Sanofi and GSK have agreed to supply up to 300 million doses of their potential Covid-19 vaccine to the European Commission (EC), after receiving regulatory approval.

The Covid-19 vaccine candidate is developed under collaboration between Sanofi and GSK and leverages the same recombinant protein-based technology Sanofi uses in its seasonal influenza vaccine, combined with GSK’s adjuvant technology.

The agreement is said to confirm the companies’ announcement made on 31 July 2020 and ensures protection for the EU population.

On 3 September 2020, Sanofi and GSK have commenced the Phase 1/2 randomised, double-blind and placebo-controlled clinical trial, to evaluate the safety, tolerability and immunogenicity of their adjuvanted Covid-19 vaccine, in 440 healthy adults across 11 investigational sites in the US.

Sanofi Pasteur executive vice president and global head Thomas Triomphe said: “Sanofi and GSK bring proven science and technology to the fight against the global Covid-19 pandemic, with the shared objective of delivering a safe and effective vaccine.

“The initiation of our clinical study is an important step and brings us closer to a potential vaccine which could help defeat Covid-19.

“Our dedicated teams and partner continue to work around the clock as we aim to deliver the first results in early December. Positive data will enable a prompt start of the pivotal phase 3 trial by the end of this year.”

Sanofi, GSK recently signed supply agreements with US and UK governments

In addition to the ongoing Phase 1/2 trial, the companies are planning to start a Phase 3 clinical trial by the end of 2020, and seek regulatory approval in the first half of 2021.

Sanofi and GSK also recently signed agreements with the US and UK governments, and are planning to supply a considerable amount of vaccine to COVAX, the vaccines pillar of the ACT-Accelerator, a global collaboration aimed at providing access to Covid‐19 tools.

With the current supply agreement, Sanofi and GSK are ramping up the production of the antigen and adjuvant, to manufacture up to one billion doses per annum of its vaccine to meet the global demand.

In addition to the current recombinant protein-based vaccine, the companies are developing a messenger RNA (mRNA) vaccine in partnership with Translate Bio.