The use of COVID-19 convalescent plasma (CCP) as a therapeutic option, despite its ups and downs, has shown the European Union’s renewed interest in plasma-derived medicinal products (PDMPs).
Last spring, plasmapheresis was considered one of the most promising treatments for COVID-illness. Plasma is one of the blood components, together with red blood cells and platelets, that can be transfused to other patients and can also be used for manufacturing PDMP.
The principle behind this potential therapeutic option is simple: plasma obtained from the blood of healthy people who overcame the disease has specific antibodies that could be valuable in treating other COVID-19 patients.
Some hospitals in Europe have started calling on COVID-survivors to donate their plasma to be used for immediate transfusion in targeted therapies or for manufacturing other medicines.
Plasma therapies have immediately generated quite a buzz as the list of renowned donors included people like the Oscar-winning actor Tom Hanks and the Italian opera singer Andrea Bocelli.
Several countries have adopted programmes to use CCP as an experimental therapy, including the US Food and Drug Administration (FDA), which granted emergency authorisation in August for blood plasma as a coronavirus treatment.
In November, the Dutch health ministry announced the production of 4,000 doses of an ‘antibody medicine’ using convalescent plasma tailored for people with weakened immune systems, like cancer and transplant patients
In Romania, the health ministry has published a set of guidelines “for the collection, testing, processing, storage and distribution of plasma” from recovered COVID-19 patients, while the Bucharest mayor Gabriela Firea has proposed to offer €1,000 in meal vouchers for plasma donors.
The EU executive jumped on the CCP wagon too, as it launched a European donor database and treatment centres together with the association representing more than 80% of the EU’s blood services – the European Blood Alliance (EBA) – and the European infectious disease agency (ECDC).
The initiative included the adoption of common guidelines with the EU-27 national blood authorities regarding the collection, transfusion, and authorisation, as well as guidance on monitoring procedures and gathered data on the use of CCP.
Last June, EU’s Health Commissioner Stella Kyriakides acknowledged the need for new donations of blood plasma, as it would play an active role in the fight against COVID-19.
“Hospitals and blood services across the EU are using or trialling plasma donated by recovered COVID-19 patients to boost the ability of new patients to fight the virus,” she said.
Mixed results, collection issues remain
But beyond the ‘plasma hype’, clinical trials have shown mixed results so far.
In October, a study conducted in India published in the medical journal BMJ said the treatment offered limited effectiveness in reducing mortality and severity of symptoms.
Likewise, the US National Institutes of Health (NIH) quashed a trial of convalescent blood plasma as it had not been proven as an effective treatment for the virus.
However, another study published in the New England Journal of Medicine recognised CCP as capable of delaying or stopping the progression of illness in mildly ill older infected adults.
For the Commission, the line is the same since the beginning of the pandemic: “When it comes to research on therapeutics for COVID-19, all options have to be explored to make sure that safe and effective treatments can be made available as quickly as possible,” said Commissioner Kyriakides.
This is why, in September 2020, the Commission mobilised €4 million of funds in the EU’s research and innovation programme Horizon 2020 in favour of the project Support-e that aims to determine if CCP is an effective and safe treatment.
The COVID-crisis has also highlighted the need for plasma donations, as according to the Plasma Protein Therapeutics Association (PPTA), plasma collectors have experienced significant declines in collections during the pandemic.
Plasma-protein therapies are used to meet the clinical needs of rare disease patients, but the already critical situation when it comes to collecting source plasma in Europe has been worsened by the impacts of social distancing measures and other mobility restrictions.
Italian MEP Simona Baldassare, a medical doctor who has been quite vocal in favour of serology treatment of COVID-19 with CCP, proposed to the Commission last spring to establish a ‘European plasma bank’ to coordinate plasma supply and demand in emergencies, with a view to raising awareness of the need to donate plasma across Europe.
She mentioned clinical trials at the San Matteo di Pavia general hospital and the Carlo Poma di Mantova hospital that had led some of the most severely affected regions in Italy to set up specific ‘plasma banks’ at blood transfusion centres.
Contacted by EURACTIV, she said that, although all efforts are legitimately focused on vaccines, other medical results achieved during the pandemic should not be overlooked.
“Plasma banks are an important building block. Unfortunately, despite the Commission’s Support-e project, our proposal for a European plasma bank has not been followed up to date,” she added.
According to the Commission, the organisation of health services including blood and plasma collection is a national responsibility of member states, and it would therefore not be possible to consider the establishment of a European plasma bank.
[Edited by Zoran Radosavljevic]