Peter Kenny
21 December 2021•Update: 22 December 2021
GENEVA
The World Health Organization issued an emergency use listing (EUL) Tuesday for Nuvaxovid following its assessment and approval earlier by the European Medicines Agency (EMA).
The vaccine was developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI).
Nuvaxovid is the fifth vaccine recommended in the EU for preventing the coronavirus, said the EMA
“It is a protein-based vaccine and, together with the already authorized vaccines, will support vaccination campaigns in EU Member States during a crucial phase of the pandemic,” according to the EMA.
The drug is the originator product for the Covovax vaccine that received WHO emergency use listing Dec. 17, said the WHO.
“Both vaccines are made using the same technologies,” it said. “They require two doses and are stable at 2 to 8 C refrigerated temperatures.”
The announcement came one day after WHO Director-General Tedros Ghebreyesus said that more than 3.3 million people have lost their lives to COVID-19 in 2021 -- more than from HIV, malaria and tuberculosis combined in 2020.
WHO’s Strategic Advisory Group of Experts, also known as SAGE, on immunization has also issued policy recommendations for Nuvaxovid/Covovax.
The EUL procedure assesses the suitability of novel health products during public health emergencies.
It aims is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality.
The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
The EMA said that Nuvaxovid works by preparing the body to defend itself against the virus.
“The vaccine contains a version of a protein found on the surface of SARS-CoV-2 (the spike protein), which has been produced in the laboratory,” it said.
It also contains an “adjuvant,” a substance to help strengthen the immune responses to the vaccine.
