Building the Foundation Now
As the immediate COVID-19 crisis wanes, plans for stabilization are taking shape, while the possibility of a new infectious threat in the months and years to come remains top of mind.
Now is the time for reflection and assessment; turning lessons learned into triumph over the next emerging pathogen.
“Leaders at all levels hold the key. It is their responsibility to prioritize preparedness with a whole-of-society approach that ensures all are involved and all are protected.”19 While healthcare is a large and complex system with weighty goals and competing priorities, blood cannot be taken for granted as fundamental to its success.
Implementation of PI is one way to strengthen a blood establishment’s ability to execute its mission of providing a safe and adequate blood supply.
Preparations for future crises always fall prey to financial cuts and austerity measures in lean times unless there is a mechanism to prevent that. Cost-benefit analyses will understandably tend to prioritise the urgent over the long-term. So governments should put in place legislation – or strengthen existing legislation – now to ensure their countries are as prepared as possible for whatever crisis is coming.20
Planning and commitment are crucial. Part of that commitment comes in the form of funding for preparedness measures. To what extent did shortfalls in preparations impact lives and budgets in this most recent pandemic crisis? What can be done to improve? No one can afford a second wave or a new pandemic without appropriate measures in place. While blood for transfusion is just one piece of the larger healthcare system, and PI is just one piece of blood system operations, interruptions in the blood supply can have an immediate negative impact on the ability to deliver healthcare universally. PI can be deployed now to support daily operations and as a wide-ranging solution to blood safety and availability.
Cerus is committed to working side by side with key partners – blood centers, national health agencies, and others – to ensure that the lessons we have collectively learned from the COVID-19 pandemic are not forgotten, but instead can be leveraged to create a more sustainable and more consistent blood supply.
Achieving sustainability requires targeted local actions:
Establishment of a healthcare continuity plan that includes measures to ensure safety, uninterrupted availability and stewardship of all blood products.
Proactive implementation of broad-based solutions (PI being one example) with appropriate funding and regulatory frameworks (e.g. explicitly allow PI in place of certain tests or donor deferrals).
1 Blumenthal D, Fowler E. It’s not too early to prepare for the next pandemic. HBR. Accessed May 4, 2020. https://hbr.org/2020/04/itsnot-too-early-to-prepare-for-the-next-pandemic
2 UN Department of Economic and Social Affairs. Everyone Included: Social Impact of COVID-19. Accessed May 8, 2020. https://www.un.org/development/desa/dspd/everyone-included-covid-19.html
3 Gallian P, et al. PLoS neglected tropical diseases 2017;11:e0005254-e
4 AABB 2015. Intercept-treated platelets from CHIKV positive donations were transfused to 10 recipients with no clinical evidence for transmission. Abstract # S26-020B. Transfusion 2015 Suppl. 3, 17A
5 Rezza, 2018. J Travel Med: doi: 10.1093/jtm/tay004
6 Rasongles P, et al. Transfusion 2009;49:1083-91
7 Cerus Corporation. INTERCEPT Platelets: Technical Data Sheet. Accessed May 5, 2020. https://www.interceptbloodsystem.com/sites/default/files/resources/prd-tds_00121_v11.0.pdf
8 ECDC. Dengue outbreak in Réunion, France, and associated risk of autochthonous outbreak in the EU/EEA. 18 June 2019. Accessed May 5, 2020. https://www.ecdc.europa.eu/sites/default/files/documents/RRA-dengue-Reunion-18-June-2019.pdf
9 WHO. Interim Guidance: Maintaining a safe and adequate blood supply during Zika virus outbreaks. February 2016. Accessed May 5, 2020. https://www.who.int/csr/resources/publications/zika/Safe-blood_supply18Feb2016.pdf
10 ECDC. Local transmission of dengue fever in France and Spain – 2018. 22 October 2018. Accessed May 5, 2020. https://www.ecdc.europa.eu/sites/portal/files/documents/08-10-2018-RRA-Dengue-France.pdf
11 PEI, Stufenplan Stufe 2. Accessed March 18, 2020 at: https://www.pei.de/SharedDocs/Downloads/DE/arzneimittelsicherheit/haemovigilanz/anhoerungen/2019-12-23-anhoerung-wnv-stufe2.pdf?__blob=publicationFile&v=2
12 Cazenave JP, Waller C, Kientz D, Mendel I, Lin L, Jacquet M, et al. An active hemovigilance program characterizing the safety profile of 7,483 transfusions with plasma components prepared with amotosalen and UVA photochemical treatment. Transfusion. 2010;50:1210-9.
13 Dean CL, Hooper JW, Dye JM, Zak SE, Koepsell SA, Corash L, et al. Characterization of Ebola convalescent plasma donor immune response and psoralen treated plasma in the United States. Transfusion. 2020.
14 Geisen C, Kann G, Strecher T, et al. Pathogen-reduced Ebola virus convalescent plasma: First steps towards standardization of manufacturing and quality control including assessment of Ebola-specific neutralizing antibodies. Vox Sanguinis. 2016;110(4).
15 General European OMCL Network (GEON): Quality Management Document. PA/PH/OMCL (16) 122. Change Control Accessed May 5, 2020. https://www.edqm.eu/sites/default/files/recommandation-omcl_16_122_r_change_control_web_publication.pdf
16 WHO. Disease Outbreak News. Accessed May 5, 2020. https://www.who.int/csr/don/en/
17 Pierelli et al. TRANSFUSION 2018; 58, pp 3027. Emergency response of four transfusion centers during the last Chikungunya outbreak in Italy.
18 FDA Recommendations for Investigational COVID-19 Convalescent Plasma. Updated April 13, 2020. https://www.fda.gov/vaccinesblood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/recommendations-investigational-covid-19- convalescent-plasma#Pathways%20
19 Global Preparedness Monitoring Board. A World at Risk: Annual report on global preparedness for health emergencies. September 2019. Accessed May 5, 2020. https://apps.who.int/gpmb/assets/annual_report/GPMB_annualreport_2019.pdf
20 Lewis P. Legal Provision for Crisis Preparedness: Foresight not Hindsight. Chatham House. 21 April 2020. Accessed May 5, 2020. https://www.chathamhouse.org/expert/comment/legal-provision-crisis-preparedness-foresight-not-hindsight#
21 Cerus internal resources