New Delhi, Jan 4 (TIWN) The All India Drug Action Network (AIDAN) said it is shocked to learn of the 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".

"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 said.

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. It is also not clear under which provisions of the extant law the SEC has recommended for grant of REU approval and in "clinical trial mode" at that, AIDAN said. 

"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 said.  "The hypothesis being propagated that the whole virion inactivated vaccine is likely to be effective against mutations of the virus is not being supported by any efficacy from the trial because no data have as yet been generated in the Phase 3 trial. Yet this appears to have been used to justify the totally non-sequitur decision which has no basis in the science of rational vaccine development", it said.