Concern as India approves COVID-19 vaccine before trial completion

pharmafile | January 4, 2021 | News story | Sales and Marketing COVID-19, Vaccine 

Experts have expressed concern over India’s emergency approval of its homegrown COVID-19 vaccine, Covaxin, before studies have been completed.

The vaccine’s approval on Sunday prompted questions from experts and politicians regarding the efficacy and safety of the jab, which has been green-lighted despite not having yet completed Phase III trials.

Health watchdog All India Drug Action Network said in a statement that it was “shocked” by the decision to approve the vaccine before the trials have been completed, and without efficacy data having been published.

It wrote that there were “intense concerns” about the implications of rolling out an incompletely studied vaccine, and urged India’s Subject Expert Committee to reconsider its recommendation of the jab.

VG Somani, India’s Drugs Controller General, had previously told a press conference that the vaccine was “safe and provides a robust immune response”, and had been approved as an “abundant precaution” to provide the country with more vaccination options.

Covaxin was approved alongside AstraZeneca and Oxford University’s jab, which is also being manufactured in India.

News of the emergency vaccine approval comes as India records 16,504 new coronavirus cases and 214 deaths in the last 24 hours.

Darcy Jimenez

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