The Plasma Protein Therapeutics Association (PPTA), a trade association representing the interests of commercial manufacturers of plasma-derived treatments has recently published a statement on its website regarding the zika virus and plasma protein therapies.
The statement can be consulted here below and online on the PPTA website.
PPTA statement on Zika Virus and Plasma Protein Therapies
Recent scientific and public press reports have heightened awareness of the Zika virus and its emergence in the Americas (1). The temporal link between the emergence of the virus in Brazil and the birth of babies with microcephaly (2) is most alarming. PPTA is aware that persons who rely on plasma protein therapies are understandably concerned whether these therapies are safe with respect to the Zika virus.
Zika virus is a Flavivirus that is primarily transmitted by the Aedes mosquitos (3), however it has been reported that it may be transmitted, even if rarely, from mother to child and also by transfusion of infected blood or by sexual contact (4). PPTA member companies have considerable experience with the capacity of their production processes to effectively eliminate Flaviviruses, in case they were present in the plasma. Based on these experiences, Zika virus is not a concern for the safety of plasma protein therapies.
Practically all Zika infection cases detected in Europe and the USA so far acquired the disease outside of these geographical areas. While the number of cases of travelers to the risk areas showing Zika infection at return may increase, the current situation indicates an almost total absence of Zika infection in the European or USA plasma donor population. In addition, donor screening procedures make it highly unlikely that any person showing disease symptoms typical of Zika would be accepted for donation.
Zika virus is of intermediate size (approximately 40 nm in diameter) and is similar to other Flaviviruses like the West Nile (WNV), Dengue, Yellow Fever and Japanese Encephalitis viruses, as it has a lipid envelope. The relatively large size and lipid envelope makes it highly susceptible to steps with virus inactivation and removal capacity used during the manufacturing processes, such as solvent-detergent (S/D), low pH incubation, caprylate, pasteurization or dry-heat treatments, nanofiltration or fractionation processes. The effectiveness of these processes has been demonstrated on other lipid-enveloped model viruses which are quite similar to Zika virus, e.g. Bovine viral diarrhea virus (BVDV) or Tick-borne encephalitis virus (TBEV), and most importantly the WNV, another Flavivirus which is even more closely related to the Zika virus (5–10). Based on these data, PPTA is assured that existing manufacturing methods will also be effective against the Zika virus.
PPTA is aware that there are recommendations by agencies and blood collection organizations to defer potential donors of blood components (2,11,12) who have traveled to areas considered at risk for Zika virus (i.e., Mexico, the Caribbean, and Central and South America) (1, 13). However, based on the practical absence of the virus in areas used for plasma sourcing such as the US (1) and Europe (1, 13), the low-levels and short-lived viraemia in the blood of infected individuals (14, 15), as well as the established and very substantial processes with virus inactivation and removal capacity during manufacturing of plasma-derived products, PPTA does not consider that deferral of donors is warranted for donation of plasma for manufacturing use.
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Jim is aged 66 and has Haemophilia A with a high titer inhibitor which he developed at age 14.
Maria Elisa Mancuso (MD, PhD) is a Haematologist and works as a Senior Haematology Consultant at the Center for Thrombosis and Haemorrhagic Diseases of IRCCS Humanitas Research Hospital in Rozzano, Milan, Italy. She is Adjunct Clinical Professor at Humanitas University. She obtained a post-degree in Clinical and Experimental Haematology and a PhD in Clinical Methodology. She is involved in clinical research and has published several original articles in peer-reviewed journals a The Lancet, Blood, Journal of Thrombosis and Haemostasis, Haematologica, Thrombosis and Haemostasis, British Journal of Haematology and Haemophilia. She is reviewer for several peer-reviewed journals and member of the Editorial Board of JTH. She is a member of several scientific societies (ISTH, WFH, ASH, EAHAD, SISET, AICE) and was a medical member of the Inhibitor Working Group of the European Hemophilia Consortium. She is co-chair of the ADVANCE Study Group. She has acted also as co-chair of the Scientific and Standardization Subcommittee of ISTH on FVIII, FIX and rare bleeding disorders. She has been involved as principal and co-investigator in several clinical trials, and she takes care of both children and adults with hemophilia and other congenital bleeding disorders with a specific scientific interest in novel therapies, prophylaxis, inhibitors, and chronic hepatitis C.
As a patient with factor II deficiency, the diagnostic and treatment of rare bleeding disorders is a matter dear to my heart. My motivation to participate in the work of the ERIN committee is to improve both diagnostic and treatment for patients with rare bleeding disorders across Europe.
Economist and financial expert by profession, executive coach and trainer by passion and haemophilia advocate by every drop of my blood through my son (who has severe haemophilia A with inhibitors). Bringing a good decade of practical experience from the corporate insurance world, laser focus, growth mindset and resilience from my own experience, offering you anything I can just do, in hope that together we can make life more fulfilled for those impacted by bleeding disorders.
Amy Owen-Wyard is a Registered Mental Health Nurse. With experience working with children, young people, their families and adults with severe and enduring mental health conditions. Amy was also involved in a service improvement to provide a holistic care approach for those in general hospitals to support both their mental and physical health, whilst sharing her expertise and knowledge in mental health with the wider multidisciplinary team.
