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The long-awaited vaccine must be tested quickly, but without compromising safety. How does it work? The heads of the licensing authority comment on the huge expectations and widespread skepticism they face.
“That’s terrible”: Claus Bolte, Head of Approval, Swissmedic Institute for Therapeutic Products.
What if things get tough? Suppose the US would quickly approve a corona vaccine, soon after Federal Councilor Alain Berset called and asked that things finally move forward in Switzerland, so what? “Even if there were pressure attempts, which I can’t imagine, we wouldn’t go into them,” Raimund Bruhin says firmly. Claus Bolte sits next to her and nods determinedly.
The two men play a central role in vaccine poker in Switzerland, if not the central role. Bruhin is the director of the Swissmedic Therapeutic Products Institute, while Bolte is in charge of the approval department. As long as Swissmedic does not give the green light, there will be no vaccination against the virus in Switzerland. The work is already underway, this week the second request for approval for a corona vaccine was received in Bern, it comes from the American company Pfizer. Swissmedic acts independently. Organizationally, the institute with its 360 full-time positions is affiliated with the Berset department, but neither the Federal Council nor the Federal Office of Public Health have the right to issue instructions on approval decisions.
But of course they have expectations, as does the population. It does not take much imagination to imagine the violent storms Swissmedic could be exposed to in the coming months. Of course, Raimund Bruhin, Claus Bolte and their colleagues have practiced with conflicting goals. The pharmaceutical industry has always wanted its products to be tested and approved as soon as possible. Swissmedic, on the other hand, has a legal obligation to wait until all the requirements have been accurately verified: safety, efficacy, quality. The institute also has experience with pandemics, especially due to the 2009 swine flu, when pressure to find a vaccine was also high. “We can handle it,” says director Bruhin.
What if the EU gives the green light again sooner?
However, a situation like that of the coronavirus today is unknown territory for Swissmedic, and not only scientifically. The institute has hardly ever been as exposed as it will be in the coming months. Swissmedic was heavily criticized for swine flu because authorities in other countries were quicker to approve the vaccines. Today the damage to health and the economy, and therefore expectations, are many times greater. Politics, economics, merchants, innkeepers, thousands of people across the country, especially the older generations and the sick – all are anxiously waiting for a vaccine to kill the ghost on the market. It is impossible to imagine what would happen if, for example, the EU authority approved a vaccination for risk groups while Swissmedic still hesitates.
And that’s not all. While some things may not go fast enough, others prefer that there was never a vaccine. The proportion of skeptics about vaccines in Switzerland is higher than in almost any other country. This was revealed in a 2018 survey conducted by the British Wellcome Trust in 140 countries. Confidence in the health system in Germany has reached the highest levels, but at the same time 22 percent say that vaccines are not safe. Additionally, there are currently conspiracy theorists who believe that dark forces want to use the pandemic to inject nasty substances or microchips into humanity. This implicitly implies that the licensing authorities are incompetent or corrupt. How do you handle this as the head of Swissmedic?
Some Skepticism Is Healthy, Says Head of Approval
Differently. Quite calm and sober Raimund Bruhin, the director. He is a doctor by nature, like most people here, a former cardiac surgeon with more than twenty years of clinical experience at home and abroad, who later moved to the defense department and from there joined Swissmedic in 2018. Bruhin knows no vaccine skeptics, as he puts it. He explains that they are so numerous with a “certain irrationality” and reservations about the authorities. Many would also have forgotten about the serious diseases that were eradicated thanks to vaccination.
The case is different with Claus Bolte, the head of approval. He is also a man of medical rationality: doctor, surgeon, researcher, he has been involved in clinics and pharmaceutical companies in Europe and the United States for more than twenty years, with Swissmedic since 2012. But unlike his boss, Bolte, who lives In central Switzerland, he meets several vaccine skeptics in his private setting who would never get vaccinated. Does that bother you, do you take it as a reproach? The answer comes unexpectedly: Bolte believes that some skepticism is healthy. “We must not forget that it is healthy people who receive vaccines. No wonder the safety requirements are significantly higher here than with other drugs. “There have been isolated cases of serious side effects because the very rare risks only come to light when they are used widely.
