Not the First, Not the Last
Over the past decade, the World Health Organization (WHO) has tracked numerous outbreaks around the world (Table 2).
Surveillance systems are in place across the globe to enable rapid response to emerging pathogens. The question for authorities is not ‘if’ another pathogen will threaten citizens, but ’when’. 1, 16
Several of the outbreaks listed in the table have provided a backdrop to demonstrate the effectiveness of PI in addressing both safety and availability issues for platelets.
No test for CHKV was available, so quarantine was applied to red blood cell (RBC) for 5 days and RBC importation from not affected regions was activated. Platelet concentrates (PCs) were subjected to PI with INTERCEPT, thanks to four regional centers, where PI was already being performed, that took over PI-PLT production for the rest of Rome’s area. PI procedures were increased by 236%, producing additional 1,425 pathogen reduced (PR) PCs in 57 days, beside their production (996 PR PCs) for local needs.17
The COVID-19 pandemic brought difficulties to many areas of the healthcare system, and blood establishments were not spared. With few other treatment options available to clinicians, blood establishments rapidly initiated the provision of COVID-19 convalescent plasma (CCP) from recovered patients.18 Many blood establishments across the globe have opted to treat CCP with PI, and in some regions, it is required. More than 80 blood establishments in 22 countries adopted PI as part of their CCP production. Where PI was already in routine use, its inclusion in the manufacturing process for CCP was straightforward. At other sites, despite the hardship, some leaders found it necessary and feasible to implement PI to ensure the highest level of safety for patients receiving CCP.
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