Intranasal Covid-19 vaccine: Bharat Biotech to complete phase 3 trials in April

G. Naga Sridhar | | Updated on: Mar 15, 2022

In January, DCGI has permitted the vaccine maker to undertake phase 3 trials

Country’s first intranasal Covid-19 vaccine, being developed by Bharat Biotech International, is nearing completion of development and, if things go according to plan , may soon add to the basket of currently available vaccines to fight the pandemic.

According to sources, the phase 3 trials of the intranasal vaccine candidate BBV154 are likely to be completed within a month from now allowing the Hyderabad-based company to process the efficacy data. Then the data have to submitted to the drug regulator for approval.

“The trials are progressing well in nearly a dozen centres across the country and are expected to be completed in about a month,’‘ a source told BusinessLine .

The trials are being conducted on 5,000 healthy volunteers. “The process of trial for a nasal vaccine is simpler and faster than an intramuscular vaccine candidate,’‘ the source added. 

Trials so far

Bharat Biotech, the maker of the first indigenous Covid-19 vaccine Covaxin, completed phase 1 trials on 400 healthy individuals.

In November last year, it completed phase 2 trials on about 650 volunteers in 10 centres across the country.

In the last week of January, the Drug Controller General of India (DCGI) permitted the vaccine maker to undertake phase 3 trials. BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine.

The vaccine has been developed using a new technology licensed from Washington University. Bharat Biotech believes in a cocktail approach of administering two doses of two different vaccines using a combination of intramuscular and nasal in a first of its kind approach.

“If successful, intranasal vaccines make the roll out of booster doses easier and faster as administering intranasal vaccines is much easier when compared to that of intramuscular vaccines,” said one of the directors of a city-based corporate hospital adding that any danger of the fourth wave of the pandemic be dealt with a comprehensive programme for a booster dose to all.

Published on March 15, 2022
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