Sanofi, GSK get Indian approval for late-stage trial of COVID-19 vaccine

(Reuters) – Sanofi SA and GlaxoSmithKline Plc have received an approval from Indian authorities for a late-stage clinical trial of their protein-based COVID-19 vaccine candidate, the drugmakers said on Thursday.

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

The Indian arm of the studies will enrol roughly 3,000 adults between the ages of 18 years and 55 years, according to 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.

The Indian drug regulator did not immediately respond to a request for comment.

“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, said in a statement.

India reported on Thursday nearly 46,000 new COVID-19 cases in the last 24 hours, according to 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 companies said study participants can get vaccinated with an approved COVID-19 shot during the study if they wish to.

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