The novel oral polio vaccine Type 2 (nOPV2), developed by a team of scientists from the Medicines and Healthcare products Regulatory Agency (MHRA), has been prequalified by the World Health Organization (WHO) today (January 9).
Three years after receiving Emergency Use Listing (EUL) and with 950 million doses administered worldwide, nOPV2 has been prequalified by the WHO following an analysis of results in vaccinated populations, confirming the strong safety profile and efficacy of the vaccine.
The nOPV2 vaccine helps protect children from polio while simultaneously reducing the risk of vaccine-derived outbreaks.
The prequalification is a WHO-awarded sign of quality assurance and will make it easier for more countries to access and utilize nOPV2. WHO member countries are now permitted to receive and use nOPV2 without needing to meet the strict readiness and surveillance requirements previously required in the EUL.
The prequalification ensures broad and long-term accessibility for international agencies to distribute nOPV2 in developing countries.
„Until complete eradication, polio will continue to pose a threat to children worldwide. The novel oral polio vaccine Type 2 has already protected millions of children, and today’s announcement by WHO will mean better access for many. Prequalification is the result of years of collaboration, and through continuous partnership, rapid and accurate detection, and broad vaccination coverage, polio will finally be eradicated.“
Dr. Andrew Macadam, Chief Scientist, MHRA
Polio is an infectious disease caused by the poliovirus, usually transmitted through contact with infected feces via contaminated food and water.
While many people never show symptoms, in extreme cases, especially in babies and children under five years old, polio can lead to permanent paralysis or death.
The original oral polio vaccines (OPVs), which have reduced polio cases by over 99% since 1988, work by administering children a live but weakened version of the poliovirus.
Unlike the OPVs used in the UK, OPVs can be transported over long distances without requiring refrigeration, allowing the vaccine to be delivered to hard-to-reach parts of the world.
However, in rare cases, if not enough children are vaccinated with an OPV, the weakened virus in the vaccine can be transmitted to under-immunized population groups and, over time, evolve into a form that can lead to paralysis.
Genetic modifications to nOPV2 are equally effective as other OPVs in protecting against polio and significantly reduce the risk of the poliovirus mutating and becoming harmful again.
In response to the increased risk of vaccine-derived outbreaks in Africa and Asia, nOPV2 received a WHO Emergency Use Listing three years ago as the first vaccine on the list.
Regulierungsbehörde für Arzneimittel und Gesundheitsprodukte (MHRA)