Hetero gets nod for phase III of Sputnik V trials

The subject expert committee (SEC) that advises the Indian drug regulator has given its nod to Hetero Biopharma for conducting phase-III clinical trials of Russian Covid-19 vaccine Sputnik V that it will be manufacturing in India.

SEC has asked Hetero Biopharma to study immunogenicity samples on Day 21, 28 and 42 of the shots being administered. The vaccine comprises two human adenoviral vectors — Ad26 and Ad5 — that have to be injected 21 days apart.

The committee has also asked the company to assess the neutralising antibodies and gamma interferon during the study, as per minutes of the SEC meet held on April 23. Sources said Hetero Biopharma will be conducting bridging phase-III trials on around 300 volunteers using test batches of Sputnik V it has manufactured at its facilities in Hyderabad.

The study is slated to take anywhere from 45 days to couple of months.

As per norms, Hetero Biopharma has to conduct a separate phase-III study as it will be manufacturing the vaccine doses in India.