References
- World Health Organization. State of the world’s vaccines and immunization. Geneva: World Health Organization; 2009. https://apps.who.int/iris/bitstream/handle/10665/44169/9789241563864_eng.pdf
- World Health Organization. Thirty-third world health assembly, Geneva, 5-23 may 1980, resolutions and decisions, annexes. Geneva: World Health Organization; 1980. https://apps.who.int/iris/bitstream/handle/10665/154893/WHA33_1980-REC-1_eng.pdf?sequence=1&isAllowed=y
- World Health Organization. Global polio eradication initiative applauds WHO African region for wild polio-free certification. News Release, 25 August 2020. https://www.who.int/news/item/25-08-2020-global-polio-eradication-initiative-applauds-who-african-region-for-wild-polio-free-certification
- Editorial. The lancet infectious diseases, February 11, 2021. https://doi.org/https://doi.org/10.1016/S1473-3099(21)00080-3
- Walensky RT, 16 July 2021. https://twitter.com/CDCDirector/status/1416131780806119427
- Kartoglu U, Milstien J. Tools and approaches to ensure quality of vaccines throughout the cold chain. Expert Rev Vaccines. 2014;13(7):843–854.
- World Health Organization. Guidelines on the international packaging and shipping of vaccines. World Health Organization, 2020. https://apps.who.int/iris/bitstream/handle/10665/338012/9789240015432eng.pdf?sequence=1&isAllowed=y. Accesssed: November 17 2021.
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonized tripartite guideline: quality risk management: Q9. 9 November 2005. https://database.ich.org/sites/default/files/Q9%20Guideline.pdf
- United States Pharmacopeia. < 1079> Risks and mitigation strategies for the storage and transport of finished drug products (in excerpted USP-NF standards referenced in the USP COVID-19 vaccine handling toolkit). https://www.usp.org/sites/default/files/usp/document/our-impact/covid-19/uspnf-standards-vaccine-handling.pdf. Accessed: November 9 2021.
- European Union. Good Distribution Practice of Medicinal Products for Human Use ( 2013/C 68/01). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52013XC1123%2801%29. Accessed November 11 2021.
- World Health Organization. Temperature-controlled transport operations by road and by air. Supplement 12 to WHO technical Report Series, No. 961, 2011, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharma- ceutical products. May 2015. https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/distribution/trs961-annex9-supp12.pdf
- Kartoglu U. Pharmaceutical and vaccine quality illustrated. Geneva: EPELA; 2016. 47. http://epela.net/illustrated/
- World Health Organization. Product information sheets, 2000 edition. Department of vaccines and biologicals, WHO/V&B/00.13 (this document is no longer electronically available)
- World Health Organization. WHO/PQS/E006/IN03.1. Irreversible freeze indicator: PQS performance specifications. https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/catdocumentation.aspx?id_cat=35. Accessed: November 15 2021.
- Kartoglu U. The book of VVM. Geneva: Extensio et Progressio; 2019. Available from: https://kartoglu.ch/vvm.
- Lavenuta G. Negative temperature coefficient thermistors, Part I: characteristics, materials, and configurations. Fierce Electronics. 1977. https://www.fierceelectronics.com/embedded/negative-temperature-coefficient-thermistors-part-i-characteristics-materials-and
- Smith JM Global pharmaceutical supply group, Johnson & Johnson “ensuring product quality and patient safety for temperature sensitive products,” Parenteral Drug Association (PDA) Pharmaceutical Cold Chain Interest Group (PCCIG) Meeting, Bethesda, MD, March 23-24, 2009
- United States Pharmacopeia. General chapter <1118> “monitoring devices- time, temperature, and humidity,” The U.S. Pharmacopeia Convention (Rockville, MD, 2005) (in Excerpted USP-NF Standards referenced in the USP COVID-19 Vaccine Handling Toolkit). https://www.usp.org/sites/default/files/usp/document/our-impact/covid-19/uspnf-standards-vaccine-handling.pdf. Acccessed: November 9 2021.
