Bharat Biotech's Covaxin, India's Indigenously-made Covid-19 jab, is 77.8 per cent effective in protecting against the deadly infection, according to data released from phase 3 trials conducted on 25,800 participants across India
Bharat Biotech's Covaxin, India's Indigenously-made Covid-19 jab, is 77.8 per cent effective in protecting against the deadly infection, according to data released from phase 3 trials conducted on 25,800 participants across India. Trial data and results were studied and approved by the DCGI's Subject Expert Committee on Tuesday, said an NDTV report.
In March, the interim analysis of phase 3 results showed Covaxin was 81 per cent effective in preventing Covid-19 in people without prior infection after the second dose.
The data had also reflected that there was 100 per cent reduction in chances of hospitalisation in case of infection
With the approval of the Phase 3 data, Bharat biotech is likely to secure an EUL (Emergency Use Listing) from the World Health Organisation (WHO).
The report stated that the company is likely to hold a pre-submission meeting with the WHO authorities on Wednesday.
According to another news report, Bharat Biotech had told the government that it has already submitted 90 per cent of the documents required by the WHO.
Last month, Bharat Biotech had said that it expects to get WHO approval for Covaxin by September.
The approval from WHO will also allow export of Covaxin and facilitate easier international travel for Indian citizens who received the domestic vaccine yet to be validated by most of the foreign governments.
Covaxin was cleared for emergency use last year while it was still in clinical trials. The government had allowed to administer it under "restricted use in emergency situations in public interest".
DCGI's approval will also help resolve doubts as the government looks to expedite vaccination ahead of the likely third wave and protect the Indian population against mutant strains of the virus, IBNS said. (SAM)