Combination vaccines: development, clinical research and approval

Abstract

Vaccine has without question been among our most powerful tools for preventing diseases, disability and death, and controlling health care costs. Recent advances in gene cloning and expression, peptide synthesis and other technologies have created opportunities for developing bioengineered vaccines that promise a substantial return on research and development costs. The implementation and improvement of combination vaccines is an important tool to accelerate the global immunization of infants against multidiseases. It will reduce the number of injections that individuals must receive in order to develop immunity against several diseases, in the hope that fewer immunization will lead to increase vaccination rates saving and improving lives in several countries, especially in developing countries.The book Combination Vaccines: Development, Clinical Research and Approval is a comprehensive and concise reference on several aspects of multidisease and multivalent combination vaccines. It describes a large number of combination vaccines in current uses and under development and gives data from controlled studies on these vaccines revealing the effects of this combination in relation to immunogenicity and safety in comparison with the individual vaccines. The list of available combination vaccines and the schedules for routine pediatric immunization shows the complexity of the technical task involved in their development.Data on the efficacy of combination vaccine for most widely used vaccines is highlighted in terms of its component and the type of immune response associated with protection. A summary of the general properties of the vaccines and the target potential populations are also given.The book is also an update on the latest vaccines submitted for licensure such as a multivalent vaccine against rotavirus diarrhea, which kills 6-800,000 children each year and the new vaccines developed against Streptococus pneumoniae, responsible for 1,2-million childhood death from pneumonia.Moreover, the conventional sequence for evaluation and licensure of combination vaccines are described such as formulations, stability, and compatibility of antigens and preclinical testing. The book is a guideline to all those who are interested in testing vaccine combinations.

Promises and pitfalls for recombinant oligoclonal antibodies-based therapeutics in cancer and infectious disease

“…These regulations require characterization of the bulk activity of the product, but not the individual antibodies. A similar consideration applies to the regulation of multivalent vaccines, which does not require assessment of individual vaccine antigen components [102]. However, recombinant biologics are regulated by the Center for Drug Evaluation and Research (CDER) and different rules apply.…”