- WHO. Ervebo, product overview [internet]. Geneva: World Health Organization; 2021. Available from: https://extranet.who.int/pqweb/content/ervebo
- US Food and Drug Administration. Coronavirus (COVID-19) update: FDA allows more flexible storage, transportation conditions for Pfizer-BioNTech COVID-19 vaccine. 25 February 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-more-flexible-storage-transportation-conditions-pfizer
- European Medicines Agency. More flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine. 17 May 2021. https://www.ema.europa.eu/en/news/more-flexible-storage-conditions-biontechpfizers-covid-19-vaccine
- Therapeutic Goods Administration. Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved. 8 April 2021. https://www.tga.gov.au/media-release/wider-storage-and-transportation-conditions-pfizer-covid-19-vaccine-now-approved
- Health Canada. Guidelines for temperature control of drug products during storage and transportation (GUI-0069). https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/compli-conform/gmp-bpf/docs/GUI-0069_V3_EN_Aug%2010.pdf. Acccessed: November 15 2021.
- Medicines and Healthcare Products Regulatory Agency. Rules and guidance for pharmaceutical distributors 2017 (green guide). 4th ed. London: The Pharmaceutical press; 2017.
- Medicines and Healthcare Products Regulatory Agency. Rules and guidance for pharmaceutical manufacturers and distributors 2017 (orange guide). 10th ed. London: The Pharmaceutical press; 2017.
- United States Pharmacopeia. < 1083> Good distribution practices-supply chain integrity. 2011. https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/c1083.pdf. Acccessed: November 15 2021.
- US Food and Drug Administration. Federal food, drug, and cosmetic act (FD&C act). US code title 21. https://www.ecfr.gov/cgi-bin/text-idx?SID=85f732062d36d1151565dda714602187&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl. Acccessed: November 15 2021.
- World Health Organization. Model guidance for the storage and transport of time- and temperature sensitive pharmaceutical products. In “WHO Expert Committee on specifications for pharmaceutical preparations 45th report. WHO Technical Report Series. No. 961; 2011. Annex 9”. Online https://apps.who.int/iris/bitstream/handle/10665/44079/WHO_TRS_961_eng.pdf
- World Health Organization. Technical supplements to WHO technical report series, no. 961, 2011. https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/distribution/trs961-annex9introduction.pdf?sfvrsn=64f4568_2. Accessed: October 31 2021.
- International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical Products for Human Use. Q7 Good manufacturing practice guide for active pharmaceutical ingredients. Step 4 version. 10 November 2000. https://database.ich.org/sites/default/files/Q7%20Guideline.pdf
- International Air Transport Association. Temperature Control Regulations (TCR). 2022 TCR Online. https://www.iata.org/en/publications/store/temperature-control-regulations/. Accessed: January 19 2022.
- International Air Transport Association. Guidance for vaccine and pharmaceutical logistics and distribution. Edition 5&Last Edition, 1 June 2021. https://www.iata.org/en/programs/cargo/pharma/vaccine-transport/
- World Health Organization. Immunization Practices Advisory Committee (IPAC) statement on out of cold chain (OCC) and controlled temperature chain (CTC) use of vaccines. 2016. https://www.technet-21.org/fr/forums/discussions/ipac-position-statement-on-the-controlled-temperature-chain-ctc-and-the-use-of-vaccines-out-of-cold-chain-occ. Acesswed: November 22 2021.
- World Health Organization. Use of menafrivac (meningitis A vaccine) in a controlled temperature chain (CTC) during campaigns: guidance for immunization programme decision-makers and managers. WHO/IVB/13.04. Geneva: World Health Organization; 2013. https://apps.who.int/iris/handle/10665/86018
- Chen D, Kristensen D. Opportunities and challenges of developing thermostable vaccines. Expert Rev. Vaccine. 2009;8(5):547–557.
- Kristensen DD, Lorenson T, Bartholomew K, et al. Can thermostable vaccines help address cold-chain challenges results from stakeholder interviews in six low and middle income countries. Vaccine. 2016;34(7):899–904. https://doi.org/https://doi.org/10.1016/2Fj.vaccine.2016.01.001