Ensuring quality and integrity of vaccines throughout the cold chain: the role of temperature monitoring.

ABSTRACT

INTRODUCTION: Vaccines have continually proven their inestimable value to the world through the eradication of smallpox, gains achieved toward a polio-free world, and controlling other vaccine-preventable diseases. Although vaccines require certain temperatures and conditions to maintain their potency, supply chain controls vary greatly at different legs of the global journey. Vaccine manufacture is closely managed, but inconsistencies plague the cold chain when vaccines are shipped and stored in variable conditions. Monitoring vaccine temperatures throughout the cold chain is of paramount importance to ensure quality. The emerging COVID-19 vaccines present the world with new challenges and additional opportunities to establish best practices for safeguarding human health. AREAS COVERED We review the risks associated with the vaccine cold chain that require temperature monitoring throughout shipment and storage. Electronic and chemical monitoring devices are compared along with data needs. Regulatory oversight and guidance are also discussed. EXPERT OPINION Regulatory oversight has contributed to the creation of a risk management and quality culture among private sector players in the vaccine field. Meanwhile, the public sector (the main player at the country level) remains largely untouched by regulatory oversight. Adherence to best practices shall only be possible with increased regulatory oversight of public sector operations.