DCGI approves Bharat Biotech’s nasal COVID-19 booster shot trials
Author : Pankaj Singh | Published Date : 2022-01-06
Bharat Biotech reportedly received approval from India's drug regulator to start late-stage trials of its nasal coronavirus vaccine to be administered as a booster dose.
In December, the Hyderabad-based company filed a late-stage trial application with the Drugs Controller General of India (DCGI). It claims that an intranasal vaccine as a booster dosage will be easy to deliver in mass inoculation programs. It plans to enroll 5,000 candidates in clinical studies (50% vaccinated with Covishield and 50% vaccinated with Covaxin).
India approved the delivery of COVID-19 booster shots on Christmas as a precautionary step in light of a surge in Omicron variant cases across the country, with healthcare and frontline workers slated to receive jabs on January 10.
The usage of Bharat Biotech's intranasal vaccine, BBV154, has yet to officially receive the country’s approval. BBV154 received approval from the FDA in August for mid-to-late-stage investigations, sources cited.
Bharat Biotech International Limited (BBIL) claimed that their whole-virion inactivated COVID-19 vaccine candidate BBV152 (Covaxin) is safe, well-tolerated, and immunogenic in pediatric participants in phase II/III research.
The vaccine maker conducted phase II/III open-label and multicenter research in healthy children and adolescents aged between 2 and 18 years to assess the reactogenicity, safety, and immunogenicity of Covaxin.
The Central Drugs Standard Control Organization (CDSCO) received the data in October 2021, and DCGI recently approved it for emergency usage in children aged 12 to 18.
It is worth mentioning that the locally manufactured version of Bharat Biotech's inactivated vaccine Covaxin, and AstraZeneca COVID-19 shot by Serum Institute of India, both provided through injections, have dominated the country's immunization drive.
Knowledgeable sources cited that the country recorded 58,097 new COVID-19 cases this Wednesday, more than double the level seen only four days before, bringing the total number to more than 35 million.
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Pankaj Singh . .
Endowed with a post graduate degree in management and finance, Pankaj Singh has been a part of the online content domain for quite a while. Having worked previously as a U.K. insurance underwriter for two years, he now writes articles for fractovia.org and other online portals. He can be contacted at- [email protected] | https://twitter.com/PankajSingh2605
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