New Delhi: In a major boost to India, Bharat Biotech’s first-of-its-kind needle-free intranasal vaccine for COVID-19 received emergency use authorisation from the Drugs Controller General of India (DCGI) on Tuesday. The regulator approved the vaccine for primary immunisation of those aged 18 years and above, for restricted use in emergency situations, Union health minister Mansukh Mandaviya tweeted.
Bharat Biotech’s nasal vaccine uses a chimpanzee cold virus to deliver a harmless copy of the coronavirus spike protein to the lining of the nose. It has been specifically formulated to allow intranasal delivery and has been developed in partnership with Washington University St Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy.
The DCGI had earlier given its nod to conduct clinical trials for Bharat Biotech’s intranasal vaccine as a booster dose. The drug regulator had also permitted the firm to conduct a phase 3 clinical trial to compare the immunogenicity and safety of BBV154 (intranasal) with Covaxin.
Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (2-dose) schedule and a heterologous booster dose for subjects who have previously received two doses of the two commonly administered COVID vaccines in India.
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