Covid-19: Bharat Biotech gets approval for phase-3 trial of intranasal booster dose
The Drugs Controller General of India today permitted its domestic pharma major Bharat Biotech for conducting human trials of its intranasal Covid-19 booster dose for those who have already been inoculated with two doses of the Covaxin injection.
The trials would be conducted at nine sites across India according to official sources, reports our New Delhi correspondent.
Bharat Biotech is the manufacturer of India's indigenous Covid vaccine Covaxin which is one of the mainstays of India's Covid-19 drive, launched on January 16 last year.
India has so far administered more than 164.44 crore doses of Covid-19 vaccines.
"The Phase III clinical trial should be conducted as per protocol titled "A Phase III randomised open-label multi-centre study to compare immunogenicity and safety of BBV154 with Covaxin," the sources said.
Bharat Biotech had in December last sought the nod from DCGI to conduct the phase-3 study for its intranasal Covid-19 vaccine as a booster dose to participants previously vaccinated with SARS-CoV-2 vaccines --Covishield or Covaxin.
The Hyderabad-based company has said the nasal vaccine, BBV154, stimulates immune responses at the site of infection -- the nose -- and is very effective in blocking infection and transmission of Covid-19.
Comments