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Dr Reddy's Sputnik Vaccine Gears Up for Phase 3 Clinical Trial, Gets DCGI Nod

The phase 3 study of Sputnik V will be conducted on 1,500 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study

Dr Reddys Sputnik Vaccine Gears Up for Phase 3 Clinical Trial, Gets DCGI Nod

Sentinel Digital DeskBy : Sentinel Digital Desk

  |  2021-01-16T12:51:14+05:30

NEW DELHI: Hyderabad based, Dr Reddy's Laboratories announced that the Drugs Control General of India (DCGI) has given them the nod to conduct phase 3 clinical trial for the Sputnik V vaccine.

Earlier, GV Prasad, Co-chairman & MD of Dr Reddy's Laboratories said, "The phase 2 study in India conducted by Dr Reddy's & RDIF showed a very good safety profile. The further reinforces our confidence in the safety of Sputnik V, which has now been administered to more than 1 million people in Russia & 3000,000 people in Argentina. We are working towards fast-tracking the launch of the Sputnik V vaccine in India."

It is to be mentioned that in the Phase 2 study of Sputnik V was recently conducted in India. No safety concerns were identified and the study met the primary endpoints of safety.

"This is an important milestone in the progress of this pivotal clinical trial of the vaccine. We expect to commence the phase 3 study within this month and will continue to fast-track our efforts to bring in a safe and efficacious vaccine for the Indian population", the Co-chairman added.

In September 2020, Dr Reddy's along with Russian Direct Investment Fund (RDIF) started the clinical trials of the Sputnik V with the aim to acquire the distribution rights in India.

Sputnik V was registered by the Ministry of Health of Russia and became the world's first registered vaccine against Covid-19 based on the established human adenoviral vector platform.

The vaccine's efficacy is confirmed to be at 91.4% based on data analysis of the final control point of clinical trials in Russia.

CurrentlyAccording to reports, the vaccine's clinical trials are underway in the UAE, Egypt, Venezuela and Belarus while it has been registered in Algeria, Argentina, Belarus, Bolivia and Serbia for inoculation.

Meanwhile, in India, the mass COVID-19 vaccination drive has rolled out in all the states. The drive is said to be conducted in three phases and in the first phase - the covid warriors which include doctors, nurses, paramedical staff, ambulance drivers, cleaning staff which were on the field physically dealing with the Covid patients will get vaccinated

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