Containment of type 2 polioviruses in Europe continues with training of national auditors

Wild poliovirus type 2 (PV2) has been declared eradicated worldwide, but is still present in laboratories and vaccine manufacturing facilities across the globe. To minimize the risk that the virus could ever re-enter the environment, all countries holding PV2 materials are required to either destroy or safely contain them in accordance with GAPIII, the WHO Global action plan to minimize poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of oral polio vaccine use. All facilities planning to hold PV2 in the future must be certified for poliovirus containment in accordance with the Containment Certification Scheme (CCS).

Member States of the WHO European Region planning to keep any PV2 materials for research or vaccine-manufacturing purposes were invited to a WHO-organized training on CCS on 6–10 March 2017 in Copenhagen, Denmark. Delegates from 11 countries with expertise in the auditing of good manufacturing practices, risk management, biosafety management and other areas attended the training, which was one of a series being conducted around the world.
The course focused on:

• the CCS process and mechanism;
• GAPIII requirements for certification;
• auditor and audit team roles and responsibilities; and
• the audit programme, including practical exercises in:
  • audit preparation;
  • conducting opening and closing meetings;
  • conducting on-site auditing activities;
  • preparing audit findings and conclusions; and
  • reporting audit results and follow-up.

The training highlighted the challenges and costs of certifying and permanently monitoring a poliovirus essential facility (PEF) so that each country could carefully examine the rationale for retaining PV2 materials.

Background

The poliovirus containment initiative implemented under the GAPIII framework is currently focused on the containment of all PV2 materials, either wild or of vaccine origin. In accordance with GAPIII, those Member States who designate PEFs on their territories should establish a National Authority for Containment (NAC) to be responsible for containment certification of PEFs in compliance with the CCS. One of the major functions of an NAC is to conduct initial and periodic audits of PEFs to ensure their safe and secure operation.