As the Covid-19 pandemic spread across the world two years ago, one of India’s leading biotech companies was racing to develop a vaccine with crucial backing from the Indian government. The shot engineered by Bharat Biotech was, in part, an important effort to create a home-grown product that could bolster the fortunes of the Indian pharmaceutical industry.
However, a STAT review of documents detailing the steps taken toward government approval found that regulators endorsed the vaccine, called Covaxin, despite discrepancies in the number of clinical trial participants. Moreover, questionable changes were made to the trial protocols — which are established procedures for testing a vaccine or medicine — to expedite the approval process.
For instance, the number of people enrolled in the Phase 1 portion of the trial differed from what was later published in a medical journal. There were also important changes made to the protocol for Phase 2 testing, when immunogenicity data from the previous Phase 1 stage were not yet available. In addition, the protocol for Phase 3 was approved while Phase 2 was still underway and the final vaccine candidate was selected without Phase 2 data, according to protocol documents and minutes of meetings held by an expert committee that reported to India’s Central Drugs Standard Control Organization (CDSCO), the national regulator responsible for approving medicines