The World Health Organization granted an emergency use license Wednesday to a coronavirus vaccine developed in India, offering reassurance for a shot the country's regulators allowed long before advanced safety and efficacy testing was completed.
The UN health agency said in a statement that it had authorized Covaxin, made by India's Bharat Biotech. The action makes Covaxin the eighth COVID-19 vaccine to receive WHO's green light.
An expert group convened by WHO said there was insufficient data about the vaccine's safety and efficacy in pregnant women; studies are being planned to address those questions. Despite India's repeated endorsement of its homegrown vaccine, Bharat Biotech has faced problems scaling up production. In July, India's Health Ministry said the company was making 25 million doses of the vaccine on average each month and expected to increase monthly production to 58 million doses.
The federal prosecutor's office in Brazil is investigating possible irregularities in the Health Ministry's contract to buy 20 million doses of Covaxin. Anna Marriott, health policy manager for Oxfam, said WHO's authorization of India's Covaxin should "silence those who have claimed that the experience and expertise to develop and manufacture life-saving medicines and vaccines do not exist in developing countries."
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