The FMD Vaccine Challenge Project is dedicated to finding a solution-agnostic approach to addressing the problem of FMD in Eastern Africa and encourages all interested parties to apply. All information relevant to the competition and to potential competitors will be shared on this website and via a mailing list (sign up at the bottom of this page). Please send any inquiries to FMDchallenge@galvmed.org, and the Project Manager will respond in a timely manner.

Resources directly related to the AgResults FMD Vaccine Challenge Project:

OIE Twinning Project between The World Reference Laboratory for FMD (WRL-FMD) at The Pirbright Institute, UK, and The African Union Panafrican Veterinary Vaccine Centre (AU-PANVAC), Ethiopia.

• Eastern African FMDV Reference Antigen Panel: The antigen panel comprises sixteen FMDV isolates that can be used to evaluate serological responses of FMDV vaccines in the context of their suitability for use in Eastern African countries.  This page includes information about the costs and procedures associated with accessing this panel from WRL-FMD.
• FMD Vaccine Evaluation for Eastern Africa: This document outlines the serological assays offered in support of FMD vaccine development and evaluation with specific reference to Eastern Africa. These services are seen as relevant to the developers or evaluators of vaccines intended for use against the four major serotypes of FMD circulating in Eastern Africa (serotypes O, A, SAT1 and SAT2), and are intended to assist those involved in the development of vaccines associated with the AgResults FMD Vaccine Challenge Project. This page includes WRL-FMD costs for testing sera raised against vaccines with the FMDV Reference Antigen Panel.
• Vaccine valency test requirement: WRLFMD has published guidance on its website for use of the Virus Neutralisation Test (VNT) to determine the expected level of protection of vaccines submitted to the AgResults FMD Vaccine Challenge Project. This guidance, summarized as follows, is specific to, and developed for, the AgResults project:

• • Using VNT, an indicator of heterologous cross-protection is considered to be a log10 reciprocal titre of 1.5 (cut-off value) after a single dose vaccination with serum collected 21 days later.
  • Three out of five cattle should have titres at or greater than this level for a pass.
  • Due to limited data and the use of only five cattle, the precision of such an evaluation will be low and these threshold values should be regarded solely as a pragmatic indicator.

Based on the recommendation of the project’s Technical Committee and specifically for the purposes of the valency test requirement of the project’s Target Product Profile (TPP), we will use the WRLFMD guidance above and apply it to the vaccination regime specified by the manufacturer (using results from either one-dose or two-dose vaccination sera):

1. • Thus, if a log10 reciprocal titre of 1.5 or higher is achieved in 3/5 cattle, this will be considered a “pass” for both one-dose and two-dose vaccination sera.
   • As stipulated in the TPP, the vaccine must achieve this “pass” in at least 70% of isolates per serotype set (O, A, SAT1, SAT2) – for a minimum of three out of four isolates per serotype set.

As stated in the Competition Rules, with respect to testing for vaccine valency, such data must be generated by an FMD reference laboratory that (a) has the capabilities to test against the full approved Eastern African FMDV Reference Antigen Panel set forth in the Target Product Profile and (b) is neutral, independent, impartial and conflicts-free (including that such laboratory may not have any financial interest in the applicable Competitor or vaccine and may not hold any intellectual property with respect to such vaccine).  Pre-approved FMD reference laboratories are listed below, but Competitors should consult with the Project Manager before proceeding with such testing:

The Pirbright Institute
Ash Road, Pirbright, Woking, GU24 0NF,
UK
Email: enquiries@pirbright.ac.uk
Tel: +44 (0)1483 232441
www.pirbright.ac.uk

Sciensano
Juliette Wytsmanstraat 14
1050 Elsene
Belgium
Email: info@sciensano.be
Tel: +32 2 642 51 11
www.sciensano.be

Resources indirectly related to the Project:

Foot and Mouth Disease vaccination and post-vaccination monitoring guidelines.

The East African Community Mutual Recognition Procedures (EAC MRP) were developed by national drug registration authorities in the EAC Partner States and endorsed by the EAC. A key objective of the MRP is to allow applicants to save time through simultaneous submissions of quality veterinary medicine dossiers to minimum two EAC countries. Through one submission, other concerned countries may accept the reference country’s assessment of the application. Detailed information is available on the EAC website, including a revised (Oct 2021) version of a Frequently Asked Questions brochure, developed with feedback from industry, National Regulatory Agencies (NRA), and the EAC secretariat on regulatory obstacles around the implementation of MRP.

An annotated version of the Guideline on the Technical Documentation required to be included in a Registration Dossier For an Immunological Veterinary Product has been published by the EAC, specifically to assist assessors with evaluation of vaccines against Foot and Mouth Disease in the context of the EAC MRP.

Note: In recognition of the fact that the Government of Burundi is a signatory of the MRP but does not have the capacity to put in place a national regulatory authority, unless and until the Government of Burundi establishes a national regulatory authority for purposes of administering the MRP, sales of the FMD vaccine in Burundi will be considered to be made under a valid Product Registration if the Competitor receives Product Registration for the FMD vaccine via MRP in other EAC countries (Kenya, Rwanda, Tanzania, or Uganda).

Registration in Ethiopia must be done as an individual country registration.

Upon request from vaccine manufacturers, the Project Manager is able to provide contact information for regulators, distributors, logistics companies and potential buyers in the six target countries. These contacts do not necessarily represent a comprehensive list of companies in each of these categories, but rather represent the list of contacts that the Project Manager is aware of at the time of the request, without bias or favouritism. Please send requests to: FMDchallenge@galvmed.org

“Willingness to pay” research studies for livestock vaccines in Eastern Africa:

1. Drivers of vaccination preferences to protect a low-value livestock resource: Willingness to pay for Newcastle disease vaccines by smallholder households
2.  Willingness to pay for contagious bovine pleuropneumonia vaccination in Narok South District of Kenya