Panel nod for Sputnik trials by Hetero Pharma

Hyderabad firm already has deal with RDIF to manufacture vaccine

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.