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For 400 million euros, Germany is buying antibody drugs that have not yet been approved, including a drug that former President Trump hailed as a “miracle.” How does Covid-19 therapy work and what can’t?
What did Minister Spahn buy?
The federal government has bought 200,000 doses of two antibody products for Germany for 400 million euros. According to the Federal Ministry of Health, it is REGN-COV2 and the agent Bamlavinimab from the American pharmaceutical company Eli Lilly. Both have already received emergency approval in the US, but have yet to be approved in the EU. According to Health Minister Jens Spahn, the so-called monoclonal antibodies will be used in Germany as the first EU country from next week. Because the drugs have not yet been approved, they can only be administered to patients in university hospitals under strict control.
What kind of antibodies are these?
Monoclonal antibodies are made in the laboratory and are designed to inactivate the virus after infection. Monoclonal means that the antibodies used are all the same and attack the virus on a clearly defined target. In contrast to this, after a vaccine, the human body forms a mixture of antibodies that can bind to the virus in different places. In this case, experts speak of polyclonal antibodies.
What resources are already used in the US?
The REGN-COV2 agent from the American company Regeneron is a combination of two monoclonal antibodies, casirivimab and imdevimab, which bind to the so-called spike protein of the coronavirus and can deform its structure. Antibodies are supposed to slow down the penetration of viruses into human cells and their reproduction. The combination of two different antibodies is intended to prevent the SARS-CoV-2 virus mutation.
The advantage of the mixture is that it increases the probability that at least one antibody can be really effective in each special application, explained the Frankfurt virologist Sandra Ciesek in NDR-Podcast “Coronavirus Update”. In contrast, the product of the American company Eli Lilly contains only one monoclonal antibody.
For which patients are the drugs intended?
Both agents can be used in the United States to treat patients 12 years of age or older who are at risk of developing severe symptoms of Covid 19. The drugs can reduce the likelihood of a severe course, according to the Food and Drug Administration of USA Patients who are in the hospital or need oxygen should not receive the drug.
According to Regeneron, test people whose immune systems had not yet produced their own antibodies to the virus benefited the most. FDA chief Stephen Hahn said the studies gave the best results within the first 10 days after infection. Many scientists say that there is still not enough data in general. Also in Germany, the funds are intended to benefit adult patients with mild or moderate symptoms and risk of severe disease.
How do these antibodies against Covid-19 work?
The antibodies are supposed to prevent the virus from entering the cell. According to Regeneron, treatment leads to a reduction in viral load, that is, the amount of detectable virus, and a faster resolution of symptoms.
What results of the study are there?
The agent is currently being tested in a phase II / III outpatient study. REGN-COV2 also showed antiviral effects in hospitalized patients with Covid-19, according to the Association of Research Pharmaceutical Companies. A phase III study is also being carried out in which it is administered to volunteers for its prevention. Regeneron has been working with Swiss pharmaceutical company Roche since last summer, which plans to sell the drug in Europe once it has been approved.
According to an assessment by the Paul Ehrlich Institute (PEI), responsible for vaccines and biomedical drugs, there is basically nothing in the way of an application based on an individual risk-benefit assessment. Treatments can be given to adults suffering from Covid-19 with mild or moderate symptoms and a risk of severe disease “in certain individual cases.”
A group of specialists from the Robert Koch Institute also looked at REGN-COV2 in December and concluded that the agent can be used in controlled clinical trials. It is a “very promising therapeutic option” in the initial phase of a coronavirus infection and can also be used as prophylaxis after contact with the pathogen.
What does former US President Trump have to do with it?
After Trump was infected with the coronavirus in October, he was treated, among other things, with Regeneron’s antibody cocktail. At the time, the drug was not yet approved in the US After his comparatively quick recovery, Trump publicly described the cocktail as a “miracle” and a “cure” and promised to make it widely available in the shortest time possible. However, many researchers were much more skeptical. Among other things, because it has been shown that antibodies probably cannot really help with advanced Covid 19 disease.
What is known about the side effects?
In a clinical study, there was no increase in serious side effects in patients treated with the Regeneron agent compared to a control group. However, the FDA notes that there is some potential for serious hypersensitivity reactions, among other things, with the two antibodies used. Also, they are still being investigated, so certain risks may not yet be known. According to the FDA, two out of 850 cases of Eli Lilly’s drug had more serious side effects in studies. Also in this case, some side effects may not even be known.
Which clinics in Germany receive the medication?
The Federal Ministry of Health has informed several university hospitals in Germany that they will receive the drug in the coming days. The University Medical Center Hamburg-Eppendorf (UKE) will also use the two new corona antibody drugs purchased by the federal government. This is what the head of infectology Marylyn Addo said to the Ed. The drugs have been announced to arrive at UKE in the coming weeks. How many doses and when exactly is not yet clear, Addo says. According to infectologist Christoph Spinner, the clinic to the right of the Isar at the Technical University of Munich is waiting for the medication.
Are antibody agents a way out of the crisis?
Experts like the infectologist Addo warn against too high expectations. “The data is promising, but no one in the expert community is currently assuming that this is the drug that will flip the switch in the pandemic.” The drug could be one more component in the fight against the pandemic and may be suitable for certain patients, but that now needs to be solved more precisely.
When could the funds also be approved in Europe?
The European Medicines Agency (EMA) does not yet have an approval process for such antibody treatment, according to information on the authorities’ website. However, Regeneron plans to apply for EU approvals together with pharmaceutical company Roche as a partner, as a spokeswoman for the German press agency said. Eli Lilly and other companies are likely to follow suit.
(With information from Anja Martini, tagesschau.de and dpa, AFP)
