BENGALURU (Reuters) – 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. 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.
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.
(Reporting by Anuron Kumar Mitra in Bengaluru; Editing by Sherry Jacob-Phillips)
