Coronavirus | Panel seeks more data to give emergency use authorisation for Sputnik V vaccine

Will approach regulator with requisite data soon: Dr. Reddy’s Laboratories.

A Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has sought more data on Russia’s Sputnik V vaccine trials from Dr. Reddy’s Laboratories to accord emergency use authorisation (EUA) for the COVID-19 vaccine.

“The committee recommended that [the] firm should submit immunogenicity and safety data of Phase II and III trial as per approved protocol for further consideration. Further, the firm is requested to present its data with more clarity,” minutes of the February 24 meeting of the SEC made public on Friday said.

Dr. Reddy’s Laboratories has an agreement with Russian Direct Investment Fund (RDIF) for conducting clinical trials and distribution of Sputnik V in India. The committee’s recommendation followed Dr. Reddy’s Laboratories submitting a proposal seeking grant of permission to import (marketing authorisation) for emergency use of the vaccine. It had submitted the safety and immunogenicity data of Phase-2 component of the Phase-2/3 trial in India, and interim safety, efficacy and immunogenicity data from overseas Phase-3 clinical trial.

A spokesperson of Dr. Reddy’s Laboratories said, “We confirm the DCGI (Drugs Controller General of India, who heads CDSCO) has recommended Dr. Reddy’s to present further data on the Sputnik V vaccine before considering its approval for emergency use. We understand the importance of effective investigation and we will approach the regulator with the requisite data soon.” While RDIF has a manufacturing pact with a Hetero group firm, Sputnik V is to be initially imported.

Covaxin for under-18

The SEC meeting asked Covaxin maker Bharat Biotech, which sought permission to conduct Phase-3 clinical trial of the vaccine candidate in for those aged 5-18 years, to submit efficacy and safety data of the ongoing Phase-3 clinical trial in adults along with the age subgroup analysis.

“The design of trial should be revised to Phase II/III. Sample size and other consequential changes should be made to the protocol, accordingly,” the Committee recommended, asking Bharat Biotech to submit revised clinical trial protocol for review. One of the two vaccines being administered to frontline health workers since mid-January, Covaxin was accorded emergency use authorisation in clinical trial mode by the DCGI.

Covaxin for Brazil

On Friday, Bharat Biotech said it has signed an agreement with Brazil for supplying 20 million doses of Covaxin. The vaccine will be delivered in the second and third quarter of 2020. “There is a strong interest in Covaxin from many countries and the company is fully committed to ensuring supplies promptly and efficiently,” a statement from the Hyderabad-based vaccine maker said.

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