Bharat Biotech denied permission for simultaneous Phase I, II trials of COVID-19 intranasal vaccine

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation has denied Bharat Biotech permission to simultaneously conduct Phase I and Phase II trials of its intranasal vaccine for COVID-19. Bharat Biotech is developing the intranasal vaccine in partnership with the Washington University School of Medicine and US-based vaccine maker Ocugen.

In a meeting on January 19, the SEC asked Bharat Biotech to conduct Phase I trials for the vaccine and submit immunogenicity data before moving to Phase II trials. The non-invasive, single-dose vaccine will be far easier to administer and will work faster and longer, Bharat Biotech had said, and claimed that it will be eco-friendly.

"An intranasal vaccine will not only be simple to administer, but will reduce the use of medical consumables such as needles, syringes, etc., significantly impacting the overall cost of a vaccination drive," Bharat Biotech Chairman Krishna Ella had said.

He had claimed that one drop of the intranasal vaccine would be "sufficient".

Bharat Biotech's intranasal vaccine is the only such vaccine to reach trial stage in India. The company will have the right to distribute the vaccine in all markets, except US, Japan and Europe, after it is approved by the drug regulators.

Earlier this month, the Drug Controller General of India had given emergency use authorisation to Bharat Biotech's Covaxin and Serum Institute of India's Covishield.

Both the vaccines are being administered as part of the nationwide COVID-19 vaccination campaign, launched on January 16.

Also read: SEC approves Phase 1 trial of Bharat Biotech's COVID-19 nasal vaccine

Also read: Healthcare workers declining COVID-19 vaccine is a matter of sadness: Govt