Home >Science >News >India approves late-stage trial for Glaxo-Sanofi Covid vaccine

Sanofi SA and GlaxoSmithKline Plc have received an approval from the Indian authorities for a late-stage clinical trial of their protein-based coronavirus vaccine candidate, reported news agency Reuters.

France's Sanofi and Britain's GSK in May kicked off global trials to include more than 35,000 adults to test the dose. They hope to get approvals by the end of 2021 after early-stage results showed the vaccine produces a robust immune response, the report added.

The Indian arm of the studies will enroll nearly 3,000 adults between the ages of 18 years and 55 years, as per India's clinical trial registry.

The assessment is expected to run for a year and the first enrolment in India is shown to have been made on Tuesday.

"As the virus continues to evolve, we are anticipating what will be needed in the coming months and years, and accordingly, have adapted our vaccine development program," Annapurna Das, Sanofi's India head, has said.

Meanwhile, the World Health Organization has recommended using arthritis drugs Kevzara from Sanofi with corticosteroids for Covid-19 patients after data from some 11,000 patients showed they cut the risk of death.

A WHO group evaluating therapies concluded treating severe and critical Covid patients with these so-called interleukin-6 antagonists that block inflammation "reduces the risk of death and the need for mechanical ventilation".

India on Thursday reported nearly 46,000 new cases of coronavirus in a span of hours, as per the data from the health ministry. Experts have warned that actual figures could be higher than those reported.

The highly contagious Delta variant of the coronavirus, first identified in the South Asian country, is also hurting global recovery plans as the death toll surpassed four million worldwide.

GSK and Sanofi's vaccine candidate uses the same technology as one of Sanofi's seasonal influenza vaccines. It will be coupled with an adjuvant, a substance that acts as a booster to the shot, made by GSK.

Sanofi also plans to test the vaccine as a booster, regardless of which shot a person may have received first.

The drugmakers said that study participants can get vaccinated with an approved coronavirus dose during the study if they wanted to.

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