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    DCGI approval for Bharat Biotech’s nasal booster dose trials

    HealthCOVID-19DCGI approval for Bharat Biotech’s nasal booster dose trials
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    DCGI approval for Bharat Biotech’s nasal booster dose trials

    The producer of India’s indigenous vaccine, Covaxin, will now be able to conduct trials of its nasal vaccine as a booster dose at nine locations in the country.

    The Drug Controller General of India today gave its approval to Indian biotechnology-pharma company, Bharat Biotech, to conduct Phase-III clinical trials of a nasal vaccine it has developed. The trials of the intranasal booster dose will be conducted on people who have received both doses of Bharat Biotech’s Covaxin.

    Covaxin producer will now be able to conduct trials of its nasal vaccine as a booster dose at nine locations in the country.

    An intranasal vaccine has logistical advantages and will be easier to administer in mass vaccination drives. The company claims that the BBV154 vaccine stimulates a broad immune response, especially at the site of infection (in the nasal mucosa that lines the nasal cavity) – essential for blocking both infection and transmission of COVID-19.

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    Besides ease of administration – as it does not require trained health care workers, the nasal vaccine also eliminates risks of injuries and infections that might be associated with a needle administered jab. It can elicit a high degree of compliance, especially as it suits children and adults.

    The non-invasive and needle-free nasal route has excellent potential for vaccination due to the organised immune systems of the nasal mucosa.

    Biotechnology feat

    The biotechnology company has applied to the Drug Controller General of India for approval for phase-III trials of the BBV154 vaccine in December 2021.

    If given the green signal following the trials, Bharat Biotech claims it will be able to undertake large-scale to meet global demands.

    The attenuated avirulant vaccine comes from a modified chimpanzee adenovirus. (This is a harmless, weakened adenovirus that usually causes the common cold in chimpanzees.) In this respect, the operative biologicals of this vaccine are somewhat like the AstraZeneca vaccine that also uses a chimpanzee adenovirus vaccine vector that has been genetically changed to stop it from adversely affecting humans.

    According to the company, mice, hamsters and macaques immunized with a single dose of the vaccine “conferred superior protection against SARS-CoV-2 challenge”.

    It claims that intranasal immunization “can create an immune response in the nose, which is the point of entry for the virus—thereby protecting against disease, infection, and transmission.”

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