Hetero gets nod for Sputnik V Phase 3 trials

It has been asked to study and monitor the vaccine’s immunogenicity on Day 21, Day 28, and Day 42 of the trial

The subject expert panel of India’s drug controller had approved the proposal to start Phase 3 trials of Sputnik V vaccine by Hyderabad-based Hetero Biopharma.

According to the minutes of the meeting of the Drug Controller General of India's subject expert committee (SEC), the pharma company has been asked to study and monitor the vaccine’s immunogenicity on Day 21, Day 28, and Day 42 of the trial.

Earlier, the SEC had approved the emergency use of Sputnik V based on interim data from Russia and the positive results of phase 3 trials conducted by Dr Reddy's Laboratories.

“Neutralizing antibodies and gamma interferon should be assessed during the study,” the SEC said in a recommendation at its meeting on April 23.

Hetero Biopharma is among the six vaccine producers in India, who will be manufacturing the Russia-developed Sputnik V vaccine.

Also read: India to receive first batch of Russia's Covid-19 vaccine on May 1

The Russian Direct Investment Fund (RDIF) has entered into agreements with Dr Reddy’s Laboratories, Gland Pharma, Panacea Biotech, Stellis Biopharma, Hetero Biopharma and Virchow Biotech to produce 850 million doses of the vaccine in India. A portion of the vaccine will be exported to foreign countries.

The SEC also allowed Bharat Biotech to unblind the participants in the Phase 3 clinical trials of Covaxin after the vaccine maker submitted the second interim safety and efficacy data about the vaccine.

The approval would allow the participants who received placebo during the trials to get Covid-19 vaccines as the immunisation drive opens for those in the 18-45 age group.

“After detailed deliberation, the committee recommended that the clinical trial participants between the age group of 18-45 may be unblinded upon the request of the participants or the principal investigator after they have completed two months after second dose,” the SEC said.

The committee also recommended that the firm should present the complete safety and efficacy data along with causality analysis of all serious adverse events (SAEs) including deaths.