Programmpunkt

10:15

Titel: Hyperimmunization, plasma for special purposes. Where are we standing?
ID: VS-3-2
Art: Abstractvortrag
Redezeit: 10 + 5 min
Session:
ARGE Plasmapherese
VS-3

Referent: Stephan Kiessig (Mannheim)


Abstract - Text

Offenlegung Interessenkonflikt:

The author declares no conflict of interests. 

Methods

Blood products needed to for calibrators and controls in diagnostics. More products (AB plasma, serum and platelet lysates) in GMP quality are used for cell-based drugs. To draw products, other issues need to be addressed in a new directive:



Cooperation with the health care system to run basic/booster vaccination
Cooperation vaccine manufacturers to inform the vaccinated about the necessity of plasma donation
Guide for ethics committees/insurances
Adjusted donor compensation to cover the risks of donors
Clear reporting system for adverse events (pharmacovigilance)
Clear legal statement on safety for the donors/physicians

Results

The current transfusion law allows the immunization of donors. The use of a vaccine for hyperimmunization is clearly off-label. Only a study plan accepted by an ethics committee gives the physician a legal background and insurance. In general, a GCP-like procedure must be present for all parties involved. This requires a study plan, an ethical vote, including donor education, informed consent and insurance.

Background

Facing the Corona situation, we are recognizing that Immunoglobulins with defined high titers can play a very important role in the treatment. There is still an urgent need for different kinds of plasma.


Plasma the direct therapeutic use can be drawn from different types of donors:



Convalescent patients
After vaccination of healthy individuals (according to licensed time schedule = on-label use of the vaccine)
Hyperimmunization of healthy donors (off-label-use of the vaccine)

Conclusion

National health authorities, health insurance companies, blood donation services, plasma centers, fractionators as well as local and national regulatory authorities must be involved in the process of developing a new guideline.