STAT+: Indian regulators are pushed to release Covid-19 vaccine trial protocol
As Indian regulators consider emergency approval of a Covid-19 vaccine from the Serum Institute of India, consumer groups are urging authorities to release key documents – such as the clinical trial protocol and study data – amid concerns over transparency and adverse events.
An independent panel of experts set by the Drug Controller General of India meets on Friday to consider the vaccine, which is the Serum Institute’s version of a shot originally co-developed by AstraZeneca (AZN) and the University of Oxford. Earlier this month, the panel delayed its decision while waiting for U.K. regulators to grant emergency use for the AstraZeneca version, which occurred this week.
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