Janet Ogundepo
The World Health Organisation has issued a prequalification approval for a novel oral polio vaccine type 2 under its Emergency Use Listing regulatory pathway.
According to the WHO’s Director-General, Tedros Ghebreyesus, the approval of the vaccine was a historic milestone for polio eradication and has blazed a trail for other new vaccines.
Global Polio Eradication Initiative, in a statement, noted that since the roll-out of the vaccine, about one billion doses had been administered across 35 countries, predominantly in the African region, and has protected millions of children against the disease.
The prequalification approval is the first time the WHO will approve a vaccine under its EUL.
The GPEI stated that the approval would enable additional countries to access the vaccine more easily for a more sustainable response to type 2 variant poliovirus outbreaks.
“This is a historic milestone for polio eradication and for public health,”. “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,” Ghebreyesus said in a statement by GPEI.
“The GPEI said, “WHO EUL is reserved for using 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 is the final step of the process, allowing for streamlined regulatory approval for nOPV2 use in countries that need it.”
UNICEF Executive Director, Catherine Russell, noted that the approval illustrated how innovation could help protect children against the variant poliovirus type 2, “with thanks to the support of donors and partners, and the commitment of governments and community health workers.
“UNICEF is committed to helping ensure the safe and adequate supply of vaccines to countries while working with communities to build trust in vaccines. We need to keep going till we reach every child, and eradicate polio once and for all.”
About 500 million doses of the vaccine have been administered to children in Nigeria since the rollout and further contributed to the WHO Prequalification.
Data from the GPEI further noted that the vaccine has helped bring about an 85 percent reduction in variant poliovirus cases in Nigeria since 2021.
Development of the vaccine began in 2011 through a consortium of experts led by the Bill & Melinda Gates Foundation, including the United Kingdom’s National Institute for Biological Standards and Controls, the U.S. Centers for Disease Control and Prevention, the US Food and Drug Administration, PATH and the University of California at San Francisco.
The Chief Executive Officer of the Bill & Melinda Gates Foundation, Mark Suzman, said, Supporting the development of new vaccines is one of the most important investments we can make to protect people against preventable diseases like polio.
“With easier access to nOPV2 for more countries, this vaccine will keep even more children safe in areas still grappling with poliovirus. We look forward to working with partners across sectors to support more groundbreaking innovations.”
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