New Delhi, April 12
An expert panel of India’s central drug authority has recommended granting approval to Russian COVID-19 vaccine Sputnik V for restricted emergency use with certain conditions, paving the way for a third vaccine to be available in the country, sources said on Monday.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on Monday deliberated upon the application of Dr Reddy’s Laboratories seeking emergency use authorisation for Sputnik V.
“After detailed deliberation for grant of permission for restricted use in emergency situations subject to various regulatory provisions,” a source said.
The recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.
If approved, it will be the third COVID-19 vaccine to be available in India after Bharat Biotech’s Covaxin and Oxford-AstraZeneca’s Covishield, being manufactured by Serum Institute of India in Pune. According to sources, around 10 crore doses of the vaccine (Sputnik V) is likely to be imported for emergency use in the country in the next six months.
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.
The SEC earlier had reviewed the application by Dr Reddy’s in two meetings earlier 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.
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