The World Health Organisation (WHO) on Wednesday recommended Emergency Use Listing (EUL) status for Bharat Biotech’s Covid-19 vaccine Covaxin.
“WHO has granted emergency use listing (EUL) to #COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of Covid-19 (sic),” the global health body said in a statement.
“The Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that the #Covaxin vaccine meets WHO standards for protection against #COVID19, that the benefit of the vaccine far outweighs risks & the vaccine can be used across the globe,” it added.
WHO said that Covaxin was also reviewed by its Strategic Advisory Group of Experts on Immunization (SAGE), which recommended the use of this vaccine in two doses, with a dosing interval of four weeks, in all age groups 18 and above.
“Available data on vaccination of pregnant women with the #Covaxin vaccine are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry,” said WHO.
Following this, Union health minister Mansukh Mandaviya congratulated scientists and Bharat Biotech for the feat.
“WHO today granted for Emergency Use Listing (EUL) of Made-in-India Covaxin. On this occasion, I congratulate scientists of ICMR and Bharat Biotech,” Mandaviya said.
The WHO’s advisory group was expected to make a decision on the shot known as Covaxin last week, but asked for additional clarifications from Bharat Biotech before conducting a final risk-benefit assessment for the vaccine’s global use.
Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the Delta variant.
In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.
Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.
The emergency use listing would allow Bharat to ship the vaccine to countries that rely on WHO guidance for their regulatory decisions.
Covaxin is the seventh to win WHO backing following two mRNA shots by Pfizer/BioNTech and Moderna, adenovirus vector vaccines developed by AstraZeneca and Johnson & Johnson, and China’s inactivated vaccines from Sinovac Biotech and Sinopharm.
The nod also mean that the shot may be accepted as a valid vaccine for millions of Indians who have received it and want to travel outside the country.