May 16, 2021

No approval for Sputnik V vaccine but; Drug authority seeks extra information from Dr Reddy’s



An professional panel of India’s central drug authority has sought extra information and knowledge from Dr Reddy’s Laboratories, which has sought emergency use authorisation for Russian COVID-19 vaccine Sputnik V, whereas deferring its determination on it until the subsequent assembly, sources stated.

In gentle of a February 24 assembly of the Topic Professional Committee (SEC) on COVID-19 of the Central Medication Commonplace Management Organisation (CDSCO), the agency offered the interim security and immunogenicity information of the Gam-COVID-Vac mixed vector vaccine generated within the nation, together with the interim information from the continued Russian examine.

In keeping with the sources, the SEC, which deliberated on the EUA utility on Thursday, advisable that the agency ought to current information pertaining to all immunogenicity parameters, unblinded information of significant adversarial occasions and RT-PCR constructive circumstances, together with causality evaluation reported until date for additional examination.

“It has additionally requested the Hyderabad-based agency to submit a comparative evaluation of the section three immunogenicity information generated on the Indian and Russian research at numerous time factors. It has additionally requested the drug-maker to submit the factsheet,” a supply stated.

“We’ve got had our assembly with the SEC in the present day and can await the suggestions from the CDSCO. We are going to present an replace as soon as we’ve the suggestions,” Dr Reddy’s Laboratories stated in an announcement.

On February 19, the agency stated it had approached medication regulator DCGI for emergency use authorisation (EUA) for Sputnik V.

In September final 12 months, Dr Reddy’s partnered with the Russian Direct Funding Fund (RDIF) to conduct the medical trials of Sputnik V and for its distribution rights in India.

The Medication Controller Common of India (DCGI) has already given the EUA nod to 2 COVID-19 vaccines — Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca, being manufactured by the Serum Institute of India in Pune.

Sputnik V has demonstrated an efficacy fee of 91.6 per cent within the interim evaluation of section three medical trial, which included information on 19,866 volunteers in Russia.