Intranasal COVID Vaccine: Bharat Biotech Completed Phase 3 Trial

New Delhi: The manufacturer of COVID-19 vaccine Covaxin, Bharat Biotech International Limited (BBIL), said on Monday that it has completed the clinical development for phase III trials and booster doses for the BBV154 (Covaxin) intranasal COVID-19 vaccine.

The manufacturer said that 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 2 doses of the two commonly administered Covid-19 vaccines in India. Data from both Phase III human clinical trials have been submitted for approval to the National Regulatory Authorities, it said, according to India Today.

The primary dose schedule was conducted for safety and immunogenicity in 3100 subjects and was compared with COVAXINÒ. The trials were conducted at 14 trial sites across India.

The heterologous booster dose studies were conducted for safety and immunogenicity in 875 subjects, where a booster dose (3rd dose) of BBV154 intranasal vaccine was administered to study participants who were previously vaccinated with licensed COVID-19 vaccines. The trials were conducted at nine trial sites across India.

As per Bharat Biotech’s website, “An intranasal vaccine stimulates a broad immune response neutralising IgG, mucosal IgA, and T cell responses and creates an immune response at the site of infection (in the nasal mucosa) essential for blocking both infection and transmission of Covid-19.”

Being an intranasal vaccine, BBV154 may produce local antibodies in the upper respiratory tract, which may provide the potential to reduce infection and transmission.
Bharat Biotech is the second company to submit an application for the phase-III trial of the third dose in India. India has approved Covidshield, Covaxin and Sputnik V for vaccination in the country. Covaxin is approved for use under the 28-day Multi-Dose Vial Policy (MDVP) from DCGI and the WHO Emergency Use Listing (WHO EUL).

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