India's drug regulator on Wednesday granted approval to Bharat Biotech for conducting late-stage trials of its nasal COVID-19 vaccine to be used as a booster shot, according to a Mint report, which cited ANI.
The vaccine maker submitted the late-stage trial application to the Drugs Controller General of India (DCGI) in December, adding that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.
"DCGI's Subject Expert Committee has granted 'in principle' approval to Bharat Biotech for the conduct of 'Phase III superiority study and Phase III booster dose study' for its intranasal COVID vaccine and has asked it to submit protocols for approval," according to the report on Wednesday.
Bharat Biotech and DCGI did not immediately respond to Reuters requests for comment.
As a precautionary measure in light of rising Omicron coronavirus variant cases across the country, India approved the administration of COVID-19 booster shots on Christmas, with healthcare and frontline workers set to receive them from Jan.
10.
The country is yet to approve the use of Bharat Biotech's intranasal vaccine, BBV154. In August, BBV154 received regulatory approval for mid- to late-stage trials. Local media had reported the mid-stage trial has completed.
India's inoculation drive so far has been dominated by a domestically produced version of the AstraZeneca COVID-19 shot by Serum Institute of India and Bharat Biotech's inactivated vaccine Covaxin, both administered through injections.
On Wednesday, the country reported 58,097 new coronavirus cases, twice the number seen only four days ago, taking its total caseload to over 35 million.
(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)
Dear Reader,
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.
Digital Editor
RECOMMENDED FOR YOU