If phase 1/2 data is positive, the companies plan to move into phase 3 by December.
Sanofi and GSK announced today the start of the phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine.
The phase 1/2 clinical trial is designed to evaluate the safety, tolerability and immune response, and is enrolling 440 Americans across 11 sites in the US.
The companies anticipate first results in early December 2020, and plan initiation of a phase 3 trial that same month. If these data are sufficient for licensure application, they will request regulatory approval in the first half of 2021.
“The initiation of our clinical study is an important step and brings us closer to a potential vaccine which could help defeat COVID-19,” Thomas Triomphe, executive vice president and global head, Sanofi Pasteur, said. “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.”
Back in July, it was announced the US government has reached a deal with the 2 pharmaceutical companies to deliver 100 million doses of the vaccine.
“GSK is proud to be working in partnership with Sanofi to make this vaccine available at scale as soon as possible,” Roger Connor, president, GSK Vaccines stated at the time. “We thank the US government for playing a very important role in providing early, significant funding to enable the development and scale-up of this potentially important vaccine.”
Sanofi and GSK are scaling up manufacturing to produce up to 1 billion doses per year globally. The companies plan to supply a significant portion of total worldwide available supply in 2021/2022 to COVAX, the vaccines pillar of the ACT-Accelerator (Access to COVID‐19 Tools), a global collaboration of leaders of governments, global health organisations, businesses and philanthropies to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines.