Some people shouldn't run

Speed ​​over security?Race for the approval of the corona vaccines

"Research is tremendously fast at the moment. We as the Ministry of Research are currently assuming that broad sections of the population will be able to be vaccinated by the middle of next year," said Federal Research Minister Anja Karliczek. "If it goes faster, that's great, of course."

At the end of 2019, the SARS-CoV-2 coronavirus was noticed in the Chinese city of Wuhan as the cause of an unknown lung disease. On January 10, 2020, Chinese scientists published the genetic code and within hours, research institutes and companies began working on vaccines. "Never before have so many scientists worked so intensively to contain a pandemic. And the progress made in research should give us confidence that we will be able to return to everyday life at some point."

Overview on the subject of coronavirus (imago / Rob Engelaar / Hollandse Hoogte)
The developments are in full swing: According to the WHO, almost 200 institutes and companies worldwide are now researching more than 160 projects on SARS-CoV-2 vaccines. "At the beginning we had actually expected that it would emerge relatively quickly that a certain vaccine technology would simply lead to vaccines faster or better. But we have now seen that in fact vaccines that work with very different technologies have all made it into the testing with volunteers or even in this final testing stage, "explains Rolf Hömke, research spokesman for the Association of Researching Pharmaceutical Companies. More than 40 vaccine candidates are currently being tested in human clinical trials.

Around a dozen of them are in the third clinical phase, in which - controlled by a placebo group - tens of thousands of participants have to prove whether the vaccine really protects, whether there are rare side effects and whether it is safe and effective for risk groups such as the elderly or those with previous illnesses is. A wide variety of technologies have made it into this crucial phase. "One is vaccines that simply contain inactivated viruses, killed viruses, so to speak."

New concepts - hardly any previous experience

Such vaccines are well known and experience with them is great. At the forefront, however, are also new concepts: for example vector viruses. "That means that there are no coronaviruses in it, but other viruses that do not make you sick. They have now been given a gene from the coronavirus with genetic engineering."

The vaccine from Oxford University and the pharmaceutical company AstraZeneca as well as the Russian Sputnik-V are based on this principle. There is also a vaccine that is being developed by the Ludwig Maximilians University, the German Center for Infection Research and the Dessau company IDT Biologika. "Then there is another technology. These are vaccines that only contain genetic material from the coronavirus, usually as messenger RNA."

(picture alliance / Igor Golovniov) COVID-19: Why it takes so long to develop a vaccine
Developing a vaccine is a complex, lengthy process. As a rule, it takes several years from the first experiments in the test tube to the approval of an active ingredient. Now everything should go a little faster.

The two German developers BioNTech and CureVac, together with their partners from the pharmaceutical industry, rely on these messenger or messenger RNA vaccines. They play a role in protein production. The catch: "You have to be clear that for some of the vaccines that are currently being discussed, completely new technologies have been used. Keyword: mRNA vaccine, keyword: vector vaccine, for which it is either even there are no vaccines or only very few vaccines that have already been used in humans, so of course you don't have the opportunity to fall back on a lot of previous experience. "

However, so far there has been no evidence that these new vaccines are particularly prone to side effects, says Thomas Mertens from Ulm University Hospital, chairman of the STIKO, the permanent vaccine commission at the Robert Koch Institute. Given the fact that research only started around nine months ago, the pace at which it is currently being set is impressive - especially since vaccines typically take decades to develop and approve. The European Medicines Agency has been evaluating two potential vaccines in an accelerated process since mid-October: the vaccine from the University of Oxford and AstraZeneca and that from BioNTech and Pfizer.

A "rolling review process" - an accelerated evaluation process - should guarantee speed and security: "The main thing is that the development path can be shortened appropriately," says Klaus Cichutek, President of the Paul Ehrlich Institute in Langen, Hesse, which works for the German side in the context of European drug approval. The institute held talks with the manufacturers right from the start, the personnel capacities were increased, what is possible, backed up, procedures shortened. The companies researching corona vaccines no longer have to collect the data packages first and submit them at the end, but can instead pass them on to the Paul Ehrlich Institute to see how they will be finished.

