Indian scientists divided over restricted use approval for Covaxin — Science Chronicle

While some scientists have raised concerns about granting restricted use approval to Covaxin even in the absence of efficacy data, four-dozen scientists have in a statement slammed them saying “reprehensible utterances are causing huge credibility crisis for the Indian scientific community”. Apparently, questioning the approval process by the Indian regulator is seen as being anti-Indian […]

Indian scientists divided over restricted use approval for Covaxin — Science Chronicle

India’s drug regulator approved two COVID-19 vaccines on 3 January, a decision Prime Minister Narendra Modi hailed on Twitter as “a decisive turning point to strengthen a spirited fight!” against the pandemic and a testament to the Indian scientific community’s self reliance. But some scientists and patient advocates are sharply critical of the move—in particular, the decision to greenlight Covaxin, a vaccine developed in India by Bharat Biotech, without awaiting the results of a phase III trial to determine efficacy and safety…

Efficacy data from a challenge study in rhesus macaques and immune responses in a human phase II trial suggested the vaccine was likely to be very effective.

The approval of a vaccine without phase III data is “unconscionable,” says Vineeta Bal, an immunologist at India’s National Institute of Immunology.

Scientists criticize ‘rushed’ approval of Indian COVID-19 vaccine without efficacy data — https://www.sciencemag.org/news/2021/01/scientists-criticize-rushed-approval-indian-covid-19-vaccine-without-efficacy-data

It worked in monkeys so let’s just skip the Phase III trial.

See my earlier post I would not take Covaxin without efficacy data: Gagandeep Kang — Science Chronicle

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