Even though the efficiency of plasma therapies against COVID-19 are not yet demonstrated, increasing Europe’s blood collection capacity will contribute to address chronic shortages, the European Commission has said.
Plasma is seen as a potential therapeutic option for treating the COVID illness, either by immediate transfusions from COVID survivors to patients or by manufacturing plasma-derived medicinal products.
However, clinical trials on the effectiveness of COVID-19 convalescent plasma (CCP) as a treatment against the disease have shown mixed results so far.
What must be proven is whether antibodies in blood plasma of healthy people who overcame the disease are able to contain the progression of the infection in other COVID-19 patients.
Contacted by EURACTIV, a European Commission spokesperson said pressing ahead with plasma therapies will be helpful regardless. Although recent studies on CCP have indicated negative results, studies on very early transfusion with high potency CCP are currently ongoing and are supported by EU research funding.
The funding, allocated via the Emergency Support Instrument (ESI) – the Commission’s financial aid to member states addressing the COVID emergency – is being used by blood establishments across the EU to purchase and install new plasma collection equipment and to collect CCP.
According to the spokesperson, this plasma can be used in studies of CCP transfusion in line with the Commission’s guidance or sent to the industry that is developing therapeutics manufactured from donated CCP.
“COVID Convalescent Plasma is a promising resource that could help us tackle the actual crisis and other future pandemics,” said Pierre Tiberghien, president of the European Blood Alliance (EBA), an association representing more than 80% of the EU’s blood services.
However, its effectiveness and best therapeutic use have not been demonstrated yet, which is why several clinical trials and monitored access programmes are still underway in all member states and the UK.
Addressing plasma shortage
The Commission spokesperson added that, beyond the pandemic, the increased plasma collection capacity of EU blood services will contribute to addressing a current shortage, as well as dependence on third countries for plasma used in the manufacture of medicinal products.
Plasma-derived medicinal products (PMDPs) are used to treat rare and chronic diseases, often of genetic origin, but also immunodeficiencies, bleeding disorders and neurological illnesses associated with the absence or malfunctioning of specific proteins.
Europe depends on US plasma imports for more than 38% of its need, according to a study on the plasma proteins market in Europe by the Marketing Research Bureau.
In 2019, the Commission supported a conference on EU plasma supply organised by the European Directorate on Quality of Medicines, which adopted a set of recommendations on plasma collection at national levels.
Among the recommendations, the conference suggested strengthening Europe’s strategic independence on plasma for PDMPs from foreign countries and developing strategies to prevent supply disruptions in the event of a shortage.
Increasing strategic autonomy and reducing the risk of shortages caused by over-reliance on third-country medicine production is one of the core aspects of the new EU’s pharmaceutical strategy launched in November.
EU member states supportive of SUPPORT-E
A European Commission-backed project called SUPPORT-E officially started last September to determine whether CCP is an effective and safe treatment, and more broadly, to support high quality clinical and scientific evaluation of CCP.
The project received €4 million in grants from the EU’s research and innovation programme Horizon 2020 to fund selected clinical trials and monitored access use programmes.
The assessment of the inclusion of monitored access use programmes in the project will end in the next few weeks, said a spokesperson for the European Blood Alliance (EBA), which takes part in the programme.
“The EU has been very supportive so far,” the EBA’s Tiberghien told EURACTIV, citing EU funding provided via the SUPPORT-E project itself but also via emergency pandemic funding to national governments. This has helped move forward “the CCP collection programmes across all Europe and creating, in collaboration with the EBA, a dedicated database,” Tiberghien said.
Thanks to this open-access database managed by the Commission, the EBA and the European infectious disease agency (ECDC), it is possible to get information about the EU countries that are running convalescent plasma therapies, as well as the number of reported collections and transfusions.
Up to now, member states have been very collaborative and interested in the opportunity given by SUPPORT-E, with several expressions of interest that have been made so far, an EBA spokesperson said.
On 10 March, the Commission published updated guidance on CCP in light of the most recent scientific evidence.
The European Commission Substances of Human Origin (SoHO) team is handling the issuing of the guidance, with the support of both the ECDC and the EBA, with the blessing of competent authorities for blood and blood components at EU member states level.
Besides an update of the scientific literature, this latest revision addresses the eligibility of vaccinated donors and recommends limiting the transfusion of CCP to patients early in the course of the disease as well as using donations with high levels of neutralising antibodies.
According to the ECDC, the most developed CCP program is in the USA and is regulated by the Food and Drug Administration (FDA). Brazil and other countries have also developed a program of CCP therapy.
[Edited by Frédéric Simon]