The Virology division’s duties include conducting research into the pathogenesis and prevention of viral diseases, the marketing authorisation and batch control of viral vaccines, the approval of clinical trials of viral vaccines, the evaluation of diagnostic methods for viruses, the assessment of virus inactivation methods and viral safety in biomedicines, and the characterisation of new viral pathogens. Experts from the division provide advice to applicants on clinical trials and on scientific and regulatory issues in the field of virology. They represent the PEI on the committees of the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines (EDQM) and the World Health Organization (WHO).
Head of Division’s Research Group
The scientists carry out research into the pathogenesis and replication cycles of hepatitis B, hepatitis C and hepatitis E viruses and of ZIKA viruses. The research group develops new vaccine platforms and, together with the division’s regulatory sections, conducts testing-related research projects.
Viral Vaccines Section
The section oversees the whole marketing authorisation cycle and batch control of viral human vaccines, e.g. influenza vaccines which need to be adapted annually to the circulating virus subtypes. It also deals with the marketing authorisation and experimental testing of innovative vaccines, currently vaccines against Ebola. The section is responsible for certain key tasks of the WHO Collaborating Centre for the Standardization and Evaluation of Vaccines at the PEI and, in particular, conducts research into the characterisation of influenza vaccines.
AIDS, New and Emerging Pathogens Section
The section handles the approval of clinical trials of HIV vaccines. In its own experimental work, the research group characterises novel and emerging infectious diseases. Its scientists are investigating the evolution of HIV during anti-retroviral therapy and are developing new therapy concepts and animal models for the testing of vaccines against AIDS.
Viral Safety Section
The scientists test and evaluate methods for the removal or inactivation of viruses and prions in the manufacture of biomedicines. The section creates a large number of reference materials, such as a standard for ZIKA or, currently, for hepatitis E, and conducts research into the standardisation of test methods, the selection of the necessary model viruses and the development of novel, improved detection systems and inactivation methods.
Molecular Virology Section
The section assesses molecular biological detection methods for viruses, based on the nucleic acid amplification technique (NAT), with regard to their performance parameters, such as sensitivity and specificity, and tests biomedicines for viral contamination. In addition, the section creates reference materials for checking and harmonising these test systems – at present for the West Nile virus.
In its research, the section uses NAT to investigate the spread of significant infectious agents and the emergence of new viruses that have an effect on blood safety.