Thread by @WHO

🆕 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 #COVID19, that the benefit of the vaccine far outweighs risks & the vaccine can be used 🌍.

#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. #COVID19

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. #COVID19

#Covaxin was found to have 78% efficacy against #COVID19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements.

#Covaxin EUL expands the availability of 💉, the most effective medical tools we have to end #COVID19. It was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan & suitability in low- & middle-income countries.

WHO’s EUL procedure assesses the quality, safety and efficacy of #COVID19 vaccines and is a prerequisite for #COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

The EUL procedure assesses the suitability of novel health products during public health emergencies. The aim is to make medicines, vaccines & diagnostics available as rapidly as possible while adhering to stringent criteria of safety, efficacy & quality
extranet.who.int/pqweb/vaccines…

The Technical Advisory Group for Emergency Use Listing is an independent advisory group that provides a recommendation to WHO whether an unlicensed vaccine can be recommended for emergency use under the EUL procedure, and if so, under what conditions. extranet.who.int/pqweb/vaccines…