The Lübeck entrepreneur Winfried Stöcker claims to have developed a vaccine against Covid-19 and administered it not only to himself, but also to 100 volunteers – without authorization. He received a criminal complaint that an investigation was in progress for a violation of the Medicines Act, he was informed. Stocker saysthat he did not want to earn any money with the drug. Because he wanted to make the vaccine available to the general public as quickly as possible, he took the unconventional route. Markus Löffler, an expert in clinical studies, says in an interview why such examinations are strictly regulated, are closely monitored by the authorities – and when a drug can actually be called a vaccine.
SPIEGEL: Mr. Löffler, we do have some approved vaccines against Covid-19 in Germany, but still too little vaccine on site. The Lübeck entrepreneur Winfried Stöcker announced that he had tested a vaccine he had developed on 100 people. In the current situation there is no need for “lengthy double-blind tests”. You should just vaccinate the first 1000 people, if that goes well, 10,000 and then the rest. Is it that simple?
Spoonbill: If someone – as in this case probably happened – replicates part of a virus protein and provides it with a potentiator, he has a candidate for a so-called protein subunit vaccine. It’s an established concept. The height of creation is rather low at this point. Only when evidence is provided that this candidate provides 70, 80 or 90 percent protection against disease and is sufficiently safe can one actually speak of a vaccine. This requires randomized, placebo-controlled studies.
SPIEGEL: Can you explain that in more detail?
Spoonbill: In these studies, people are randomly assigned to a group that is given either a drug or a dummy drug called a placebo. In this way you can show the effectiveness in the actually vaccinated group compared to the people who received the placebo.
SPIEGEL: Is there no easier way? According to his own statements, Mr. Stöcker measured the antibody concentrations of those vaccinated with his agent.
Spoonbill: So far, there is no blood test that clearly shows immunity to the coronavirus with sufficient certainty. There is a very plausible connection that the presence of neutralizing antibodies indicates immunity. But it’s just a clue, not enough evidence. Just measuring the antibodies is not enough in the absence of scientific evidence that such a test or other tests provide such a clear indication of immunity that they could replace randomized, placebo-controlled vaccine trials. If this evidence is available at some point, one must of course consider whether a new vaccine can only be approved on the basis of such tests. But I think that such a decision should then be made by expert committees, for example at the WHO or Ema, and not just someone who says: I’ll do it this way now.
Someone who gets vaccinated assumes that this vaccine will protect them. Otherwise the vaccination would be pointless. This is why manufacturers have to prove their effectiveness and safety.
SPIEGEL: So we still need clinical studies. And for this you need a permit …
Spoonbill: Yes. Anyone who wants to clinically test a vaccine needs a permit from the Paul Ehrlich Institute in Germany. This specifies what must be checked and monitored during the study. An ethics committee is also involved. It’s about tests on people who are associated with a risk for the participants. It is absolutely legitimate to look very carefully.
SPIEGEL: Mr. Stöcker complains that the Paul Ehrlich Institute reported him when he reported there and reported on his experiments. What do you make of it?
Spoonbill: I cannot express myself sufficiently competently on the legal issues in this case.
SPIEGEL: What happens after a study has been approved?
Spoonbill: Everything is documented down to the last detail. In the early phase of a clinical study, all subjects are monitored very closely. Verifying that any possible side effects are investigated. Side effects with a certain severity must be reported to the authorities immediately, this is mandatory. We have just seen how important close monitoring is with the AstraZeneca vaccine: because possible serious side effects are reported, a pattern can be recognized.
SPIEGEL: What happens if something is noticed in the clinical study?
Spoonbill: As a rule, there is a data safety monitoring board, which consists of independent experts who analyze everything in detail and decide whether a study may have to be stopped or can continue. In addition, there is monitoring by the authorities. One of the principles in medicine is: “Primum non nocerce” – first of all, do not harm. Anyone who tests a vaccine candidate on humans, however, has to accept a controlled safety risk for the test subjects.
The fact that these studies are allowed at all is due to the fact that there are crucial gaps in knowledge: We have a possible vaccine that could protect against Covid-19, but we can only confirm or reject this through studies. This is the only reason why it is okay to carry out these examinations with all the necessary conditions.
SPIEGEL: What are the requirements?
Spoonbill: To give an example – insurance that comes into effect if one of the participants suffers damage. If you just test a drug like that on volunteers, that kind of thing falls behind. In a clinical study, among other things, a test plan is drawn up on what is to be examined when and how. You have to stick to it exactly. If someone collects data single-handedly, they are not valid and therefore do not stand up to scientific verification. For example, one cannot be sure what data has been collected but has been kept secret. That means: You will never come to a product, i.e. a vaccine, that has proven its safety and effectiveness on your own, without reliable data.
SPIEGEL: The vaccine candidates, which, like that of the Lübeck entrepreneur, are based on a virus protein, are numerous. Most of the preparations that are being tested in clinical studies are currently of this type. None of these have yet been approved in the EU. Why did it take longer with these vaccines?
Spoonbill: I cannot answer that. However, it must be remembered that vaccine development actually happened at the speed of light. The products that will be approved this year were also still developed extremely quickly.
“Anyone who receives a vaccine has a right to know that it is safe and effective. All those who want to develop vaccines have to prove that. ”
SPIEGEL: Medicine has at times benefited from pioneers who tested something unconventional on themselves. Isn’t that important too?
Spoonbill: There are, of course, some very famous self-experiments in medicine. The German doctor Werner Forßmann pushed a catheter into his heart himself. He later received a Nobel Prize. Barry Marshall, an Australian doctor, himself drank fluids containing Helicobacter pylori bacteria to prove that they can cause stomach ulcers. Years later, he was also honored with the Nobel Prize.
SPIEGEL: Then what’s the catch?
Spoonbill: A self-experiment is limited to a specific person. It is very important that this person can determine for himself what consequences this attempt will have, what problems it may bring with it, in order to assess the personal risk associated with it on this basis. So the person has to be an expert. The person must freely choose to perform the experiment on themselves. As soon as a second person arrives, for example a doctor vaccinates someone else with a vaccine candidate, it is no longer a self-experiment, then completely different rules apply. Werner Forßmann, to come back to this, put the catheter himself. He hasn’t asked a colleague to try this, nor has he tried the procedure on a volunteer.
Another caveat to self-experiment: it’s always anecdotal. He can therefore only give hints. In that sense it can be valuable, but it never replaces clinical trials. Whoever gets a vaccine has a right to know that it is safe and effective. All those who want to develop vaccines have to prove it.