New Coronavirus (SARS-CoV-2) and Plasma Protein Therapies (updated 17 February 2020)

Recent international reports have highlighted the emergence of a new coronavirus in Wuhan, Hubei Province, China (1). The 2019 Novel Coronavirus (2019-noCoV), now called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first identified by Chinese authorities in December 2019 and since then has been associated with pneumonia in over 70,000 persons in China and more than 1,700 deaths (1-3). *

In addition, there has been a growing number of cases identified outside of Hubei Province and internationally (1-3). On January 21, 2020 the U.S. Centers for Disease Control and Prevention (CDC) confirmed the first case of a person being infected with SARS-CoV-2 in the U.S. (4), and on January 24, 2020 the first case of a person infected with SARS-CoV-2 was identified in Europe (5). More cases continue to be reported internationally (1-3), and thus on January 30, 2020 the World Health Organisation (WHO) declared the SARS-CoV-2 outbreak a public health emergency of international concern (6). The disease caused by the SARS-CoV-2 is now known as ‘COVID-19’, an abbreviation for ‘coronavirus disease 2019’ (7, 8).

PPTA considers that the SARS-CoV-2 outbreak is not a concern for the safety of plasma protein therapies manufactured by PPTA member companies based on the following information:

To date, the majority of SARS-CoV-2 cases has been reported from the Hubei province in China. Most of the individuals diagnosed with the virus in other countries have acquired the infection through travel to Wuhan City, Hubei Province, however, there are now limited cases of person-person transmission seen amongst close contacts of infected individuals returning from Wuhan (1, 9, 10). Nevertheless, based on the current epidemiological evidence, the virus is not currently spread widely in the communities in the U.S and Europe (1, 9, 11) and therefore, it is unlikely that the virus is present in U.S. and European populations. Moreover, donor screening procedures are in place to prevent individuals from donating plasma who show typical disease symptoms (raised temperature/ fever, cough, difficulty breathing) of a coronavirus infection, including COVID-19.

The SARS-CoV-2 is a large sized virus (approximately 120 nm in diameter) (12, 13). 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) (14), low pH incubation, caprylate-, pasteurization- (15) or dry-heat treatments (16), nanofiltration or fractionation processes and others (17). The effectiveness of these processes has been demonstrated on other lipid-enveloped model viruses which are quite similar to 2019-nCoV, e.g. human coronavirus 229E and OC43, SARS-CoV, and porcine coronavirus TGEV (10, 15, 18, 19).

Based on these data, PPTA is convinced that existing manufacturing methods provide significant safety margins against the SARS-CoV-2.

Public health bodies in the U.S. (CDC) and in Europe (ECDC), the WHO, as well as Chinese authorities, are continuously monitoring the situation and have put in place proactive measures to monitor SARS-CoV-2 infection in Europe and in the U.S., as well as internationally, including issuing travel guidance for Wuhan City, Hubei Province, China (1, 20, 21, 22), testing (23, 24) and reporting guidance, and adding entry health screening and travel restrictions at major U.S. (25) and international airports for passengers coming from Wuhan City and / or China (26). 

Based on strict screening procedures for plasma donors and the established processes of virus inactivation and removal during manufacturing of plasma-derived products, PPTA concludes that the SARS-CoV-2 is not a concern for the safety margins of plasma protein therapies manufactured by PPTA member companies.

Background:

The novel coronavirus, now called SARS-CoV-2, belongs to the family of Coronaviridae, which are known to infect animals and humans, causing respiratory and gastrointestinal illness.

Seven different coronaviruses are known to infect humans, causing mild to moderate illness. In rare cases, animal coronaviruses can evolve and infect humans. This has been observed in the past with Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), both known to cause severe illness (12, 13). There is no published data documenting transmission of respiratory coronaviruses by blood transfusion (12, 13).

It appears that the SARS-CoV-2 can be spread through human-to-human contact via respiratory droplets. More research is needed, however, to fully understand the mode of transmission, clinical course of disease and epidemiology, and whether particular population groups are at a higher risk of illness (12, 13).

* Case numbers listed in this statement are dynamic due to a rapidly evolving situation and will be updated periodically


References:

