New Delhi: Hyderabad-based drug maker Bharat Biotech has received regulatory approval to start a Phase I clinical trial to test a vaccine-3 covid intranasalnya as a booster dose (third dose) in people who have received doses Covaxin, official sources said.
Separately, the drug regulator also gave permission to the pharmaceutical companies to conduct clinical trials to compare the phase 3 immunogenicity and safety of an intranasal vaccine candidate with Covaxin, which has also been developed and produced by Bharat Biotech.
This trial will be conducted at nine sites, including AIIMS Delhi and PATNA.
The development assumes significance as it is so nasal vaccine received final approval for use, it has the potential to improve vaccination against Covid because the odds are much more affordable, easy to manage and does not require a clinical setting or health worker for dose administration.
Currently, more than 23 doses have been given covaxin crore, accounting for 14% of the total of nearly 165 crore doses given throughout the country.
General controller medications India (DCGI) provide a ‘certificate of objections’ to the vaccine manufacturers based Hyderabad on Thursday that enabled it to undertake clinical trials of multi-centric phase of randomized candidate intranasal vaccine as shooting a third for those who had received two doses of vaccine Covid.
Bharat Biotech gets a nod of regulators for trial phase-3 nose vaccines
