This is a statement from BioTest which is relevant to anyone using Haemoctin. We don’t believe there is anyone using this product in Scotland at the moment but some of the information in the statement is of wider appliability, particularly to those on plasma derived products.
Novel Coronavirus (SARS-CoV-2) and the safety of Biotest plasma products (1)
In view of the emerging SARS-CoV-2 pandemic, it should be emphasized that Biotest plasma products provide for high margins of safety with respect to SARS-CoV-2 for the following reasons (in decreasing order of relevance):
- SARS-CoV-2 is easily inactivated by the manufacturing processes established at Biotest:
a. Coronaviruses are large (125 nm), lipid-enveloped viruses which are easily and reliably inactivated by standard virus inactivation and removal steps, such as nanofiltration or solvent/detergent (S/D) treatment.
b. As a minimum, and also as required by European regulatory guidance, Biotest manufacturing processes have two effective virus inactivation or removal steps against lipid-enveloped viruses, working by different mechanisms of action. Even in a hypothetical worst case scenario of an SARS-CoV-2-infected plasma donor contributing to a Biotest plasma pool, no infectious SARS-CoV-2 would be able to get into a final Biotest product. It is also noted that many Biotest manufacturing processes exceed the minimum virus inactivation/removal capacity required by European regulatory guidance.
- Although likely high SARS-CoV-2 concentrations would be found in the aerosols exhaled by infected persons, only low SARS-CoV-2 concentrations are expected in the blood of these persons. As recently published2, SARS-CoV-2 RNA in the bloodstream could be detected in only about 15% of patients showing clinical signs of SARS-CoV-2 infection.
- While the number of infected persons in China is slowly approaching 100 000, comparatively few have been reported up to now in the countries where Biotest is sourcing plasma from (selected European countries, Canada and USA). However, we are well aware that this may change.
- Any plasma donor presenting himself with clinical signs of SARS-CoV-2 infection (fever, cough, difficulty breathing) would be deferred from donation. In addition, blood and plasma collection centers have started to include SARS-CoV-2 specific questions as part of the donor examination to reduce the risk of an infected donor (e.g. questions about recent travel to China or other countries with a significant SARS-CoV-2 risk, or contact with persons who recently travelled to these countries).
The global situation and knowledge about the new virus are at the time of writing rapidly evolving3. We will update this statement as needed in order to ensure customers and the medical community are provided with the best information available.
1. A general safety assessment for plasma products has also been published by the Plasma Protein Therapeutics Association (PPTA). See https://www.pptaglobal.org/media-and-information/ppta-statements/1055-2019-novel-coronavirus-SARS-CoV-2-and-plasma-protein-therapies
2. Chan JF, Yuan S, Kok K-H, et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. The Lancet. Published online January 24, 2020. See https://doi.org/10.1016/S0140-6736(20)30154-9
3. Recommended web sites:
- Johns Hopkins University / Center for Systems Science and Engineering (CSSE), offers daily epidemiological updates and graphics, see https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6
- European Centre for Disease Prevention and Control (ECDC): regular updates on SARS-CoV-2 topic, see https://www.ecdc.europa.eu/en/coronavirus
- CDC (FDA): regular updates on SARS-CoV-2 topic, see https://www.cdc.gov/coronavirus/index.html
Updated: 23 March 2020