On Wednesday, the World Health Organisation (WHO) issued an emergency use listing for Covaxin, developed by Indian company Bharat Biotech, making it the eighth Covid-19 vaccine validated by the organisation.
The emergency use procedure assessed the quality, safety and efficacy of Covid-19 vaccines, is a prerequisite for Covax vaccine supply and also allows countries to expedite their own regulatory approval to import and administer vaccines.
"This emergency use listing (EUL) expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.
“However, we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory," she added.
The Technical Advisory Group (TAG), 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 and the vaccine can be used globally.
The WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE), recommended the use of the vaccine in two doses, with an interval of four weeks, in all groups aged 18 and over.
The vaccine was found to have 78% efficacy against Covid-19 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, says the WHO.
The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single-dose vials and multidose vials of 5, 10 and 20 doses.
