Expert panel seeks additional data from Dr Reddy’s for Russian vaccine Sputnik V

The Subject Expert Committee (SEC) has sought additional data and information from Dr Reddy’s Laboratories, which has sought emergency use authorization for Russian COVID-19 vaccine Sputnik V.

The pharmaceutical company, in light of the Feb. 24 meeting of the SEC on COVID-19 of the Central Drugs Standard Control Organization (CDSCO), presented the interim safety and immunogenicity data of the GAM-COVID-Vac combined vector vaccine generated in the country, together with the interim data from the ongoing Russian study.

Sources said the SEC recommended that the firm should present data pertaining to all immunogenicity parameters, unblended data of serious adverse events and RT-PCR positive cases, along with causality analysis reported till date for further examination. “It has also asked the Hyderabad-based firm to submit a comparative analysis of phase 3 immunogenicity data generated on the Indian and Russian studies at various time points. It has also asked the drug-maker to submit the factsheet.”

In an official statement, Dr Reddy’s confirmed that the company had a meeting with SEC and will await the feedback from the CDSCO. “We will provide an update once we have the feedback.” Reports highlight that the drug regulator was not satisfied with the logistical arrangements as the Russian COVID-19 vaccine needs to be stored at -25 degrees.

Dr Reddy’s had partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V and for its distribution rights in India. The vaccine has been developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Russia. The vaccine has completed dosing 1300 trial participants in India as part of its bridging studies.

According to late stage trial results published in The Lancet, Sputnik V vaccine gives around 92% protection against COVID-19. It has also been deemed to be safe and offer complete protection against hospitalization and death. Basically, it works in a similar way to the Oxford-AstraZeneca jab developed in the UK, and the Janssen vaccine developed in Belgium.

Also Read: EU wants to buy 10 mn AstraZeneca COVID-19 vaccine from Serum Institute of India

The Drugs Controller General of India (DCGI) has already given the EUA nod to two COVID-19 vaccines – Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca, being manufactured by the Serum Institute of India.