India's drug regulator has granted permission for the restricted emergency use of Russian COVID-19 vaccine 'Sputnik V' with certain conditions, paving the way for a third vaccine to be available in the country, sources said on Monday.
The approval by the Drugs Controller General of India came after the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organization on Monday recommended 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 of Bharat Biotech and Covishield of Oxford-AstraZeneca manufactured by Serum Institute of India in Pune.
According to sources, around 10 crore doses of the Sputnik V vaccine is likely to be imported for emergency use in the country in the next six to seven months.
The SEC on Monday deliberated 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 and is to be administered intramuscularly in two doses of 0.5 ml each with an interval of 21 days.
It 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 and other suggestions made during the meeting, another source said.
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 and 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 on Friday.
In light of the SEC meeting held on 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.
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.
