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GSK and Sanofi to begin clinical trial for potential Covid-19 vaccine

Catherine Wylie
Thursday 03 September 2020 06:07 EDT
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Pharmaceutical giants GlaxoSmithKline (GSK) and Sanofi Pasteur have enrolled more than 400 people for a clinical trial of their Covid-19 vaccine candidate.

The Government has already signed a deal with the companies for 60 million doses of a potential coronavirus vaccine.

A total of 440 healthy adults are being enrolled in the trial across 11 sites in the United States and the companies anticipate initial results in early December.

If the first two phases go well, the companies aim to move into a phase three trial by the end of the year, and if the data is sufficient for licensure application, it is planned to request regulatory approval in the first half of 2021.

The vaccine produced by GSK and Sanofi, which together have the largest vaccine manufacturing capability in the world, is based on the existing DNA-based technology used to produce Sanofi's seasonal flu vaccine.

Roger Connor, president of GSK Vaccines said: "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 by two of the leading vaccine manufacturers globally.

"We now look forward to the data from the study, and if positive, beginning a phase three trial by the end of the year."

Thomas Triomphe, executive vice president and global head of Sanofi Pasteur, said: "Sanofi and GSK bring proven science and technology to the 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."

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