Monitoring and safety assessment in Phase I to III clinical trials.

Safety issues play an important role for registration of new vaccines due to growing awareness of regulators and growing safety concerns of the general public, whether they are justified or not. Safety of a vaccine implies much more than merely monitoring and reporting adverse events, but relies on a holistic view including control of manufacturing, surveillance of possible long term effects, epidemiological data, the vaccination schedule and signals from post marketing surveillance. Vaccine safety has scientific and organisational implications. To achieve a balanced risk-to-benefit evaluation the input of a central safety department is recommended from planning of a clinical development to post-marketing phase. The concept of data evaluation and data assessment should be medically driven in close cooperation with the biometricians. An integrated safety plan with standardized procedures improves the likelihood of detecting a realistic AE-profile, prior to marketing a vaccine. The unique opportunity of a controlled clinical trial should be taken advantage of by optimizing both the organisation and the scientific methods. Further development of methodology of safety monitoring and assessment should be given the same importance as proving efficacy and complying with the regulatory requirements.

[Oral vaccines against poliomyelitis and vaccination-related paralytic poliomyelitis in Germany. Do we need a new immunization strategy?]. / Schluckimpfung gegen Poliomyelitis und impfassoziierte paralytische Poliomyelitis in Deutschland. Brauchen wir eine neue Impfstrategie?

Oral vaccination against poliomyelitis, which was carried out worldwide, lead to eradication of poliomyelitis in the United States, in South America and parts of Europe; in other parts of the world, paralytic poliomyelitis is still a severe risk of health. In those countries where poliomyelitis has been eradicated, it is presently discussed whether the vaccination schedules should be changed to an inactivated polio vaccine (IPV), as in polio-free countries only cases of paralytic poliomyelitis after vaccinations have been reported. Behringwerke's data from a 30-year period of analysing adverse drug reaction reveal the following: using the trivalent oral polio vaccine (OPV), based on WHO case definition, the risk for vaccine-associated paralytic poliomyelitis with permanent damage is approximately 1 case for 4.5 million vaccinations (0.22 per million) in vaccinees, and approximately 1 case for 11 million (0.09 per million) in contact persons. This low risk is in line with the data ascertained worldwide.