New Delhi: An expert panel of India's central drug authority has recommended granting approval to the Russian COVID-19 vaccine Sputnik V for emergency use in the country with certain conditions, sources said.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Monday took up the application of Dr Reddy's Laboratories seeking emergency use authorisation for Sputnik V.
The Drugs Controller General of India (DCGI) will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.
The vaccine would be imported from Russia for emergency use in the country, they said.
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.
The Drugs Controller General of India (DCGI) has already given the emergency use authorisation for two COVID-19 vaccines — Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca, being manufactured by Serum Institute of India in Pune.
Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia.
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.
As per media reports, India by end of the third quarter of this year will be getting vaccines from five additional manufacturers. The country currently manufactures Covishield and Covaxin.
In addition to Sputnik, India could roll out Johnson and Johnson (Bio E), Cadilla Zydus, Novavex (Serum Institute of India) and Nasal Vaccine (Bharat) by the end of this year.
On the second day of the nationwide vaccination drive (Tika Utsav), a total of 37,63,858 doses were given till 8 pm on Monday taking the cumulative number of shots administered in the country to 10,82,92,423.
As per the Health ministry's provisional report, 71,000 Covid Vaccination Centres (CVCs) were operational on Monday, which is much more in comparison to other days as on an average 45,000 CVCs are functional on any given day.
Meanwhile, the government is expected to soon issue guidelines on Adverse Events Following Immunisation (AEFI) that will help doctors as well as Covid-19 vaccine recipients to identify and treat unusual signs and symptoms in cases of 'serious and severe' instances like rare blood clots.
Some of these events were reported in countries after the administration of AstraZeneca-Oxford University's Covid vaccine. The guidelines are being prepared even as a review of 'serious and severe' AEFIs in India indicates possible "genetic" connections in the events reported in European countries, official sources said.