COVID-19 jab approval may take more time in India

NEW DELHI: Though the Centre on Monday advised states to be ready for the COVID-19 vaccine rollout in the next 10 days, India’s drug regulator is unlikely to green-light the vaccine makers who sought emergency use authorisation (EUA) by then, officials told The New Indian Expres.

For, submitting the additional data requested by the subject expert committee of the Central Drugs Standards Control Organisation (CDSCO) on COVID-19 last Wednesday, on the vaccine candidates will take time.

The committee had sought more information on the safety and immunogenicity of two coronavirus vaccines that were evaluated — Covaxin by Bharat Biotech and Covishield by Serum Institute of India (SII), developed by AstraZeneca-Oxford University. These companies, along with US-based Pfizer, whose application has not been reviewed so far, have applied for emergency approval in India so far.

Sources in the CDSCO said no date for the panel’s next meeting has been fixed so far.

“Given the details that have been asked for it is possible that the companies will come back to us only after 2-3 weeks as the availability of data depends on the status of clinical trials,” said an official. However, SII might be quicker in coming back. Its bridging trial in India on 1,600 volunteers is in advanced stage, he said.

Meanwhile, authorities in all states were were instructed to keep the required infrastructure and manpower ready by December 25 for a possible rollout of the vaccine.