In late December 2023, the World Health Organization issued its first-ever prequalification approval for a vaccine being used under its Emergency Use Listing (EUL) regulatory pathway – novel oral polio vaccine type 2 (nOPV2). Since rollout of this next-generation vaccine began in March 2021, the Global Polio Eradication Initiative (GPEI) has administered nearly 1 billion doses of nOPV2 across 35 countries, protecting millions of children against illness and paralysis. Prequalification will enable additional countries to access the vaccine more easily for more sustainable response to outbreaks of type 2 variant poliovirus (cVDPV2).
“This is a historic milestone for polio eradication and for public health,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Novel oral polio vaccine type 2 has blazed a trail for other new vaccines that address critical health emergencies, and its use demonstrates the utility of the EUL mechanism in helping to rapidly get new products to where they’re needed most.”
The EUL to PQ pathway
WHO EUL is reserved for the use of yet-to-be-licensed vaccines, medicines and diagnostic tools during public health emergencies like polio outbreaks. Following rigorous assessments of existing quality, safety and efficacy data from completed clinical trials, the pathway enables expedited availability of products to the places impacted by these emergencies. The vaccine’s manufacturer, Bio Farma Indonesia, has been instrumental in ensuring supply and enabling nOPV2 to earn full licensure from the Indonesian regulatory authority, Badan POM. WHO Prequalification (PQ) is the final step of the process, allowing for streamlined regulatory approval for nOPV2 use in countries that need it.
