The two companies aim to move into Phase 3 by the end of 2020, pending positive Phase 1/2 data; with the target of producing up to one billion doses in 2021.
Developed by the Sanofi / GSK partnership, the vaccine candidate uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines, along with GSK’s established pandemic adjuvant technology.
US trial
The Phase 1/2 clinical will evaluate the safety, reactogenicity and immunogenicity of the vaccine candidate. A total of 440 healthy adult participants are being enrolled in the randomized, double blind and placebo-controlled trial.
The trial is taking place across 11 investigational sites in the US.
Sanofi and GSK anticipate the first results from the Phase 1/2 trial will be available in December this year, which would support their goal to start a Phase 3 trial the same month. They would then plan to request regulatory approval in the first half of 2021.
Sanofi and GSK launched their vaccine partnership in April. Pre-clinical studies show ‘promising safety and immunogenicity’, according to Sanofi and GSK, with the results to be published later this year.
“Preclinical data showed an acceptable reactogenicity profile and data based on two injections of the adjuvanted recombinant vaccine showed high levels of neutralizing antibodies that are comparable to levels in humans who recovered from the COVID-19 infection,” says a statement from the two companies.
In the meantime, Sanofi and GSK are scaling up antigen and adjuvant manufacturing in preparation for their 2021 target of one billion doses.
100m doses for Operation Warp Speed
Sanofi and GSK announced in July they would supply up to 100 million doses of the COVID-19 recombinant protein-based vaccine to the US’ Operation Warp Speed. The US government also has the option to discuss the purchase of up to 500 million doses in the long term. Sanofi and GSK are also lined up to supply the UK with up to 60 million doses of the vaccine.
The partners have also pledged to supply a ‘significant portion’ of total worldwide available supply in 2021/2022 to the World Health Organization’s COVAX, which seeks to provide fair and equitable global access to COVID-19 vaccines, tests and treatments.
In a separate program, Sanofi is also developing a messenger RNA vaccine in partnership with Translate Bio. The Phase 1/2 study is expected to start in November, with the earliest potential date for approval in the second half of 2021. Sanofi expects to be in a position to supply annual capacity of 90 – 360 million doses of this mRNA vaccine.