Bharat Biotech's intranasal vaccine becomes first nasal jab to enter phase 2/3 trials after drug regulator's nod
Friday, 13 August 2021 (21:35 IST)
New Delhi: Bharat Biotech's intranasal vaccine against Covid-19 has become the first nasal vaccine that has received regulatory approval for Phase 2/3 clinical trials in India, the Centre announced on Friday.
The ministry of science and technology stated that the nasal vaccine is the first of its kind Covid-19 jab to undergo human clinical trials in India.
"The regulatory approval has been received for conducting a Phase 2 randomized, multi-centric, clinical trial of Heterologus Prime-Boost Combination of SARS-CoV-2 Vaccines to evaluate the immunogenicity and safety of BBV152 (COVAXIN®) with BBV154 (Adenoviral Intranasal COVID-19 vaccine) in Healthy Volunteers,” a statement by the ministry read.
The union ministry said that the vaccine was able to elicit a high level of neutralizing antibodies in animal studies.
"Phase 1 Clinical trial has been completed in age groups ranging ≥18 to ≤60 years. The Company reports that the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial has been well tolerated. No serious adverse events were reported. Previously, the vaccine was found to be safe, immunogenic and well-tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit a high level of neutralizing antibodies in animal studies," the ministry informed.
Dr Renu Swarup, Secretary, Department of Biotechnology and Chairperson, Biotechnology Industry Research Assistance Council said that the Department through Mission COVID Suraksha is committed to the development of safe and efficacious COVID-19 vaccines.
"The focus of this mission is to consolidate and streamline available resources towards a warpath for accelerated vaccine development in order to bring a safe, efficacious, affordable and accessible COVID-19 Vaccine to the citizens at the earliest. The intranasal vaccine is among the efforts of our mission and now has become the first intranasal vaccine being developed in the country entering into late-stage clinical trials," she added. (UNI)
