COVID-19 vaccine: Drug regulator seeks additional data from Dr Reddy's on Sputnik V

The Subject Expert Committee of the Drugs Controller General of India on Friday sought additional data from drug maker Dr Reddy's Laboratories for Russian COVID-19 vaccine Sputnik V.

Dr Reddy's is seeking emergency use authorisation for the human adenoviral vector-based platform vaccine candidate developed by Russia's Gamaleya National Research Institute of Epidemiology and Microbiology. This is the second time the committee has sought additional data from the company after an initial evaluation in February.

"The committee 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," news agency Reuters reported.

Also read: COVID-19: Panacea Biotec to produce 100 million doses of Sputnik V in India annually

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. RDIF has partnered many Indian pharma companies, including Panacea Biotec, Stelis Biopharma, Gland Pharma and Virchow Biotech Private Limited, for production of Sputnik V.

India has stepped up vaccination against the coronavirus as the country is in the midst of a second wave of cases. From April 1, vaccination has been opened up for all citizens above the age of 45 years. India reported 1,31,968 new COVID-19 cases in the preceding 24 hours as on Friday morning. A total of 32.16 lakh doses were administered till 8 pm on Friday as per the provisional data. India has so far administered 9.78 crore doses of COVID-19 vaccines.

While some of the states have been alleging vaccine shortage, the Centre has said there are enough vaccine stocks available and more are in pipeline. Prime Minister Narendra Modi on Thursday said the country will have to prioritise COVID-19 vaccination as per the availability of vaccines.  

Also read: Will have to prioritise COVID-19 vaccination as per availability: PM Modi