But too much skepticism gets insane, Claus Bolte continues. He also knows this from his circle of friends. In such cases, he sometimes tries to seriously explain what his job is like and what enormous progress vaccines have brought to humanity. “But I’m not upset about it. I don’t think this skepticism has anything to do with our work. It’s more of a feeling. It is difficult to discuss it objectively. ”
Two data trucks for a single vaccine
You have to try anyway. According to experts, the benefits of the expected corona vaccination will largely depend on whether Swissmedic and the other authorities involved can convince the general public of the safety of the vaccine. One point often raises discussions: Swissmedic has announced that it wants to test the corona vaccine in an accelerated process. How can you prevent security from suffering as a result?
“Rolling submission” is the magic word. Pharmaceutical companies not only send the data and documents of their vaccines at the end of the entire process, but in portions, in data packages, the scope and delivery date of which are jointly agreed in advance. Vaccine approval requests are real material battles. In the paper age, archives averaged two trucks, as Bolte recalls. In the case of Corona, these mountains of data arrive in Bern in stages: first the laboratory numbers, then the results of the first cell cultures. And so.
In this process, Swissmedic experts are practically in tune with pharmaceutical companies. As soon as the investigators have completed a phase, the state examiners come into play immediately. In this way, the approval phase can be greatly shortened, as Bolte explains. This carries the risk of authorities working in vain if a vaccine fails in the final stages of development. But this is accepted in view of the scope of the pandemic.
Six people bow down on candidates for the crown
You can save more time on staff planning. For each “candidate,” as the presented vaccines are affectionately known in the jargon, a team of five to six plus a reviewer is employed. In the case of corona vaccines, they are freed from all other tasks. That speeds up the process a lot, Bolte emphasizes. “Even if we lag behind other approvals, for example in oncology or Alzheimer’s research.” But that’s secondary, Corona dominates everything.
Third important point: Swissmedic relies heavily on cooperation with authorities in other countries, which has expanded in recent years. Currently, conference calls on corona vaccines are held every two weeks. The Swiss institute joined forces with authorities in Australia, Canada and Singapore a long time ago, and Britain will join the group after Brexit. At the moment, in view of Corona, Bolte, Bruhin and their teams are also exchanging ideas with colleagues from the EU and the US more than usual. They share their own observations and questions to achieve the goal faster together. In this way, Swissmedic also wants to avoid having to try again because other countries are quicker to approve a vaccine, as was the case with swine flu. At the time, the Swiss felt compelled to orient themselves to the EU authority’s decision on one of the three vaccines for reasons of time.
Express filing like in the US is not a problem
However, it is not expected that the vaccines will be approved in all the countries involved at the same time. Political pressure is particularly high in the United States. President Donald Trump is said to have urged the FDA for speedy approval. In fact, the United States is planning what is prohibited in vaccination-critical Switzerland: Americans want to put the first corona vaccines on the market “as an emergency” before the FDA has completed its work and decided on their approval. In Switzerland, according to the Covid-19 Law, this turbo process is possible for medicines and other products for the treatment of patients with Covid-19, but not for vaccines that are used in healthy people.
Important differences between countries are also possible with the “fine print”, with detailed specialized information about the application. Swissmedic and the other authorities will not approve a vaccine per se for all population groups, but will differentiate it according to age or certain previous diseases. There is a background that shows two things: firstly, Swissmedic’s independence was not always as absolute in practice as it was on paper, which, secondly, can be quite complicated.
Mixed experiences of the Pandemrix case
The case concerns the Pandemrix swine flu vaccine. In 2009, Swissmedic initially stipulated restrictions for children and the elderly, while the EU authorities waived them. Understanding in Switzerland was limited, the frenetic pace and impatience were great. The Federal Office of Public Health immediately put pressure on Swissmedic. A little later, the restrictions were gradually lifted in Switzerland. However, people who received Pandemrix subsequently developed narcolepsy from sleeping sickness in several European countries. The evidence of a causal relationship was so strong that Sweden paid compensation to those affected. Among them are children and youth.
“This is terrible, fortunately Switzerland was hardly affected by the reluctance,” says Claus Bolte. He and Director Bruhin were not yet at Swissmedic at the time. But the case shows that safety must always come first, even today in the corona pandemic. Swissmedic bosses have difficult months ahead.
