Serum Institute gets nod for Oxford vaccine trials

NEW DELHI: India’s drug controller on Monday gave approval to Pune-based vaccine manufacturer Serum Institute of India (SII) for conducting phase II and III clinical trials on the vaccine against the coronavirus disease (Covid-19) developed by Oxford University and Astrazeneca, according to the Union health ministry.

The trials are expected to begin within the week, according to people aware of the matter.

This would make the Oxfordastrazeneca vaccine — called Covishield — the first one to enter phase II and III trials in India. Phase I human trials have started on two indigenously developed vaccines — Bharat Biotech International Ltd’s Covaxin and Zydus Cadila’s ZYCOV-D — to assess their safety.

The company has already bet big on the vaccine working — investing up to $450 million in mass-producing the vaccine.

Serum Institute of India declined to comment on

the regulatory approval for it to conduct the trials.

Four other vaccine candidates being supported by the Department of Biotechnology (DBT) under the science ministry are in advanced stages of pre-clinical trials and are likely to enter human trials in another four to six weeks.

Confirming the development, a senior official in the Central Drugs Standard Control Organisation (CDSCO) said: “The subject expert committee that went through the data and protocol submitted for the trial was satisfied with the results, and based on their opinion the drugs controller permitted its trial in India.”

It was always understood that India’s drug regulator would approve the clinical trials once on July 20, Oxford University published research that showed that the initial trial results of the vaccine candidate were promising.