Events on 28 September 2023

The Arenaviridae have the dubious distinction of containing among their members one of greatest proportions of hazard group 4 viruses of any recognised taxonomic family. These viruses cause persistent asymptomatic infections in their rodent reservoirs, however zoonotic spill over often results in viral haemorrhagic fever (VHF) and high mortality. Transmission to humans occurs via contact with infected rodent excreta, through contaminated food and inhalation of aerosols. Human to human transmission also occurs. In sub-Sharan West Africa, Lassa virus (LASV) has been identified as a VHF since 1969 and is endemic over much of rural Nigeria, the countries of Mano River Union, Ghana, Togo and Benin.

From a global health security perspective, it is of significant international interest since it the most commonly imported VHF into non-endemic countries. In nearly every imported circumstance, the cryptic nature of Lassa fever and related difficulties in diagnosis, places enormous demand on clinical, laboratory and public health resources of the recipient country. Given our current understanding of LASV and other evolving members of the genus, attention should be focused on other new and emerging mammarenaviruses which have similar incubation times and could result in similar human disease with a propensity to overburden public health systems.

The IVDR is the new regulatory instrument for placing IVDs on the European market. The aims of the IVDR are to provide a robust, transparent and sustainable IVD framework, harmonize divergence in implementation (as experienced with the IVDD) and most importantly to increase patient safety. The document runs to 156 pages (compared to 43 for the IVDD, containing 114 articles and 15 annexes. The IVDR places more emphasis on the economic operators (actors) involved in the IVD supply chain, from the manufacturer to the customer.

Manufacturers have the obligations to design and manufacture products in compliance with the IVDR; evaluate product performance and manage risk, have a Quality Management System, create and maintain product technical documentation, conduct post market surveillance, and implement field safety corrective actions. One of the biggest changes with IVDR is the introduction of a new rules-based approach for product classification. Under IVDR, Notified Bodies perform conformity assessment on 80% of IVDs (compared to 20% under the IVDD, which becomes stricter as the risk class increases. There are also enhanced concepts for performance evaluation and clinical evidence.

Under the IVDR there is a requirement to state the clinical purpose in the intended use. Thus, in order to comply with the new regulation, manufacturers must revise all intended purpose statements in product labelling. Further, there is the obligation to gather a large amount of data to evaluate both analytical and clinical performance. Manufacturers are required to continually evaluate performance across the whole product lifecycle through post market surveillance and vigilance, with reports for the highest-risk devices uploaded to the new EUDAMED database on an annual basis.

This lecture will overview previous viral pandemics affecting humans and highlight lessons learned (or not). This lecture will provide the audience with background information relevant to the two subsequent talks on pandemics currently affecting and what might come next. At the end of this talk the audience will have knowledge on some major pathogenic viruses that have impacted hugely on the human population including:

Smallpox; influenza; polio; yellow fever; HIV and Ebola that bring us up to the novel coronavirus outbreaks that have plagued mankind during more recent years.

Pandemics Present

Future: Preparedness planning & what might come next