In addition, the three phases of the clinical trial can be planned and combined in an overlapping manner: "But only when the efficacy data are available does the complete review begin, i.e. the approval process. There is no compromise in the care taken when evaluating applications at Paul -Honest Institute, "says Cichutek. The so-called pharmacovigilance will also be particularly intensive, i.e. the monitoring of safety after approval in order to uncover late effects. There will not only be a passive procedure in which doctors, pharmacists and vaccinated people report side effects. "We will also introduce active pharmacovigilance, that is, pharmacoepidemiological studies with the introduction of vaccination, to be sure that we can identify possible risk signals very quickly and then take the appropriate measures."

In Germany, transparency, trust and acceptance are central

Ultimately, the acceptance of the population is central: In order to successfully suppress the virus, at least 60 percent of people would probably have to get vaccinated, estimates Thomas Mertens. That requires trust, says Johannes Bauernfeind, CEO of AOK Baden-Württemberg: "In Germany, pharmaceutical companies have to prove that the vaccine is really safe, harmless and effective. We need an incredible amount of transparency in Germany. We must inform the population comprehensively how the approval of the respective vaccines came about so that they can be vaccinated accordingly with full confidence. This is not the case in other countries. A vaccine may be approved quickly and prematurely, just to make global political decisions Competition to be ahead. "

In the case of the Russian vaccine Sputnik-5, the final phase of the clinical trial is mixed with the vaccination of the population. China has vaccinated hundreds of thousands with experimental vaccines outside of traditional testing procedures. Political pressure is also high in the USA. After a survey showed that almost 80 percent of the US population feared that the approval process would be driven primarily by politics and not by science, the pharmaceutical industry was forced to take an unusual joint action in early September: The board of directors of nine American and European drug manufacturers issued a joint statement. They promise to "maintain the integrity of the scientific process and not submit a vaccine for approval or emergency approval until safety and efficacy have been demonstrated by a phase III clinical trial."

The US approval authority FDA has now tightened the conditions for accelerated approval: For example, the test subjects from phase III should be observed for at least two months after the last dose of immunization.

Impatience in the population

How desperately the vaccine is, however, shows the willingness of Great Britain to think about human challenge studies - vaccinating healthy people in order to then specifically infect them - with the potentially deadly corona virus, for which there is no safe treatment in an emergency. Thomas Mertens: "This then takes place under special medical supervision and naturally only takes place with people who do not have a high risk of serious COVID disease. In other words: Especially the group that is particularly vulnerable, so to speak, old people and sick people, you will not be able to use them in such a challenge attempt. And that means that you cannot obtain any data for these risk groups. "

(dpa / picture alliance / SvenSimon) Human Challenge Study: Targeted infection for vaccine development
In human challenge studies, test persons are first vaccinated and then infected in a controlled manner. Such a study is now to begin in England.

But impatience is also great in Germany. The Federal Ministry of Research has launched a special program, among other things, for expanding development and production capacities in Germany. The volume: 750 million euros. And BioNTech, CureVac and IDT Biologika have successfully applied for funding.

"We are all putting pressure on at this point, because we all want to have a changed situation. However, this period of time until we have the vaccine and until we then perhaps experience a changed risk situation in the pandemic will still take time. That restricts all of us, and that is why every pressure on this vaccine approval system arises, "says Tim Steimle, head of the pharmaceuticals division at Techniker Krankenkasse. "We want a vaccine here. The vaccines should, as we all wish, be available yesterday rather than in a few weeks, a few months. But if they are available, then they should be safe in any case. "

Quality standards would have to be recognized and adhered to internationally. This is exactly what worries the former head of the German Cochrane Center, Gerd Antes: "All of these products that are now being developed are subject to an examination that actually normally takes much longer, which is now being accelerated enormously for reasons of time and also for political reasons . That can work in some places. For example, we have unacceptable waiting times in drug development, bureaucratic obstacles, all of which can be left out. What we cannot leave out is actually the biological time that is required to identify side effects, for example , reliably detectable. If I do not let this time, there will be a bitter awakening later when the vaccination actually takes place. "

Gerd Antes calls for a depoliticization of the decision-making process. Because: "We definitely need the vaccination. And with compromises. That is why the studies are so important. We need the vaccination with the potential disadvantages, so also with the limited safety and with a not too high effectiveness. We need to know what we're doing and that has to be communicated transparently. "

