In Germany, every vaccine batch must be tested for quality before delivery and then approved. The Paul Ehrlich Institute, as the federal institute for vaccines and biomedical drugs, is responsible for this in this country. Its president, Klaus Cichutek, has become a popular explanation of the vaccination start in the corona pandemic. In an exclusive DW interview, he talks about the safety of the previously approved vaccines from BioNtech / Pfizer and Moderna, about possible side and long-term effects of the vaccination and whether the vaccines should also be released for children.
DW: Mr. Cichutek, BioNtech / Pfizer and Moderna are the first two vaccines against the coronavirus on the market in the EU. How well are the vaccines working so far?
Klaus Cichutek: So far, the reactogenicity (describes the vaccination reactions or the side effects of a vaccine, editor’s note) as usual with vaccines and as we expected. The first data looks very good: the vaccines have achieved an effectiveness of 90 percent and more in the clinical studies. And in the elderly, the effectiveness was still over 80 percent. I think we have two very good approved vaccines, both of which have been developed and reviewed according to the usual standards. So everything looks good right now.
Both vaccines must be given twice. How long does the vaccination last?
We don’t know that today. But we have evidence of persistent immunogenic activity (the immune reaction of the body, editor’s note). Some of our data shows that the vaccines produce an immune response that has been around for more than eight months. And it’s still going on. That’s good news. And tests in monkeys show that even a low level of neutralizing antibodies is enough to protect us from the virus. I believe that vaccination protection will last for a longer period of time, but we will have to wait for more dates on that. These data are currently being collected in order to be able to make longer-term statements about the safety and effectiveness of the vaccines.
What side effects of the vaccines are you aware of so far?
Most of the known side effects only occur for a short time in the first one to three days. Mild to moderate pain at the injection site, possible tiredness, sometimes a slight fever, headache, muscle or joint pain. Swelling at the puncture site can also occur. But basically these are known side effects of vaccination. They never last long and they don’t cause any real harm. In the face of a life-threatening disease like COVID-19, these minor side effects can be accepted. But it seems like these side effects are a little more common than with the annual flu shot.
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Can you rule out serious side effects?
Such side effects cannot currently be ruled out. Most side effects start in the first few weeks after the vaccination. We currently know that complications are very rare. These include allergic reactions and, very rarely, facial paralysis. However, these symptoms were also found in the placebo group in the clinical test phase. Apart from that, the vaccines offer a very high level of safety.
Some people worry about the possible long-term effects of vaccination. What do you know about this?
We need more data from vaccination practice. The clinical test phase III will continue for another two years and will thus observe long-term consequences. The test subjects are carefully observed and every sign or side effect is recorded. So far, however, there is no evidence of long-term effects of the vaccination. The usual drug monitoring by the Paul Ehrlich Institute and other medical agencies will also investigate possible undesirable side effects in vaccinated people. With it you’ll get Information on our website and our own “SaveVac” app, in which all vaccinated persons can enter possible undesirable side effects. These data allow us to better understand the effects and better research side effects.
In Germany, a possible vaccination requirement for nurses and medical staff is being discussed. Do you understand that some people are skeptical of vaccinations?
I can only advise you to find out more. Our strategy is to keep people informed about vaccines as transparently as possible. First, all the usual pre-approval testing has taken place. Second, we ensure active drug monitoring with which we can react immediately to any side effects. And third, you always have to weigh the benefits and risks of a vaccination: the bottom line is that the side effects have so far been mild and short-lived.
How good is the vaccination protection really? Can you get infected with the coronavirus despite a vaccination?
We have little practical experience because vaccination has not been carried out for long. We know from the clinical test phase that very few infections occur after a vaccination. Usually when someone was already infected with SARS-CoV-2 without being noticed before receiving the vaccination. Out of 100 people vaccinated, 95 did not show any symptoms of COVID even after coming into contact with infected people. And it looks like the few infected will only show a mild course of the disease.
The BioNTech / Pfizer vaccine is approved for people over the age of 16, and that of Moderna is approved for people over the age of 18. Can and should children be vaccinated soon?
Some vaccine candidates are also tested in children. We expect study results on this this year. Then the currently issued licenses could also be extended to children and young people. But it also depends on whether the vaccination commissions will recommend this use.
The vaccines continue to be checked for quality and effectiveness even after they have been approved
Some women fear that the vaccines could affect a current or future pregnancy. Are these fears justified?
We currently have little data on vaccination reactions in pregnant women. Therefore, it is currently not recommended that pregnant women get vaccinated. I don’t see a problem at all in the event that a woman gets vaccinated and then later becomes pregnant. The first findings from non-clinical studies in animals show that the vaccinations have no effect on fertility, pregnancy or the development of fetuses. But of course we have to wait for data from people here.
There have been reports of problems with allergic reactions to the vaccination. Should allergy sufferers get vaccinated or better not?
There is no one-size-fits-all answer here. If you know that you are allergic to the contents of medication, this speaks against a vaccination. People who have a common pollen allergy or food intolerance can get vaccinated. But they should stay at the vaccination site for at least 15 minutes to check. Doctors can then help with any reactions that may occur. But – to emphasize again – this is extremely seldom the case.
Klaus Cichutek has been President of the Paul Ehrlich Institute since 2009, based in Langen, Hesse, which was named after the German doctor and Nobel Prize winner Paul Ehrlich. Cichutek is a biochemist and professor at the Johann Wolfgang Goethe University in Frankfurt am Main.
The interview was conducted by Joscha Weber.