Bharat Biotech’s coronavirus vaccine Covaxin is 77.8% effective against the infection, ANI reported on Tuesday, citing unidentified officials on the phase 3 trial results of the jab. Bharat Biotech had submitted the trial results to the Drug Controller General of India over the weekend.
On Tuesday, a Subject Expert Committee of the Central Drugs Standard Control Organisation, the country’s top drug regulatory body, reviewed and accepted the data, according to The Indian Express.
The data has not yet been published in a peer-reviewed journal. However, Bharat Biotech can now approach the World Health Organization for emergency use listing of the vaccine, which would make it easier for Covaxin to receive approvals in other countries. Bharat Biotech is expected to submit its proposal to the WHO on Wednesday, reports said.
A review of phase 3 trials of a vaccine by the drug regulator of the country of its origin is required for emergency use listing by the WHO, according to Business Standard.
Meanwhile, All India Institute Of Medical Sciences, New Delhi, Director Dr Randeep Guleria told India Today that Covaxin may have sufficient data by September for it to be used to vaccinate children. “Vaccine trial in India is already going on...Bharat Biotech is doing the trials and the data should be out quickly,” he said. “I think by September the data should be out and we should have the regulatory approvals by then.”
He added that Pfizer’s Covid-19 vaccine could also be reviewed for use among children.
The indigenously developed Covaxin shot was granted emergency use authorisation in India in January though data of phase 3 trials were not available at that time. The company had then said it would submit efficacy results by March. On June 9, it said that the data will be made public in July.
In April, an interim analysis of Covaxin’s phase three data had shown that it was 78% effective against Covid-19. This was slightly lower than the 81% efficacy reported by the company in March.
The phase 3 trials involved 25,800 participants, of which 2,400 were above the age of 60 and 4,500 volunteers had comorbidities. The vaccine showed a 93% efficacy against severe disease and 60% effectiveness against asymptomatic cases of Covid-19, Business Standard reported.
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