The Centers for Disease Control and Prevention (CDC) is responding to the rapidly evolving situation of the outbreak of respiratory disease (COVID-19) caused by a novel coronavirus (SARS-CoV-2). Though this was first detected in Wuhan City, Hubei Province, China, it has now been detected in over 60 countries worldwide, including the United States. MASAC recognizes that, whereas this is causing global concern, there are unique concerns that have been raised within the bleeding disorders community. This letter is to provide some interim guidance for the bleeding disorders community, direction to appropriate sources of information and highlights important information related to product supply and safety.
The CDC website is an excellent source of up-to-date information on what you should know about this respiratory disease, travel information, and information for specific groups and healthcare professionals. In this potential emerging global pandemic, the national and international situations are changing quickly, so it is important to check reliable news sources such as the CDC frequently.
MASAC Document #242, “Regarding Doses of Clotting Factor Concentrate in the Home” is a policy that was implemented to specifically address preparedness around the potential for unexpected events such as natural disasters and other situations which may risk interruptions in the supply of treatment products. This policy addresses expectations around the monthly supply as well as on-demand doses that should be available to cover such situations. MASAC continues to recommend adherence to MASAC Recommendation #242. Deviations from this that would limit supply to patients, or stockpiling of products by individuals, jeopardize putting all patients at risk unnecessarily. MASAC and NHF staff remain in regular communication with all manufacturers of products dispensed within the USA and there has been no indication of an impact on product supply or quality.
MASAC is providing the attached communication from Roche/Genentech regarding its product HEMLIBRA (emicizumab-kxwh). This statement provides specific reassurance regarding supply chains to its manufacturing facilities worldwide, that they have not identified any critical component that would impact their ability to supply Hemlibra in the future, and their commitment to keeping the hemophilia community informed as this situation evolves. This reassurance has also been supported by other manufacturers who’ve been in communication with MASAC and NHF. We will continue to assess and monitor the situation and keep the community apprised if we learn of any potential impact to the supply chain for all other therapies. The supply chain includes related medications and ancillary supplies used by the bleeding disorders population, which are often manufactured in or contain stabilizing components sourced from countries outside the USA.
Person to person transmission of SARS-CoV-2 is well documented. However, we also recognize that the bleeding disorders community may have concerns as to the potential risk of transmission of SARS-CoV-2 from blood and blood product donors. MASAC Document #253, “MASAC Recommendation Concerning Products Licensed for the Treatment of Hemophilia and Other Bleeding Disorders” includes information on the product features that have been implemented over the last several decades to address the potential risk of transmission of pathogens from plasma-sourced clotting factor concentrates. These comprehensive strategies including donor deferral, rigorous pathogen screening, viral inactivation and nanofiltration exclusion processes during manufacturing all contribute to the safety of these vital therapies. These processes have been implemented to not only deal with known pathogens but also as part of preparedness for previously unknown (novel) pathogens. The appearance of COVID-19 presents another opportunity to review the value of these processes and what is known thus far as it applies to the SARS-CoV-2 virus.
MASAC is providing the attached communication from the Plasma Protein Therapeutics Association entitled “New Coronavirus (SARS-CoV-2) and Plasma Protein Therapies (updated February 17, 2020)”. This communication provides reassurance that SARS-CoV-2 is not a concern for the safety of plasma protein therapeutics based on the characteristics of this virus – specifically that it is a very large virus (120 nm diameter) and has a lipid envelope making it highly susceptible to processing steps with virus inactivation and removal capacity. These processes include products that undergo processing steps that involve solvent-detergent, low pH incubation, caprylate-, pasteurization- or dry-heat treatments, nanofiltration or fractionation processes and others. Most but not all plasma-derived products sold in the US include a nanofiltration step with other viral inactivation or elimination processes and are available for review within the Tables that accompany MASAC #253.
MASAC is committed to remaining diligent in review of the rapidly evolving news flow and has encouraged open channels of communication with manufacturers, regulatory organizations and colleagues in the Division of Blood Disorders at the CDC. We will provide updated guidance if new information has implication for the bleeding disorders community.