Sanofi, GlaxoSmithKline score EU supply pact for 300M coronavirus shots

Sanofi is working on an mRNA-based COVID-19 shot that will enter phase 1/2 testing in November. (Sanofi)

With the fourth quarter fast approaching, it's do-or-die time for a group of drugmakers chasing the first approved vaccine for COVID-19. Sanofi and GlaxoSmithKline are running a bit behind other companies in terms of clinical testing, but that doesn't mean they aren't ready to ink their own momentous supply deals. 

Sanofi and GSK have signed a deal with the EU to supply up to 300 million doses of their recombinant protein-based COVID-19 vaccine after a regulatory approval that could come as early as the first half of 2021, the partners said Friday. 

To help meet the expected demand if their contender wins approval, both drugmakers are ramping up manufacturing for the antigen and adjuvant used in the shot, which is scheduled to enter phase 3 human testing later this year. With its souped-up manufacturing in place, Sanofi and GSK are aiming to produce around 1 billion doses per year, the companies said. 

The EU deal will not only provide Sanofi and GSK's shot to the region's member nations but will also free the bloc to divert some of those doses to low- and middle-income countries, the drugmakers said. 

Sanofi is working not only on the GSK-partnered recombinant-protein candidate but also on an mRNA-based prospect that's set to enter phase 1/2 testing in November. Working with partner Translate Bio, Sanofi hopes to eventually roll out between 90 million and 360 million doses per year if a regulatory approval comes through. 

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The EU's supply tie-up with Sanofi and GSK comes as the bloc works to secure doses from a suite of drugmakers at the forefront of the COVID-19 vaccine race.

Earlier this month, Pfizer and BioNTech announced they were working to close a supply deal with the EU for up to 300 million doses of their mRNA-based vaccine starting at the end of the year.

A final EU deal would be the single largest signed by Pfizer and BioNTech in their quest to distribute 100 million doses of their BNT162 shot by the close of 2020. The agreement would provide an initial order of 200 million doses to the EU's 27 members states with the option for an additional 100 million doses at a later date, the companies said.

The EU also penned an agreement with AstraZeneca in August for 400 million doses of the University of Oxford's adenovirus-based shot, dubbed AZD1222.

RELATED: Top vaccine players Sanofi, GSK win $2.1B Warp Speed funding for COVID-19 shot

Sanofi and GSK's European deal is its first major supply pact in the region, but the drugmakers are also on the hook for a massive order from the U.S.

In late July, the U.S. government agreed to pay Sanofi and GSK up to $2.1 billion to speed up clinical development and manufacturing of the pair’s candidate.

More than half of the money was earmarked to run clinical trials, while the rest will go to manufacturing scale-up and delivery of an initial 100 million doses of the vaccine. The deal also gives the U.S. government an option for an additional 500 million doses over the long term.