Hours after Bharat Biotech’s Covisd19 vaccine, Covaxin, received clearance from the government’s Subject Expert Committee (SEC) for emergency use, All India Drug Action Network (AIDAN) urged the DCGI to withdraw the approval.

India’s first indigenously developed Covid19 vaccine, Covaxin, was recommended on Saturday for “restricted use in emergency situation, subject to multiple regulatory conditionalties” by the Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO).

The Drugs Controller General of India (DCGI) will take a final call on approving the rollout of the vaccine in the country.

AIDAN said it is shocking to learn about SEC’s recommendation to grant approval to Covaxin which is in the “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 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,” a media report quoted AIDAN as saying.

It appears that no efficacy data for the vaccine candidate were submitted from the phase 3 trials which 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 among 755 participants.

AIDAN said for maintaining 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, the All India Drug Action Network said.

AIDAN further 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.”

AIDAN said it wants to know the efficacy estimates for the dosing regimen and dosing schedule that will be followed in India as concluded by the SEC, the specific data and analysis of the foreign trials of the AstraZeneca/Oxford vaccine that was the basis of the SEC’s decision, the extent of the data for safety and immunogenicity from the Phase 2/3 bridging study in India that was submitted and reviewed by the SEC, the “multiple regulatory conditionalities” proposed by the SEC.

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