Sanofi and GSK began a phase 1/2 clinical trial of their jointly developed COVID-19 vaccine candidate last week, opening enrollment for 440 participants after pre-clinical studies show promising positive safety and immunogenicity.
The vaccine is based on the recombinant protein-based technology utilized by Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology. It will undergo a randomized, double-blind, and placebo-controlled trial to assess its safety, tolerability, and immunogenicity at 11 investigational sites throughout the U.S. Efforts are being supported by funding from and collaboration with the Biomedical Advanced Research and Development Authority.
“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 of 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.”
That is pending positive data, of course, but supposing this is achieved, the companies hope to request regulatory approval within the first half of next year. Sanofi is handling the clinical development and registration sides of the project. From there, the partners would push to produce up to 1 billion doses of the candidate in 2021.
“Moving this vaccine candidate into clinical development is an important moment in the progress towards addressing the global pandemic we are all facing,” Roger Connor, president of GSK Vaccines, said. “This builds on the confidence shown by governments already in the potential of this protein-based adjuvanted vaccine candidate, which utilizes established technology from both companies, and can be produced at scale by two of the leading vaccine manufacturers globally.”
Pre-clinical data has borne out hopes so far, showcasing high levels of neutralizing antibodies comparable to humans who have recovered from COVID-19 infections. That data should be published later this year.
Supposing the vaccine proves successful, Sanofi and GSK would provide up to 100 million doses to the U.S. government, under an agreement reached earlier this year. The government could then purchase another 500 million doses if it so desired. Separate agreements would bring 60 million doses to the U.K., and a great deal to the COVAX Facility, an operation dedicated to equitable distribution of vaccines throughout the world.