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Table 1 Management of COVID-19 vaccines cold chain logistics

From: Management of COVID-19 vaccines cold chain logistics: a scoping review

Theme/main category Challenges (C), Authors (reference) Origin, Article type, Conceptual framework Key points on challenges to cold chain management
Requirements for Cold Chain Logistics C1
Holm MR, Poland GA. Critical aspects of packaging, storage, preparation, and administration of mRNA and adenovirus-vectored COVID-19 vaccines for optimal efficacy. Vaccine. 2021;39(3):457–9
USA, Review Infrastructure requirements
• Lack of proper storage systems
i) Each vaccine has different packaging and requirements for storage, preparation, and administration
ii) Several vaccines require ultra-cold or have cold-storage requirements that are different than what vaccine administrators are prepared for
C2
Grau S, Ferrández O, Martín-García E, Maldonado R. Accidental Interruption of the Cold Chain for the Preservation of the Moderna COVID-19 Vaccine. Vaccines (Basel). 2021;9(5):512
Spain, Case study Formulation stability i) No information is available on the impact on stability when vaccine is exposed to unexpected changes in temperature
ii) Findings:
•Accidental interruption of the storage temperature conditions had no consequences for the integrity of the mRNA contained in the Moderna COVID-19 vaccines
C3
Yu YB, Briggs KT, Taraban MB, Brinson RG, Marino JP. Grand Challenges in Pharmaceutical Research Series: Ridding the Cold Chain for Biologics. Pharmaceutical Research. 2021;38(1):3–7
USA, Review Temperature monitoring
•Difficulties in monitoring and controlling vaccine temperature
i) Cold chain requires building extensive infrastructure and is very expensive to maintain. The complexity of the cold chain is illustrated in documents, such as the CDC Vaccine Storage and Handling Toolkit and the WHO pamphlet “The vaccine cold chain”
ii) Cold chain can be standard (2 °C to 8 °C) or deepfreeze (as cold as -70 °C)
iii) Cold chain breaches, if unnoticed before injection, could cause adverse drug events in patients
C4
Rashid M. Identify constraints of vaccine supply chain: A Case study of Finnish Red Cross. 2020
Finland, Case study using qualitative method Operational Constraints
• Difficulties in monitoring and controlling vaccine temperature
• Lack of proper storage systems
• Inappropriate coordination with local organisations
• Lack of vaccine monitoring bodies
i) Study conducted to investigate the constraints of vaccine supply chain for the Finnish Red Cross humanitarian Organization
ii) Data was collected via content analysis of webpages, observation, and semi-structured interview
iii) Findings:
•Humanitarian organisations need to review their vaccine supply chain
•IoT technology needed to improve the visibility of data flow
•Real-time data and continuous monitoring of vaccine temperature is essential for developing performance of vaccine supply chain in humanitarian organisations
•Cold chain equipments such as long lasting passive cold boxes, medical refrigerators, and refrigerated trucks are required for effective storage and transportation system
C5
Crommelin DJ, Anchordoquy TJ, Volkin DB, Jiskoot W, Mastrobattista E. Addressing the cold reality of mRNA vaccine stability. Journal of Pharmaceutical Sciences. 2021 Mar 1;110[3]:997–1001
Netherlands, Commentary (Expert opinion) Regulatory requirements i) For vaccine licensure, the stability and expiry date of the vaccine in its final container, when maintained at the recommended storage temperature, should be demonstrated using final containers from at least three final lots made from different vaccine bulks
ii) Highlights the assay capabilities and acceptance criteria for the relevant quality attributes for the proposed storage conditions for mRNA vaccines
iii) In the context of the extended controlled temperature chain (ECTC) initiative of the WHO an mRNA vaccine is potentially allowed to be kept at temperatures outside of the frozen cold chain (e.g., 2–8 °C for a limited period of time) under monitored and controlled conditions
Packing and Storage C6
Ramakanth D, Singh S, Maji PK, Lee YS, Gaikwad KK. Advanced packaging for distribution and storage of COVID-19 vaccines: a review. Environ Chem Lett. 2021:1–1
India, Review Regulatory requirements i) Packaging plays a crucial role in protecting, preserving, transporting, and distributing vaccines
ii) Review illustrated that typical packaging and distribution system for the COVID-19 vaccine consists of different packaging levels maintaining cold storage throughout the supply chain
iii) The United States Food and Drug Administration issued guidelines for vaccine manufacturers regarding storage and temperature monitoring. The end consumer should be aware of the history of the product storage conditions
  C7
Wolicki J. Vaccine storage and handling; Vaccine administration–2020. Centers for Disease Control and Prevention. 2020
US, Policy and guidance document Operational constraints i) COVID-19 Vaccine Addendum provides information, recommendations, and resources on storage and handling best practices to help safeguard the COVID-19 vaccine supply and ensure patients receive safe and effective vaccines
ii) Vaccine storage units consist of purpose-built or pharmaceutical-grade (large or compact)
•Household-grade refrigerator or freezer
•Use of equipment, e.g., temperature monitoring devices presented with certificate of calibration
•Handling a temperature excursion in the vaccine storage unit
•Transport system recommendations
•Alternatives during power outage
  C8
Training for mid-level managers (MLM). Module 1: cold chain, vaccines and safe-injection equipment management. Geneva: World Health Organization; 2008, republished 2020 under the licence: CC BY-NC-SA 3.0 IGO
Switzerland, Policy and guidance document Operational constraints
•Lack of trained personnel
•Difficulties in monitoring and controlling vaccine temperature
•Lack of proper storage systems
