Govt's decision to stay Covovax's trials on children a setback for SII

The central drug authority’s expert panel refused to grant permission to Serum Institute of India (SII) to conduct trials of Covovax on children, a move that has jolted the vaccine maker which expects to launch the jab for adults by September 2021.

The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) recommended that Pune-based SII should submit the safety and immunogenicity data of Covovax from the clinical trials in adults before proceeding for the clinical trial in children.

The decision is sure to jolt Adar Poonawalla, CEO of SII, who had taken to social media to express excitement about the first batch of Covovax and its potential for beneficiaries younger than 18.

Read | Zydus Cadila applies for emergency-use nod from DCGI for its Covid-19 vaccine

Currently, Covovax’s trials are in the third phase on adults in India. SII was seeking permission to conduct the trials on 920 children, split in half in the age group of 12-17 and 2-11.

If it had been approved, Covovax would become the third vaccine in India to conduct trials on children, after Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D.

Poonawalla is expecting to launch the vaccine by September this year and supply approximately 20 crore doses of Covovax between August and December to the Centre on demand.

This nanoparticle protein-based vaccine is by US-based biotechnology firm, Novavax which produced the vaccine NVX-CoV2373. This is manufactured by SII in India and marketed under the name ‘Covovax’.