Bharat Biotech’s first nasal covid vaccine gets approval for phase 2/3 trial


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India’s Bharat Biotech has received the approval to conduct a phase 2/3 human clinical trial for its nasal COVID-19 vaccine, BBV154. Phase 1 trial of the vaccine has shown that its doses were ‘well tolerated’ and there was no report of serious adverse events.

Bharat Biotech’s intranasal vaccine is the first in the country to receive the Biotechnology Industry Research Assistance Council’s approval for the late-stage human clinical trials.

As per the statement, previously, the nasal vaccine was found to be immunogenic, safe, and well-tolerated in the pre-clinical toxicity studies. The nasal vaccine was able to elicit high-level neutralizing antibodies in animal studies.

Significance:

Bharat Biotech’s nasal vaccine for COVID-19 will be significant as it will save on medical equipment such as syringes and will also be able to save time taken for the vaccination of the candidate.

First nasal covid vaccine by Bharat Biotech: Key details

BBV154, the adenoviral intranasal vaccine is the first of its kind vaccine to undergo human trials in India.

As per the Ministry of Science and Technology, the phase 1 trial of the vaccine in the healthy volunteers of age group ranging from 18 to 60 years was well-tolerated.

The vaccine has now received approval to conduct the phase 2 randomized clinical trial of the heterologous prime-boost combination of Sars-CoV-2 vaccines in order to evaluate the immunogenicity and the safety of COVAXIN with BBV154 in healthy volunteers.

Bharat Biotech’s nasal COVID vaccine has been developed with the support of the Department of Biotechnology and Biotechnology Industry Research Assistance Council.

Mission COVID Suraksha:

It was launched to reinforce and accelerate the COVID-19 vaccine development efforts as part of the third stimulus package, Atmanirbhar 3.0.

Dr. Renu Swarup, Secretary, Department of Biotechnology stated that the department through the Mission COVID Suraksha has been committed to developing safe COVID-19 vaccines.

BBV154 COVID vaccine of Bharat Biotech is the first nasal vaccine being developed in India to enter into late-stage clinical trials.

Background:

Bharat Biotech, in January 2021, had sent a proposal to the Drugs Controller General of India to conduct the phase 1 trials of the nasal vaccine.

On the other hand, Bharat Biotech, till now has delivered over 4 billion doses of COVAXIN worldwide. COVAXIN was one of the two vaccines that India used to launch its massive nationwide Covid inoculation program in January 2021.





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