2019 Novel Coronavirus (2019-nCoV) and Plasma Protein Therapies
Recent international reports have highlighted the emergence of a new coronavirus in Wuhan, Hubei Province, China. The 2019 Novel Coronavirus (2019-nCoV) was first identified by Chinese authorities in December 2019 and since then has been associated with pneumonia in over 2000 persons in China and more than 50 deaths.
In addition, there has been a growing number of cases identified outside of Hubei Province and internationally. On January 21, 2020 the U.S. Centers for Disease Control and Prevention (CDC) confirmed the first case of a person being infected with 2019-nCoV in the U.S.4 More cases have since then been confirmed internationally.
The Plasma Protein Therapeutics Association (PPTA) considers that the 2019-nCoV 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 cases detected has been in the Hubei province in China. Individuals diagnosed with the virus in other countries acquired the disease through travel to Wuhan City, Hubei Province. Based on the current epidemiological evidence, it is unlikely that the virus is present in U.S. and European populations. Moreover, donor screening procedures are in place to prevent donations from individuals showing disease symptoms typical of a coronavirus infection (raised temperature/ fever, cough, difficulty breathing) from donating plasma.
The 2019-nCoV is a large sized virus (approximately 120 nm in diameter). 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),7 low pH incubation, caprylate, pasteurization8 or dry-heat treatments,9 nanofiltration or fractionation processes and others.10 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.8, 11, 12
Based on these data, PPTA is convinced that existing manufacturing methods provide significant safety margins against the 2019-nCoV.
Public health bodies in the US (CDC) and in Europe (ECDC), as well as the WHO and Chinese authorities, are continuously monitoring the situation and have put in place proactive measures to monitor 2019-nCoV infection in Europe and in the U.S, as well as internationally, including issuing travel guidance for Wuhan City, Hubei Province, China1, 13, 14, 15 testing16, 17 and reporting guidance for 2019-nCoV, and adding entry health screening at major U.S.1 and international airports18 for passengers coming from Wuhan City.
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 2019-nCoV is not a concern for the safety margins of plasma protein therapies manufactured by PPTA member companies.
The 2019 Novel Coronavirus (2019-nCoV) 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.5, 6 There is no published data documenting transmission of respiratory coronaviruses by blood transfusion.5, 6
It appears that the 2019-nCoV can be spread through human-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.