Bharat Biotech gets DGCI nod for nasal COVID booster dose trials

Bharat Biotech gets approval for intranasal booster dose trials and the trials will be done at 9 different sites.

Bharat Biotech, India's largest vaccine manufacturer, received approval from the Drugs Controller General of India (DCGI) on Friday for its intranasal Covid booster dose. The trial is said to have involved 900 subjects. 

The DCGI's Subject Expert Committee (SEC) has given a nod to Bharat Biotech for its Phase-III booster trails. The dose is a first of its kind in the country and was asked to submit protocols for approval three weeks ago. 

As per the reports, Bharat Biotech is the second group to submit reports for its Phase-III trials of the third dose. The reports suggest the intranasal vaccines have the potential to control the spread of the new Covid-19 variants like Omicron. It also emphasises the simple use of the nasal vaccine and needs no healthcare worker to perform the vaccination. 

In India, three vaccines have government authorisation and are widely used i.e., Covishield, Covaxin, and Sputnik V. Under the DCGI's 28-day Multi-Dose Vial Policy (MDVP) and the WHO Emergency Use Listing (WHO EUL), the Hyderabad-based Bharat Biotech produced Covaxin use is authorised. 

Recently, Bharat Biotech's and Serum Institute of India was approved for market sale for their vaccines Covaxin and Covishield. However, this does not mean that the two vaccines will be available in stores anytime soon. While people will be able to purchase them from hospitals and clinics, specifics are still being worked out.

Safety data must be submitted to the Drugs Controller General of India, or DCGI, within 15 days for emergency use. Still, market approval data must be submitted to the regulator within six months. 

Bharat Biotech, the producer of Covaxin and Serum Institute of India, manufacturer of Covishield, delivered data of ongoing clinical trials to the regulator, which has authorised the market sale after a subject expert committee Covid-19 suggested permission on January 19.