French pharmaceutical giant Sanofi on Thursday said it would start human trials of the potential coronavirus vaccine it is developing with British peer GSK, following promising preliminary tests.
The launch of phase 1 and 2 trials represent an “important stage and another step towards the development of a potential vaccine to help us beat Covid-19,” said Sanofi Pasteur executive vice-president Thomas Triomphe.
The vaccine combines leading technology from both Sanofi and GlaxoSmithKline.
A protein-based vaccine owned by Sanofi and used to treat influenza was paired with a GSK-developed add-on, known as an adjuvant, that boosts the recipient’s immune response.
“The pre-clinical trials show a promising security profile and immunogenity,” that is, the ability to bring about an immune response, a Sanofi statement said.
The companies’ labs are to recruit 440 healthy participants to carry out tests where neither those tested nor observers know who has received a vaccine and who has been given a placebo.
The tests are designed to evaluate the vaccine’s safety, tolerability and immune response.
“Positive data will enable a prompt start of the pivotal phase 3 trial by the end of this year,” Roger Connor, president of GSK Vaccines, said in reference to the final step before a vaccine is brought to market.
The firms hope to receive regulatory clearance in the first half of 2021 and take production capacity to a billion doses for distribution throughout the year.
Both say they are committed to making the vaccine available globally.
Several countries have already reserved doses – with 60 million promised to the British government and 300 million reserved by the European Commission.
The United States has reserved 100 million with an option for up to 500 million more.
Sanofi and GSK have also pledged to make a “significant portion” of 2021/2022 production available to the WHO-led COVAX shared facility designed to guarantee all countries rapid, fair and equitable access to Covid-19 vaccines.
According to the World Health Organization, 75 countries had signed up to using the facility, which would ensure distribution of two billion doses by late July 2021.
Other potential vaccines are even closer to market approval, notably two under development by US giant Pfizer and biotech firm Moderna.
Meanwhile, Sanofi is pursuing a parallel second vaccine attempt in partnership with US-based Translate Bio.
