Citing the lack of efficacy data for the recently-approved Bharat Biotech vaccine against COVID-19, Dr.Gagandeep Kang of the Wellcome Trust Research Laboratory of Christian Medical College said that there was little to no data on how effective the vaccine would be against the new strains of the virus.
Although Phase 1 and 2 trials were done and animal models were promising, it was not enough to justify the hasty approval of 'Covaxin' she opined in an interview with Karan Thapar for The Wire.
"Essentially you are handing people who are anti-vaccine, anti-science a weapon that they can use. It is horrendously hard to think why experts would think that this was a good way to go," Dr Kang said, referring to the lack of transparency in the approval process.
Referring to the recent declaration of clinical trials for the vaccine, Dr.Kang expressed confusion as the vaccine had already undergone trials.
"Does this mean the government will buy the vaccine and conduct clinical trials or does it mean that the government wants Bharat Biotech to give the vaccine to a larger number of people in the form of a single-arm clinical trial?" She asked.
When asked about the Oxford AstraZeneca vaccine that produced two varying results (60 per cent efficacy with two doses, 90% efficacy with half, followed by a full dose of the vaccine) Dr.Kang said the results were serendipitous but not reliable. "It requires follow up, but in my opinion, should not have gone to a regulator," she said.
Despite the similarities in the way both Ebola and Nipah vaccines were cleared without Phase 3 trials, Dr.Kang said the same precedent did not apply to COVID-19 as there were differences in the way the virus spread and its overall mortality rate.
She expressed hope in Covaxin and India's potential for manufacturing a wide array of vaccines but lamented the lack of transparency that surrounded the process.