Expert panel recommends emergency use authorization of Russian Vaccine, Sputnik-V

The Subject Expert panel of the Central Drugs Standard Control Organization (CDSCO) has recommended emergency use authorisation to the Russian COVID-19 vaccine, Sputnik-V. The recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.

After necessary approval from the DCGA, Sputnik-V will be the third vaccine to get emergency use authorisation from the drug regulator after Bharat Biotech's Covaxin and Oxford-AstraZeneca's Covishield, being manufactured by Serum Institute of India in Pune.

The clinical trial of the vaccine in India is being done by Dr Reddy's Lab. The Hyderabad based, multinational Indian pharma company, Dr. Reddy's Laboratories has also inked an agreement with the Russian Direct Investment Fund, RDIF for the supply of the Russian vaccine in India.

The Subject Expert Committee of the Indian drug regulator in its last meeting on April 1, 2021, had asked Dr Reddy's to submit data on how the shot activates the body's immune response against the coronavirus. RDIF has claimed effectiveness of 91.6 per cent for the Sputnik V vaccine. Dr Reddy's had applied for emergency use of Sputnik-V in February this year.

Dr Sudhakar K, Minister for Health & Family Welfare and Medical Education, Government of Karnataka, in a tweet said, "The Central Drugs Standard Control Organisation's (CDSCO) expert panel recommends granting approval to Russian COVID-19 vaccine Sputnik V for emergency use in India." He added, "Once DCGI approves #SputnikV, India will have its third vaccine after Covishield and Covaxin."

https://twitter.com/mla_sudhakar/status/1381798464422440961

As per reports, the vaccine is indicated for active immunisation to prevent COVID-19 in individuals aged 18 years and above and is to be administered intramuscularly in two doses of 0.5 ml each with an interval of 21 days. It has to be stored at -18 degrees Celsius.

According to recommendations by the SEC, the firm has been asked to submit revised factsheets to CDSCO after incorporating the latest safety and efficacy data and other suggestions made during the meeting, another source said.

Besides, the firm should submit the safety, efficacy and immunogenicity data from the ongoing clinical trials in India and Russia for review as and when available. It has been asked to submit safety data including the data on AEFI and AESI with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country.