Laboratory worker at the Regeneron pharmaceutical company in Tarrytown, New York
Photo: BRENDAN MCDERMID / REUTERS
Germany will be the first EU country to use corona drugs with so-called monoclonal antibodies to fight the Sars-CoV-2 virus.
Federal Minister of Health Jens Spahn (CDU) told »Bild am Sonntag« that the federal government had »bought 200,000 cans for 400 million euros«.
Apparently, it concerns on the one hand the drug from the US manufacturer Regeneron, with which the then US President Donald Trump was treated last fall, and on the other hand the preparation "Bamlanivimab" from the American pharmaceutical company Eli Lilly.
The drugs will be used in Germany from next week, according to Spahn, initially in university hospitals.
Antibody drugs are not yet approved in Europe.
What are Monoclonal Antibody Drugs?
In therapy with antibodies, patients suffering from Covid-19 receive a cocktail of artificially generated corona antibodies that have been cloned in the laboratory, i.e. duplicated identically.
Monoclonal means that the antibodies used are all the same and attack the virus at a clearly defined target.
They are directed against a key protein of the Sars-CoV-2 virus, i.e. they dock on the coronavirus and thus prevent it from entering the cells.
The virus can only multiply there.
In the case of the Regeneron preparation, the active ingredient dose contains two different monoclonal antibody variants in order to also include a possible mutation of the virus.
Research is also being carried out into combinations with three antibodies.
Regeneron and Eli Lilly are currently the only ones who have received emergency approvals in the USA for their antibody drugs "REGN-COV2" and "Bamlanivimab".
In both cases, the funds can be used in patients with mild to moderate Covid 19 disease who are at high risk of a severe course.
However, both preparations have not yet been researched through extensive studies in different stages and symptoms of the infections, and the data situation is so far rather thin.
Among other things, it is still open whether they can also help seriously ill patients.
The Regeneron agent is currently being tested in a phase II / III study with outpatients.
According to the Association of Research-Based Pharmaceutical Manufacturers (vfa), "REGN-COV2" also shows antiviral effects in hospitalized Covid-19 patients.
In addition, a phase III study is running in parallel, in which volunteers are given it for prevention.
According to vfa, the British vaccine manufacturer AstraZeneca has also developed a drug with two genetically engineered antibodies.
In Germany, a consortium of researchers from Cologne University Hospital, the University of Marburg, the German Center for Infection Research (DZIF) and the Boehringer Ingelheim company is also working on the drug BI 767551, the monoclonal antibody active ingredient of which is derived from an antibody in the plasma of convalescent patients should be, as the association says.
One study is currently examining both injection and inhalation application.
The Berlin Charité is working on a similar project with Miltenyi Biotec, among others.
What hope is associated with antibody therapy?
Jens Spahn described the effect of antibody drugs in an interview with "Bild am Sonntag" as "passive vaccination".
The funds could "help high-risk patients in the early phase that a severe course is prevented," said the Minister of Health.
It is possible that the administration of antibodies can also protect healthy people from infection and can be used by doctors and nurses as long as they have not yet been vaccinated across the board.
Especially in the transition phase, in which many people have to wait months for a vaccination, the antibody drugs could prove useful in avoiding serious cases, gaining time and relieving hospitals.
Unlike a vaccination, however, the effect of an antibody drug lasts far less long, even if the antibodies are made more durable through changes.
Vaccinations, especially those linked to an RNA messenger substance, work by training the body to develop targeted measures against the pathogen; they support the natural defenses.
That is why it takes a few weeks for the protective effect of the vaccination to fully develop in the body; a second vaccination dose should then ensure sustainability.
An antibody injection gives the body defense mechanisms that it can use immediately, but the immune system does not learn anything.
As soon as the active ingredient molecules have exceeded their lifespan in the body, the patient is just as unprotected as before the treatment.
Who is eligible for antibody treatment?
In the USA, the preparations can currently be used to treat patients aged twelve and over who are at risk of developing severe Covid 19 symptoms.
Patients who are already in the hospital or need ventilation with oxygen should not be given the drug.
According to Regeneron, those test persons whose immune system had not yet produced their own antibodies against the virus benefited most.
Stephen Hahn, head of the US FDA, said the best results were found in studies within the first ten days after infection.
US manufacturer Eli Lilly states in a recent study that its antibody drug "Bamlanivimab" has reduced the risk of severe Covid-19 disease for residents of a nursing home by 80 percent and for home staff by 60 percent.
However, the European Medicines Agency EMA has not yet started an approval process for antibody treatments.
However, Regeneron plans to apply for approvals in the EU together with the pharmaceutical company Roche, as a spokeswoman for the authority of the news agency dpa said.
According to an assessment by the Paul Ehrlich Institute (PEI), which is responsible for vaccines and biomedical drugs in Germany, nothing stands in the way of application based on an individual benefit-risk assessment.
Treatments could be given "in certain individual cases" to adults suffering from Covid-19 with mild or moderate symptoms and a risk of severe disease.
A specialist group at the Robert Koch Institute dealt with "REGN-COV2" as early as December and came to the conclusion that the agent can be used in controlled clinical trials.
It is a "promising therapy option" in the early phase of a coronavirus infection and can also be used as prophylaxis after contact with the pathogen.
Icon: The mirror
bor / dpa