Russia inks deal with Dr Reddy’s for Sputnik-V trial in India

| | New Delhi
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Russia inks deal with Dr Reddy’s for Sputnik-V trial in India

Thursday, 17 September 2020 | PNS | New Delhi

As the world races to develop vaccines to combat the deadly Covid-19, India on Wednesday witnessed two major developments in the sector: While the Russian Direct Investment Fund (RDIF) inked a deal with Dr Reddy’s Laboratories to conduct a clinical trial and distribution of 100 million doses of    its Covid-19 vaccine, Sputnik V, in India, the Serum Institute of India (SII) got the DCGI nod to resume the clinical trial of the Oxford coronavirus vaccine candidate here but with certain precautionary conditions.

Under the agreement,  RDIF, which is Russia’s sovereign wealth fund, will supply 100 million doses of Russia’s shot  to the Indian drug maker. Both the trials and supply deal depend on central drug regulator’s approval. If the trials are successful, the vaccine will be available in India by the end of this year, said the RDIF in a statement. It was developed by the Gamaleya National Research Institute of Epidemiology and Microbiology on August 11 and was registered by the Ministry of Health of Russia to become the world’s first registered vaccine against Covid-19 based on the human adenoviral vectors platform.

The RDIF further said, “Upon regulatory approval in India, RDIF shall supply to Dr. Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, which is based on well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic.”

“Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India,” it added.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said: “We are very pleased to partner with Dr.Reddy’s in India. India is amongst most severely impacted countries from Covid-19 and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against Covid-19.”

GV Prasad, Co-Chairman and Managing Director of Dr. Reddy’s Laboratories,  said that the Phase I and II results have shown promise, and we will be conducting Phase-III trials in India to meet the requirements of the Indian regulators. “Sputnik-V vaccine could provide a credible option in our fight against Covid-19 in India,” he said.

Meanwhile, giving its nod to the SII to start the trial, the DCGI asked the SII to submit details of medication used in accordance with the protocol for management of adverse events.  The DCGI also revoked its order on new recruitment for phase two and three trials to the SII.

The DCGI had on September 11 directed SII to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ‘’an unexplained illness’’ in a participant in the study.

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