Expert panel calls for more data on Sputnik V

Immunogenicity parameters, serious adverse events among details sought when EUA application came up

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.