Covid-19 vaccine: Dr Reddy’s begins process of Sputnik V’s emergency use approval in India
If approved by the Drugs Controller General of India, it will be the third vaccine to gain emergency use approval in the country.
Dr Reddy’s Laboratories Limited on Friday announced that it has initiated the process of emergency use authorisation for the Russian Sputnik V coronavirus vaccine. If approved by the Drugs Controller General of India, it will be the third vaccine to get emergency use approval in India.
“As part of the review process, Dr Reddy’s will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 21st February 2021,” a statement from the pharmaceutical company said. “The vaccine is currently undergoing the phase 3 clinical trial in India.”
Sputnik V, which has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Russian health ministry on August 11.
“Sputnik V has demonstrated an efficacy rate of 91.6% in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia, who received both the first and second doses of the vaccine,” the company statement read. “Sputnik V maintained a consistent efficacy at 91.8% even among the group of 2,144 volunteers over 60 years old.”
In September, Dr Reddy’s partnered with the Russian Direct Investment Fund to hold the clinical trials of the Sputnik V vaccine and for its distribution in India.
“The efficacy of Sputnik V was reported to be 91.6% by the Lancet, which is an impressive development in the fight against Covid-19,” said GV Prasad, co-chairman and managing director, Dr Reddy’s Laboratories. “The initiation of the EUA [emergency use authorisation] process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India.”
The Sputnik V vaccine uses two separate human common cold virus, also known as adenovirus, that were modified so that the gene causing the infection is removed and replaced with a code to make SARS-CoV-2’s “spike protein”, according to The Indian Express. The human adenovirus then act as a carrier to transport this code to the cells when vaccination is done so that the body can develop an immune response as antibodies to protect itself in case the real virus attempts to infect.
India, which has reported the highest number of coronavirus infections after the United States, plans to vaccinate around 30 crore people with two doses in the first six to eight months of the year. The country’s vaccination programme began on January 16. The recipients include 3 crore doctors, nurses and other front-line workers, to be followed by people who are either over 50 or have illnesses that make them vulnerable to the virus.
Beneficiaries, however, will not be able to choose between the Oxford University-AstraZeneca Covishield vaccine, produced by the Serum Institute of India, and Covaxin, a government-backed, indigenous one from Bharat Biotech.