On Friday, 13 August, India's first intranasal COVID-19 vaccine received approval for phase 2 of 3 of clinical trials.
The vaccine is being developed by Bharat Biotech in collaboration with the Department of Biotechnology and its PSU, the Biotechnology Industry Research Assistance Council (BIRAC).
This intranasal vaccine, being called BBV154, is the first of its kind in India to receive regulatory approval for Phase 2 trials.
"Bharat Biotech's BBV154 Covid vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials."Dr Renu Swarup, Secretary, Biotechnology and BIRAC Chairperson, as quoted by IANS
What do we know about this vaccine? FIT breaks it down.
What type of vaccine is BBV154?
Bharat Biotech's BBV154 Covid vaccine is a chimpanzee adenovirus SARS-CoV-2 vectored vaccine, similar to Oxford/AstraZeneca's Covishield.
However, unlike Covishield, which is injected into the muscle in two doses, BBV154 comes in the form of a nasal spray.
The intranasal technology used in the making of the vaccine has been in-licensed from the Washington University in St Louis, USA
Is there an advantage to intranasal vaccines over injectables?
Yes, for one, it is needle-free and noninvasive, making it easier to administer and also less painful.
According to Bharat Biotech, BBV154 also triggers an immune response in the nose (the site of COVID-19 infection). This means that the vaccine could potentially also cut transmission.
“It is also easy to scale it up... can produce 100 million doses a month,” Bharat Biotech founder Krishna Ella was quoted by the Hindu back in July.
What do we know about the Phase 1 clinical trials of the vaccine?
The phase 1 trials were conducted on participants aged 18 to 60 years.
Not much data is available as the trial results are still in the pre-print stage and have not been peer reviewed yet.
According to the company, the vaccine was showed encouraging results in the trials with 'no serious adverse effects' being reported.
When will the vaccine be available in India?
There is no clear timeline for when the vaccine will be rolled out yet. The vaccine still has to clear phase 3 human clinical trials before it can receive emergency use authorisation (EUA).
(Written with inputs from IANS and the Hindu.)
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