ABSTRACT
In the European Union three different procedures for licensing medical products exist: the national licensing procedure, the centralised licensing procedure as well as the mutual recognition facilitation procedure (MRFP). The paper will discuss all three procedures with respect to the licensing of vaccines. In addition it focuses on the advantages and disadvantages of each procedure and discusses the resulting consequences for vaccine application as well as the development of vaccination schemes.
ABSTRACT
For the production and control of adsorbed vaccines it is necessary to know and respect some basic features of adsorption. Among others these are the surface charges of adsorbents and antigens, the pH of the medium, the buffer components and the maturation process. They are important for the adsorption behaviour and have influence on the stability of the adsorbate and potency of the vaccine. Individually different conditions for optimal adsorption of antigens can be respected with a production strategy, where every antigen is adsorbed separately in a controlled manner, before it is mixed with other antigens to the final bulk vaccine. This strategy is favoured over strategies with sequential or competitive adsorption of the antigens.
Subject(s)
Adsorption , Technology, Pharmaceutical , Vaccines, Combined/chemistry , Aluminum Compounds/chemistry , Aluminum Hydroxide/chemistry , Antigens/chemistry , Diphtheria Toxoid/chemistry , Drug Stability , Gels , Hydrogen-Ion Concentration , Ions/chemistry , Phosphates/chemistry , Proteins/chemistry , Reference Standards , Surface Properties , Terminology as Topic , Tetanus Toxoid/chemistrySubject(s)
Pertussis Vaccine/biosynthesis , Pertussis Vaccine/standards , Animals , Antigens, Bacterial/analysis , Bordetella pertussis/immunology , Drug Stability , Humans , Pertussis Vaccine/toxicity , Quality Control , Reference Standards , Vaccines, Combined/biosynthesis , Vaccines, Combined/standards , Vaccines, Combined/toxicitySubject(s)
Pharmacopoeias as Topic , Vaccines/toxicity , Animals , Europe , Guinea Pigs , Humans , Immunologic Tests , Mice , Vaccines/standardsSubject(s)
Diphtheria/epidemiology , Emigration and Immigration , Hepatitis, Viral, Human/epidemiology , Poliomyelitis/epidemiology , Public Health , Tuberculosis/epidemiology , Diphtheria/prevention & control , Hepatitis A/epidemiology , Hepatitis A/prevention & control , Hepatitis B/epidemiology , Hepatitis B/prevention & control , Hepatitis, Viral, Human/prevention & control , Humans , Immunization Programs , Poliomyelitis/prevention & control , Risk Factors , Tuberculosis/prevention & controlABSTRACT
The prophylactical effect of human anti-Pertussis immunoglobulin was shown in a passive protection test in mice over a time of 9 days, which is more than three times the half live time. In the agglutination test one could find a half life time of 64.7 hours; in the neutralisation test, which is the only valuable for the clinical effect, we could find an average value of half life time of 51.6 hours. We found a nearly parallel decrease in both titers. In the view of our results we discussed former clinical trials and the prospects for a future use of anti-Pertussis immunoglobulins in prophylaxis and therapy; in both fields only those preparations should be used, which are tested for clinical efficiency in a neutralisation test.
Subject(s)
Antibodies, Bacterial/immunology , Bordetella pertussis/immunology , Immunity, Maternally-Acquired , Immunoglobulins/immunology , Whooping Cough/immunology , Agglutination Tests , Animals , Half-Life , Humans , Immunization, Passive , Mice , Neutralization TestsABSTRACT
A reproducible method for potency-testing of pertussis-sera and - immunoglobulines in a neutralisation test in the mouse is described. The tests were done on two human immunoglobulines, one crude immune serum from the rabbit, and two purified resp. concentrated rabbit immune sera, one of which - the US-Standard for Pertussis Sera - was used as the standard preparation for the potency evaluation. There is no correlation between the results of the neutralisation test and the agglutination titer among the different preparations. That means, the agglutination titer is not suitable for comparing the potency of pertussis sera resp. - immunoglobulines. It seems necessary to establish a uniforme method as well as a standard preparation for potency testing of pertussis sera and - immunoglobulines on the basis of the neutralisation test in the mouse - at least on the European level.
Subject(s)
Pertussis Vaccine/therapeutic use , Whooping Cough/prevention & control , Agglutination Tests , Animals , Bordetella pertussis/immunology , Immunoglobulins/standards , Immunoglobulins/therapeutic use , Mice , Neutralization TestsABSTRACT
Neutralisation tests were done with pertussis immunoglobulins and immunosera in which mice were immunised by intraperitoneal injection and challenged 4 hours later by intracerebral injection. The results of the neutralisation tests were compared with those of the agglutination tests done with the same preparations. For 2 pertussis immunoglobulins a correlation was found between the results of both tests, but generally no correlation exists between the agglutinating activity and the protective value of the preparations. There is a more than 100-fold difference in their relationship. Therefore a neutralisation test should be used for potency testing of pertussis immunoglobulins.
