Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Overview of the Regulatory Environment for Developing New Vaccines Including the Specific Smallpox Vaccine and Pandemic Influenza Virus Vaccines ***

Dr. Cortina Kaletta (Abschlußjahr: 2006)

Language: English

Vaccines are crucial to maintaining public health: They are a safe, cost-effective, and efficient way to prevent sickness and death from infectious diseases. In most cases, vaccines are administered prophylactically but may also be given to individuals who have been exposed to a disease in an attempt to prevent the progress of the disease. Other vaccines may be given to alter the course of a non-infectious disease like cancer. Vaccines for human use may contain inactivated organisms that maintain their immunogenic properties, living organism that are naturally avirulent or that have been treated to attenuate their virulence. Both bacterial and viral vaccines are manufactured using a seed-lot system with a strict control of the manufacturing process and intermediates. The most important aspect during development is the comparability of the test material. The preclinical evaluation of the vaccine candidate demonstrates the immunogenicity and safety and guarantees the protection of clinical trial participants from potential adverse effects. The clinical testing programme should generate data concerning appropriate route of administration, dose schedules, and age categories of exposed subjects in relation to the efficacy of the vaccine. Special consideration should be taken for vaccines against pathogens that are eradicated but may be used as bio weapons (e.g. smallpox) or for pandemic influenza viruses where the organism still not exists in order to make a vaccine available as soon as possible after a potential outbreak. Beside the general approval possibilities (centralised procedure, mandatory with effect from 20 May 2008 for drugs against viral diseases; decentralised procedure, national authorisations several other forms are possible e.g. accelerated approval, approval under exceptional circumstance or conditional marketing authorization in the EU as well as Emergency Use Authorization and approval under the animal rule in the USA. Pharmacovigilance of vaccines after their marketing authorization is essential because they are generally administered to wide and healthy populations. Therefore anything must be done to ensure adequate protection of public health.

Since vaccines are of major public health interest in the world, it is necessary to address all issues concerning vaccine development in a consolidated approach with the aim to maintain a high level of vaccination compliance. A harmonization between the Member States, EMEA/CHMP and European Commission to all questions related to vaccines was therefore desirable. The EMEA (since 2004 the permanent Vaccine Working Party) as well as the FDA has released a lot of vaccine guidelines covering the different topics in order to ensure the consistency and safety of vaccine development.

Pages: 47