The World Health Organization on Wednesday authorized the emergency use of a COVID-19 vaccine developed in India, endorsing a drug that the country’s regulators authorized long before advanced safety and efficiency tests were completed.
The UN health agency said in a statement that it authorized the use of Covaxin, developed by the Indian laboratory Bharat Biotech. That makes Covaxin the eighth COVID-19 vaccine to be approved by the WHO.
“The announcement of this emergency use expands the availability of vaccines, the most effective medical tools to end the pandemic,” said Dr. Mariângela Simão, assistant to the WHO director general for access to medicines and health products.
Covaxin was developed by Bharat Biotech in partnership with the Medical Research Council of India, the government research body. The vaccine is made from a killed coronavirus to elicit an immune response and is given in two doses.
The WHO said it found about 78% effective in preventing severe COVID-19 and was “extremely useful” for poor countries because of its simpler storage conditions.
A group of experts convened by the WHO indicated that there was insufficient data on the safety and efficiency of the vaccine in pregnant women. Studies are planned to address these issues.
India’s drug regulator approved the use of Covaxin in January, months before extensive human trials were completed, prompting concerns from health experts that the vaccine was approved prematurely.
Bharat Biotech published results in July showing that the vaccine was 93% effective in preventing severe cases of COVID-19 and approximately 65% effective with the more contagious delta variant.
In March, Prime Minister Narendra Modi received the first of two doses of the vaccine. By mid-October, more than 110 million doses had been administered, making Covaxin the second most widely used COVID-19 vaccine in India after AstraZeneca.
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Cheng reported from London.
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