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Vaccines are often jointly approved in the EU. It is a process in which two countries are called rapporteurs and collect all the necessary information, which is then reviewed by experts from all member countries. The final decision is made by the European Commission.
The procedure begins when a manufacturer submits a request to sell a vaccine.
The manufacturer is obliged to provide the results of all clinical studies performed, along with previous laboratory tests, animal tests, and information on manufacturing and quality control processes.
Clinical trials, in humans, are carried out in three stages by the manufacturer:
Phase 1: The vaccine is tested in a small group of people to monitor how the body reacts and to rule out acute safety risks. This is usually the first time the preparation has been tested in humans.
Phase 2: More people are being tested for more studies on side effects. In addition, it is examined whether the body develops immune responses in the form of antibodies.
Phase 3: The vaccine is tested in a much larger number of people to see if it protects against infection. Two groups are treated with a vaccine or ineffective saline. Neither the researchers nor the subjects know who is being treated with what; That information is kept secret until the study is evaluated. After a fixed number of disease cases, the groups are compared. If enough more people have been infected in the control group compared to the vaccinated group, the vaccine is considered to be effective. In some cases, a check is done at half time. If the result shows a clear effect, the active vaccine is often offered to the control group for ethical reasons. If, on the contrary, it seems ineffective, the experiment can be interrupted.
If the disease that the vaccine is intended to protect against is very rare, you cannot wait for enough people to become infected. In such cases, it may be sufficient to measure the antibody content.
For the vaccine to be approved, there must be a reasonable balance between benefit and risk. In serious illnesses, an increased risk of side effects can be tolerated and vice versa.
After approval, there are often requirements for ongoing evaluation, for example, to detect rare side effects that are noticed only when large numbers of people are vaccinated. The risk of spreading the infection and the duration of immunity are also evaluated.
Once the vaccine is approved, all the scientific documentation that served as the basis for approval is published.
Source: Medical Products Agency