  1. U.S CDC: Coronavirus Disease 2019 (COVID-19) Situation Summary: https://www.cdc.gov/coronavirus/2019-nCoV/summary.html (updated February 07, 2020) [Accessed February 17, 2020]
  2. European Centre for Disease Control (ECDC): COVID-19 : https://www.ecdc.europa.eu/en/novel-coronavirus-china [Accessed February 17, 2020]
  3. Coronavirus COVID-19 Global Cases by Johns Hopkins CSSE: https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6 [Accessed February 17, 2020]
  4. U.S CDC: First Travel-related Case of 2019 Novel Coronavirus Detected in United States. https://www.cdc.gov/media/releases/2020/p0121-novel-coronavirus-travel-case.html [Accessed January 22, 2020]
  5. ECDC: Outbreak of acute respiratory syndrome associated with a novel coronavirus, China; First cases imported in the EU/EEA; second update 26 January 2020 https://www.ecdc.europa.eu/en/publications-data/risk-assessment-outbreak-acute-respiratory-syndrome-associated-novel-0 [Accessed February 13, 2020]
  6. World Health Organisation (WHO): Statement on the second meeting of the International Health Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus (2019-nCoV) https://www.who.int/news-room/detail/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov) (updated January 30, 2020) [Accessed February 11, 2020]
  7. Twitter: https://twitter.com/WHO/status/1227248333871173632?s=20 (February 11, 2020) [Accessed February 12, 2020]
  8. ECDC: Disease background of COVID-19: https://www.ecdc.europa.eu/en/2019-ncov-background-disease (Updated January 31, 2020) [Accessed February 17, 2020]
  9. ECDC: ECDC statement following reported confirmed case of 2019-nCoV in Germany https://www.ecdc.europa.eu/en/news-events/ecdc-statement-following-reported-confirmed-case-2019-ncov-germany (Updated January 28, 2020) [Accessed February 11, 2020]
  10. ECDC: Risk assessment: Outbreak of acute respiratory syndrome associated with a novel coronavirus, China: first local transmission in the EU/EEA − third update https://www.ecdc.europa.eu/en/publications-data/risk-assessment-outbreak-acute-respiratory-syndrome-associated-novel-1 (Updated January 31, 2020) [Accessed February 12, 2020]
  11. ECDC: Risk assessment: Outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): increased transmission beyond China – fourth update (Updated February 14, 2020) [Accessed February 17, 2020].
  12. U.S CDC: Coronaviruses: https://www.cdc.gov/coronavirus/types.html [Accessed February 12, 2020]
  13. Encyclopaedia Britannica: Coronavirus https://www.britannica.com/science/coronavirus-virus-group [Accessed January 27, 2020]
  14. Rabenau HF, Biesert L, Schmidt T, et al. SARScoronavirus (SARS-CoV) and the safety of a solvent/ detergent (S/D) treated immunoglobulin preparation. Biologicals 2005;33:95-9.
  15. Gröner A, Broumis C, Fang R et al. Effective inactivation of a wide range of viruses by pasteurization. Transfusion. 2017 May;57(5):1184-1191 [Accessed January 27, 2020]
  16. Yunoki M, Urayama T, Yamamoto I, et al. Heat sensitivity of a SARS-associated coronavirus introduced into plasma products. Vox Sang 2004;87:302-3
  17. Keil SD, Bowen R, Marschner S: Inactivation of Middle East respiratory syndrome coronavirus (MERS-CoV) in plasma products using a riboflavin-based and ultraviolet light-based photochemical treatment. Transfusion. 2016 Dec;56(12):2948-2952.
  18. Lamarre A, Talbot PJ. Effect of pH and temperature on the infectivity of human coronavirus 229E. Canadian Journal of Microbiology. 1989;35(10):972-4. 51.
  19. Bucknall RA, King LM, Kapikian AZ, Chanock RM. Studies with human coronaviruses II. Some properties of strains 229E and OC43. Proceedings of the Society for Experimental Biology and Medicine. 1972;139(3):722-7.
  20. ECDC Risk assessment: outbreak of acute respiratory syndrome associated with a novel coronavirus, China; First cases imported in the EU/EEA; second update. Updated January 26, 2020) https://www.ecdc.europa.eu/en/publications-data/risk-assessment-outbreak-acute-respiratory-syndrome-associated-novel-0 [Accessed January 27, 2020]
  21. U.S. CDC: Novel Coronavirus Information for Travelers https://www.cdc.gov/coronavirus/2019-ncov/travelers/index.html (Updated February 10, 2020) [Accessed February 17, 2020]
  22. WHO: Novel Coronavirus (2019-nCoV) https://www.who.int/westernpacific/emergencies/novel-coronavirus [Accessed February 11, 2019)
  23. WHO: Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases. https://www.who.int/health-topics/coronavirus/laboratory-diagnostics-for-novel-coronavirus [Accessed January 22, 2020]
  24. ECDC: Laboratory testing of suspect cases of 2019 nCoV using RT-PCR. https://www.ecdc.europa.eu/en/publications-data/laboratory-testing-suspect-cases-2019-ncov-using-rt-pcr (Updated January 16, 2020) [Accessed January 22, 2020]
  25. U.S. CDC: Travelers from China Arriving in the United States https://www.cdc.gov/coronavirus/2019-ncov/travelers/from-china.html (Updated February 07, 2020) [Accessed February 11, 2020]
  26. Fortune: https://fortune.com/2020/02/06/countries-china-travel-restrictions-coronavirus/ (updated February 06, 2020); [Accessed February 12, 2020]

This statement was updated on February 19 2020 and replaces an earlier version. PPTA will update this content periodically, as new information and data emerges.

  • Created on .
Copyright © 2020 PPTA. All rights reserved. (202) 789-3100