Bharat Biotech on Wednesday got 'in principle' approval to conduct phase-3 trials for the nasal COVID-19 vaccine - BBV154 as booster dose by the Subject Experts Committee (SEC) of the Drug Controller General of India (DCGI), ANI reported.
The SEC took the decision based on the Hyderabad-based company's application seeing permission to test its intranasal COVID vaccine on 5,000 subjects comprising an equal number of persons fully vaccinated with Covaxin and Covishield.
The authority has also asked Bharat Biotech to submit protocols for approval.
The company which also manufactures the COVID vaccine Covaxin was recently granted emergency use authorisation (EUA) for 12-18-year-olds.
Based on the novel adenovirus vector, BBV154 is an intranasal vaccine for COVID which prompts an expansive immune response neutralizing IgG, mucosal IgA, and T-cell responses. Primarily, the jab is effective in blocking both infection as well as transmission of the novel coronavirus.
An intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has the potential to prevent transmission.
Meanwhile, the Central Drugs Standard Control Organisation (CDSCO) recently approved the extension of Covaxin's shelf life up to 12 months from the date of manufacture.
Covaxin is approved for use under the 28-day multi-dose vial policy from DCGI and the WHO Emergency Use Listing (WHO EUL).
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