IgNS Statement Regarding the Novel Coronavirus (COVID-19 or SARS-CoV-2)

 

The recent outbreak of the 2019 Novel Coronavirus (COVID-19 or SARS-CoV-2) has raised awareness around the safety of plasma protein therapies in the US and worldwide.  COVID-19 (or SARS-CoV-2), initially detected in Wuhan City, China, has now spread to over 37 locations, both internationally and within the US.

This new strand of Coronavirus is similar to, and in the same viral family as the Middle Eastern respiratory syndrome (MERS-CoV) and the Severe Acute Respiratory Syndrome (SARS-CoV).

COVID-19 (or SARS-CoV-2), a large, lipid-enveloped virus, was most likely introduced to the human population through contact with the secretions of infected animals in Wuhan, China.  There are currently 60 known cases of the virus in the US and over 82,500 cases worldwide. These numbers are rising rapidly with the death toll reaching over two thousand eight hundred worldwide.

Due to its morphology (presence of a lipid envelope) and size, COVID-19 (or SARS-CoV-2) is considered to be highly susceptible to viral inactivation and removal processes currently employed by plasma protein product manufacturers. These processes include the use of solvent/detergent treatment, caprylate, nanofiltration, pasteurization, and other dedicated viral inactivation and removal steps.

Further, strict screening processes and ongoing monitoring of qualified plasma donors in the US provides an additional layer of safety around plasma used to manufacture plasma protein therapies.

The Plasma Protein Therapeutics Association (PPTA) has issued an update to address the concerns of plasma safety in the face of a potential pandemic (www.pptaglobal.org).

Based on the available data, PPTA does not believe that COVID-19 (or SARS-CoV-2) poses a risk to the plasma supply in the US.

Please visit the PPTA website or contact individual product manufacturers for more information.

References

1. CDC: Coronavirus Disease 2019 (COVID-19) Situation Summary: https://www.cdc.gov/coronavirus/2019-nCoV/summary.html (updated February 25, 2020) [Accessed February 27, 2020]

2. Coronavirus COVID-19 Global Cases by Johns Hopkins CSSE: https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6[Accessed February 27, 2020]

3. Plasma Protein Therapeutics Association https://www.pptaglobal.org/media-and-information/ppta-statements/1055-2019-novel-coronavirus-2019-ncov-and-plasma-protein-therapies [Accessed February 27, 2020]