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Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.
In two separate agreements announced on July 31, 2020, Sanofi and GlaxoSmithKline (GSK) will supply a COVID-19 recombinant protein-based vaccine to the US government and the European Union.
The companies have entered into a collaboration with the US government to accelerate the development and manufacturing of the vaccine candidate, which was developed by Sanofi in partnership with GSK. The vaccine candidate is based on the recombinant protein technology used by Sanofi to produce an influenza vaccine and GSK’s established pandemic adjuvant technology.
Under the collaboration, the US Department of Health and Human Services (HHS) and Department of Defense will help fund the development activities and secure scale-up of Sanofi’s and GSK’s manufacturing capabilities in the United States, which is expected to significantly increase capacity. The US government will provide up to $2.1 billion, more than half of which will go to support further development of the vaccine, including clinical trials, with the remainder used for manufacturing scale up and delivery of an initial 100 million doses of the vaccine. Sanofi will receive the majority of the US government funding. The US government has a further option for the supply of an additional 500 million doses longer term, which helps meet Operation Warp Speed’s goals of providing millions of doses of a safe and effective COVID-19 vaccine.
“The global need for a vaccine to help prevent COVID-19 is massive, and no single vaccine or company will be able to meet the global demand alone,” said Thomas Triomphe, executive vice-president and global head of Sanofi Pasteur, in a company press release. “From the beginning of the pandemic, Sanofi has leveraged its deep scientific expertise and resources to help address this crisis, collaborating with the US Department of Health and Human Services to unlock a rapid path toward developing a pandemic vaccine and manufacturing at large scale. With our partner GSK, we expect our Phase [I/II] study for the recombinant adjuvanted approach to start in September.”
“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 HHS Secretary Alex Azar in the press release. “Today’s 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.”
Meanwhile in Europe, Sanofi and GSK are in advanced discussions with the European Commission (EC) to supply up to 300 million doses of the COVID-19 vaccine. The doses would be manufactured in European countries including France, Belgium, Germany, and Italy.
“Today’s announcement helps to ensure that millions of Europeans will have access to a potential vaccine protecting against COVID-19, once proven safe and effective. It has been our steadfast commitment to provide a vaccine that is affordable and accessible to everyone, and we are grateful to the European Commission for their ongoing engagement and shared support of this effort,” Triomphe said in a company press release.
"GSK is proud to be working in partnership with Sanofi to make this vaccine available as soon as possible in Europe. Both companies have significant R&D and manufacturing capability in Europe and are already working hard to scale up production across our networks. This announcement from the EC supports our ongoing efforts,” added Roger Connor, president of GSK Vaccines, in the press release.