A subject expert committee has recommended to the Central Central Drugs Standard Control Organization (CDSCO) to grant permission to Hetero Biopharma to conduct Phase III trial of Russia's Sputnik V vaccine.
The Hyderabad-based firm figures in the small list of companies in the country with whom Russian Direct Investment Fund (RDIF) has formed manufacturing partnership for Sputnik V.
Recommending that Hetero Biopharma be permitted to take up the Phase III trial, the Committee prescribed two conditions. The “immunogenicity samples should be taken at Day 21, 28 and 42. Neutralizing antibodies and gamma interferon should be assessed during the study. Accordingly, CDSCO may grant approval for conduct of clinical trial,” said the minutes of the meeting held last week.
An important step towards manufacturing of Sputnik V vaccine in India, it follows the Drugs Controller General of India (DCGI) earlier this month giving emergency use authorisation for the vaccine to Dr. Reddy’s Laboratories, which is the marketing partner of RDIF and had conducted Phase II and III trials. The permission had paved way for import of the vaccine. The company expects the first consignment of Sputnik to come in May.
Sources said the Phase III trial by Hetero would be bridging trial and form part of the approval process for manufacturing and use of the Russian vaccine made in India. Technology transfer, inspection of facility as well as other clearance for the vaccine form part of the process and could take two months. Besides Hetero, the RDIF has announced manufacturing pacts with Gland Pharma, Stelis Biopharma, Virchow Biotech and Panacea Biotec for an estimated 850 million doses of vaccine based on the human adenoviral vector platform.
