Benzinga | Jul 8, 2021 09:19AM EDT

Sanofi, GSK Get Nod For Late-Stage COVID-19 Vaccine Trial In India

* Sanofi SA (NASDAQ:SNY) and GlaxoSmithKline Plc (NYSE:GSK) have received approval from the Drug Controller General of India (DCGI) for a late-stage clinical trial of their protein-based COVID-19 vaccine candidate.

* The companies in May started global trials to include more than 35,000 adults to test the candidate and hope to get approvals by the end of 2021.

* Phase 2 interim results showed that the vaccine produces a robust immune response.

* According to India's clinical trial registry, the Indian arm of the studies will enroll roughly 3,000 adults between the ages of 18 years and 55 years.

* The assessment is expected to run for a year, and the first enrollment in India is already done.

* 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 made by GSK.

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

* Price Action: GSK shares are down 1.19% at $39.76, and SNY shares are down 0.43% at $50.99 during the premarket session on the last check Thursday.