WHO authorizes Indian-made COVID vaccine, months into use

NEW DELHI (AP) — 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 U.N. 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.

“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr. Mariângela Simão, WHO’s assistant director-general for access to medicines and health products.

Covaxin was developed by Bharat Biotech in partnership with the Indian Council of Medical Research, the government’s apex research body. The vaccine is made using a killed coronavirus to prompt an immune response and is given in two doses.

WHO said the vaccine was found to be about 78% effective in preventing severe COVID-19 and was “extremely suitable” for poor countries due to its much easier storage requirements.

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.

India’s drug regulator authorized Covaxin in January, months before extensive testing in people had been completed, prompting concern from health experts that the shot was given the nod prematurely.

Bharat Biotech published results in July showing the vaccine was about 93% effective in preventing severe COVID-19 and roughly 65% effective against infection with the more contagious delta variant.

Indian Prime Minister Narendra Modi took the first shot of the two-dose vaccine in March. By mid-October, over...