The subject expert committee (SEC) of the Indian drug regulator will meet on Thursday to consider Bharat Biotech International’s proposal to remove its jabs Covaxin from ‘clinical trial mode’, which, if successful, may boost uptake of the indigenous covid-19 vaccine.
“The SEC would meet on Thursday to review the application. The company has asked the regulator to consider removing the ‘clinical trial mode’ condition," a person in the know said on condition of anonymity.
The SEC is tasked with vetting applications for covid-19 diagnostics, vaccines and drugs, and recommends to the Drugs Controller General of India V.G. Somani whether to approve an application or not. Generally, the DCGI follows the recommendation made by the panel.
The company has submitted its interim phase 3 trial data to the regulator, which showed that the vaccine had an efficacy of 80.6%.
This is significant considering that Serum Institute of India’s Covishield—the vaccine that got a full authorisation in January—had an efficacy of around 53% for the current regimen of two full doses given four weeks apart, and an average of 62% for intervals ranging between 4-12 weeks.
Covaxin had also got an emergency licensure in January, albeit controversially as it did not have any efficacy data, but the authorisation was in ‘clinical trial mode’, which mandated that every vaccine taker had to sign an informed consent when getting the jab and was supposed to be followed up more actively.
The more onerous condition for authorisation was on account of the vaccine not having any efficacy data, unlike Covishield which had efficacy data from the trials of AstraZeneca plc and University of Oxford as well as an emergency use authorisation from the UK Medicines and Healthcare products Regulatory Agency.
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