Representative image. Photo: Reuters/Dado Ruvic/Illustration/File Photo
New Delhi/Hyderabad: An expert panel of India’s central drug authority has sought additional data and information from Dr Reddy’s laboratories, which has sought emergency use authorisation (EUA) for Russian COVID-19 vaccine Sputnik V, while deferring its decision on it till the next meeting, sources said.
In light of a February 24 meeting of the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), the firm presented the interim safety and immunogenicity data of the Gam-COVID-Vac combined vector vaccine generated in the country, along with the interim data from the ongoing Russian study.
According to the sources, the SEC, which deliberated on the EUA application on Thursday, recommended that the firm should present data pertaining to all immunogenicity parameters, unblinded 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 the 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,” a source said.
“We have had our meeting with the SEC today and will await the feedback from the CDSCO. We will provide an update once we have the feedback,” Dr Reddy’s Laboratories said in a statement.
On February 19, the firm said it had approached drugs regulator DCGI for emergency use authorisation for Sputnik V.
In September last year, Dr Reddy’s partnered with the Russian direct investment fund to conduct the clinical trials of Sputnik V and for its distribution rights in India.
The Drugs Controller General of India 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 in Pune.
Sputnik V has demonstrated an efficacy rate of 91.6% in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia.