Sputnik V Could Get Emergency Use Approval in 10 Days: Reports

Amid claims of vaccination shortage from various states, India is aiming to ramp up availability of various other vaccines, with Sputnik V reportedly being among them.

The Russian vaccine, currently in the clinical trial phase in India, is expected to get emergency use approval in the country in the next 10 days, ANI reported, quoting sources.

News 18 reported, also quoting top level government sources, that the jab could receive authorisation in India soon.

The approval, if granted, will make Sputnik V the third coronavirus vaccine to be administered in India.

According to reports, the Subject Expert Committee (SEC) of the Indian drug regulator sought additional data on Sputnik V once earlier in April, and again as recently as 9 April.

Also Read: Need More Data For Sputnik V Emergency Nod: Indian Drug Regulator

Reuters reported that in its latest request while vetting the vaccine, the committee has asked drugmaker Dr Reddy’s to submit more immunogenicity data from both its Indian studies and an ongoing Russian study, along with data on serious adverse events.

About Sputnik V

In September 2020, Dr Reddy's had partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V and for its distribution rights in India. The company had conducted Phase 2 trials in India with 1,500 participants, reported IANS.

Phase three trials are still underway in India.

Russia had registered Sputnik V in August, ahead of large-scale clinical trials, which had raised concerns among many experts over the fast-track process. However, later reviews have shown the vaccine to be both safe and effective in preventing COVID-19.

The efficacy of Sputnik V is 91.6 percent, according to data published in Lancet.

The vaccine is based on human adenoviral vectors, which cause common cold. It uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration.

The RDIF had earlier announced four manufacturing deals with Indian pharmaceutical makers -- Virchow Biotech Private Limited, Gland Pharma Private Limited, Stelis Biopharma and Hetero Biopharma.

Also Read: RDIF and Stelis Biopharma to Supply 200 Mn Sputnik V Vaccine Doses

Other Vaccines Under Consideration

ANI reported, quoting top government sources, that in addition to Covishield and COVAXIN, India could have five more vaccines by the end of the third quarter of 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,” the source said.

Sources also added that India is encouraging all COVID-19 vaccine manufacturers to come to India so that Indians have “equitable access to the highest quality vaccines in the world”. The government will provide “manufacturing assistance, financial support, and partnership in running and designing clinical trials," sources told ANI.

India is in the middle of a severe second wave of COVID-19, with fresh cases far outstripping those in the peak of the first wave. On Sunday, the country reported a single-day spike of 1,52,879 new COVID-19 cases, as well as 839 deaths, taking the tally of cases to 1,33,58,805. The death toll meanwhile stands at 1,69,275.

(With inputs from IANS, Reuters, ANI and News18.)

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