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20200318 Inform) New Coronavirus (SARS-CoV-2) and the Safety Margins of Plasma Protein Therapies
New Coronavirus (SARS-CoV-2) and the Safety Margins of Plasma Protein Therapies
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 in Wuhan province, China (1, 2). Infection with the virus is in most cases associated with an illness known as ‘COVID-19’, an abbreviation for ‘coronavirus disease 2019’ (3, 4).
Since then, SARS-CoV-2 has spread outside of Hubei Province and internationally (1, 2, 5), including the U.S. (6) and Europe (7). On January 30, 2020 the World Health Organisation (WHO) declared the SARS-CoV-2 outbreak a public health emergency of international concern (8). On March 11, 2020 the WHO declared the COVID-19 outbreak a pandemic (9). International public health bodies (CDC, ECDC, WHO, as well as countries’ individual authorities), are continuously monitoring the situation. To limit SARS-CoV-2 spread, increasingly stringent measures are being put in place to limit the spread of the virus, including travel guidance (10, 11) and movement restrictions within the affected regions (12, 13), testing (14, 15, 16) and reporting, as well as adding entry health screening and travel restrictions also at major U.S. and international airports for passengers coming from affected regions (12, 13). For up to date case numbers and other relevant information, please see regularly updated online references.i
PPTA considers that the SARS-CoV-2 outbreak is not a concern for the safety of plasma protein therapies manufactured by PPTA member companies.
The following important information should be taken into account:
- The SARS-CoV-2 is a large sized virus (approximately 120 nm in diameter) (17, 18). 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) (19), low pH incubation, caprylate-, pasteurization- (20) or dry-heat treatments (21), nanofiltration or fractionation processes and others (22). 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 (23, 24).
- Regular donor screening procedures are in place to prevent individuals from donating plasma who show clinical disease symptoms (raised temperature/ fever, cough, difficulty breathing) generally associated with coronavirus infection, including COVID-19.
Based on 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.
For other therapy choices, PPTA encourages patients to talk with their doctor if they have any questions about their therapy.
Background on Coronaviruses:
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 (17, 18). There is no precedent for transfusion-transmission of any respiratory virus including influenza (‘flu’), MERS, SARS, or SARS-CoV-2 according to scientific data available, and thus the risk of SARS-CoV-2 transmission by blood and blood components is currently seen as ‘only theoretical’ (25, 26).
It appears that the SARS-CoV-2 can be spread through human-to-human contact via respiratory droplets, as well as fomites. 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 (17, 27).
– updated 13 March 2020
i. World Health Organization (WHO): https://www.who.int/emergencies/diseases/novel-coronavirus-2019
U.S. Centers for Disease Control and Prevention (CDC): https://www.cdc.gov/coronavirus/2019-nCoV/summary.html
European Centre for Disease Control (ECDC): https://www.ecdc.europa.eu/en/novel-coronavirus-china
Johns Hopkins University: https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6
- U.S. CDC: Coronavirus Disease 2019 (COVID-19) Situation Summary: https://www.cdc.gov/coronavirus/2019-nCoV/summary.html (updated March 13, 2020) [Accessed February 17, 2020]
- European Centre for Disease Control (ECDC): COVID-19 : https://www.ecdc.europa.eu/en/novel-coronavirus-china [Accessed February 17, 2020]
- ECDC: Disease background of COVID-19: https://www.ecdc.europa.eu/en/2019-ncov-background-disease (Updated January 31, 2020) [Accessed February 17, 2020]
- Twitter: https://twitter.com/WHO/status/1227248333871173632?s=20 (February 11, 2020) [Accessed March 13, 2020]
- Coronavirus COVID-19 Global Cases by Johns Hopkins CSSE: https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6 [Accessed February 17, 2020]
- 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 March 13, 2020]
- 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 March 13, 2020]
- 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]
- WHO: WHO Director-General's opening remarks at the media briefing on COVID-19 - 11 March 2020: https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020 (March 11, 2020) [Accessed March 13, 2020]
- U.S. CDC: Novel Coronavirus Information for Travelers https://www.cdc.gov/coronavirus/2019-ncov/travelers/index.html (Updated February 10, 2020) [Accessed March 13, 2020]
- ECDC: Rapid risk assessment: Novel coronavirus disease 2019 (COVID-19) pandemic: increased transmission in the EU/EEA and the UK – sixth update https://www.ecdc.europa.eu/en/publications-data/rapid-risk-assessment-novel-coronavirus-disease-2019-covid-19-pandemic-increased (Updated March 12, 2020) [Accessed March 13, 2020]
- U.S. White House: Proclamation—Suspension of Entry as Immigrants and Nonimmigrants of Certain Additional Persons Who Pose a Risk of Transmitting 2019 Novel Coronavirus https://www.whitehouse.gov/presidential-actions/proclamation-suspension-entry-immigrants-nonimmigrants-certain-additional-persons-pose-risk-transmitting-2019-novel-coronavirus/ (March 11, 2020) [Accessed March 12, 2020]
- ECDC: National information resources for the public on COVID-19 https://www.ecdc.europa.eu/en/novel-coronavirus-china/sources-updated [Accessed March 13, 2020]
- WHO: Coronavirus disease (COVID-19) technical guidance: Laboratory testing for 2019-nCoV in humans. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/laboratory-guidance [Accessed March 13, 2020].
- CDC: Information for Laboratories https://www.cdc.gov/coronavirus/2019-nCoV/lab/index.html [Accessed March 13, 2020]
- ECDC: Laboratory support by specialised laboratories in the EU/EEA https://www.ecdc.europa.eu/en/novel-coronavirus/laboratory-support [Accessed March 13, 2020]
- U.S. CDC: Coronaviruses: https://www.cdc.gov/coronavirus/types.html [Accessed March 13, 2020]
- Encyclopaedia Britannica: Coronavirus https://www.britannica.com/science/coronavirus-virus-group [Accessed January 27, 2020]
- 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.
- 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]
- 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
- 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.
- 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.
- 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.
- Transfusion news: https://transfusionnews.com/2020/03/04/risk-of-transfusion-transmission-of-sars-cov-2-is-only-theoretical/ (March 04, 2020) [Accessed March 12, 2020]
- U.S. Food and Drug Administration (FDA): Updated Information for Blood Establishments Regarding the Novel Coronavirus Outbreak: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/updated-information-blood-establishments-regarding-novel-coronavirus-outbreak?utm_campaign=What%27sNew2020-03-11&utm_medium=email&utm_source=Eloqua (March 11, 2020) [Accessed March 12, 2020]
- ECDC: Disease background of COVID-19 https://www.ecdc.europa.eu/en/2019-ncov-background-disease [Accessed March 13, 2020]
This statement was updated on March 13, 2020 and replaces an earlier version. PPTA will update this content periodically, as new information and data emerges.
- Created on January 29 2020.