Dr. Julian Schulze zur Wiesch is Senior Consultant in Charge in Infectious Diseases at the University Medical Center Hamburg-Eppendorf (UKE). He and his team are researching the coronavirus. The UKE is one of the first clinics in Germany and the entire EU to use the two antibody drugs recently bought by the federal government US pharmaceutical companies Eli Lilly and Regeneron will be used in the treatment of Covid-19 patients. It should be given to patients with mild or moderate symptoms who have risk factors for a severe course. Germany has ordered 200,000 doses of the drug. Schulze zur Wiesch, however, is cautious about placing too high hopes in the corona drugs. He says: You could be another building block in the fight against the pandemic, but not the ultimate savior. It is more important to avoid that people get infected with the corona virus in the first place. This can be achieved above all with an effective vaccination. Read here what he says about the state of drug development at Covid-19.
The virus and the pandemic affect us all. The desire for a highly effective and easy-to-administer drug is understandable – but unfortunately it is only partially realistic. The wide-ranging vaccination of the population and compliance with general protective measures are the most important levers for most viral diseases in order to be able to control a pandemic. Because the primary goal is of course to avoid every single infection.
Only through concentrated action and favorable circumstances has it been possible to get several effective vaccines approved and widely used in record time. This included preliminary scientific results from basic research, existing vaccine platforms – which were developed in the past for vaccines against other corona viruses, among other things – and RNA vaccine technology.
The development times for vaccines are often several years. The start of vaccinations in Germany and Europe, which may have been perceived as “clumsy” in some places, should not make us forget how fast the research developments were this time.
Because the Sars-Cov-2 virus has only been known for a year. During this time, we medical professionals have learned a lot about the structure of the very complex disease picture Covid-19, even if many questions remain open in detail. During this time, models for studying the virus were established in the laboratory. With their help, we can now advance drug development and testing.
At the beginning of the pandemic, drugs approved for other diseases were usually tested
Depending on the mode of action, medication can either protect against infection or prevent a severe course of the infection. In simple terms, drugs can either inhibit or prevent the virus from docking on the cells of the body – as can the virus from replicating in the cell. In addition, drugs are used to treat excessive inflammatory reactions or other sequelae in Covid-19.
In order to ensure the safe use of new drugs, new drugs are tested in several study phases and then have to go through a complex approval process at European and national level. Drug development takes time, and treating patients within these studies is costly because their safety must be guaranteed at all times. Building the structures for such studies at the various clinics was a particular challenge, especially during the pandemic.
Worldwide, it looked like this, especially in the initial phase of the pandemic: Because doctors initially had no treatment options at all, many small studies were carried out in different centers, mostly with drugs that were already approved for other diseases. This is called “re-purposing”. This included some antiviral HIV drugs or the malaria drug hydroxychloroquine. Unfortunately, many of these drugs fell short of expectations.
Drugs have the potential to prevent or reduce infection
In retrospect, better coordination and concentration on particularly promising drugs and studies would probably have been better right from the start. However, this was difficult to organize in the initial phase of the pandemic. The World Health Organization (WHO) later carried out such studies with study teams from around the world.
A medicinal approach to avoid SARS-CoV-2 infections is, in addition to vaccination, the prophylactic administration of so-called monoclonal antibodies or fusion proteins. Both block the docking points of the SARS-COV-2 in the body, and are useful, for example, for contact persons of infected people or high-risk populations. Such drugs, if taken in a timely manner, can prevent or at least alleviate infection for a few weeks. But they are not very cheap and the administration and production are not entirely trivial.
The corona antibody drugs Bamlavinimab and Casirivimab / Imdevimab are also about to be approved by the EU. The available data on the active ingredients should be assessed as cautiously positive, but so far there are limited data on the benefits in everyday use. These drugs could be another building block in fighting the pandemic. But we do not expect the ultimate savior.
First of all, it should be checked for which group of people or patient groups the administration of the active ingredient is even possible and at which point in time the drug should be used.
The study results published so far give reason to hope that the prophylactic administration of these antibodies can prevent infection or, if given early, especially in patients with certain immune deficiencies, can lead to a milder course of the disease.
Two drugs are currently approved in the EU
However, if someone has already become infected, medication can be of vital importance, especially for seriously ill patients: They can alleviate the course of the disease and, ideally, also lower the mortality rate. Two drugs are currently approved in the EU for treatment in this phase: Remdesivir, a virostat that is given via the vein as an infusion in the early phase of the disease to patients who need oxygen. And dexamethasone, a proven and broad-acting drug that reduces the function of the immune system and is used in ventilated patients in the later disease phase.
In addition, many clinics use anticoagulant drugs to prevent thrombosis. In individual cases and within studies, those affected also receive blood plasma from healed patients: It already contains antibodies against Covid-19 and can thus relieve the patient’s body.
Many other drug candidates are currently in the various phases of clinical development or are about to be approved.
It remains to be seen whether these drugs or others that are still being developed can influence the course of the disease in individual patients and the pandemic as a whole. The level of knowledge about this changes almost weekly. Therefore, further developments are difficult to predict, even for experts. In the long term, I believe: the importance of the success of both the broad-based vaccination efforts and compliance with hygiene rules cannot be overestimated. Possible further drug developments can be helpful and alleviate the severity of the disease in individual patients – but ultimately the combination of all measures will help to defeat the pandemic.