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The first vaccine listed under WHO emergency use
.tmb-1200v.jpg?sfvrsn=5a3ee2e8_1 "The first vaccine listed under WHO emergency use")
WHO stated today nOPV2 vaccine (Bio Farma, Indonesia) for urgent needs to address the growing cases of vaccine-derived poliomyelitis strain in a number of African and eastern Mediterranean countries. Countries in the WHO regions of the Western Pacific and Southeast Asia have also been affected by these outbreaks. The emergency list or SAD is the first for a vaccine and paves the way for a potential COVID-19 vaccine list.
The world has made incredible progress in eradicating polio, reducing the number of polio cases by 99.9% in the last 30 years. But the final steps to stopping this disease are proving to be the most difficult, especially with the continuous outbreak of circulating polio viruses (cVDPV).
cVDPVs are rare and occur if an attenuated poliovirus strain contained in an oral polio vaccine (OPV) circulates for a long time among under-immunized populations. If enough children are not immunized against polio, the weakened virus can pass between individuals and eventually return genetically to a form that can cause paralysis. CVDPV type 2 is currently the most prevalent form of vaccine-derived virus.
The SAD procedure and how it could help speed up access to the future COVID-19 vaccine
The SAD procedure assesses the suitability of health products that have yet to be licensed during public health emergencies, such as polio and COVID. The goal is to make these drugs, vaccines, and diagnostics more readily available to deal with emergencies. The assessment basically measures the threat posed by an emergency and the benefit that the use of the product could have based on solid evidence.
The procedure was introduced during the West African Ebola outbreak in 2014-2016, when multiple diagnoses of Ebola were given an emergency list; since then, numerous COVID-19 diagnostics have also been on the list. NOPV2 is the first such list of vaccines.
The SAD pathway includes a rigorous assessment of phase II and phase III clinical trial data, as well as significant additional data on safety, efficacy and quality of production. These data are reviewed by independent experts who take into account the current amount of evidence of the vaccine under consideration, monitoring plans for its use and plans for further studies.
Experts from individual national authorities are invited to participate in the review of the SAD and are engaged to assist in facilitating the necessary decision-making process at the state level for approval of use. Once the vaccine is listed for emergency use, the WHO engages its regional regulatory networks and partners to sensitize national health authorities about the vaccine and its expected benefits based on data from clinical studies to date.
In addition to deciding whether to use the vaccine, each country must complete the readiness procedure for implementing the vaccine under the SAD. The vaccine company also undertakes to continue collecting data to allow full licensing and pre-qualification of the WHO for the vaccine. WHO prequalification will assess additional clinical data obtained through testing and application of the vaccine on an ongoing basis to ensure that the vaccine continues to meet the required quality, safety and efficacy standards for wider availability (ie procurement from UN agencies and others).
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