Panel seeks more data to give EUA for Sputnik V vaccine
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Will strategy regulator with requisite data quickly: 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 assembly of the SEC made public on Friday stated.
Dr. Reddy’s Laboratories has an settlement with Russian Direct Investment Fund (RDIF) for conducting scientific trials and distribution of Sputnik V in India. The committee’s advice adopted Dr. Reddy’s Laboratories submitting a proposal looking for grant of permission to import (advertising and marketing authorisation) for emergency use of the vaccine. It had submitted the protection and immunogenicity data of Phase-2 element of the Phase-2/3 trial in India, and interim security, efficacy and immunogenicity data from abroad Phase-3 scientific trial.
A spokesperson of Dr. Reddy’s Laboratories stated, “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 producing pact with a Hetero group agency, Sputnik V is to be initially imported.
Covaxin for under-18
The SEC assembly requested Covaxin maker Bharat Biotech, which sought permission to conduct Phase-3 scientific trial of the vaccine candidate in for these aged 5-18 years, to submit efficacy and security data of the continuing Phase-3 scientific trial in adults together with the age subgroup evaluation.
“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 really useful, asking Bharat Biotech to submit revised scientific trial protocol for evaluation. One of the 2 vaccines being administered to frontline well being staff since mid-January, Covaxin was accorded emergency use authorisation in scientific trial mode by the DCGI.
Covaxin for Brazil
On Friday, Bharat Biotech stated it has signed an settlement with Brazil for supplying 20 million doses of Covaxin. The vaccine shall be delivered within 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,” an announcement from the Hyderabad-based vaccine maker stated.
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