Emergency use of nOPV2 has protected millions against polio. Prequalification will ensure broad, long-term accessibility.
Just ahead of the new year, the World Health Organization (WHO) prequalified the novel oral polio vaccine type 2 (nOPV2) for use in response to poliovirus type 2 outbreaks, shortly after the vaccine obtained full licensure in Indonesia.
WHO’s decision comes three years after nOPV2 became the first vaccine to receive a WHO Emergency Use Listing (EUL) to protect children from polio while lowering the risk of seeding new type 2 vaccine-derived outbreaks. Approximately a billion doses of nOPV2 have been delivered since EUL approval, and surveillance data confirms that the vaccine is working as intended.
The development of nOPV2 builds upon decades of research on oral polio vaccines. In 2011, a consortium of researchers banded together to test a modified version of the existing type 2 Sabin oral polio vaccine. “We proposed design modifications that we believed held potential for creating a more genetically stable vaccine,” said Andrew Macadam, PhD, a principal scientist at the Medicines and Healthcare Products Regulatory Agency in the UK, and one of the developers of nOPV2. “It is gratifying to know that this research culminated in a product that is protecting millions of children around the world and helping accelerate the end of a horrible disease.”
Since 2015, PATH has served as the convener of the nOPV2 product development consortium —facilitating data-sharing and coordination among partners, and providing technical assistance, such as developing assays to assess the stability of vaccine attenuation and supporting evaluation of surveillance data. PATH also sponsored an nOPV2 Phase 3 study, conducted by Medical Research Council Unit The Gambia (MRCG) at the London School of Hygiene & Tropical Medicine (LSHTM), to generate data needed for WHO to consider prequalification. We integrated data from the Phase 3 study and clinical trial data from other partners for the WHO prequalification application, which was submitted by Bio Farma, the manufacturer of nOPV2.
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