Vaccine donations: policy statement of the partners of the Global Alliance for Vaccines and Immunization

Vaccine donations WHO/V&B/00.25 ORIGINAL: ENGLISH DISTR.: GENERAL Policy statement of the partners of the Global Alliance for Vaccines and Immunization1 A vaccine donation is defined as a shipment of vaccine for which a government does not pay. Properly managed, vaccine donations may be useful to immunization programmes. However, if there is no control over the specifications of the vaccine, or if the donated vaccine does not meet the needs of the government’s immunization programme, the donation could leave a country vulnerable to problems and actually disrupt the programme. Furthermore, a vaccine donation must be part of a sustainable vaccine supply; if, once the donated supply is exhausted, there is no provision for sourcing the vaccine, the sustainability of the immunization programme is threatened. The aim of these guidelines is to improve the management of donated vaccines, and not to hinder donations. Vaccines shipped through UNICEF Supply in Copenhagen may technically be considered as donations, but as their specifications are developed by a collaborative effort between national officials and UNICEF country staff, such vaccines are not included in these guidelines. Most recipients of vaccine donations are countries dependent on UNICEF and other donors for their supply of vaccines. Many lack infrastructure to handle donations adequately. WHO recommends that all countries, including those which receive all their vaccines from UNICEF, exercise at least two essential national control functions: a published set of requirements for licensing or other control procedures appropriate to the country’s needs, and surveillance of vaccine field performance (monitoring of adverse events following immunization). In the case of a problem in the field which may be vaccine related, or of doubt of vaccine potency because of a cold chain break in transport, UNICEF can be notified and, if vaccine testing is needed, WHO laboratories can be used. 1 This document is an abbreviated version of a previous WHO statement on vaccine donations (WHO/VSQ/97.05), and was endorsed by the Board of the Global Alliance for Vaccines and Immunization (GAVI).
  
       WHO has already published guidelines for receipt of donations of drugs (WHO/DAP/96.2). For the most part, these guidelines are applicable for vaccines as well. Five proposed minimum specifications for vaccine donations restate these guidelines in a manner applicable to vaccines:
the vaccine is epidemiologically appropriate for the immunization programme; that is, the donated vaccines are consistent with the goals of the immunization programme;
the vaccine is subject to prescribed licensing and or other control procedures set up by the recipient government, and is in compliance with quality standards in both donor and recipient countries;
the vaccine is consistent in presentation and specifications with other vaccines in the programme; that is, the donated vaccine should be familiar to the health professionals in the recipient country in such characteristics as potency, liquid or freeze-dried presentation, transport, shelf life, number of doses per vial, thermostability, and label language and information;
responsible officials in the recipient country should be informed of all donations that are being considered, prepared, or actually under way, and the vaccine should be shipped only on their request;
prior to the donation of a vaccine that is new to the recipient country, efforts should be undertaken to assure sustainable use of the vaccine after the period of donation. Copies may be requested from: World Health Organization Department of Vaccines and Biologicals CH-1211 Geneva 27, Switzerland • Fax: + 41 22 791 4227 • E-mail: vaccines@who.int • © World Health Organization 2000 This document is not a formal publication of the World Health Organization (WHO), and all rights are reserved by the Organization. The document may, however, be freely reviewed, abstracted, reproduced and translated, in part or in whole, but not for sale nor for use in conjunction with commercial purposes. The views expressed in documents by named authors are solely the responsibility of those authors. This document is available on the Internet at: www.who.int/vaccines-documents/ Ordering code: WHO/V&B/00.25 Printed: August 2000