New Coronavirus (SARS-CoV-2) and the Safety Margins of Plasma Protein Therapies
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 assessment is shared by notable international and national public health bodies, including the WHO, the ECDC, and others.
Background on COVID-19:
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). With the exception of asymptomatic cases, the proportion of which remains yet to be confirmed further, infection with the virus is associated with an illness known as ‘COVID-19’, an abbreviation for ‘coronavirus disease 2019’ (1-3).
COVID-19 is characterized most frequently by respiratory infection, which can progress to pneumonia, severe lung damage and death (1-3).
On January 30, 2020 the World Health Organisation (WHO) declared the COVID-19 outbreak a public health emergency of international concern (PHEIC) (4). Due to the global spread of the disease (1-3, 5) the WHO declared the COVID-19 outbreak a pandemic on March 11, 2020 (6). International public health bodies (CDC, ECDC, WHO) as well as countries’ individual health authorities and governments (7-9), are continuously monitoring the situation and putting in place various stringent measures, including travel guidance (10, 11) and movement restrictions within the affected regions (12-14), testing and reporting (14-17), as well as adding entry health screening and travel restrictions at U.S., European and international airports (10-14). For up to date case numbers and other relevant information, please see regularly updated online 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 assessment is shared by notable international and national public health bodies, including the WHO (18-19), the ECDC (20), and others (21, 22-24).
The following important information should be taken into account:
- SARS-CoV-2 is a respiratory virus and primarily infects the airways. There is no reported evidence for the transmission of respiratory viruses, including the influenza (‘flu’) virus, and the coronaviruses responsible for Severe Acute Respiratory Syndrome (SARS) (SARS-CoV) and Middle East Respiratory Syndrome (MERS) (MERS-CoV) by blood and blood components, including plasma and plasma-derived medicinal products (22-24).
- The SARS-CoV-2 is a large sized virus (approximately 120 nm in diameter) (25-27). 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) (28), low pH incubation, caprylate-, pasteurization- (29) or dry-heat treatments (30), nanofiltration or fractionation processes and others (31). 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 (32-33).
- Regular donor screening measures are in place to prevent individuals from donating plasma who show clinical disease signs or symptoms of respiratory disease (such as raised temperature/ fever, cough, difficulty breathing, chest pain) which are generally associated with coronavirus infection, including COVID-19 (18-21; 23-24).
- Although the majority of persons infected with SARS-CoV-2 develops disease symptoms typical of COVID-19 infection, cases of asymptomatic infections during which an infected person does not show signs of disease but may be able to infect other people, have also been reported (34-35). However, even in these cases, infectivity has not been established in blood or blood products.
In summary, based on the sensitive nature of the virus, being large and lipid-enveloped, as well as the established processes with steps offering virus inactivation and removal capacity during the manufacturing processes 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 SARS and MERS, both known to cause severe illness in humans (17-19). According to the scientific data available no transfusion-transmission of any respiratory virus including influenza (‘flu’), MERS, SARS, or SARS-CoV-2 has been reported. Therefore, the risk of SARS-CoV-2 transmission by blood and blood components is currently seen as ‘only theoretical’ (18-24). Plasma-derived medicinal products are considered safe with regard to SARS-CoV-2 due to the characteristics of the virus, as well as steps with significant and robust virus removal and virus reduction capacity employed during manufacturing (18-24).
The SARS-CoV-2 is spread human-to-human via close contact and respiratory droplets, and through touching droplet-contaminated surfaces or objects and then touching the eyes, nose or mouth (‘fomites’) (1-3, 34-35). A presumed majority of infected persons progresses to develop clinical symptoms of COVID-19; however, asymptomatic infections have also been reported (34-35). Persons of any age can be infected with SARS-CoV-2 but individuals of advanced age and with underlying conditions (hypertension, diabetes, cardiovascular disease, chronic respiratory disease and cancer) may suffer from more severe COVID-19 manifestations and higher mortality rates (1-3, 36-38). Infection in children appears to be mild, when compared to adults (1-3, 39).
More research is needed, however, to fully understand the mode of transmission, clinical course of disease, epidemiology as well as potential risk factors (1-3, 36-39).
