Possible Game Changer: Bharat Biotech’s Nasal Vaccine Against COVID-19 Cleared For Use

By OB Bureau On Sep 6, 2022

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.

Big Boost to India’s Fight Against COVID-19!

Bharat Biotech’s ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation.

— Dr Mansukh Mandaviya (@mansukhmandviya) September 6, 2022

According to Bharat Biotech, its COVID-19 intranasal vaccine, BBV154, has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase III. The vaccine candidate was evaluated earlier in phase I and II clinical trials with successful results. Bharat Biotech chairman and managing director Krishna Ella had recently said that the firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no single instance of side effect or adverse reaction reported so far, News18 reported.

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.