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.

The Federal Minister of Health Jens Spahn had announced that certain monoclonal antibodies against the SARS-CoV-2 coronavirus could be used in Germany from February 2021, as soon as they are available in Germany. In the meantime, these are, on the one hand, the antibodies Bamlanivimab and Etesevimab, which were developed by the US pharmaceutical company Eli Lilly. Bamlanivimab can be used both as a monotherapy and in combination with the antibody Etesevimab. The other is the combination treatment with RegnCoV-2, consisting of the two antibodies Casirivimab/Imdevimab from the Swiss pharmaceutical company Roche and the US company Regeneron.

Because of the new emerging SARS-CoV-2 variants, the COVRIIN expert group at the Robert Koch Institute has specified the possible use of the available monoclonal antibodies. According to this, the use of monoclonal antibodies in monotherapy (only one monoclonal antibody) could possibly not lead to complete virus elimination in immunocompromised patients and promote the development of so-called escape mutations in the virus genome. Therefore, combination therapy with two monoclonal antibodies should be preferred in this patient group. In immunocompetent patients, on the other hand, monotherapy with Bamlanivimab is possible, provided the infection is not with one of the SARS-CoV-2 variants of concern, B.1.135 (South African variant) or P1 (Brazilian variant). If the status is unclear, the local epidemiological situation should be considered.

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

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