourla, Ph.D., announced Wednesday morning.
The deal is worth $225 million upfront to BioNTech, which includes $75 million in cash and an equity investment worth $150 million. BioNTech could also receive approval and sales milestones worth up to $200 million and a share of the profits. In a slight twist on the traditional development deal, BioNTech will pay Pfizer $25 million upfront for proprietary antigen sequences identified by Pfizer.
The tie-up is a direct shot across the bow at GSK, which has the world’s most successful shingles vaccine in Shingrix. The U.K. pharma easily cast aside Merck’s Zostavax, which cornered the market prior to the 2017 launch of Shingrix. The shot brought in £502 million in the third quarter of 2021, and the company expects a massive rebound this year with double-digit sales growth.
GSK expressed confidence in Shingrix after the news of the impending competition broke in a statement to Fierce Biotech.
“Shingrix is already a hugely successful vaccine based on its proven 97% efficacy in people in their 50s and 60s, 91% for those 70 and older, and crucially its very strong duration of efficacy (90% at eight years), supported by our AS01 adjuvant," a company spokesman said.
Pfizer and BioNTech will now work together on the first mRNA-based shingles vaccine. The deal follows the pair’s massively successful collaboration on the COVID-19 vaccine, Comirnaty, but they’ve also previously worked together on an influenza shot through a 2018 agreement.
The companies will use proprietary antigen technology identified by Pfizer combined with BioNTech’s mRNA platform, which was also used for Comirnaty. Development costs will be shared, and clinical trials are slated to begin in the second half of this year. Pfizer will have global commercialization rights to the vaccine, while BioNTech will have rights in its home base of Germany. Gross profits will be shared.
But how the shot will compare, or overcome, Shingrix is another question. BioNTech CEO Ugur Sahin, M.D., said the goal is to develop a vaccine with a favorable safety profile and high efficacy that can be easily scaled up globally.
That could be key, as GSK suffered supply challenges in the first years of the Shingrix launch. But GSK said those issues are fully resolved and the shot is expected to be available in 35 markets in the next two years, the spokesman said.
On the safety issue, Merck was hit with lawsuits back in 2017 from plaintiffs who alleged the shot caused serious injuries and even death following vaccination. But Merck scored a huge win in July 2021 when an initial case was decided in the pharma’s favor.
Shingrix was also slapped with a warning label in March 2021 warning of an increased risk for a rare neuro autoimmune disorder called Guillain-Barré Syndrome. The FDA, in adding the label, maintained that the shot’s benefits outweigh its risks. Back in 2018, doctors raised concerns about side effects that might deter patients from returning for their second shots. The CDC reported that one in six recipients experienced side effects that were severe enough to keep them from normal activities.
Shingles is caused by the varicella zoster virus, which initially causes the common childhood infection chickenpox. The virus remains dormant but can reactivate later in life causing the painful, debilitating condition.
Editor's note: This story was revised at 2 p.m. ET on Jan. 5, 2022, to include comment from GlaxoSmithKline.