India – India seeks more data on AstraZeneca COVID vaccine

India’s Subject Expert Committee (SEC) has asked to see additional data on AstraZeneca’s COVID-19 vaccine before deciding whether to grant emergency use authorization (EUA). The Central Drugs Standard Control Organization (CDSCO) wants to see immunogenicity data from patients in the UK and India and safety data beyond the 14 November cut-off shared with it to date.

Serum Institute of India, which is partnered with AstraZeneca on ADZ1222, a viral vector vaccine, put an EUA proposal to SEC at a meeting last week. The proposal was supported by interim safety data from an Indian Phase 2/3 clinical trial, plus interim safety and efficacy from the global late-phase program.

SEC has agreed to consider data from multiple countries but found gaps in the evidence presented at the meeting. The CDSCO committee wants Serum to submit updated safety data, as well as immunogenicity data from clinical trial sites in the UK and India…