On Wednesday, the news came that the UK is approving a vaccine to vaccinate the population against covid-19. It is Pfizer / Biontech’s vaccine that has received a so-called emergency approval from the British Medicines Agency.
Britain’s health minister has told the British media that they are ready to start the first vaccinations as early as next week. But Sweden and the EU will have to wait a while longer before a vaccine can be approved and started given.
– One should be aware that it is an emergency approval that the UK has given. Some countries have chosen to use it, but that possibility does not exist in Sweden. In the EU, they are instead working to speed up the process as much as possible for full approval, says Veronica Arthurson, head of the unit for drug safety at the Medical Products Agency.
Then it can be approved in the EU
However, it is likely that the first vaccine that will be approved in the EU is the same vaccine as in the UK. The European Medicines Agency (EMA) has set a preliminary decision date of 29 December for the Pfizer / Biontech vaccine. On January 12, it is time for a decision on Moderna’s vaccine.
– Provided that the data is sufficient and nothing unexpected happens, it can then go fairly quickly for the European Commission to make the formal decision. In that case, the vaccination, according to the Public Health Agency’s recommendations on priorities, can probably begin in January in Sweden, says Veronica Arthurson.
There has been much speculation about possible side effects of the vaccines and information has been leaked from the pharmaceutical companies’ phase 3 tests on humans. But only with an approval is the entire scientific basis published.
Then the product information is also released, which is aimed at caregivers and patients, where it is stated, among other things, how the vaccine should be taken and who should not take it. In addition, all known side effects are listed.
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Most common side effects
As Pfizer’s vaccine has now been approved in the UK, there is also a list of side effects, some so common that more than one in ten people vaccinated can count on being affected.
Very common (may affect more than one in ten users)
Pain at the injection site
• Muscle pain
• Joint pain
Common (may affect up to one in ten users)
Swelling at the injection site
Redness at the injection site
Uncommon (may affect up to 100 users)
Enlarged lymph nodes
• Feeling sick
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Common in vaccinations
All these side effects are among those usually seen in vaccinations against various infectious diseases.
– In general, the most common side effects of vaccination are local tenderness, swelling and redness around the injection site. Systemic reactions such as muscle pain, headaches, fever and fatigue are also natural reactions from the body’s immune system, says Veronica Arthurson.
It is currently not possible to say what serious side effects the covid-19 vaccines may have. The Medical Products Agency will monitor and investigate all signals of suspected side effects, such as autoimmune reactions, after the vaccine has been approved.
– Some potential side effects can take a long time to develop and then it can take time before a person gets a diagnosis. That is why it is so important to report suspected side effects and follow up the safety of the vaccines even after approval, says Veronica Arhurson.
The British patient information on Pfizer’s vaccine also states that it is not yet approved for people under 16 years of age. It also states that pregnant women should consult their doctor first, and that as a precautionary measure should be avoided within two months of being vaccinated.
READ MORE: Pfizer’s vaccine is approved in the UK
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