Paul-Ehrlich-Institut

Coronavirus and COVID-19

Biomedicines

In various studies world-wide, scientists have examined a number of medicines to treat and prevent COVID-19. Some of them have already been used successfully to treat other virus infections and have been studied in clinical trials. All of these medicines must be re-evaluated scientifically for safety and efficacy in COVID-19. A combined use of multiple therapeutics is also conceivable.

Antibodies from persons who have recovered from a COVID-19 (convalescent plasma)

The administration of serum from persons who have recovered from COVID-19 to those infected with the virus, or, alternatively, purified antibodies against SARS-CoV-2 (so-called hyper-immunoglobulins) represents a passive form of immunisation. These antibodies bind and neutralise the virus and thus support the immune system in fighting the infection.

Immunotherapy with monoclonal antibodies

Anti-inflammatory monoclonal antibodies bind to surface molecules on cells and interrupt inter- and intracellular signalling pathways, e.g. via the interleuikin-6 receptor. The aim is to prevent or inhibit an exuberant immune response which is often observed in the course of COVID-19.

Mesenchymal stem cells

These cells are precursors for many different cell types in the human body. Their purpose is to have an anti-inflammatory effect in patients severely affected by COVID-19 following a transplantation, thus protecting lung tissue and regenerating damaged lung tissue. In Germany, they always require a manufacturing authorisation pursuant to the Good Manufacturing Practice (GMP) for the use in humans.

SARS-CoV-2 neutralising monoclonal antibodies

SARS-CoV-2 monoclonal antibodies bind structures on the virus or block receptors on human cells thus preventing the virus from entering the cell, the human immune response from overreacting, or the virus from interacting with the immune system.

Several drugs with monoclonal antibodies for the treatment of COVID-19 are now available in Germany. These include the recently authorised antibody-containing medicine Ronapreve, which has so far not been distributed in Germany via the usual distribution channel through Roche Pharma AG or through pharmaceutical wholesalers, but has been made available by the Federal Ministry of Health (Bundesgesundheitsministerium, BMG) under the Ordinance Assuring the Supply of Products for Medical Needs (Medizinischer Bedarf Versorgungssicherstellungsverordnung, MedBVSV) under the name Regn-CoV2. Regn-CoV2 corresponds in its composition to the medicinal product Ronapreve, which has been authorised in the EU since 12 November 2021, and can be used in accordance with the authorised product information. Dispensing continues to take place via star and satellite pharmacies, which are listed on the website of the Robert Koch Institute.

Since 12 November 2021, the monoclonal antibody Regkirona (regdanvimab) from the company Celltrion has also been authorised in the European Union and can be used according to the product information after market launch in Germany. It is not yet known when Regkirona will be available.

In addition, the monoclonal antibodies bamlanivimab and etesevimab, which were developed by the U.S. pharmaceutical company Eli Lilly and were also provided by the BMG within the framework of the MedBVSV, can be used within the remaining shelf life until the end of November 2021.

RKI - Stocking pharmacies for monoclonal antibodies (star and satellite pharmacies): www.rki.de/covid-19-arzneimittelbevorratung (German only)
HCP information from the Federal Ministry of Health (BMG): "Authorisation of Ronapreve (casivirimab/imdevimab) and availability in Germany" (German only)
German Federal Gazette - Announcement of the general ruling on the purchase and use of the monoclonal antibodies bamlanivimab and etesevimab or casirivimab and imdevimab (18 November 2021) (German only)
Section - COVRIIN: Expert advice on COVID-19 at the interface of intensive medicine, infectious medicine and emergency medicine (German only)
FAQ Vaccines and Biomedicines - Monoclonal Antibodies

Antivirals

Antivirals inhibit the activity, structure, and replication of the virus in the human body (e.g. protease inhibitors, RNA-polymerase inhibitors).

Further Information

European Medicines Agency EMA Receives Marketing Authorisation Application for the Monoclonal Antibody Xevudy (sotrovimab) against COVID-19
European Commission grants EU Marketing Authorisations for SARS-CoV-2 Neutralising Monoclonal Antibodies Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab)
CHMP Recommends Authorisation of SARS-CoV-2 Neutralising Monoclonal Antibodies Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) against COVID-19
EMA Ends Rolling Review for Bamlanivimab/Etesevimab Monoclonal Antibody Cocktail Following Withdrawal by Eli Lilly
Use of Monoclonal Antibodies against COVID-19
Monoclonal Antibody Cocktails against COVID-19 in Rolling Review
Paul-Ehrlich-Institut Approves First COVID-19 Therapy Study with Convalescent Plasma
RECOVER – the Paul-Ehrlich-Institut Authorises another COVID-19 Therapy Study with Reconvalescent Plasma
Recommendation of the Paul-Ehrlich-Institut for the Collection and Manufacture of COVID-19 Convalescent Plasma
Therapy against COVID-19 Symptoms under Development - Clinical Trials for Sarilumab authorised
Call for Blood Donations made by the PEI, Robert Koch Institute (RKI), and the Federal Centre for Health Education (BZgA) – Please observe the Appointments offered for Blood Donations!
RKI, Paul-Ehrlich-Institut and BZgA Call for Blood and Plasma Donations - Please Donate Even During Lockdown!

Content

  1. Role of the Paul-Ehrlich-Institut
  2. COVID-19 Vaccines
  3. Proof of Vaccination as Defined in the COVID-19 Protective Measures Exemption Directive and the Directive on Coronavirus Entry Regulations
  4. FAQ Coronavirus
  5. Biomedicines
  6. Safety of COVID-19 Vaccines
  7. Research Work
  8. SARS-CoV-2 Test Systems