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Dr Reddy’s Laboratories To Submit Additional Immunogenicity Data For Emergency Approval Of COVID-19 Vaccine Sputnik V

On 19 February, Dr Reddy’s Laboratories announced that it has initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) of the well-studied human adenoviral vector-based platform vaccine candidate, Sputnik V

Dr Reddy's To Submit Additional Data For Emergency Approval Of COVID-19 Vaccine Sputnik V
Highlights
  • Sputnik V is developed by Russia's Gamaleya National Research Institute
  • Sputnik V has demonstrated an efficacy rate of 91.6 per cent
  • Phase 3 clinical trial of Sputnik V was done on 19,866 volunteers in Russia

New Delhi: The Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee (SEC) has recommended additional immunogenicity data from Dr Reddy’s Laboratories which applied to the national drugs regulator seeking emergency use approval for Sputnik V, a Russian COVID-19 Vaccine. “Today, SEC meeting helped discuss the application of Dr Reddy seeking emergency use approval for Sputnik V vaccine. However, the pharma company has been asked to submit additional immunogenicity data. Once the firm presents the additional data then the only further evaluation will be done,” a government official said.

Also Read: COVID-19 Mutation That May Weaken Effectiveness Of Vaccines Found In New York

On 19 February, Dr Reddy’s Laboratories announced that it has initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) of the well-studied human adenoviral vector-based platform vaccine candidate, Sputnik V. In September last year, Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India. The vaccine is currently undergoing the phase 3 clinical trial in India.

According to Dr Reddy’s, Sputnik V has demonstrated an efficacy rate of 91.6 per cent 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. Sputnik V maintained a consistent efficacy at 91.8 per cent even among the group of 2,144 volunteers over 60 years old. Sputnik V is being developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology to fight against COVID-19 based on the human adenoviral vector platform.

Also Read: Will Russia’s Sputnik V Be India’s Third COVID-19 Vaccine? Dr Reddy’s Laboratories Answers

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

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