Sanofi and GlaxoSmithKline (GSK) have forged an agreement with the US government for 100 million doses of their jointly-developed COVID-19 vaccine, while they are also advancing discussions with the EU for access to the candidate.
Sanofi/GSK have also been selected by the US government to be included in Operation Warp Speed – a targeted initiative which is aiming to deliver 300 million doses of a COVID-19 vaccine to American citizen, free of charge, by January 2021.
A number of other companies, including Moderna, Pfizer/BioNTech, AstraZeneca/Oxford University and Johnson & Johnson have also been selected as part of the initiative.
“The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” said US Department of Health and Human Services (HHS) Secretary Alex Azar.
“This investment supports the Sanofi and GSK adjuvanted product all the way through clinical trials and manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people,” he added.
As part of this agreement, the US government will provide up to $2.1bn to support further development of the vaccine, including clinical trials, and the manufacturing scale-up and delivery of the initial 100 million doses.
Under the terms of the deal the US government has a further option for the supply of an additional 500 million doses for the long term.
The vaccine candidate is based on Sanofi’s recombinant protein technology, used to produce its influenza vaccine, and GSK’s established pandemic adjuvant technology.
Sanofi, which is leading the clinical development of the vaccine, expects a phase 1/2 trial to begin in September, with a large-scale phase 3 trial also planned before the end of 2020. If the vaccine proves effective in these studies, Sanofi/GSK hope to achieve regulatory approval by the first half of 2021.
Last week, Sanofi/GSK also agreed a deal with the UK government for 60 million doses of their potential COVID-19 vaccine. These doses will primarily be administered among priority groups, including frontline health and social care workers.
The two companies have also said that they are advancing discussion with the European Commission for a supply agreement for up to 300 million doses of their COVID-19 vaccine.
If an agreement is reached with the EU, the doses of Sanofi/GSK’s candidate will be manufactured in European countries including France, Belgium, Germany and Italy.