Specific treatments and vaccines are currently in research and development (40-42). ‘Convalescent plasma’, which is plasma donated by individuals who recovered from COVID-19, is currently considered as possible treatment for COVID-19 (43-44).
– updated April 03, 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 26, 2020) [Accessed April 01, 2020]
- European Centre for Disease Control (ECDC): COVID-19 : https://www.ecdc.europa.eu/en/novel-coronavirus-china (updated March 31, 2020) [Accessed April 01, 2020]
- Coronavirus COVID-19 Global Cases by Johns Hopkins CSSE: https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6 [Accessed April 01, 2020]
- World Health Organisation (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. Government: https://www.coronavirus.gov/ [Accessed April 01, 2020]
- U.S. Government: Government Response to Coronavirus, COVID-19: https://www.usa.gov/coronavirus [Accessed April 01, 2020]
- European Commission: Coronavirus response https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response_en [Accessed April 01, 2020]
- ECDC: Rapid risk assessment: Novel coronavirus disease 2019 (COVID-19) pandemic: increased transmission in the EU/EEA and the UK – seventh update https://www.ecdc.europa.eu/en/publications-data/rapid-risk-assessment-coronavirus-disease-2019-covid-19-pandemic (Updated March 25, 2020) [Accessed March 27, 2020]
- CDC: Information for Laboratories https://www.cdc.gov/coronavirus/2019-nCoV/lab/index.html (Updated March 31) [Accessed April 01, 2020]
- ECDC: Laboratory support by specialised laboratories in the EU/EEA https://www.ecdc.europa.eu/en/novel-coronavirus/laboratory-support (Updated February 08, 2020) [Accessed April 01, 2020]
- Transfusion news: https://transfusionnews.com/2020/03/04/risk-of-transfusion-transmission-of-sars-cov-2-is-only-theoretical/ (March 04, 2020) [Accessed April 01, 2020]
- U.S. Food and Drug Administration (FDA): Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-information-blood-establishments-regarding-novel-coronavirus-outbreak (February 04, 2020) [Accessed April 01, 2020]
- U.S. 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 April 01, 2020]
- U.S. CDC: Coronaviruses: https://www.cdc.gov/coronavirus/types.html (Updated February 15) [Accessed April 01, 2020]
- Encyclopaedia Britannica: Coronavirus https://www.britannica.com/science/coronavirus-virus-group [Accessed April 01, 2020]
- Lim, Y.X.; Ng, Y.L.; Tam, J.P.; Liu, D.X. Human Coronaviruses: A Review of Virus–Host Interactions. Diseases 2016, 4, 26.
- 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.
- ECDC: Factsheet for health professionals on Coronaviruses 2019: https://www.ecdc.europa.eu/en/factsheet-health-professionals-coronaviruses (Updated January 30, 2020) [Accessed April 01, 2020]
- WHO: Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19) 2020: https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid19-final-report.pdf (February 28, 2020) [Accessed April 01, 2020]
- Liang W, Guan W, Chen R, Wang W, Li J, Xu K, et al. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020 Mar;21(3):335-7. 22.
- Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-13. 23.
- Guan W-j, Liang W-h, Zhao Y, Liang H-r, Chen Z-s, Li Y-m, et al. Comorbidity and its impact on 1,590 patients with COVID19 in China: A Nationwide Analysis. www.medrxiv.org. 25 February 2020:20027664
- U.S. National Institutes of Health (NIH): NIH clinical trial of remdesivir to treat COVID-19 begins (February 25, 2020) [Accessed April 01, 2020]
- U.S. NIH: NIH clinical trial of investigational vaccine for COVID-19 begins (March 15, 2020) [Accessed April 01, 2020]
- European Medicines Agency (EMA): Update on treatments and vaccines against COVID-19 under development. (March 31, 2020). [Accessed April 03, 2020]
- U.S. FDA: Investigational COVID-19 Convalescent Plasma - Emergency INDs: https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds (March 24, 2020) [Accessed April 01, 2020]
- Nature: News: How blood from coronavirus survivors might save lives: https://www.nature.com/articles/d41586-020-00895-8 (March 24, 2020) [Accessed March 27, 2020]
This statement was updated on April 3, 2020 and replaces an earlier version. PPTA will update this content periodically, as new information and data emerges.
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