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Chapter 13 : Licensing of Pneumococcal Conjugate Vaccines for Children and Adults: Regulatory Perspective from the European Medicines Agency and the U.S. Food and Drug Administration

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Licensing of Pneumococcal Conjugate Vaccines for Children and Adults: Regulatory Perspective from the European Medicines Agency and the U.S. Food and Drug Administration, Page 1 of 2

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Abstract:

This chapter provides European Union (EU) and U.S. regulatory perspectives for the licensure of pneumococcal conjugate vaccines indicated for the pediatric and adult populations. In the United States, vaccines are regulated as biological products by the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration (FDA). For certain new drugs and biological products to prevent or treat serious or life-threatening illnesses, the FDA has published final regulations under which the agency would accelerate the approval of these products. Since the mid-1990s, a new registration system in the EU has governed the granting of marketing authorizations, which manufacturers must obtain for any medicinal product they intend to market, including a vaccine. Potential applicants for new pneumococcal conjugate vaccines indicated for children and adults are expected also to use the EU centralized procedure. The postmarketing evaluation of the safety of Prevnar conducted by the applicant as a postmarketing commitment included an observational study evaluating the safety of Prevnar in approximately 60,000 infants. An assessment of the benefit of a new conjugate vaccine comprising fewer serotypes than the 23vPS vaccine is complicated by the loss of protection afforded by the additional serotypes in the polysaccharides (PSs) vaccine. To facilitate the clinical development of new pneumococcal conjugate vaccines, a series of global and national workshops and meetings were held in consultation with the World Health Organization (WHO) and particular advisory bodies to formulate licensure criteria.

Citation: Gruber M, Pratt D, Haase M. 2008. Licensing of Pneumococcal Conjugate Vaccines for Children and Adults: Regulatory Perspective from the European Medicines Agency and the U.S. Food and Drug Administration, p 183-196. In Siber G, Klugman K, Mäkelä P (ed), Pneumococcal Vaccines. ASM Press, Washington, DC. doi: 10.1128/9781555815820.ch13

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References

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