Mumbai: Following the Drug Controller General India’s (DCGI) approval to Serum Institute’s Covishield, the All India Drug Action Network (AIDAN) has said the regulator, in the interest of transparency and public welfare, should share the rationale behind the decision along with the disclosure of the data, evidence and information reviewed by the Subject Expert Committee (SEC) and the data and analysis on the basis of which the restricted emergency use approval was granted. (AIDAN is an independent network of several non government organizations).
In the case of Covaxin, the AIDAN has urged the DCGI to reconsider the recommendations of the SEC in the light of the intense concerns arising from the absence of efficacy data and the limited regulatory review of the vaccine candidate, the implications of the public rollout of an untested product and lack of transparency.
The AIDAN, in a release, said for Covishield, it would like to know the efficacy estimates for the dosing regimen and schedule that would be followed in India, as concluded by the SEC. Further, it also wanted to know the specific data and analysis of the foreign trials of the AstraZeneca/Oxford vaccine that was the basis of the SEC’s decision. “Any restricted emergency use (REU) granted by the DCGI on the recommendation of the SEC must be accompanied by the legal provisions under which the approval is granted, the specific approved use of the vaccine candidate and details of restrictions/conditions,’’ it added.
Further, the AIDAN argued that the objective of a bridging study to assess the vaccine candidate in an Indian population would be undermined if the data generated from the trial was not reviewed in the process of regulatory approval.
As far as Covaxin was concerned, the AIDAN said it appears that no efficacy data for the vaccine candidate was submitted from the ongoing Phase 3 trials being conducted by Bharat Biotech and ICMR. “The only data for humans, available through publication pre prints are for safety and immunogenicity from Phase 1 and 2 trials, across a total of 755 participants. In the interest of transparency, it will be in the fitness of things that the trial data on the basis of which decisions have been taken by the SEC are immediately made public,’’ it added.
‘’We are baffled to understand what scientific logic has motivated the top experts in the SEC to approve this vaccine posthaste. Moreover, this is a violation of the criteria in the draft regulatory guidelines for development of COVID 19 vaccines published by Central Drugs Standard Control Organisation on September 21, 2020. The decision to approve an incompletely studied vaccine, even under accelerated process, raises more questions than answers and likely will not reinforce faith in our scientific decision making bodies,’’ said AIDAN.
