Bharat Biotech gets DCGI permission to conduct phase-3 trials for intranasal booster dose

INDIA – Bharat Biotech, based in Hyderabad, has received permission from the Drugs Controller General of India (DCGI) to conduct a phase-3 clinical trial for its intranasal Covid vaccine in the country.

The randomized multi-centric clinical trial will assess the immunogenicity and safety of the intranasal vaccine ‘BBV154’ as a booster dose on participants who have previously received SARS-CoV 2 vaccines.

The booster dose was proposed for people who had already received two doses of Covishield or Covaxin vaccine.

The intranasal booster dose is supposed to be administered six months after the second vaccine shot. The trials will take place at nine different locations, including All India Institute of Medical Sciences (AIIMS) Delhi, Economic Times reported.

The DCGI, on the other hand, stated that granting permission to conduct clinical trials does not imply that permission to market this vaccine will be granted automatically based on the study’s findings.

The intranasal vaccine is said to be effective in preventing the spread of new Covid variants. Bharat Biotech had applied to DCGI for permission to conduct a phase-3 study in December 2021. On January 27, the DCGI finally granted permission.

Advantages of nasal vaccine

The vaccine is non-invasive and painless because it is administered through the nose and does not require a needle.

Nasal vaccine administration is simpler and does not require trained health care workers because it is needle-free. Furthermore, it eliminates the risks associated with needles (injuries and infections).

An intranasal vaccine, according to Bharat Biotech, stimulates a broad immune response at the site of infection (in the nasal mucosa), which is critical for preventing both infection and transmission of COVID-19.

Krishna Ella, Chairman of Bharat Biotech, previously stated that the use of intranasal vaccine would affect the overall cost of a vaccination drive.

The company received regulatory approval to conduct phase 2 clinical trials for its nasal vaccine in August 2021.

Previous studies have shown that immunization of mice, hamsters, and macaques with a single dose of the vaccine provided superior protection against SARS-CoV-2 challenge “more so than one or two intramuscular immunizations of the same vaccine and dose.”

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