Submit more immunogenicity, safety data on Sputnik V vaccine: CDSCO panel to Dr Reddys
Once Dr Reddy's Labs submits the data, its Emergency Use Authorization application will be considered," a source said.
New Delhi: Looking into an application for emergency use authorization in India for the Russia-made Sputnik V COVID-19 vaccine, an expert panel of the country's Central Drug Authority on Wednesday asked Dr Reddy's Laboratories, the Indian manufacturer of the vaccine, to provide some additional details including immunogenicity and safety data, sources said.
On February 19, Dr Reddy's Laboratories said it had approached drugs regulator DCGI for emergency use authorization (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 in accordance with the protocol approved by the CDSCO. Once it submits the data, its EUA application will be considered," a source said.
The drug major presented the safety profile of the phase 2 study and the interim data of the phase 3 trial on Wednesday, the source said.
Meanwhile, the SEC also asked Hyderabad-based Bharat Biotech to submit the efficacy data of Covaxin on adults before seeking permission to conduct the phase-3 clinical trial on children aged 5-18 years.
In September last year, Hyderabad-based Dr Reddy''s Laboratories 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 the 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 the Serum Institute of India in Pune.
The vaccines are being administered to healthcare and frontline workers across the country.
Sputnik V has demonstrated an efficacy rate of 91.6 percent in the interim analysis of its phase 3 clinical trial, which includes 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 of age.
"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 20 lakh people worldwide.