GSK inks deal to produce CureVac's COVID-19 vaccine—and develop a next-gen version, too

After a recent trial setback, GlaxoSmithKline and partner Sanofi’s COVID-19 vaccine program looks to be a more distant contender in the first wave of immunizations. But as one of the world’s largest vaccine makers, the British pharma doesn’t want to miss out on this pandemic opportunity.

GSK will help CureVac manufacture up to 100 million doses of the German biotech’s first-generation mRNA COVID vaccine candidate, CVnCoV, in 2021, the two companies said Wednesday. In the meantime, the two companies will also work on a next-gen vaccine to tackle emerging variants.

“The key is to make sure that we follow and get ahead of the future of this virus,” GSK CEO Emma Walmsley said. The mRNA technology’s ability to be quickly modified and manufactured makes it a good platform for this purpose, she added.

The GSK collaboration follows Bayer's announcement that it will produce 160 million doses of CureVac's CVnCoV in 2022. Bayer is CureVac’s main partner on the shot, offering support across clinical development, regulatory filings, supply chain management, commercialization and manufacturing.

The first-gen vaccine is currently in phase 3 testing—a U.K. trial has finished enrolling 15,000 participants, and another global phase 2b/3 study aims to recruit more than 35,000 volunteers. The vaccine can be stored at normal refrigeration temperatures, a major logistics advantage over rival mRNA shots by Moderna and Pfizer/BioNTech. Ultracold requirement has caused challenges during the early rollouts of those two FDA-authorized shots.

CureVac, with no commercial products, has been lining up manufacturing support for CVnCOV. Besides Bayer, it has signed CDMO Rentschler Biopharma to make 100 million doses per year, and fellow German chemical company Wacker will also contribute 100 million doses.

RELATED: Vaccine manufacturing greenhorn Bayer to make 160M doses of CureVac's COVID-19 shot

For GSK, the deal gives the British pharma a clearer path in the COVID vaccine race. The new COVID pact came as GSK’s Sanofi-partnered recombinant protein-based COVID-19 vaccine candidate is under reconstruction after an earlier version failed to trigger strong enough immune responses in people aged 50 years and older, delaying a phase 3 efficacy trial.

Besides gearing up manufacturing now, GSK will work with CureVac on a multivalent mRNA COVID vaccine to target emerging variants of the novel coronavirus.

GSK’s disappointed in the Sanofi program delay, but as the scientific community learns more about the virus, “there’s potential opportunity for us to move into a next-generation solution,” Walmsley said during a press briefing.

RELATED: GSK hands CureVac $294M to form mRNA infectious disease pact

Newly emerged variants of the coronavirus have raised concerns that existing COVID-19 vaccines might become less effective, making it likely that new shots may be needed. Through the potentially €150 million deal, GSK and CureVac aim to tackle those variants with new multivalent vaccines or booster shots for existing options, with the goal to introduce the product in 2022.

GSK is also in talks with several other companies with a variety of technologies about how it can support their supply, Walmsley said.

GSK first partnered with CureVac in July with a €150 million equity investment and an upfront payment of €120 million to the German company. But that pact circles around utilizing CureVac’s mRNA platform for other infectious diseases outside of COVID.

Sanofi itself has an mRNA program in development with Translate Bio, and the French pharma is also lending its vaccine manufacturing capacity to other players, including Pfizer/BioNTech’s rival mRNA shot Comirnaty.