Hyderabad: While expert panel of India’s central drugs authority has reportedly reviewed and accepted the phase-3 trial data of Bharat Biotech’s COVID-19 vaccine Covaxin, it is unlikely to get a complete approval until next year, reports have said. According to a report in the Economic Times, a senior government official said the vaccine maker may have to wait until next year to get full approval from the Drugs Controller General of India (DCGI).Also Read - Bharat Biotech's 'Pre-submission' Meeting For Covaxin EUL With WHO Today. Why is it Crucial?
The government official said the phase-3 trials of Covaxin have not ended yet and Bharat Biotech needs to carry out follow-up studies. Also Read - Covaxin For Children Above 2 Years Will Be Available In By September, Says AIIMS Chief Randeep Guleria
“They have to establish data indicating how much protection the vaccine gives. The duration schedule is defined in their protocol. Till that is established, full licensure cannot be granted,” the official said. Also Read - Bharat Biotech's Covaxin Shows 78 Per Cent Efficacy In Phase 3 Trial Conducted Across India: Reports
Another official explained that a full licence is usually granted one year after the last trial participant is recruited.
Bharat Biotech submitted the results of its phase-3 trial efficacy data of Covaxin to the DGCI over the weekend.
The COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Tuesday reviewed the data and accepted it. Their recommendations have been sent to the DCGI now, a source said.
According to the data submitted by the Hyderabad-based firm, the indigenously developed vaccine has shown 77.8 per cent efficacy in the trial conducted on 25,800 subjects.
Bharat Biotech held a pre-submission meeting with the World Health Organisation (WHO) on Wednesday for international emergency use listing (EUL) of its COVID-19 vaccine Covaxin.
Though the meeting was not a detailed review on the product, the vaccine maker had an opportunity to submit a summary on overall quality of the jab, according to the WHO.
Last month, Bharat Biotech said that it expected to get approval for emergency use listing of Covaxin from the WHO by July-September.
As per WHO guidelines, EUL is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies.
According to WHO, pre-submission meetings provide an opportunity for advice and guidance before submission of a medicines dossier, as well as an opportunity for the applicant to meet WHO medicine assessors who will be involved in assessing their product.
Sources had earlier indicated that Bharat Biotech International Limited (BBIL) has conveyed to the Centre that it has already submitted 90 per cent of documents to WHO for obtaining EUL for Covaxin.
The remaining documents are expected to be submitted by June, the city-based vaccine maker had told the Central government during a discussion last month on obtaining theWHO’s authorisation for EUL for Covaxin.
(With PTI inputs)