The Subject Expert Committee of India’s drug regulator on Monday approved Sputnik-V, the coronavirus vaccine developed by Russia, for emergency use, the Business Standard reported. The decision to give the final approval to the vaccine will now be taken by the Drugs Controller General of India.
If approved, Sputnik-V will become the third vaccine that to be administered in India after Covaxin and Covishield.
Hyderabad-based pharmaceutical company Dr Reddy’s Laboratories had last week sought the government’s approval for the vaccine to be used in India, according to the Hindustan Times. The vaccine will also be manufactured by several other medicine companies in India including Hetero, Gland Pharma, Stelis Pharma and Virchow Group, according to the Business Standard. A total production of 90 crore doses of the vaccine are currently lined up in the country.
The vaccine had shown a 91.6% efficacy in late stage trials, according to results published in February. No serious adverse events were found to be linked with the vaccination. The trial, however, did not include efficacy data of the vaccine for new variants of the coronavirus.
The vaccine is administered in two doses separated by 21 days, while it requires a minus 18-20 degree Celsius cold chain to remain stable. Efforts are underway to develop a freeze dried version of the jab, which will stay stable in the 2 to 8 degrees Celsius temperature range, according to the Business Standard.
The vaccine is likely to cost Rs 500 per dose, the newspaper reported, quoting unidentified officials.
Sputnik V’s clearance by the Subject Expert Committee came amid a huge surge in coronavirus cases in the country, which has seen the daily count cross the 1 lakh-mark in six of the last seven days. On Monday, the country reported 1,68,912 new cases of the virus. The number of active cases also rose by nearly a lakh since Sunday.
Besides the rise in cases, several states have also been hit with shortage of vaccines. At least nine states – Rajasthan, Andhra Pradesh, Chhattisgarh, Haryana, Maharashtra, Odisha. Telangana, Punjab and Delhi have flagged such concerns to the Centre in the last few days. Over 10.47 crore shots have been administered so far in India, while more than 1.22 crore have received both doses of the vaccine, according to government data.