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SEC recommends phase 3 clinical trial for Dr Reddy’s Sputnik Light booster dose

In February, Dr Reddy’s Laboratories had placed an application before the Drugs Controller General of India (DCGI) seeking approval to conduct phase 3 clinical trials for the Sputnik Light vaccine as a single booster dose against covid-19. (AP)Premium
In February, Dr Reddy’s Laboratories had placed an application before the Drugs Controller General of India (DCGI) seeking approval to conduct phase 3 clinical trials for the Sputnik Light vaccine as a single booster dose against covid-19. (AP)

Last month, the apex drug regulator had granted emergency use authorisation permission to Dr Reddy’s single shot Sputnik Light vaccine in India under some regulatory provisions

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New Delhi: The Subject Expert Committee (SEC) of India’s drug controller has recommended allowing Dr Reddy’s Laboratories to conduct phase 3 trials of Sputnik Light vaccine for covid-19 as a booster dose, people aware of the development told Mint.

In September 2020, Hyderabad-based Dr Reddy’s Laboratories partnered Russian Direct Investment Fund (RDIF) for conducting clinical trials for Sputnik’s vaccine and for its distribution rights in India in the wake of covid-19 pandemic. Sputnik vaccines are being developed at Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology and are based on the human adenoviral vector platform.

In February, Dr Reddy’s Laboratories had placed an application before the Drugs Controller General of India (DCGI) seeking approval to conduct phase 3 clinical trials for the Sputnik Light vaccine as a single booster dose against covid-19.

“Dr Reddy’s application was reviewed on last SEC meeting which recommended to grant permission for conducting phase 3 clinical trials for Sputnik Light vaccine for covid-19 as single booster dose," said a person aware of the development cited above requesting anonymity.

A spokesperson for Dr Reddy’s Lab did not immediately reply to the queries sent by Mint on Saturday.

Last month, the apex drug regulator had granted emergency use authorisation permission to Dr Reddy’s single-shot Sputnik Light vaccine in India under some regulatory provisions.

This comes in the backdrop of the Subject Expert Committee of Central Drugs Control Standard Organization (CDCSO) on Friday recommending Serum Institute of India Ltd’s Covid-19 vaccine Covovax for emergency use authorization (EUA) for 12-17-year-olds, as reported by Mint earlier. The recommendation is yet to be approved by the Drug Controller General of India. At present, only Bharat Biotech’s Covaxin is used to immunize teenagers between 15 and 18.

With the third wave of covid-19 witnessing less severity of illnesses and lower number of deaths, the union government on Thursday said it is “rational" to reopen schools, colleges, and other routine activities. At least 92% of deaths have occurred in unvaccinated individuals during the third wave of covid-19 in 2022 in India.

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