Lifting of long-time ban on use of UK plasma for manufacturing of immunoglobulins will help patients
February 25, 2021 (Annapolis, MD) - The Plasma Protein Therapeutics Association (PPTA) welcomes the decision of the UK government to lift a two decades old ban on the use of UK-donated plasma for the manufacture of immunoglobulins, following a scientific review conducted by the Medicines and Healthcare Products Regulatory Agency. The ban was imposed in 1998 to mitigate the spread of variant Creutzfeldt Jakob Disease (vCJD), but experts have now concluded that the use of UK-sourced plasma to manufacture immunoglobulins is safe and can recommence, supported by a set of robust safety measures.
Treatments for rare diseases at risk, due to the decline of plasma donations
Representatives of patient advocacy groups, expert physicians, thought leaders, and representatives from the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research came together on December 9 at a roundtable sponsored by the Plasma Protein Therapeutics Association (PPTA) to discuss the impacts on people with rare diseases if not enough plasma is available to manufacture lifesaving plasma-derived therapies. These therapies are often the only treatments available for people with primary immune deficiencies, bleeding disorders, Alpha-1 Antitrypsin deficiency, hereditary angioedema, and certain neurological conditions.
Inception Impact Assessment Underlines the Need for Timely Action to Decrease the Reliance on Third Countries for Plasma
The Plasma Protein Therapeutics Association (PPTA) welcomes the European Commission’s publication of the Inception Impact Assessment (IIA) as a necessary step in the ongoing evaluation of the EU legislation on blood, tissues, and cells (BTC). Rightfully, the assessment underlines the need for timely action to decrease Europe’s reliance on third countries for plasma. We appeal to authorities to urgently take the necessary steps to collect more plasma through plasmapheresis in Europe As highlighted by the European Commission, plasmapheresis is a more efficient collection method compared to the collection of recovered plasma.1
The journal publication, “Immunoglobulin Replacement Therapy is critical and cost-effective in increasing life expectancy and quality of life in patients suffering from Common Variable Immunodeficiency Disorders (CVID): A health-economic assessment,” is authored by Professor Philippe van Wilder with the Université libre de Bruxelles and Professor Esther de Vries of Tilburg University and offers a health economic model to estimate the value of treatment with IG therapy for CVID patients.
New position statement by CHMP regarding donor deferral criteria for sexual behaviour helps assessment of PMFs
The International Plasma and Fractionation Association and the Plasma Protein Therapeutics Association are pleased with the recent publication by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) "CHMP Position statement on quality and safety assessment for the Plasma Master File (PMF) certification with regard to donor deferral criteria for sexual risk behaviour," as such a position was highly needed, especially regarding men-having-sex-with-men (MSM). It clarifies that the application of these nationally defined deferral periods will from now on also be considered when assessing appropriateness of locally collected plasma to be included in a PMF.
Human Plasma Donations Remain Important During COVID-19 Pandemic
In a recent communication, the U.S. Food and Drug Administration (FDA) limits the collection and use of COVID-19 convalescent plasma authorized under Emergency Use Authorization for the treatment of hospitalized patients with COVID-19.1 It is important to note, however, that this development does not mean that the need for plasma donations has diminished. Both normal source plasma donations, from healthy individuals, and convalescent plasma donations, from individuals who have recovered from COVID-19, are still needed to fight COVID-19 and the many non-COVID-19 conditions (e.g., immune deficiencies and blood clotting disorders) for which plasma protein therapies are ordinarily used.
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What Does the COVID-19 Vaccine Mean for Plasma Donation?
March 11, 2021 marked the one-year anniversary of when the World Health Organization (WHO) declared the COVID-19 outbreak a pandemic. Since then, it has been a year of breaking news, mask-wearing, social distancing, and questions. The latest of which seems to be, if I received the COVID-19 vaccine, can I donate plasma?
The short answer is yes.
The U.S. Food and Drug Administration (FDA) has stated that persons who are healthy and meet certain eligibility criteria can donate source plasma.
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