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Roselyne Sachiti
Features, Health and Society Editor
The World Health Organisation (WHO) last week listed the Sinopharm COVID-19 vaccine for emergency use, giving the green light for this vaccine to be rolled out globally.
This is good news especially for countries like Zimbabwe who already had faith in the Chinese made vaccines and started Sinopharm inoculations early this year followed by Sinovac.
Many have been asking what listing for emergency use entails.
According to WHO, the emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies.
WHO says the objective 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,” says WHO.
The world health body further points out that the EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan.
“These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.”
As part of the EUL process, WHO further says the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine.
“The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.”
WHO also listed the Pfizer/BioNTech vaccine for emergency use on December 31 2020; two AstraZeneca/Oxford COVID-19 vaccines on February 15 2021, produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India; and COVID-19 vaccine Ad26.COV2.S developed by Janssen (Johnson & Johnson) on March 12 2021.
Online Reporter