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Mr Bolte, Swissmedic has received four authorization requests so far. Which vaccine has the advantage?
Claus Bolte: Astra Zeneca, Pfizer / Biontech and Moderna submitted their applications within a few weeks. Janssen joined them a little later. Since this is an ongoing process, clinical studies have yet to be completed, you can definitely talk about a face-to-face career. We will know more soon.
Concrete?
We have to check the plausibility of the results of clinical studies, that is, be able to understand them. For some points it is necessary to clarify the efficacy, quality and safety. Our inquiries are answered faster and slower.
Do manufacturers make the results of clinical studies available to all approval bodies at the same time?
With slight temporary differences, yes. Switzerland, along with the US, Canada, Europe and England, is one of the countries to which information will be provided first.
What data is still missing?
We are still lacking data on efficacy and safety, especially for the age groups over 65 and 12-18 years. And we still don’t know enough about how people with pre-existing diseases and high-risk patients react to vaccines.
When do you know more?
We expect another set of data next week that will hopefully shed some light on that. If we cannot clearly establish the risks for the elderly or pre-ill age, we would have to refrain from approving first for these population groups.
The Swiss vaccination plan, which plans to vaccinate especially vulnerable people and health workers first, would then be obsolete.
That is a possible scenario. So the federal government would have to redesign its vaccination strategy. A conflict of objectives that we naturally do not want. However, we assume that we will receive relevant data from pharmaceutical companies in due time.
Can you now say which vaccine will be best for which population group?
Not yet. Pharmaceutical companies follow different strategies. While some administered their preparation to at-risk patients in the first two phases of the trial, others waited. We urgently need more data to show how vulnerable people in particular have reacted. Ultimately, only long-term observations provide information on rare side effects.
Claus Bolte (58) has been working for the Swiss authority for the authorization and supervision of pharmaceuticals and medical devices Swissmedic since 2012. First he was Head of Clinical Review. He has been in charge of the approvals department since 2017. Before joining Swissmedic, Bolte worked for more than 20 years as a physician and surgeon in hospitals and as a researcher in the pharmaceutical, biotechnology and medical device industries in Europe and the United States.
You must rely on the information provided by the manufacturer.
Otherwise it would not be possible. With vaccines in particular, clinical studies are conducted globally in different climatic zones. The study protocols are legally binding, they are verified and approved by the authorities. The behavior of people, the route of administration, cold chains; everything is documented by the manufacturers and inspected on site. It is a division of labor in a network of international drug authorities.
The head of infection control at the Federal Office of Public Health (BAG), Virginie Masserey, said in an interview with the “NZZ am Sonntag” that the vaccines will start in January. Do you share this optimism?
Several preparations are being carried out in parallel. BAG and the army are already working on the logistics. The cantons are evaluating a fine distribution strategy. Vaccination centers must be established and cold chains guaranteed. So that everything is ready when we give the green light. If all this comes together, a nationwide vaccination campaign starting in January is realistic. But again: there is no vaccine without approval.
The patience of the population is exhausted.
The speed with which we can issue approvals is essentially due to the willingness of the manufacturers to provide us with the necessary data in an efficient way. We work with a lot of pressure for it. We are currently deferring other requests for authorization.
How do you make sure the vaccine is absolutely perfect?
There is no absolute certainty in this pandemic. With each new active ingredient, the risks are somewhat higher at first than if you have known a preparation for a long time. Approvals are only granted worldwide if the benefit-risk balance is positive. Research doesn’t stop after vaccines are approved. After introduction, vaccines are closely monitored with pharmacovigilance.
A 90-year-old woman was vaccinated in England. This was made possible by an emergency approval. Why doesn’t Switzerland have such a procedure?
No corresponding legal basis for vaccines has been created. The Covid-19 regulation only allows us to place drugs on the market while we are still testing them. In haste, we have a great responsibility. Compromising security would be fatal. The world looks at us. There is great responsibility associated with this.
What do you mean?
Our decisions about which vaccines are approved for which population group also form the basis of evaluation for around 80 approval authorities around the world. We enjoy the trust of everyone, that forces us.
The approval and distribution of vaccines has accelerated around the world in recent days. The UK was the first country to receive emergency approval to clear the way for corona vaccines from Biontech and Pfizer. The British had secured 40 million doses of the preparation in advance. According to its own information, the European Medicines Agency wants to decide on the Biontech vaccine at the end of December and probably in mid-January on the vaccine from the American company Moderna.
In the US, emergency approval of the Biontech and Pfizer corona vaccine was granted yesterday Friday. The Modern vaccine will follow on December 17. Chinese authorities say more than a million people have already been vaccinated with local drugs. Switzerland has signed contracts with three vaccine manufacturers. In addition to Moderna (a total of about 7.5 million vaccine doses), there are the vaccine manufacturers Pfizer / Biontech (about 3 million vaccine doses) and Astrazeneca (about 5.3 million vaccine doses. ). The approval could take place from January.
