India’s homegrown coronavirus vaccine “Covaxin”, which received restricted emergency approval on Sunday, is the subject of mounting questions from medical experts and the political opposition over a lack of efficacy and trial data.
India gave its first approval to the Oxford-AstraZeneca vaccine after its expert panel gave the green light on Friday.
That was swiftly followed by the approval of Covaxin, which has been developed by Bharat Biotech, a Hyderabad-based pharmaceutical company, in association with the Indian Council of Medical Research (ICMR), a government agency.
The news, announced by the drugs controller general of India (DCGI), was hailed by prime minister Narendra Modi and his government as a “game-changer” and a triumph for the broader agenda of the country achieving “self-reliance”.
But experts have raised concerns over the seemingly hasty approval of the vaccine, coming before the completion of stage three trials or the publication of efficacy data.
Officials have described the Bharat Biotech jab as a back-up to the Oxford-AstraZeneca one, to be used under strict monitoring conditions and only if it looks like the country is at risk of a major surge in cases. DGCI VG Somani said the vaccine had been approved in “public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains”.
But the All India Drug Action Network (AIDAN), an independent health watchdog, issued a statement saying that it is “shocked” at the approval of the vaccine and urged DGCI to reconsider its decision stating “intense concerns arising from the absence of the efficacy data”. It also said that there is “no scientific basis to claim that Covaxin will be effective in the context of infection by mutant strains.”