i) Highlighted the role of managers to receive vaccines and maintenance of relevant cold chain equipments. This includes for syringes, reconstitution syringes, safety boxes and vaccine diluent (which does not need to be refrigerated)
ii) He or she is also responsible to adapt to changing cold storage needs and make space should a need arise
Transportation and Distribution C9
Mohammed SA, Workneh BD. Vaccine Cold Chain Management in Public Health Facilities of Oromia Special Zone, Amhara Region, Ethiopia: Mixed Study. Journal of Drug and Alcohol Research. 2021;10[8]:1–9
Ethiopia, Phenomenological study Operational constraints
•Difficulties in monitoring and controlling vaccine temperature
•Lack of proper storage systems
•Inappropriate coordination with local organizations
•Lack of vaccine monitoring bodies
i) 48% health facilities had satisfactory cold chain infrastructure, while 63% had good cold chain practices
ii) Placement of vaccines during immunisation, checking the signs of damage, storage of food or any drugs other than vaccines, checking, availability of deep freezer, cold box and functional thermometer has a significant association with vaccine storage
iii) Key informants stated that cold chain infrastructure, temperature monitoring, stock management and immunisation practice affect vaccine storage
  C10
Termini RB. An Essay on Public Health and Liberty-The Impact of the 1905 United States Supreme Court Decision of Jacobson: Compulsory Vaccination under State Police Power vs. the Individual Right to Refuse a Vaccination in this Modern-Day Era of the COVID-19 Pandemic. Widener Law Review, Forthcoming. 2021
US, Policy and guidance document Regulatory requirements i) Vaccine manufacturers will have to comply with the Food and Drug Authority and Federal Food, Drug, and Cosmetic Act policies
ii) As the vaccines were authorised for use in an event of a public health emergency, the Emergency Use Authorization (EUA) authority will need to issue a letter of authorisation that entails two fact sheets prior to the vaccine being transported to other countries
•Healthcare Providers Administering Vaccine (Vaccination Providers)
•Recipients & Caregivers
  C11
Alam ST, Ahmed S, Ali SM, Sarker S, Kabir G. Challenges to COVID-19 vaccine supply chain: Implications for sustainable development goals. International Journal of Production Economics. 2021 Sep 1;239:108,193
Bangladesh, quantitative research using decision-making trial and evaluation laboratory (DEMATEL) method Operational constraints
• Difficulties in monitoring and controlling vaccine temperature
• Lack of proper storage systems
i) Inappropriate coordination with local organisations, lack of vaccine monitoring bodies, difficulties in monitoring and controlling vaccine temperature, and vaccination cost and lack of financial support for vaccine purchases are the most critical challenges
  C12
Dadari IK, Zgibor JC. How the use of vaccines outside the cold chain or in controlled temperature chain contributes to improving immunization coverage in low- and middle-income countries (LMICs): A scoping review of the literature. Journal of global health. 2021;11
US, scoping review Temperature monitoring i) Review synthesised the evidence on how the use of vaccines outside the cold chain or in a controlled temperature chain increases immunization coverage in low- and middle-income countries (LMICs), with a focus on the timelines of the Global Vaccine Action Plan (2011–2020)
ii) Vaccines can be used in: (a) controlled temperature chain (CTC) or (b) outside the cold chain (OCC)
  C13
Sun J, Zhang M, Gehl A, Fricke B, Nawaz K, Gluesenkamp K, et al. COVID-19 vaccine distribution solution to the last mile challenge: Experimental and simulation studies of ultra-low temperature refrigeration system. International Journal of Refrigeration. 2022;133:313–25
US, experimental study To overcome operational constraints
•Experimented on commercially available products, such as refrigeration container units, and retrofitted them to meet the vaccine storage temperature requirement
•Simulation studies conducted, where a testing platform was setup to assess the technical merits of the solution with the ability to control temperature at − 30 °C or − 70 °C as part of the last mile supply chain
i) Refrigeration storage container test unit was fully instrumented with thermocouples, oxygen and carbon dioxide (O2 and CO2) sensors inside the container box, scales to measure dry ice weights during sublimation and Omega 5 V differential pressure monitor to measure the pressure difference from inside and outside the container
ii) O2 and CO2 sensors located near front at reefer were used in testing with a 5-psi diaphragm compressor to pump air from inside the container to outside
iii) Lab tests were conducted to evaluate the performance of the proposed refrigeration storage container method. Aspects of temperature distribution of test unit, temperature distribution inside the vaccine dry-ice package, dry-ice sublimation, and CO2 concentration inside the refrigerated storage container were evaluated
iv) Findings:
•An effective, secure, and safe ultralow-temperature refrigeration solution that uses commercially available refrigeration container units used in the global cold-food chain can be modified to meet the requirements for vaccine storage to support the vaccine distribution supply chain
  C14
Nadimuthu LPR, Victor K. Environmental friendly micro cold storage for last-mile COVID-19 vaccine logistics. Environmental Science and Pollution Research. 2021
India, experimental study To overcome operational constraints
•A novel design, development, and experimental investigation of solar photovoltaic powered thermoelectric-based micro cold storage as a COVID-19 vaccine carrier for rural areas
i) An environmentally friendly, solar photovoltaic powered thermoelectric-based micro cold storage, which can function as a COVID-19 vaccine carrier for rural areas demonstrated that last-mile vaccine delivery was successfully done without any vaccine degradation