DCGI will now consider SEC recommendation for the third Covid vaccine to be available in India
The decision comes after Subject Expert Committee (SEC) met today to take up Sputnik V application for Emergency Use Authorisation in India
As India faces second wave of novel coronavirus cases and vaccine shortage, the expert panel of country's drug regulator on Monday approved the use of Russia's Sputnik V Covid-19 vaccine, according to reports.
The decision comes after Drugs Controller General of India (DCGI)'s Subject Expert Committee (SEC) met today to take up Sputnik V application for Emergency Use Authorisation in India.
DCGI will now consider SEC recommendation 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.
The vaccine would be imported from Russia for emergency use in the country, they said.
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.
On 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 after an initial evaluation in February.
The committee had earlier asked the company to submit a comparative analysis of late-stage immunogenicity data from both its Indian studies and an ongoing Russian study, as well as data on serious adverse events and positive cases reported till date.
On Sunday, top government sources told news agency ANI that by end of the third quarter of this year, India will be getting vaccines from five additional manufacturers. India currently manufactures Covishield and 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 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 authorisation (EUA) to any COVID-19 vaccine in the country." ANI quoted the source as saying.
Out of almost 20 COVID-19 vaccines in various clinical and pre-clinical stages, 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's 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.
On Monday, Dr Reddy's shares on BSE surged to nearly 5% 4,989.20 apiece at closing
Sputnik V vaccine equally effective for all age groups
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.
The vaccine, deemed as the "world's first vaccine" to be registered by Russian President Vladimir Putin last August, has proven equally effective for all age groups, Alexander Gintsburg, the head of the Gamaleya research institute that developed the vaccine, has said.
"Sputnik V demonstrated the same level of efficacy in all age groups. At first there were doubts that the efficacy in people aged 60 and over would be lower ... but it was absolutely not," Gintsburg told the SolovyovLive show on YouTube.
The virologist noted that quality-wise Sputnik V beats other coronavirus vaccines.
"Among those four to six vaccines that have entered mass circulation worldwide, Sputnik V apparently ranks the first in terms of its qualities," Gintsburg noted.
"The effect of this vaccine will be very long. We hope two years and more," he added.
(With inputs from agencies)
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