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Dr. Reddy's bringing coronavirus vaccine to India by 2020-end

Dr. Reddy's bringing coronavirus vaccine to India by 2020-end

Sep 16, 2020
05:18 pm

What's the story

In a major development, Hyderabad-based pharma company Dr. Reddy's Laboratories has partnered with the Russian Direct Investment Fund (RDIF) to source their Sputnik V COVID-19 vaccine for India. The company will conduct a clinical trial of the shot, which, if successful, could make the vaccine available for the public by the end of this year. Here is all you need to know about it.

Deal

Deal inked for clinical trial and supply

As part of the deal, announced a few hours ago, Dr. Reddy's Laboratories will be conducting a Phase-3 human trial of Sputnik V in India. Along with the study, the organization will also be buying 100 million doses of the shot, which has been billed as the world's officially approved COVID-19 vaccine, for people in the country.

Approvals

Both aspects remain subject to regulatory approvals

Both trial and supply aspects of the deal remain subject to approvals from the Central Drugs Standard Control Organization - which will be looking at the data of the vaccine pre and post India trial. To note, just last week, NITI Aayog member VK Paul had said that the Indian government is willing to facilitate a late-stage trial for Sputnik V.

Comment

Sputnik V vaccine could provide credible option against COVID-19

Meanwhile, speaking on the deal, GV Prasad, co-chairman & MD of Dr. Reddy's Laboratories, said, "We will be conducting Phase-3 trials in India to ensure safety and efficacy for the Indian population and 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 added.

Quote

Sputnik V will help India fight COVID-19: RDIF CEO

"India is amongst most severely impacted countries from COVID-19," RDIF CEO Kirill Dmitriev said in a statement, adding that "we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against COVID-19."

Details

Sputnik V was approved prematurely in August

Developed by Gamaleya Research Institute of Epidemiology and Microbiology and backed by RDIF, Sputnik V was registered on August 11, with President Putin claiming that the shot forms a stable immunity and one of his daughters had already been inoculated. However, as the approval was given after just two-month-long trials and no public data, many raised alarms over the safety standards.

Progress

Regardless, Russia has been moving ahead with production, distribution

Despite the questions, Russia has been moving ahead with the internal production and distribution of Sputnik V. The company started production last month and has already released the first batch of the shot in civil circulation, following necessary quality tests in the laboratories of Roszdravnadzor [Russia's medical device regulator]. The country had also expressed willingness to partner with India for scaling up the production.