Isaac Gobina

Hi Larry,

For vaccines requiring ultra-low storage temperatures (i.e. ≤60°C), WHO PQS is in the process of developing a range of performance specifications and testing protocols to ensure the performance, quality and safety of ultra-low temperature (ULT) CCE. Building on lessons learned from the Ebola vaccine, WHO PQS wants to make sure that ULT CCE takes into account the needs and challenges immunization programs face when it comes to transportation, storage, management and handling of ULT vaccines.

Right now, WHO PQS performance specifications for both active (freezers) and passive (cold boxes) ULT appliances are under development with the support of industry and non-industry partners. Dedicated specifications for ULT power systems are also being developed to ensure a continuous power supply to ULT appliances. The same goes for ULT accumulators for use in passive ULT devices. Our objective is to publish these ULT performance specifications and testing protocols in December 2020. Specifications for ULT temperature monitoring devices will follow in the new year.

In addition to ULT CCE availability, a discussion is also needed on how we will prepare our health care professionals to safely manage and handle ULT CCE. EPI Standard Operating Procedures and guidelines need to developed concurrently to ensure the safe distribution of ULT vaccines.

Isaac GOBINA, WHO PQS Secretariat