Contents

Introduction

The principles

Product characteristics

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Introduction

In the context of the current mpox outbreak, it is essential to outline key principles of Gavi’s dose donation coordination work and preferred vaccine product characteristics. Drawing from lessons learned through the COVAX Facility, these principles aim to promote: vaccine equity; a rapid response to the outbreak to bring it under control; and consistency with Gavi-funded vaccine doses purchased through the First Response Fund – while managing risks, and ensuring operational feasibility and cost-effectiveness for recipient countries. These principles have been shared with donors or their agencies currently offering to donate vaccine doses, and their feedback has been integrated.

*These principles are time-bound and will be revised after Phase I of the Mpox Continental Preparedness and Response Plan for Africa, running from September 2024 to August 2025.

The principles

• Country ownership: No vaccine doses will be shipped to a country unless they are considered acceptable by the recipient country. Recipient countries and/or a formally designated country agency – e.g. Africa Centres for Disease Control and Prevention (Africa CDC) – retain the right to accept or refuse dose donation offers.
• Visibility on key vaccine information and timelines: Donors should provide timely, comprehensive information on vaccine doses to be donated – such as batches, volumes, shelf life, storage location/conditions and availability timelines. Manufacturers should offer forward visibility on delivery schedules to enable rapid, efficient deployment; and to maximise shelf life in country.
• Fully funded: Donated vaccine doses should be fully funded by donors. Donors are encouraged to fund all ancillary costs, including safe injection equipment (e.g. syringes, safety boxes), freight, repackaging and any insurance costs.
• No country earmarking: In accordance with Gavi’s and partners’ philosophy of equitable access, vaccines should be donated without earmarking for specific countries, to allow flexible allocation according to the Access and Allocation Mechanism (AAM) and deployment across countries – in line with regional and/or global demand priorities, as well as with Gavi eligibility requirements.
• Indemnity and liability: In order to use donated vaccine doses, recipient countries should not be required to indemnify donors and/or manufacturers, given existing regulatory approvals globally, and the duration and scale of existing vaccine administrations outside of clinical trial settings. Indemnity and liability considerations will be addressed within the broader AAM framework.
• On-label use only: To ensure simplicity and to streamline operations, donated doses must be used strictly for on-label purposes in recipient countries.

Product characteristics

• Safe and effective: All donated vaccine doses must be of assured quality with, at a minimum, authorisation from a WHO Listed Authority (WLA), WHO Emergency Use Listing Procedure (EUL) or WHO prequalification (PQ).
• Minimum shelf life: Donated vaccine doses must have a minimum shelf life of six months upon arrival in the country. This aims to balance the time needed to facilitate operational roll-out with the reality of an emergency response and management of vaccines.
• Reasonable quantity of vaccine doses: Gavi has a preference to ensure donation offers are sufficiently large to be cost-effective, operationally practical and responsive to the specific demand in recipient countries.
• Source of donations: Donated vaccine doses may be sourced either directly from the manufacturer or from doses already in the possession of donor countries. Gavi will assess all available doses, considering their characteristics and the recipient country’s demand. This evaluation will be integrated within the AAM framework to align supply with the recipient country’s response timelines and demand.
• Product labelling: When donating doses, donors should indicate the language of the labels and inserts of the donated products. Translation into French may be required.