A total of 38 people have had suspected side effects after vaccination of covid-19 in Sweden, according to reports to the Medical Products Agency.
Cases of suspected side effects are reported by both healthcare and private individuals. The Medical Products Agency is currently investigating 38 such cases that together contain a total of 96 suspected side effects. It is important to keep in mind that these are precisely suspected cases. The fact that they are reported does not necessarily mean that the symptoms are due to the vaccine.
The suspected side effects that occur in most cases are known, expected and mild.
– It is, for example, headaches, local reactions at the injection site, fatigue, chills and fever, says Veronica Arthurson, unit manager at the Medical Products Agency.
Reporting suspected side effects and investigating whether they are related to the vaccine is part of phase 4 of the clinical development of a drug (see fact box below in the article).
Serious suspected side effects
Almost half of the suspected side effects, 42, are considered “serious” by the reporters. Some are already known, but unusual side effects.
– There is a case of anaphylaxis, ie a serious allergic reaction. And there is also a case of acute facial paralysis. Both are known and serious side effects, says Veronica Arthurson.
A total of 24 suspected side effects have been reported as both serious and unknown, which means symptoms that have not previously been linked to the vaccine in studies. But it sounds worse than it is, according to Arthurson. The Medical Products Agency does not see any clusters of the same type of “unknown side effects”.
Four deaths
Four deaths have been reported in Sweden, which in time coincides with people being vaccinated, but today there is no suspected causal link, according to the Medical Products Agency.
– All people are older and have some form of underlying disease, says Veronica Arthurson.
Although there is little evidence that vaccines are the cause of death, the authority wants to get to the bottom of what caused the deaths.
– There are parts in these cases that we are waiting for in order to get a complete picture of what has happened.
Clinical development in four phases
Phase 1: Studies on voluntary trial participants
After the preclinical part, the vaccine will be tested on humans. The first step is to test the vaccine on a small scale on a voluntary basis. Here, the researchers want answers about whether the vaccine is safe for humans and see what immune response it elicits. The researchers want to get an idea of how the vaccine should be dosed and what side effects may occur. This stage can take about a year.
Phase 2: Studies in the real target group
When the experiments on the voluntary group are complete and prove to be promising, it is time to study the vaccine in the real target groups. Here, the researchers study, among other things, the immune response to the vaccine in detail, the number of doses and what is an optimal vaccination schedule. This phase can be for a few months or for several years.
Phase 3: Large-scale vaccine studies
Once researchers have determined that the vaccine is safe and effective, it is time for large-scale studies on people who belong to the intended target group. Unlike drug development, vaccines are being tested on healthy people, as vaccines are meant to prevent someone from getting sick.
The results of the trials are analyzed and followed up, and the safety of the vaccine is carefully tested. This means that this phase can normally take months or years. Here you can send in an application for permission to use the product on humans.
Phase 4: Monitoring after the sale is approved
The vaccine has been approved and has started to be used. The vaccine’s efficacy and safety and its impact on the population must now be followed up. Looking at the vaccine’s efficacy and safety is done as long as the vaccine is used.
Source: Nyteknik – Senaste nytt by www.nyteknik.se.
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