Phase I clinical trials of the adjuvanted vaccine against the SARS-CoV-2 virus could begin in the second half of 2020, according to the companies.
Sanofi and GlaxoSmithKline (GSK) this week announced a plan to collaborate on development of a vaccine against SARS-CoV-2, the virus that causes COVID-19. The adjuvanted vaccine could enter clinical trials in the second half of this year and if successful, be available in the second half of 2021, acccording to a joint press release.
"As the world faces this unprecedented global health crisis, it is clear that no one company can go it alone, ” said Paul Hudson, Chief Executive Officer, Sanofi, in the news release. “That is why Sanofi is continuing to complement its expertise and resources with our peers, such as GSK, with the goal to create and supply sufficient quantities of vaccines that will help stop this virus.”
Complementary technology Sanofi will contribute its S-protein COVID-19 antigen, which was developed using recombinant DNA technology. The antigen is an exact genetic match to proteins found on the surface of the COVID-19 virus. The DNA sequence encoding the S-protein antigen has been combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product in the US.
GSK will contribute its proven pandemic adjuvant technology to the collaboration. A vaccine adjuvant is particularly important in responding to a pandemic as it may reduce the amount of protein required per dose of vaccine, optimizing the number of doses produced, as explained in the companies’ joint announcement.
“This collaboration brings two of the world’s largest vaccines companies together,” said Emma Walmsley, chief executive officer at GSK. “By combining our scientific expertise, technologies and capabilities, we believe that we can help accelerate the global effort to develop a vaccine to protect as many people as possible from COVID-19.”
Antigen plus adjuvant
The protein-based antigen plus adjuvant combination is well-established and is the basis of a variety of vaccines in current use. Adjuvant compounds have intrinsic immunomodulatory properties that, when administered in combination with an antigen, effectively enhance the immune response; adjuvants have been shown to create a stronger and longer lasting immunity against infections than the vaccine alone. It can also improve the likelihood of delivering an effective vaccine that can be manufactured at scale.
Initiation of phase I clinical trials is planned for the second half of 2020. If the results are favorable and subject to regulatory considerations, the companies aim to complete the development required for availability by the second half of 2021.
Development of the recombinant-based COVID-19 vaccine candidate is being supported through funding and a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), in the US, collaboration previously announced by Sanofi.
“Strategic alliances among vaccine industry leaders are essential to make a coronavirus vaccine available as soon as possible,” said BARDA Director, Rick A. Bright, PhD. “Development of the adjuvanted recombinant-based COVID-19 vaccine candidate holds the potential to lower the vaccine dose to provide vaccine to a greater number of people to end this pandemic, and help the world become better prepared or even prevent future coronavirus outbreaks.”
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