Home WORLD NEWS Intranasal vaccine trial a success, submitted data: Bharat Biotech

Intranasal vaccine trial a success, submitted data: Bharat Biotech

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HYDERABAD: Bharat

Biotech

International Limited (BBIL) said on Monday it has submitted phase III clinical trial data for its intranasal Covid-19 vaccine BBV154 to the Indian regulatory authorities.

The submission was made after the vaccine proved to be safe, well-tolerated, and immunogenic in subjects in controlled trials as a primary as well as heterologous booster, the company added. “Immunogenicity was evaluated through serum neutralising antibodies by PRNT assays and serum IgG’s through ELISAs,” Bharat Biotech said in a statement. “To assess vaccine response through the intranasal route, secretory IgAs were evaluated by ELISA in serum and saliva. Evaluation was also carried out for the ability of BBV154 to elicit long-term memory T and B cell responses against the ancestral and

Omicron

variants.”

Joint MD Suchitra K Ella

said if approved, the intranasal vaccine would be easier to deploy in mass immunisation campaigns as it has an easy-to-administer formulation and delivery device. “Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern,” she said.

The Hyderabad-based vaccine-maker said the intranasal vaccine may produce local antibodies in the upper respiratory tract that may provide the potential to reduce infection and transmission and that it is planning further studies on the same.

BBIL had conducted two separate and simultaneous clinical trials to evaluate BBV154. This includes a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein as a primary dose (2-dose) schedule and a heterologous booster dose for those who received two doses of Covaxin and Covishield, the two commonly administered Covid vaccines in India.

The primary dose schedule phase III trials were conducted on around 3,100 subjects at 14 trial sites across India and compared to the company’s inactivated virus vaccine Covaxin. The heterologous booster dose studies were conducted in around 875 subjects at nine trial sites.

Bharat Biotech said BBV154 is stable at 2-8°C for easy storage and distribution. The company has also established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana, with operations across India. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries, it said.

The vaccine was developed in partnership with Washington University in St Louis, which designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy.

The product development related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials, were conducted by Bharat Biotech. The product development and clinical trials were partly funded by the Indian government through the Department of Biotechnology’s Covid-19 Suraksha programme.

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