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Second Phase Clinical Trials Approved for Bharat Biotech’s Nasal COVID-19 Vaccine 

Bharat Biotech’s nasal COVID-19 Vaccine candidate obtained regulatory approval for mid-to late-stage trials, said the government’s ministry of science and technology. Early-stage trials of the vaccine candidate, BBV154, have been accomplished in participants aged 18 to 60 years, and the doses were found to be well-tolerated.

The biotech company’s COVAXIN, COVID-19 Vaccine is approved for emergency use in the country, is administered through an injection. Renu Swarup, chairperson of the Biotechnology Industry Research Assistance Council. Said that the company’s BBV154 Covid Vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials.

Bharat Biotech did not immediately respond to the request for additional details. Coronavirus cases in India have sharply dropped from the devastating peak of the second wave seen in April and May, while experts have said widespread vaccination remains the country’s best defence against any further waves of the disease. Covaxin is effective against the Delta Plus variant of the coronavirus despite slightly reduced neutralisation antibody titres, a new study by the Indian Council of Medical Research-National Institute of Virology has found. The study has also found the vaccine to be effective against the Delta and the B.1.617.3 variants.

The Delta variant has been classified by the World Health Organization (WHO) as a variant of concern. Apart from triggering India’s second Covid-19 wave during March-May, it is estimated to have caused 90% of the cases India reported the variant has been found in nearly 99 countries. More infectious than the Alpha, Beta, and Gamma variants, it is the leading cause of breakthrough infections in vaccinated individuals across the globe.

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