How long the protection lasts is open

Interruptions in clinical studies show that the system basically works despite the acceleration: When test subjects fell ill, the pharmaceutical companies AstraZeneca and now Johnson & Johnson stopped their studies for the time being. But even if everything goes smoothly and a vaccine is approved, the high hopes associated with it may initially prove to be exaggerated. Thomas Mertens, Chairman of the Standing Vaccination Commission of the RKI: "The people who all said that they would have a usable vaccine by the end of this year, I really didn't understand because everyone could have thought that it was too short is seized. "

Many manufacturers are already ramping up their production, although they do not yet know whether their product will be successful. But it will take some time before anyone who wants to be vaccinated can be vaccinated. That is why the vaccination commission is working on a recommendation for prioritization. The focus is on avoiding serious illnesses and deaths. Second, it is about preventing infections. "And the third goal would be the medical staff here, for example."

Which scenario will take effect will only be decided at the end of the third and final phase of the clinical studies. But even then the problems are not solved. There are huge logistical efforts ahead of the vaccinations. Vaccines have to be transported, stored and refrigerated, some even frozen. "In addition, there will probably be so-called multi-vials, that is, vaccine pots where the vaccine for several people is in. And then you have to take the respective portion with the syringe, so to speak. So the people who vaccinated also have to should be there on time, otherwise the vaccine may spoil. "

(picture alliance / Geisler-Fotopress / Christoph Hardt) Immunity to SARS-CoV-2 - How long are infected people protected?
Doctors and scientists have learned a lot about the SARS-CoV-2 virus in recent weeks. Things get complicated when researchers want to find out how our immune system fights the new viruses.

It is currently assumed that each individual would have to be vaccinated twice for permanent protection, says Thomas Mertens. The question remains, what is meant by permanent: How long the effect lasts will only be shown in the next few months and years. In any case, the immunity brought about by the virus only seems to last six or eight months. "Then you can easily think about it, even if there is enough vaccine. I hope I am not making a calculation error. But if you vaccinated 100,000 people every day for 150 days, you would end up with 150 days, i.e. half a day Year, 15 million vaccinated. Now you can think about it. And vaccinating 100,000 people a day is a number that we cannot achieve. Just so you realize that this is a very complex system. "

In other words: The pandemic is far from over with the approval of the first vaccines. "Now we're starting to vaccinate and then it's great, then we'll all go back to the dance floor. That is nonsense. Of course, in the long term, too, we will need the measures to contain the infection in addition to the vaccination campaign Even if we start to vaccinate, nothing will change in our daily life anytime soon. "

For the first time since polio, the world's population is to be vaccinated

"The vaccines will all have different properties and produce different levels of immunity. Then one has to see how it works in practice what the best vaccine is to protect a population." The challenge is enormous, says Jörg Vogel, Director of the Helmholtz Institute for RNA-based Infection Research. "I think, for the first time since polio, we actually have a situation where it is assumed that we actually have to vaccinate the entire world population."

The question of distributive justice also comes into play here. Rich countries have already secured hundreds of millions of cans, either directly through contracts with companies or through financial support for development and production expansion. And the cost of vaccinating so many people will be enormous. However, several companies have announced that they will be selling their vaccines at prices close to cost of production, "lower than what is charged for the annual flu shot. And if you work like that, you obviously don't make record profits," describes Rolf Hömke.

(picture alliance / Drago Prvulovic) Covid-19 vaccine: The tough struggle for distribution
The development of vaccines against COVID-19 is proceeding with turbo drive. The first approvals have already been received in China and Russia. The discussion about who gets which vaccine and when is in full swing.

But that would still be priceless for developing countries. That is why an experiment started last month: Covax, an initiative that aims to secure global access to Covid-19 vaccines for poorer countries as well. By the end of 2021, two billion vaccine doses of different technologies are to be made available to these countries, explains Nicholas Jackson from the organization CEPI, an international network for research and development of new vaccines, which was founded in 2017: "Covax is a central building block for fair access to these two billion doses An incredible 168 countries have joined Covax: 76 high-income countries and 92 middle and low-income countries. It is historical that so many countries have signed this agreement, comparable only to the Paris Agreement signed a few years ago. "

Germany is one of the major donors of the project, and many pharmaceutical companies are also participating. However, the United States, Russia and China have not yet been included. According to the World Health Organization, Covax is in negotiations with China to make Chinese vaccines available to the rest of the world. Because there a vaccine should be available to the general public as early as November or December.