Enabling accelerated vaccine roll-out for Public Health Emergencies of International Concern (PHEICs): Novel Oral Polio Vaccine type 2 (nOPV2) experience

• Published in: Vaccine Vol. 41; no. Suppl 1; pp. A122 - A127
• Main Authors: Macklin, Grace R., Peak, Corey, Eisenhawer, Martin, Kurji, Feyrouz, Mach, Ondrej, Konz, John, Gast, Chris, Bachtiar, Novilia Sjafri, Bandyopadhyay, Ananda S., Zipursky, Simona
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 06.04.2023; Elsevier Limited; Elsevier Science
• Subjects: Cell culture; Clinical trials; Decision making; Design; Disease Eradication - methods; Emergencies; Emergency response; Emergency use listing; Epidemics; Genomes; Global Health; Health care; Humans; Manufacturing; Medical research; Novel oral poliovirus vaccine; Poliomyelitis; Poliomyelitis - prevention & control; Poliovirus; Poliovirus Vaccine, Oral - adverse effects; Public Health; Public health emergency of international concern; Vaccine; Vaccines; Belgium; United States > US; Panama; Novel oral poliovirus vaccine; Vaccine; Emergency use listing; Public health emergency of international concern; Poliovirus
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2022.02.050

To address the evolving risk of circulating vaccine-derived poliovirus type 2 (cVDPV2), Global Polio Eradication Initiative (GPEI) partners are working closely with countries to deploy an additional innovative tool for outbreak response – novel oral polio vaccine type 2 (nOPV2). The World Health Organization’s (WHO) Prequalification program issued an Emergency Use Listing (EUL) recommendation for nOPV2 on 13 November 2020. The WHO’s EUL procedure was created to assess and list unlicensed vaccines, therapeutics and diagnostics to enable their use in response to a Public Health Emergency of International Concern (PHEIC). nOPV2 was the first vaccine to receive an EUL, paving the way for other emergency vaccines. In this report, we summarise the pathway for nOPV2 roll-out under EUL.