‘A Very Worrying Scenario’: Internal Documents on India Covid-19 Vaccine Raise Troubling Questions About Approval Process

November 16, 2022

(STAT News) – 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. (Read More)