State of the world’s vaccines and immunization Third edition Suggested citation: WHO, UNICEF, World Bank. State of the world’s vaccines and immunization, 3rd ed. Geneva, World Health Organization, 2009. This book is dedicated to all those individuals who work tirelessly to improve and save lives through vaccines and immunization. WHO Library Cataloguing-in-Publication Data State of the world's vaccines and immunization. -- 3rd ed. 1.Immunization programs 2.Immunization 3.Vaccines 4.Biomedical research 5.Child 6.Infant 7.Interinstitutional relations 8.International cooperation 9.Developing countries I.World Health Organization. ISBN 978 92 4 156386 4 (NLM classification: WA 110) © World Health Organization 2009 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). 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Third edition ISBN 978 92 4 156386 4 Please note the following: Page 38: Innovative regulatory pathways Traditionally, when a national regulatory authority in a developing country considers whether to host clinical trials of a new vaccine produced in another country, or whether to adopt a new vaccine in its country’s immunization programme, it would be favourably influenced if the vaccine had been approved for human use by the European Medicines Agency or the FDA. However, in 2004 and 2007, respectively, both agencies decided to no longer accept vaccines for marketing approval where they are intended for use exclusively outside their geographical jurisdictions. This decision raised a fear that the supply of new life-saving vaccines to developing countries may be hindered or delayed for lack of authoritative marketing approval. In 2005, therefore, the European Medicines Agency introduced a mechanism, known as “Article 58”, whereby it issues a “scientific opinion” based on the customary Agency process but with the addition of an evaluation of the vaccine by WHO-appointed experts from countries where the vaccine is intended to be used. This mechanism, although stopping short of formally granting a licence, involves all the steps of a regular licensing procedure. It carries enough weight to allay fears that vaccines may be introduced without having been assessed for safety and quality. Moreover, the FDA and the European Medicines Agency have agreed to work with national regulatory authorities or with networks of regulators in the regions, to provide advice on vaccine safety and efficacy as well as on clinical trial protocols. Similar collaborative agreements are being forged in other parts of the world, notably in Asia. 1 should read: Innovative regulatory pathways Traditionally, when a national regulatory authority in a developing country considers whether to adopt a new vaccine in its country’s immunization programme, it would be favourably influenced if the vaccine had been approved for human use by the European Medicines Agency (EMEA) or the FDA. However, in 2004, the EMEA decided to no longer issue marketing authorization for vaccines intended exclusively for use outside the European Union. This decision raised a fear that the supply of new life-saving vaccines to developing countries may be hindered or delayed for lack of authoritative marketing approval. In 2005, therefore, the EMEA introduced a mechanism, known as “Article 58”, whereby it issues a “scientific opinion” based on the customary Agency process but with the added input of experts — proposed by WHO to the EMEA — from countries where the vaccine is intended for use. This mechanism, although stopping short of formally granting a licence, involves all the steps of a regular licensing procedure. It carries enough weight to allay fears that vaccines may be introduced without having been assessed for quality, safety and efficacy for the intended population. Moreover, the national regulatory authorities in Europe and the United States have agreed to work with global and regional networks of regulators. Collaborative agreements are being established to promote expert advice from the European and United States regulators to regulatory authorities of developing countries hosting clinical trials or reviewing registration dossiers of vaccines manufactured under the jurisdiction of the former. Pages 49-50 By mid-2005, 53 countries, mostly in Africa and Asia, had begun implementing the RED strategy to varying degrees (see Fig. 6) ( 32 ). In 2005, an evaluation of five countries in Africa that had implemented RED found that the proportion of districts with over 80% of children fully immunized with DTP vaccine had more than doubled ( 33 ). More recently, a nine-country evaluation carried out by the CDC in 2007 found that the RED strategy had been adopted by 90% of all districts within these countries. However, few of the nine countries were implementing all five components of the strategy (see Box 11). The CDC evaluation noted that further studies would be needed over a longer period to assess the effectiveness and sustainability of the strategy. should read: By mid-2005, 53 countries, mostly in Africa and Asia, had begun implementing the RED strategy to varying degrees (see Fig. 6) ( 32 ). In 2005, an evaluation in five countries in Africa that had implemented RED carried out by staff from WHO's Regional Office for Africa, with the support of UNICEF, the IMMUNIZATIONbasics project, and the United States Centers for Disease Control and Prevention found that the proportion of districts with over 80% of children fully immunized with DTP vaccine had more than doubled ( 33 ). A nine-country in-depth evaluation carried out by the same groups in 2007 found that the RED strategy had been adopted by 90% of all districts within these countries. However, few of the nine countries were implementing all five components of the strategy (see Box 11). The in-depth evaluation noted that further studies would be needed over a longer period to assess the effectiveness and sustainability of the strategy. 2 Page 105 The search for a safer, more effective cholera vaccine produced three new-generation vaccines, of which only one is available for widespread use today. This vaccine, first licensed in Argentina in 1997 and code- named WC/rBS, is made from the whole-cell V. cholerae linked to a genetically engineered (recombinant) fragment (B-subunit) of the cholera toxin. should read: The search for a safer, more effective cholera vaccine produced three new-generation vaccines, of which only one is available for widespread use today. This vaccine, first licensed in Argentina in 1997 and code- named WC/rBS, is made from the whole-cell V. cholerae and a genetically engineered (recombinant) fragment (B-subunit) of the cholera toxin. Page 107 These observations have prompted countries where diphtheria is no longer endemic to extend vaccination protection beyond the primary three-dose series for infants by administering one, or sometimes two, booster doses every 10 years to adults through the diphtheria-tetanus (dT – low content of diphtheria) combination vaccine ( 67 ). should read: These observations have prompted countries where diphtheria is no longer endemic to extend vaccination protection beyond the primary three-dose series for infants by administering one booster dose every 10 years to adults through the diphtheria-tetanus (dT – low content of diphtheria) combination vaccine ( 67 ). Page 108 Notwithstanding clear evidence of the vaccine’s efficacy, by 1997 only 29 countries were using it routinely, prompting WHO to recommend its inclusion in the routine immunization programmes of all countries where Hib was recognized as a public health burden and where the cost of the vaccine was not prohibitive ( 70 ). should read: Notwithstanding clear evidence of the vaccine’s efficacy, by 1997 only 26 countries were using it routinely, prompting WHO to recommend its inclusion in the routine immunization programmes of all countries where Hib was recognized