Regulation for <em>Haemophilus influenzae</em> type b conjugate vaccines, based on synthetic oligosaccharides

Abstract

Introduction: The World Health Organization plays a decisive role in the regulation of vaccines to ensure their safe use, if their positive health impact is taken into account.

Objective: To demonstrate the current alignment of the Cuban Quimi-Hib® vaccine with the current regulatory framework of the World Health Organization, applicable to this vaccine.

Methods: Descriptive, longitudinal and retrospective study of the information published by the World Health Organization, in force in 2021, of the type of guidelines and trend documents, applicable in a general or particular way. The information was collected by bibliographic search in public sources and organized in tables according to type, year of issuance and content. The current requirements were compared with those available during the development and registration of Quimi-Hib® in Cuba. The evaluation of previous editions and their compliance was included.

Results: 18 documents were identified which were published by WHO between 1992 and 2017, of which 16 were normative and two were trend documents. A total of four were in force in 2003 and of the remaining 14, six had previous editions. Evidence of implementation in the evolution of nine current documents with several editions was related.

Conclusions: The World Health Organization has enacted a comprehensive regulatory framework applicable to conjugate vaccines against Haemophilusinfluenzae type b. Quimi-Hib's® research, development and sanitary registration process followed these recommendations for vaccines of this type based on natural polysaccharides, due to the absence of specific requirements for synthetic oligosaccharides. After its registration in 2003, it has been verified that its alignment with the updates made to this regulatory framework is maintained, in which there are still no specifications for Hib vaccines based on synthetic oligosaccharides.