Countries can authorise emergency use of any vaccine – WHO
By Sulochana Ramiah Mohan
The World Health Organisation (WHO) office in Colombo said WHO listed the Sinopharm COVID-19 vaccine, produced by Beijing Bio-Institute of Biological Products Co Ltd. under WHO’s Emergency Use Listing (EUL) from 7 May 2021 and that countries have the autonomy to issue emergency use authorisations for any vaccine in line with national regulations and legislation, Sri Lanka is currently administering the Sinopharm vaccine around the country.
The WHO spokesperson in Colombo told Ceylon Today, the domestic emergency use authorisations are issued at the discretion of countries and they are not subject to WHO approval.
WHO’s Emergency Use Listing (EUL) 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. WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE) has also completed its review on the Sinopharm vaccine. On the basis of all available evidence, WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks. Vaccine efficacy for the symptomatic and hospitalised disease was estimated to be 79 per cent, all age groups combined, the WHO report on Sinopharm says.
“The EUL process usually takes two to three months to complete, depending on the quality and availability of the data submitted by the vaccine developers, among other factors; the prequalification process is more complex and thus takes longer. In emergency situations, such as the current COVID-19 pandemic, and for countries whose regulatory authorities are under-resourced, WHO supports the regulatory process by running independent parallel reviews, usually involving independent experts and experts from regulatory authorities at global level,” the spokesperson said.
WHO Emergency Use Listing (EUL) is a procedure for assessing unlicensed vaccines, therapeutics, and in vitro diagnostics during public health emergencies with the ultimate goal of expediting the availability of these products to people who need them. The EUL is used during public health emergencies. When products are not licensed yet (still in development), WHO will assess the quality, safety and efficacy (or performance) data generated during development and conduct a riskbenefit assessment to decide if they can be used outside clinical trials, she said.
She further noted, the WHO prequalifies vaccines for diseases of priority to low and middle-income countries through its vaccine prequalification programme. “WHO is not a regulatory agency; instead prequalification is a WHO recommendation that ensures that candidate vaccines: meet the WHO recommendations on quality, safety and efficacy, including compliance with WHO recommended Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards; and meet the operational specifications for packaging and presentation of the relevant UN agency,” she added.