The All India Drug Action Network (AIDAN), a drug activists group has issued a statement asking the DCGI to make public all the data and analyses on which the decisions have been made to grant EUA to the COVID-19 vaccines.
“Any 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. In the interest of transparency and public welfare, we ask that the regulator share the detailed rationale for the decision along with disclosure of the data, evidence and information that was reviewed by the SEC and the data and analysis on the basis of which the REU approval is granted,” said AIDAN’s statement.
AIDAN expressed “shock” over SEC’s recommendation to grant REU approval to Bharat Biotech’s COVAXIN in ‘clinical trial mode’ and “specially in the context of infection by mutant strains”.
“Disturbingly, it appears that no efficacy data for the vaccine candidate were submitted from the Phase 3 trials that are ongoing and 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 Phase 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,” says the drug activists group.
Raising concerns about COVAXIN’s efficacy against the mutant strains of COVID-19, AIDAN’s statement says, “It is not clear if there is any scientific basis to claim that COVAXIN will be effective in the ‘context of infection by mutant strains’ when its efficacy has not been established and is currently unknown against any strain of the virus.”
It adds, “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 the development of COVID-19 vaccines published by CDSCO on 21 September 2020.”
“In light of the intense concerns arising from the absence of efficacy data and hence the limited regulatory review of the vaccine candidate, the implications of the public rollout of an untested product, and lack of transparency we urge the DCGI to reconsider the recommendations of the SEC in granting the REU approval to COVAXIN,” it concludes.