COVID-19: India’s highest drug regulatory body, Central Drugs Standard Control Organisation’s Subject Expert Committee (SEC) reviewed as well as accepted the late-stage trial data of Covaxin on Tuesday.
Covaxin efficacy: Data from the phase 3 trials of Bharat Biotech’s Covaxin – India’s only indigenous coronavirus vaccine so far – has been shared by the manufacturer, and it shows that symptomatic COVID-19 cases can be brought down by 77.8% due to the vaccine. The results of the phase 3 trials have been released merely a day before Bharat Biotech is set to meet the World Health Organisation (WHO), likely for the submission of a proposal to be included in the global health agency’s Emergency Use Listing vaccines, according to a report in IE. If the WHO does include Covaxin in its EUL, it would provide recognition to the vaccine developed by Bharat Biotech and Indian Council of Medical Research (ICMR) in countries where it has not been able to get regulatory approval yet.
As per the report, India’s highest drug regulatory body, Central Drugs Standard Control Organisation’s Subject Expert Committee (SEC) reviewed as well as accepted the late-stage trial data of Covaxin on Tuesday. The trial had 25,800 participants and the data shared by Covaxin also contained information about the vaccine’s efficacy for all forms of the disease – indicating Covaxin’s ability to reduce symptomatic cases of COVID-19, the report added.
With the review and acceptance of the data by the SEC, it is expected that there would be more confidence in the effectiveness of Covaxin, which has been an issue in the past.
Still, Covaxin has not been granted permission to be used without restriction, even as Bharat Biotech had sought complete authorisation. The drug manufacturer would need to submit the data regarding vaccine’s safety for a period of at least one year before it could receive such an authorisation, the report has said. At present, there is no vaccine for coronavirus in the world which has been given complete authorisation till now.