The evaluation of applications for the administration of monoclonal antibodies will be done every five days by the plenary session of the Commission
The online platform has opened for the submission of applications for the administration of monoclonal antibodies under the brand name Evusheld by AstraZeneca, against the SARS-CoV-2 virus for prophylactic indication in patients with severe immunodeficiency.
EVUSHELD has been approved by the European Medicines Agency for the prevention of SARS-CoV-2 in people who:
* They do not have the ability to mount an immune response to vaccination against the virus
* They have a contraindication for vaccination
Necessary conditions for the administration of the drug EVUSHELD
* Age ≥12 years and weight ≥ 40 kg
* Absence of history of previous COVID-19 illness in the last trimester
* It primarily concerns people with severe immunosuppression and risk of exposure to SARS-CoV-2
* The indication and recommendation for vaccination in people who will receive EVUSHELD remains in effect. In case of vaccination, EVUSHELD is recommended to be administered 2 weeks after vaccination
As well as one of the following criteria:
* Treatment with CAR-T cells or immediately planned treatment with CAR-T cells
* Transplantation of hematopoietic cells (within the last two years or receiving immunosuppressive treatment or with GVHD) or for immediate transplantation of hematopoietic cells
* Haematologic malignancy under active treatment and priority malignancies of the β-lymphocyte (e.g. multiple myeloma, B-cell lymphomas, CLL)
* Solid organ transplantation and receiving immunosuppressive treatment
* Receiving treatment with a biological agent directed against β – cells (anti – CD20 – rituximab, ocrelizumab, ofatumumab, veltuzumab, etc.)
* Primary immunodeficiencies (eg DiGeorge syndrome, Wiskott-Aldrich syndrome, common multiple immunodeficiency)
EVUSHELD drug administration procedure
The medicine EVUSHELD will be administered:
* Only upon request from the patient’s specialist treating physician
* The person to receive EVUSHELD at the time of administration must have a negative molecular test for SARS – CoV2 of 24 – 48 hours and complete absence of symptoms
* EVUSHELD will be administered intramuscularly, with monitoring for at least one hour after administration
The approval process to be followed is the same as that for antiviral pills. In particular, the Committee will examine the applications and enter the corresponding indication of approval or rejection in the application.
The evaluation of the applications will be done every five days by the plenary session of the Commission, based on the order of submission of the request and with prioritization according to the severity of the immunosuppression.
Appointment Scheduling & Granting
The medicine EVUSHELD will be available in Hospitals that have:
* Blood units
* Transplantation and immunocompromised monitoring units
* Features of administration of biological anti-CD20 agents
The citizen whose application has been approved should contact the selected Hospitals to schedule the administration at the Hospital that serves him.
The patient will arrive at the Hospital at the appointed time of the appointment and will be directed to the appropriately configured administration area.
The prescription will be carried out by the Hospital Pharmacy, the preparation will be transported to the site and administered to the patient.
The medicine will be administered in the following Hospitals:
1. General Hospital of Athens “Laiko”
2. General Hospital of Athens “Sismanoglio”
3. Attikon University General Hospital
4. Piraeus “Metaxa” General Cancer Hospital
5. General Hospital of Thessaloniki “Papanikolou”
6. General Hospital of Thessaloniki “Ippokrateio”
7. University General Hospital of Thessaloniki “ACHEPA”
8. University General Hospital of Alexandroupoli
9. University General Hospital of Ioannina
10. University General Hospital of Patras
11. University General Hospital of Heraklion
12. Larissa University General Hospital
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