New Delhi: The Subject Expert Committee (SEC) of the Drug Controller of India has recommended allowing Phase III trials for Dr Reddy’s. sputnik light Vaccines, people aware of development told Mint,
In September 2020, Hyderabad-based Dr Reddy’s Laboratories partnered with the Russian Direct Investment Fund (RDIF) for clinical trials for the Sputnik vaccine and its distribution rights in India in the wake of the Covid-19 pandemic. Spuntic vaccines are being developed at Russia’s Gamalya National Research Institute of Epidemiology and Microbiology and are based on the human adenoviral vector platform.
In February, Dr Reddy’s Laboratories placed an application before the Drugs Controller General of India (DCGI) seeking approval to conduct Phase 3 clinical trials for the Sputnik Lite vaccine as a single booster dose against COVID-19. was sought.
“Dr Reddy’s application was reviewed at the last SEC meeting, which recommended allowing the conduct of Phase 3 clinical trials for the Sputnik Lite vaccine for COVID-19 as a single booster dose. ,” said a person aware of the development, requesting anonymity.
A spokesperson for Reddy’s Lab did not immediately respond to sent questions. Mint on Saturday.
Last month, the apex drug regulator had granted emergency use authorization to Dr Reddy’s single shot Sputnik Lite vaccine in India under certain regulatory provisions.
This comes in the backdrop of a subject expert committee of the Central Drug Control Standards Organization (CDCSO) recommending Serum Institute of India Ltd’s COVID-19 vaccine Kovovax for Emergency Use Authorization (EUA) for children aged 12-17 years. As Mint reported earlier. , The recommendation is yet to be approved by the Drug Controller General of India. Currently, only Bharat Biotech’s Covaxin is used to vaccinate adolescents aged 15 to 18 years.
With the severity of the diseases decreasing and the number of deaths falling in the third wave of COVID-19, the central government on Thursday said it is “rational” to reopen schools, colleges and other regular activities. At least 92% of the deaths have been unrelated persons in India during the third wave of Covid-19 in 2022.
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