The needle-free vaccine will be available at private centres. A health official said it will be introduced on the Co-WIN platform soon
iNCOVACC has been specifically formulated to allow intranasal delivery through nasal drops. (Supplied)
The Union Health Ministry has approved Bharat Biotech’s intranasal Covid vaccine as a booster dose for those above 18 years of age.
The needle-free vaccine will be available at private centres. A health official said it will also be introduced on the Co-WIN platform.
It is likely to be rolled out in the national Covid vaccination programme soon.
The nasal vaccine — iNCOVACC(BBV154) — received approval of the Drugs Controller General of India in November for restricted use in an emergency situation for those above 18 years as a heterologous booster dose.
The approval for the vaccine comes amid a spurt in Covid cases in China and some other countries — and concern that there may be a spike in India as well, though experts have said it is unlikely.
The vaccine was reportedly developed in partnership with Washington University, St Louis, which designed and developed the recombinant adenoviral vectored construct and evaluated it in preclinical studies for efficacy.
Product development related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation and delivery device development, including human clinical trials that were conducted by Bharat Biotech.
Product development and clinical trials were funded in part by the Central government through the Department of Biotechnology’s COVID Suraksha Programme.
Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, and as a heterologous booster dose for subjects who have previously received two doses of the two commonly administered Covid-19 vaccines in India.
These are Bharat Biotech’s own Covaxin and Covishield developed by the Serum Institute of India (SII).
According to Bharat Biotech, iNCOVACC has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that enables mass immunisation to protect from emerging variants of concern.
It promises to become an important tool in mass vaccinations during pandemics and endemics. With the receipt of this approval, launch dates, pricing and availability will be announced in due course of time.
iNCOVACC is stable at 2-8° C for easy storage and distribution.
Bharat Biotech said it has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana, with operations across India.
(With inputs from PTI)
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