Table 5.

Potential regulatory pathways to pursue henipavirus vaccine authorisation

	Data package could include	Examples of approved vaccines for other indications
Current scenario: Ro<1
Accelerated approval (US FDA),122 conditional marketing authorisation or exceptional circumstances approval (EMA),123 or similar mechanisms	Phase 1 data, phase 2 data*, phase 3 trial feasibility assessment (results from mathematical modelling), assay validation data, surrogate endpoint or correlates of protection data, passive transfer or adoptive transfer studies, bridging data for licensure, and post-approval confirmatory studies to demonstrate clinical benefit	Approvals based on surrogate endpoints;124 conditional marketing authorisation for Ervebo (recombinant vesicular stomatitis virus–Zaire Ebola virus)125
Animal rule (US FDA)126 and exceptional circumstances (EMA)123	Natural history study data and challenge data, additional requirements requested by national regulatory authorities for licensure, and post-approval confirmatory studies to demonstrate clinical benefit (if possible to conduct)	Approvals based on the animal rule;127 exceptional circumstances: Zabdeno (Ad26.ZEBOV [adenovirus type 26 vector-based vaccine, expressing a Zaire Ebola virus glycoprotein])128 and Mvabea (MVA-BN-Filo [modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from the Zaire Ebola virus])129
Other, depending on specific national regulatory authority legislation. See Directorate General of Drug Administration, (Bangladesh)130 and the Central Drugs Standard Control Organization (India)131 as examples	To be defined by each national regulatory authority	Vary by different national regulatory authority
Alert phase: Ro ~1
Rapid response: potential shift to PHEIC and pandemic scenarios	..	..
Higher incidence scenarios: Ro>1
Accelerated approval (US FDA),122 conditional marketing authorisation (EMA),123 national regulatory authority emergency use authorisation, WHO EUL, 132, 133 and other	Phase 1 data, phase 2 data, and assay validation data†	Ebola vaccines: Ervebo125, 134

EMA=European Medicines Agency. EUL=emergency use listing. PHEIC=public health emergency of international concern. US FDA=US Food and Drug Administration.

^*Phase 2 clinical trial material can become so-called “outbreak-ready” for an investigational stockpile.

^†Investigational stockpile deployed.