The World Health Organization (WHO) authorised Bharat Biotech’s COVID-19 vaccine Covaxin emergency use listing on Wednesday.
“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 COVID19.
“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 COVID-19, that the benefit of the vaccine far outweighs risks & the vaccine can be used,” the organisation tweeted.
The organisation added that the vaccine should be administered in two doses, with a dose interval of four weeks, in all age groups 18 and above.
“Covaxin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine in two doses, with a dose 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,” the organisation tweeted.
The TAG-EUL is an independent advisory group that provides recommendations to WHO on whether a COVID-19 vaccine can be listed for emergency use under the EUL procedure.
Covaxin was shown to be effective against symptomatic COVID-19 in 77.8% of cases and 65.2 percent of cases against the novel Delta variant in 65.2 percent of cases.
The company announced in June that it has completed the final study of Covaxin effectiveness from Phase 3 studies.
Covaxin from Bharat Biotech and Covishield from AstraZeneca and Oxford University are the two most extensively used vaccinations in India.