The World Health Organization (WHO) listed the vaccine for emergency use to enable countries who do not have vaccine agreements in place to work towards vaccinating their populations.
The WHO announced today it listed 2 versions of the AstraZeneca vaccine for emergency use, granting the way for the vaccines to be rolled out internationally through COVAX.
“Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk, contributing to the COVAX facility’s goal of equitable vaccine distribution,” Mariângela Simão, MD, WHO assistant-director general for Access to Medicines and Health Products, said.
COVAX is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations and WHO. Its aim is to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.
WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
In order to be granted an EUL, vaccine developers submit data required by WHO. Once those data are submitted, WHO can rapidly assemble its evaluation team and regulators from around the world to assess the information and, when necessary, carry out inspections of manufacturing sites.
In the case of the 2 AstraZeneca vaccines, WHO assessed the quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements. The process took under 4 weeks.
The AstraZeneca vaccines are being produced at several manufacturing sites, as well as in the Republic of Korea and India. It has been found to have 63.09% efficacy and is suitable for low- and middle-income countries due to easy storage requirements.
“..We must keep up the pressure to meet the needs of priority populations everywhere and facilitate global access,” Simão said. “To do that, we need two things–a scale-up of manufacturing capacity, and developers’ early submission of their vaccines for WHO review.”