WHO released a revised WHO-UNICEF Joint Statement on Vaccine Donations WHO/IVB/10.09 which “updates previous WHO statements on vaccine donations (WHO/VSQ/97.05; WHO/V&B/00.25) and clarifies situations which were not covered by the previous policy statement, such as donations for research projects and donations in the case of emergency, epidemic or pandemic situations.”
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“…Exceptional Situations
There may be exceptional situations when it is not possible to meet the minimum requirements outlined above. These commonly include:
– Donations to research projects:
The use of vaccine donated for research purposes must be guided by the International Ethical Guidelines for Biomedical Research Involving Human Subjects issued by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization ( http:\\www.cioms.ch\frame_guidelines_nov_2002.htm), the Declaration of Helsinki, and supplemented by other internationally and nationally accepted statements of ethical guidance adopted by the recipient country.
Such projects must also comply with other national regulations and requirements related to medical research involving human subjects. New vaccines or devices that have not received regulatory approval in the country should not be used on human subjects without the appropriate approval being obtained from the National Drug Regulatory Agency for their use under the conditions of the study. Under these circumstances, it is especially important to ensure the suitability of the product, its presentation, and its schedule, as it may not be yet licensed in the recipient country nor WHO prequalified.
– Vaccines donated for emergency, epidemic or pandemic situations when it may not be possible to apply all the minimum specifications above:
In some instances the vaccine specifications and presentation may vary from what is in routine use, the remaining shelf life may be limited, and sustainability is not an issue. In such cases the most important considerations are that the vaccine is suitable to the country’s needs from the public health perspective and that the responsible officials in the recipient country are in full agreement with shipping the vaccine, and are able to respond to quality and storage aspects of the donation. In addition, as with any other donation, the vaccine is subject to prescribed licensing and/or other control procedures set up by the recipient government. In such cases it is also useful for recipient countries to have an immunization plan…”
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