The Plasma Protein Therapeutics Association (PPTA) recently posted an online update that addresses safety concerns relevant to the recent monkeypox virus (MPXV) outbreak and plasma protein therapies.
According to the new statement, while the presence of the MPXV in the blood (viremia) of individuals with symptomatic infections of monkeypox has been detected, the risk remains theoretical. To date, there have been no reported cases of transmission of MPXV by blood and blood components, including by plasma and plasma-derived products.
MPXV is spread most often by close/intimate contact, including direct contact with monkeypox rash, scabs, or body fluids from a person with monkeypox. It can also be transmitted by touching objects, fabrics (clothing, bedding, or towels), and surfaces that have been used by an infected person. There is currently no in vitro screening assay for the monkeypox virus.
The PPTA statement also describes the multiple viral inactivation steps employed in the manufacturing process of plasma protein therapies, including heat and detergent treatments, nanofiltration, plus other techniques. Another area of risk-mitigation includes existing donor screening procedures that would make it “highly unlikely” that a person exhibiting disease symptoms associated with MPXV would be accepted for donation. Donor deferral would be likely as these symptoms include raised temperature/fever, fatigue, headache, enlarged lymph nodes and skin lesions.
“Given this currently available scientific evidence, PPTA considers that MPXV infectivity does not occur in plasma or is low,” read the update. “Due to the characteristics of the virus and multiple, complimentary steps with significant and robust virus removal and virus reduction capacity utilized during manufacturing of plasma protein therapies, PPTA considers that the current MPXV outbreak is not a concern for the safety margins of plasma protein therapies manufactured by PPTA member companies.”
Scientists continue to investigate monkeypox, including modes of transmission. NHF will continue to monitor this situation and will share any relevant updates as they become available.
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