TEMPO.CO, Jakarta - COVID-19 Task Force spokesman Wiku Adisasmito said the World Health Organization (WHO) will issue the emergency use listing (EUL) for the Sinovac vaccine in May 2021.
“EUL is given as a prerequisite for the supply of the COVAX vaccine, which is the WHO's subsidized vaccine for various countries in the world,” said Wiku in a written statement on Friday, April 16, 2021.
Wiku said EUL was also a prerequisite to assist a country in deciding the feasibility of using, producing, or importing vaccines, as well as its emergency use authorization or EUA. “EUA is specifically a limited distribution permit for a country,” he added.
According to him, both EUL and EUA are two forms of limited use permits for vaccines, drugs, and in vitro diagnostic tools on the basis of considerations that had the same points.
The difference between the two permits lies in the authority body issuing them. EUL is issued by WHO, while EUA by local authorities, such as BPOM (Food and Drug Monitoring Agency).
In principle, Wiku went on, WHO gave full authority to each national regulatory body such as BPOM to issue a EUA for COVID-19 vaccines that referred to global standards on conditions that could be determined based on the data of a transparent assessment. “However, the WHO still hopes that vaccines that have received EUA from each country can register for EUL in the future,” he said.