Amidst the rising cases of the second wave of coronavirus in India, expert panel of the country’s drug regulator on Monday approved the use of Russia’s Sputnik V Covid-19 vaccine, according to reports.
The Drug Controller General of India’s Subject Expert Committee met today to take up Sputnik V application for emergency use authorization in India and took the decision during the meet.
The vaccine would be imported from Russia for emergency use in the country, they said.
DCGI will now consider SEC recommendations for the third Covid vaccine to be available in India amid vaccine shortage. The first two are Serum Institute of India’s locally-made Oxford Covid-19 vaccine ‘Covishield’ and Bharat Biotech’s indigenously manufactured Covaxin.
“India currently has 2 COVID-19 vaccines being manufactured locally: Covishield and Covaxin, and we can expect five more vaccines by Q3 2021. These vaccines are the Sputnik V vaccine (in collaboration with Dr. Reddy’s), Johnson & Johnson vaccine (in collaboration with Biological E), Novavax vaccine (in collaboration with Serum India), Zydus Cadila’s vaccine, and Bharat Biotech’s Intranasal Vaccine. Safety and efficacy are the Union government’s primary concerns while granting emergency use authorization (EUA) to any COVID-19 vaccine in the country.” ANI quoted the source as saying.
India is currently in the third phase of its mega Covid-19 vaccination drive which commenced on 16 January 2021. In total, 10,45,28,565 vaccine doses have been administered through 15,56,361 sessions, as per the provisional report till 7 am on Monday.
After an initial evaluation in February, last Friday, DCGI sought additional data from drugmaker Dr. Reddy’s Laboratories on its Sputnik V COVID-19 vaccine trial, in its second such request.
On Sunday, top government sources said that by the end of the third quarter of this year, India will be getting vaccines from five additional manufacturers. India currently manufactures Covishield and Covaxin.
Out of almost 20 COVID-19 vaccines in various clinical and pre-clinical stages, the Sputnik V vaccine will get the nod first. It is expected that Sputnik is likely to get the EUA within the next ten days, it had said.
In India, Sputnik-V trials are on for around 1,600 people between 18 and 99.
Russian Direct Investment Fund (RDIF) has tied up with a host of Indian pharmaceutical players such as Panacea Biotec, Dr. Reddy’s Laboratories and Gland Pharma for the production of vaccine doses.
Dr.Reddy has been conducting small clinical trials with Sputnik V in India under a deal with Russia’s wealth fund since last September. Several Indian companies have signed deals to produce and supply over half a billion doses of the vaccine.
As of Monday India recorded 13.5 million cases of coronavirus with 170k Deaths.