Is Sputnik V Covid-19 vaccine next to get approval in India?

Last year, the Russian manufacturers signed their first agreement with Dr Reddy's to conduct the clinical trial in India

With Covid-19 vaccines in short supply impacting India’s vaccination drive, the Centre may soon give Emergency Use Authorisation to the Russian-origin Sputnik V vaccine, which is yet to secure approval from the Central Drug Standards Control Organisation that sought more data from the company.

“It is expected that Sputnik is likely to get the EUA within the next ten days,” government sources told news agency ANI on Sunday. Neither the Union Health Secretary Rajesh Bhushan nor the spokesperson of the ministry confirmed the development.

Also Read | India's expert panel defers decision on Sputnik V vaccine, seeks more data from Dr Reddy's Laboratories

In its last meeting on April 1, the Subject Expert Committee of CDSCO sought more data on Sputnik’s clinical trial in India conducted by Dr Reddy’s Laboratories. The data was sought on six specific points including “unblinded data of all Serious Adverse Events and RT-PCR Covid-19 positive cases along with causality analysis reported till date for further examination”.

In addition, the regulators sought data on “package insert, fact sheet including indication, dosage, schedule, contraindications, warning, precautions and storage conditions.”

Last year, the Russian manufacturers signed their first agreement with Dr Reddy's Laboratories to conduct the clinical trial in India and distribute 100 million doses of the vaccine that would be shipped to the Hyderabad-based pharmaceutical company.

Subsequently, the Russians have signed agreements with Hetero, Virchow, Strides (Stelis) and Gland to use their vaccine manufacturing capacity for the production of 850 million doses of Sputnik vaccine in India.