Expert panel reviews EUA application for Sputnik V vaccine; seeks immunogenicity, safety data


An expert panel of India’s Central Drug Authority which reviewed the application of Dr Reddy’s Laboratories seeking emergency use authorisation for the COVID-19 vaccine Sputnik V on Wednesday recommended that the firm present immunogenicity and safety data, sources said.

Dr Reddy’s Laboratories on February 19 said it had approached drugs regulator DCGI for emergency use authorisation (EUA) for the Russian vaccine.

“The Subject Expert Committee (SEC) on COVID-19 of the CDSCO which discussed the application by Dr Reddy’s Laboratories seeking emergency use authorisation for COVID-19 vaccine Sputnik V on Wednesday asked the firm to submit immunogenicity and safety data as per the protocol approved by the CDSCO. Once it submits these data, its EUA application will be considered,” a source said.

The drug major on Wednesday presented the safety profile of phase 2 study, and interim data of phase 3 trial, the source said.

Meanwhile, the SEC also asked Hyderabad-based Bharat Biotech to submit efficacy data of Covaxin on adults before seeking permission to conduct phase-3 clinical trial on children aged 5-18 years.

In September last year, the Hyderabad-based firm Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V and for its distribution rights in India.

The vaccine is undergoing phase 3 clinical trial in India.

The Drugs Controller General of India (DCGI) has already given the EUA nod for two COVID-19 vaccines — Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca, being manufactured by Serum Institute of India in Pune.

The vaccines are being administered to healthcare and frontline workers across the country.

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Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia, the statement said.

The vaccine also maintained a consistent efficacy at 91.8 per cent even among the group of 2,144 volunteers over 60 years old.

“The efficacy of Sputnik V was reported to be 91.6 per cent by the Lancet, which is an impressive development in the fight against COVID-19. The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India,’ Dr Reddy’s Laboratories co-chairman and managing director G V Prasad said.

Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia on August 11, 2020 and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vector platform.

Sputnik V has already received approval in 26 countries and has been administered to more than 2 million people worldwide.





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