Hyderabad-based Bharat Biotech has applied for the Emergency Use Authorization of its COVID-19
COVAXIN vaccine again with the Comptroller General of Drugs of India (DCGI), sources told News18 on Wednesday.
COVAXIN, an inactivated candidate vaccine, is currently in phase III human clinical trials with 26,000 volunteers at 25 centers in India, after having undergone phase I and II trials with 1,000 volunteers.
Bharat Biotech had applied for emergency use authorization for its vaccine on December 7 and submitted its proposal for the grant, along with interim safety and immunogenicity data from Phase I and II clinical trials.
However, the Central Drugs Standard Control Organization (CDSCO) panel of experts recommended that the company submit the safety and efficacy data from the ongoing phase III clinical trial in the country for further consideration.
Meanwhile, the Serum Institute of India (SII) has submitted additional data requested by the DCGI to determine the safety and immunogenicity of its COVID-19 vaccine candidate, Covishield.
India is likely to have a COVID-19 vaccine approved for emergency use before the end of December as the expert panel of the Central Medicines Control Organization is ready to review requests from the Serum Institute of India and Pfizer for emergency use authorization for their candidate vaccines .
If IBS receives approval, India could be the first country to give AstraZeneca’s vaccine regulatory approval, even as the UK drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), continues to examine the data. of the trials.
Pfizer of the United States was the first to apply on December 4, followed by Pune-based Serum Institute of India and Hyderabad-based Bharat Biotech, which applied on December 6 and 7, respectively. However, Pfizer had requested more time to make a presentation to the committee.
Pfizer, whose vaccine has been licensed in the US, UK and Canada, has written to DCGI requesting a new date to present its case for the EUA of its candidate vaccine BNT162b2, after it failed to present its data to the committee of CDSCO vaccine review before.
With input from IANS
.
