New Delhi: India’s drug regulator has granted permission for the restricted emergency use of Russian COVID-19 vaccine ‘Sputnik V’ with certain conditions. It means that a third vaccine will be available in India after Covaxin and Covishield. It has been said that Sputnik V has a 91.6 per cent efficacy rate.
The approval by the Drugs Controller General of India (DCGI) came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) recommended Monday granting approval to Sputnik V for restricted emergency use subject to certain regulatory conditions.
The DCGI had in January given the emergency use authorisation for two COVID-19 vaccines – Covaxin and Covishield.
According to sources, around 10 crore doses of the Sputnik V vaccine is likely to be imported to India in the next six to seven months.
The SEC deliberated Monday upon the application of Dr Reddy’s Laboratories seeking emergency use authorisation for Sputnik V. The vaccine is indicated for active immunisation to prevent COVID-19 in individuals aged 18 years and above. It is to be administered intramuscularly in two doses of 0.5 ml each with an interval of 21 days. Sputnik-V has to be stored at -18 degrees Celsius.
According to recommendations by the SEC, the firm has been asked to submit revised factsheets to CDSCO after incorporating the latest safety and efficacy data. Besides, the firm should submit the safety, efficacy and immunogenicity data from the ongoing clinical trials in India and Russia for review as and when available.
The firm also has to submit safety data, including the data on AEFI and AESI with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country, as per the recommendations. The SEC had reviewed the application by Dr Reddy’s in two meetings held on April 1 and February 24.
The health ministry earlier had said three more COVID-19 vaccines by Zydus Cadila, Biological E and Gennova are also in the pipeline. They are in advanced clinical trials in India.
Global healthcare major Johnson and Johnson is in discussions with the Indian government to begin a clinical trial of its single-dose COVID-19 vaccine in the country, the company said Friday.
In light of the SEC meeting held April 1, Dr Reddy’s on Monday presented the interim safety and immunogenicity data from phase 2/3 clinical trial, including GMT titres for virus neutralising antibodies, comparative phase 3 immunogenicity data generated in Indian and Russian studies and unblinded data of serious adverse events and RT-PCR positive cases among others.
In September last year, Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V and for its distribution rights in India.