Bharat Biotech’s Covid-19 vaccine, Covaxin, has already been administered to 6,000 volunteers during its Phase 3 trial, the company’s founder and chairman, Dr Krishna Ella, said on Monday.
The full Phase 3 trial, across 26,000 volunteers, will be completed by the first week of February and data will be available between March and October.
Ella said he would soon be in a better position to respond to whether Covaxin can deal with the new UK strain; on Sunday, Drug Controller General VG Somani had indicated Covaxin may be able to deal with the UK strain.
There has been some criticism over the drugs regulator clearing Covaxin in a ‘clinical trial mode’ last week even though Phase 3 trials were not complete.
Ella countered this saying that as per the clearance Bharat Biotech would monitor each person getting the vaccine — as they would in a clinical trial.
The thrust of his arguments, however, was that some other vaccines had been given similar treatment, in India as well as overseas.
Citing Bharat Biotech’s track record as a vaccine developer – it holds a patent for the first chikungunya and zika vaccines and its rotavirus vaccine was pre-qualified by WHO in 2018 – Ella said the government was authorized to clear vaccines even with limited data under the provisions for accelerated approval.
He said there had been no Phase 3 trials in India either, in the case of the Oxford-AstraZeneca vaccine being developed by Serum Institute. “I am not a (vaccine) nationalist, I am a global public health person,” Ella said in response to the criticism that the clearances seem to have been based on the need to show a wholly Indian candidate.
Experts point out that while Serum had not completed its Phase 3 trials in India, Oxford-AstraZeneca had completed them in the UK,so the Indian regulators had some history to go by. Also, in several cases, local clinical trials have been waived in the past when the drugs have been approved in other countries. Without naming Oxford-AstraZeneca, Ella said, “if my trial gave half the dose it was meant to, the drugs regulator would have banned my trial”. “They use the word ‘serendipity’…I did not know the meaning of this word till now!”
Ella added that, so far, less than 10% of participants in his trials had experienced adverse reaction, whereas the ratios were much higher other vaccine makers.
He said the company is ready to roll-out 20 million doses and will be ready with 150 million doses before August 2021. While the US has cleared mRNA vaccines, he said, “we don’t know the long-term effect of these vaccines.”
