ABSTRACT
Vaccines belong to the category of immunobiologicals: products that are produced by or derived from a living organism. Immunobiologicals include a variety of products, such as vaccines, immunoglobulins, monoclonal antibodies, and antisera. The characteristic that de—nes vaccines is that these preparations are capable of inducing a speci—c and active immunity against an infecting agent or its toxin (European Pharmacopoeia 2003). Vaccination is one of the most powerful and costeffective tools in modern medicine. The worldwide immunization campaigns against a number of infectious diseases (e.g., diphtheria, tetanus, measles) have led to substantial decreases in mortality and morbidity rates and, in the case of smallpox and poliomyelitis, to complete and almost complete eradication, respectively. In the past decade, the importance of vaccines has signi—cantly increased because of the emergence of antibiotic-resistant strains of bacteria, such as Mycobacterium tuberculosis; the impact of viral infections, such as pandemic in–uenza (e.g., H5N1, H1N1), human immunode—ciency virus (HIV), and Ebola; increased biological welfare threats (e.g., smallpox and anthrax); global travel and tourism; the high incidence and economic effects of infectious diseases in large livestock industries; and various other factors (Hendriksen 2009).
