Bharat Biotech seeks DCGI nod for study of intra-nasal COVID vaccine as booster dose

Written by Ruchika Sharma Published On 2021-12-21T12:00:07+05:30 | Updated On 21 Dec 2021 5:21 PM IST

Bharat Biotech seeks DCGI nod for study of intra-nasal COVID vaccine as booster dose

New Delhi: Indian vaccine maker Bharat Biotech said on Monday it has submitted an application to the country's drug regulator to conduct a late-stage trial for a booster dose of its intranasal COVID-19 vaccine.

Indian COVID-19 vaccine makers are lobbying the government to authorise boosters as supplies have far outstripped demand, but the health ministry said there is no immediate plan to approve boosters and the priority remains complete vaccination of eligible adults.

"We have submitted phase 3 clinical trial application to DCGI (Drugs Controller General of India)," a Bharat Biotech spokesperson said in a statement, adding that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.

"India is yet to approve the use of Bharat Biotech's intranasal vaccine, BBV154," reports Reuters.

In August, BBV154 had received regulatory approval for mid- to late-stage trials. Local media had reported that the mid-stage trial has been completed.

Read also: CDSCO approves extension of Covaxin shelf life up to 12 months

BBV154 is a novel adenovirus vectored, intranasal vaccine for COVID-19.

Key Attributes of intranasal COVID vaccine:

. An intranasal vaccine stimulates a broad immune response – neutralizing IgG, mucosal IgA, and T cell responses.

. Immune responses at the site of infection (in the nasal mucosa) – essential for blocking both infection and transmission of COVID-19.

Covaxin, the company's COVID-19 vaccine already approved for emergency-use approval in the county, is administered through an injection.

Coronavirus cases in India have fallen sharply since a devastating second wave earlier this year. The South Asian nation has detected over 100 cases of the Omicron variant so far.

Bharat Biotech International Limited is an Indian multinational biotechnology company headquartered in Genome Valley, Turakapally, Hyderabad. The company was founded by Krishna Ella in 1996.

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Source : with agency inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751