Published 11:18 IST, November 17th 2020
WHO lists 1st vaccine for emergency use; makes way for emergency listing of COVID vaccine
For the first time WHO listed a vaccine, nOPV2 developed by Indonesia's Bio Farma, for emergency use in the cases of vaccine-derived poliovirus
For the first time WHO listed a vaccine, nOPV2 developed by Indonesia's Bio Farma, for emergency use in cases of vaccine-derived poliovirus strain which continue to rise. This vaccine has been listed for emergency use in several African and East Mediterranean countries and is a first-of-its-kind which lays the foundation for the potential emergency listing of a COVID-19 vaccine. Several other countries in WHO's Sout-East Asia and Western Pacific Asia regions are affected by the outbreak of this vaccine-derived polio strain of viruses (cVDPVs).
Over the last 30 years, polio cases across the world have been reduced by about 99.9%, but the last few steps to put an end to this disease has become difficult mainly due to the cVDPVs outbreaks. While these outbreaks are rare, it occurs if the weakened strain of the poliovirus in the polio vaccine circulates among the under-immunized people. If enough kids are not immunized the strain of poliovirus can pass between people and genetically revert to a form that can lead to paralysis.
WHO's Emergency Use Listing Procedure & its impact on COVID-19 vaccine
The process of EUL or Emergency Use Listing was introduced during the outbreak of Ebola in West Africa in 2014-2016. During that time several Ebola diagnostics were listed under emergency use and since then nOPV2 is the first vaccine to be listed under EUL. This procedure is aimed at assessing the suitability of a health product which hasn't received a licence during a public health emergency like a virus or infection outbreak like polio or COVID-19. The aim is to make the treatment easily and quickly available during the emergency and the procedure weighs the side effects, benefits and threats posed by the use of the product on the basis of evidence from clinical trial data.
As per the WHO press release, "The EUL pathway involves a rigorous assessment of phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy and manufacturing quality. These data are reviewed by independent experts who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and the plans for further studies."
For the EUL process, experts from the concerned fields from national authorities are invited to review and authorise the use of the product. After a treatment like a medicine, vaccine or any other diagnostic is listed under WHO's EUL, the global health body focuses on sensitizing other national health organisations about the aniticip[ated benefits and other information about the treatment. Moreover, even af5ter being listed under WHO's emergency use, the pharmaceutical company or authority has to continue to generate more data to ensure that it is able to obtain a proper license for the use at a later stage and meets WHO health and safety standards.
Updated 11:18 IST, November 17th 2020