Bharat Biotech gets nod for nasal Covid-19 vaccine's phase-3 clinical trials

India's drug controller on Friday gave permission to Bharat Biotech to conduct standalone phase-3 trials on its Covid-19 intranasal vaccine.

The drug regulator also gave approval to the Hyderabad-based company to evaluate the intranasal vaccine, BBV 154, as a booster dose on those who have already received both doses of Covaxin.

Bharat Biotech has developed the single-dose intranasal vaccine in partnership with Washington University in St Louis, US. If found effective in the trials, it could prove to be a game changer in the efforts to quell the pandemic.


"Intranasal vaccines are easier to administer in mass immunisation campaigns and help reduce/stop transmission," the company said in a statement. The company aims to conduct clinical trials on 5,000 healthy people at nine locations in the country. If approved as a booster dose, the intranasal vaccine will be given six months after the second dose," the company said.

Earlier this month the subject expert committee (SEC) under the drug regulator had deliberated upon Bharat Biotech's application for clinical trials of its intranasal vaccine as a booster or a third dose.

Intranasal vaccine may be the best choice for India because it will be single-dose and easy to administer, according to health experts.

Bharat Biotech chairman Krishna Ella had earlier said that intranasal vaccine would be the best choice. "This vaccine can be given to two-month-old babies as well and a nasal vaccine can be administered to the entire population, except for cancer patients and pregnant women."

India started administering a precaution dose (third dose), which will be the same as the primary one, from this month.