The CDC Vaccine Storage and Handling Toolkit provides vaccine providers with guidelines and recommendations for the proper storage of vaccines. The CDC recommends using purpose-built units with a digital data logger to safeguard vaccines. A recently added addendum and a separate COVID-19 Vaccine Playbook were also released to help providers understand the cold storage requirements for the Pfizer and Moderna COVID-19 Vaccines. The Pfizer vaccine requires long term storage at -70C, which is a first for vaccines.
Beyond CDC recommendations, there are few regulatory requirements or even non-regulatory guidelines that outline specific requirements for temperature performance in purpose built or non-purpose-built units. With no current standard that defines temperature performance requirements for vaccine storage, the CDC and NSF are working together to define that standard.
This joint committee is comprised of stakeholders from public health agencies (including the CDC), healthcare providers, vaccine manufactures, and equipment manufacturers. The committee is charged with developing standards that help ensure cold storage units have appropriate temperature performance to maintain the safety of vaccines. The emerging standard is expected to help close that gap by providing testing protocols that challenge units according to real-world use cases, including various vaccine load conditions and door opening scenarios.
It is expected that the committee will vote and finalize the proposed standards in early 2021. We can assume that after the standard is approved, manufacturers will be able to certify units to the standard using 3rd-party testing organizations. Certified units will provide an additional level of confidence to healthcare providers that cold storage units will maintain vaccines at required temperatures, helping to maintain the safety and efficacy of every dose.
