Civil society group All India Drug Action Network (AIDAN) has posed a set of queries to Drugs Controller General of India (DCGI), the Health Ministry and NITI Aayog on the regulatory approval processes being followed by India to clear emergency use of COVID-19 vaccines.
The public health activists specifically sought more information over Serum Institute of India’s emergency approval request for its COVID-19 vaccine, Covishield, stating that the request is in the interest of transparency and is an attempt to build public confidence in the vaccine.
In a letter to Dr Vinod Paul, NITI Aayog member; Rajesh Bhushan, Union Health Secretary; and VG Somani, DCGI on December 8, AIDAN wanted to know the exact processes and parameters for restricted emergency use (REU) approval of COVID-19 vaccine candidates in India, and whether and under what conditions interim results can be sufficient for seeking such an approval.
“If an REU for a COVID-19 vaccine is granted, kindly make public the basis of approval, including evidence reviewed; the restrictions/conditions linked to the approval; and at what point full market authorisation may be given,” the activists asked. They also sought details of the protocol, process and timelines followed in investigating any reported serious adverse events (SAEs) and wanted to know the government’s stand on indemnifying vaccine manufacturers.
AIDAN wanted the government to make public all relevant documents and details related to COVID-19 vaccine trials, including details of the composition of COVID-19 subject expert committee (SEC), and reports of committees or bodies such as drug safety monitoring boards, independent expert groups, institutional ethics committees (IECs), etc. They also sought details of all adverse events (AEs) and severe adverse events (SAEs) reported from the trial sites.
Similarly, the group sought all the information that will form the basis of scrutinising Serum Institute’s emergency approval application for its COVID-19 vaccine. For instance, they have asked the authorities to disclose the detailed clinical trial protocol for the Phase 2/3 bridging trial for Covishield along with all amendments made to the protocol.
“Not only India but several developing countries have been eagerly awaiting the development and approval of Covishield not only as an affordable vaccine but also one that will be well suited for rollout in developing country conditions. Precisely because of the hope that is being placed on this vaccine candidate, the conduct of clinical trials to determine its safety, quality and efficacy as well as the regulatory standards to review data and the approval process must be above reproach,” the letter said.
While it is not clear whether the government would heed to their request, the activists have copied their letter to key officials in the Prime Minister’s Office and stakeholder departments like Department of Pharmaceuticals and Department of Biotechnology.