After UK’s approval, Indian drug regulator might approve Oxford Vaccine

Speculations are rife that the Indian drug regulator might give approval to the vaccine developed by the University of Oxford and AstraZeneca jointly.

It has been named Covishield in India and the Serum Institute of India, which is the world's largest manufacturer of vaccines, has collaborated with Oxford-AstraZeneca for its mass production.

On December 29, the drug regulator of the UK approved the vaccine under the provision of the Emergency Use Authorisation. The UK government will very soon start the mass vaccination process.

Experts believe that after the UK’s approval, the Indian regulator will also approve it once it sits on January 1 to decide.

Three companies – Pfizer, SII, and Bharat Biotech – have already applied for approval and their applications are pending before the regulator.

While Pfizer didn’t conduct its clinical trial in India, SII recruited 1600 volunteers in 15 hospitals across the country for Phase II and III clinical trials.

The vaccine developed by ICMR and Bharat Biotech, named COVAXIN, is indigenous and its Phase III trial is still going on in various hospitals in the country.

According to reports, the trial will be conducted on 26000 volunteers and as of now, about 13000 volunteers have been enrolled.

Many experts believe that the approval by the UK regulator is a validation of the company’s claim about its safety and efficacy and that has made Indian regulator’s job easy.

“The UK regulator’s nod is a positive development,” a virologist registered with the government, said.

In the previous meeting, the Subject Expert Committee of the Drug Controller General of India (DCGI) had asked for more data from the two companies which they had provided.