WHO decision on COVAXIN approval in Sept

A WHO official has said the agency’s assessment of made-in-India Covaxin is at an advanced stage and a decision on emergency authorisation for Bharat Biotech’s vaccine is likely by mid-September. Covaxin is still to be authorised by Western authorities.

A top vaccines official at the World Health Organization says the agency expects to make a decision next month on an emergency authorization for the Indian-made Covid-19 vaccine made by Bharat Biotech, a shot that has yet to be authorized by any Western regulatory authorities.

Dr. Mariangela Simao, a WHO assistant director-general for vaccines, says the UN health agency’s assessment of the Bharat Biotech vaccine was "quite advanced” and officials hoped for a decision by mid-September.

Simao says WHO is also considering other versions of vaccines already licensed by the agency, including one made by Sinopharm. She expects they’ll begin evaluating vaccines made by Sanofi Pasteur and Novavax in September. “There are many, many vaccines in the final stages of the pipeline,” Simao says.

Last week, the US makers of Novavax said they would prioritize seeking authorization in developing countries and from WHO before getting the green light in the US and European Union.