If current clinical trials are successful, Sanofi and GSK plan to initiate phase-three trials by the end of the year, which could enable them to request regulatory approval for a vaccine in the first half of 2021.
Pharmaceutical giants GSK and Sanofi have begun phase one and two clinical trials for their adjuvanted Covid-19 vaccine.
The vaccine candidate being developed by the two companies uses the same recombinant protein-based technology as one of Sanofi’s existing seasonal flu vaccines, along with GSK’s adjuvant technology. Adjuvants are pharmacological or immunological agents that improve the immune response of a vaccine.
This clinical trial is a randomised, double-blind and placebo-controlled trial designed to evaluate the safety, tolerability and immune response of the Covid-19 vaccine candidate. A total of 440 healthy adults have been enrolled in the trial across 11 investigational sites in the US.
The companies anticipate the first results in December 2020, which will support the initiation of a phase-three trial by the end of the year if all goes to plan. If the data is sufficient a for licensing application, GSK and Sanofi aim to request regulatory approval in the first half of 2021.
Sanofi and GSK are scaling up manufacturing of the antigens and adjuvants needed for a vaccine, with the target of producing up to 1bn doses in 2021.
Aiming to begin phase-three trials
Thomas Triomphe, executive vice-president and global head of Sanofi’s vaccine business unit Sanofi Pasteur, said: “Sanofi and GSK bring proven science and technology to 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-three trial by the end of this year.”
Roger Connor, president of GSK Vaccines, added: “Moving this vaccine candidate into clinical development is an important moment in the progress towards addressing the global pandemic we are all facing.
“This builds on the confidence shown by governments already in the potential of this protein-based adjuvanted vaccine candidate, which utilises established technology from both companies and can be produced at scale.”
The development of the adjuvanted Covid-19 vaccine candidate is being supported through funding and a collaboration with the Biomedical Advanced Research and Development Authority in the US.
Sanofi and GSK previously announced a goal of supplying the US with 100m doses of the Covid-19 vaccine, while the US is providing funding of up to $2.1bn for development, clinical trials and manufacturing.
Meanwhile in China
According to a regulatory notice seen by Reuters, China has offered experimental coronavirus vaccines to aviation industry workers in a bid to inoculate high-risk groups to prevent another surge of cases as economies reopen.
Reuters reported that China has four Covid-19 vaccines in the final stage of human trials, and is now offering experimental vaccine candidates to groups such as border inspectors and medical industry workers who may face increased exposure as a result of their work. China launched the emergency vaccine programme in July.
The Civil Administration of China has reportedly asked firms in these sectors to compile a list of employees willing to take the experimental vaccine, including workers at Chinese airlines, airports and the China National Aviation Fuel Group.
Elsewhere, a study published this week suggested there is limited diversity of the novel coronavirus, SARS-CoV-2, meaning a single Covid-19 vaccine could be effective against all known strains.