Sanofi, already working with the HHS’ Biomedical Advanced Research and Development Authority on a GlaxoSmithKline-partnered COVID-19 vaccine, has won further support from the U.S. government—this time, to the tune of $2.1 billion.
The federal government will pay Sanofi and GSK up to $2.1 billion to speed up clinical development and manufacturing of the pair’s adjuvanted, recombinant COVID-19 vaccine candidate, the companies said Friday.
The deal, from Operation Warp Speed, marks the largest grant to date by the Trump administration’s COVID-19 vaccine initiative, exceeding a recent $1.6 billion commitment to Novavax for its adjuvanted nanoparticle vaccine candidate, NVX-CoV2373. It also shows the project hedging its hefty wagers on unproven vaccine technologies—such as Moderna's mRNA shot—with an investment in a proven platform that's delivered an approved product in the past.
More than half of the money will be used to run clinical trials, while the rest will go to manufacturing scale-up and delivery of an initial 100 million doses of the vaccine to the U.S. The deal also gives the U.S. government an option for an additional supply of 500 million doses over the long term.
It’s a huge bet on a shot that has yet to begin first-in-human studies. Sanofi and GSK have said they intend to kick off a phase 1/2 trial in September, followed by a phase 3 efficacy study by the end of 2020. If the trials are successful, the companies may seek U.S. approval in the first half of 2021.
But on the other hand, it might be a safer bet on a collaboration between the world’s two largest vaccine producers. The vaccine is developed with Sanofi’s recombinant DNA technology that’s used in the French pharma’s FDA-approved flu shot Flublok, plus GSK’s adjuvant AS03, which was used in the company’s H1N1 pandemic flu vaccine Pandemrix. Both are proven technologies, compared with some other projects Operation Warp Speed’s backing.
For example, Novavax has no product on the market. Moderna, after an initial $483 million grant, recently won an extra $472 million from BARDA to run a large-scale phase 3 test of its mRNA vaccine candidate, mRNA-1273. The mRNA approach, while considered cutting-edge and potentially timesaving in terms of manufacturing, has never yield a marketed product anywhere.
In addition, AstraZeneca has $1.2 billion in Operation Warp Speed support for its University of Oxford-partnered adenovirus vector-based candidate, AZD1222, with 300 million doses earmarked for the U.S. Johnson & Johnson, with $456 million backing from the U.S. government, recently rolled its Ad26.COV2.S candidate into a phase 1/2a study in the U.S. and Belgium.
Sanofi has a long-standing relationship with BARDA. The agency handed it $226 million in December for work on expanding its pandemic flu vaccine production capabilities out of Swiftwater, Pennsylvania. The two partnered up on the COVID-19 vaccine in February. An initial $30 million award from the U.S. agency led to Sanofi CEO Paul Hudson’s controversial comment that the U.S. would be entitled to the first batch of its vaccines, a statement that was soon backtracked by the company’s chairman, Serge Weinberg.
The Operation Warp Speed contract follows on the heels of a supply deal Sanofi and GSK inked with the U.K. government to provide up to 60 million doses of their vaccine. Overall, the two firms have a plan in place to deliver one billion doses in 2021.