A Subject Expert Committee that advises the Drugs Controller General of India (DCGI) on vaccines has sought additional data and clarifications on Sputnik V, the Russian COVID-19 antidote awaiting emergency use authorisation in India.
Dealing with an application for EUA, the committee meeting earlier this month called for “data pertaining to all immunogenicity parameters, including GMT titres for virus neutralising antibody and SARSCOV-2 glycoprotein specific antibodies at day 42 as per protocol.” Unblinded data of all serious adverse events and RTPCR positive cases along with causality analysis reported, till date, for further examination were aspects on which it wanted more information.
According to minutes of the April 1 meeting, made public on Friday, the committee also sought correlation of immunogenicity data, including cell-based response between phase II and phase III trials as well as comparative analysis of phase III immunogenicity data generated on Indian and Russian studies at various time points.
From indication, dosage, schedule, contra-indications, warning, precautions and storage conditions, it sought information on the SmPC (summary of product characteristics) besides information on the package insert and factsheet. Submission of lot to lot consistency data with regard to the clinical trial outcomes was also something the expert panel recommended to Dr. Reddy’s Laboratories.
The Hyderabad-headquartered pharma major, with whom the Russian Direct Investment Fund (RDIF) has partnered for clinical trials and distribution of Sputnik V in India, had updated the application after the committee meeting on February 24 had sought more data on the vaccine. The company had since also announced completion of the phase II and III (bridging) trials.
For the April 1 meeting, Dr. Reddy’s had presented “interim safety and immunogenicity data of Gam COVID Vac Combined vector vaccine (Component one and Component two) generated in the country along with the interim data from the ongoing Russian study,” the minutes said.
The development comes in the backdrop of India mounting a response to the deadly virus with Covishield and Covaxin, the two vaccines approved and used since mid-January. A surge in the number of people testing positive for the virus in recent weeks and reports of vaccine shortage from different parts of the country, however, has only compounded the challenge.
Developed by the Gamaleya National Research Institute of Epidemiology and Microbiology and commercialised by RDIF globally, Sputnik V is based on the human adenoviral vector platform and according to publication in Lancet its efficacy is 91.6%.
