Corona vaccines were developed in record time. Some find it too quickly and fear side effects and long-term consequences. An overview of what is now known about the vaccine reactions and the tolerance of the vaccine.
The time had come at the end of December last year. The first syringes against the corona virus were used. After that, the sleeves were rolled up in chord for months. On June 9th alone, more than 1.4 million people in Germany were vaccinated. But there has been no talk of such numbers for a long time. The campaign has lost some of its power and is only progressing slowly. Currently, 64 percent of the population in Germany are fully vaccinated against Sars-CoV-2, 67 percent have received at least one vaccination dose. Many of those who have not yet been vaccinated have no plans to do so in the future, surveys show. One argument of the skeptics: the vaccines were developed too quickly, too little is known about possible side effects and long-term consequences.
In Germany, the Paul Ehrlich Institute (PEI) monitors the safety of the approved vaccines. Since the start of the vaccination, the institute has been collecting reports on suspected side effects and vaccination complications and evaluating them. In this way, new risk signals can be identified quickly, as was the case, for example, with the very rare sinus vein thrombosis in connection with a vaccination with Astrazeneca.
In the latest safety report from the Paul Ehrlich Institute there are a number of side effects, but most of them are harmless. Serious side effects are still very rare. An overview of the current state of knowledge.
How often are suspected cases reported?
The data of the latest PEI safety report refer to the data collected from the start of the vaccination campaign on December 27, 2020 to August 31, 2021. The PEI’s side effect database registered a total of 156,360 individual case reports during this period, which corresponds to a reporting rate of 1.5 suspected cases per 1000 vaccine doses means. 9.7 percent of these cases were classified as serious. This includes those who have to be treated in hospital or who are assessed by experts as medically important.
By the end of August, 43.45 million people in Germany had been fully vaccinated. By far the most frequently used vaccine was the Comirnaty vaccine from Biontech / Pfizer, followed by the Astrazeneca vaccine, Spikevax from Moderna and the vaccine from Johnson & Johnson. According to the PEI, most of the reports on suspected cases of side effects were received with a reporting rate of 3.3 for the Astrazeneca vaccine, the fewest for the Biontech active ingredient (1.1). In 711 reported suspected cases, it is not known which vaccine was used.
|
Suspected cases per 1000 vaccinations |
Reporting rates |
Biontech/Pfizer |
Modern |
Astrazeneca |
Johnson & Johnson |
|
Everyone |
1,5 |
1,1 |
2,6 |
3,3 |
1,7 |
|
serious |
0,15 |
0,1 |
0,1 |
0,4 |
0,1 |
Which vaccination reactions are common?
The vaccination reactions differ depending on the vaccine inoculated. According to the PEI, the most frequently reported vaccine reactions are harmless ones that subside after a few hours or days.
There are “known systemic, temporary adverse reactions listed in the technical information such as fever, chills, headache, muscle and limb pain and general feeling of illness, which can be summarized as flu-like symptoms.” These occur shortly after the vaccination, serious or long-lasting illnesses are not associated with these vaccination reactions.
These are the 10 most common side effects:
- fatigue
- headache
- Injection site pain
- Local Reaction
- fever
- muscle pain
- chills
- Dizziness
- Body aches
- malaise
Side effects in adolescents
Young people from the age of 12 can now also be vaccinated with an mRNA vaccine. To date, the institute has received a total of 1228 reports for this age group, in which at least one vaccination reaction is reported that is similar to that of adults. Around 14 percent of the reports therefore described serious adverse reactions. Although vector vaccines for children and adolescents are not yet approved in Germany, the PEI received 25 suspicious transaction reports on vector-based vaccines.
Serious vaccination complications are rare
In very rare cases, severe adverse reactions occur after a corona vaccination. In the complete reporting period, 15,122 were reported. According to the PEI, fatal outcomes were reported in 1450 cases at different intervals from vaccination.
So far, the PEI has received the most frequent reports of suspected cases relating to the drug from Astrazeneca. The Standing Vaccination Commission now only recommends this to people aged 60 and over. This was due to serious, in some cases fatal, thrombosis in combination with thrombocytopenia (TTS). This also includes the very rare sinus vein thrombosis (read more about sinus vein thrombosis here). The PEI reports 174 reported cases of TTS after vaccination with Astrazeneca, 24 cases after vaccination with Comirnaty, 13 cases according to Johnson & Johnson and 3 cases after vaccination with the active ingredient from Moderna.
Under observation
The known, albeit very rare, side effects of mRNA vaccines include inflammation of the heart muscle (myocarditis) and pericarditis (pericarditis), which “apparently particularly affects young men after the second vaccination”. According to the PEI, the available data show that most of those affected recover quickly from this. By August 31, the PEI had received 792 suspected myo- / pericarditis reports – “regardless of the causal connection with the respective vaccination”: 703 reports according to Biontech / Pfizer, 89 according to Moderna. Most of the suspected cases therefore occurred in male adolescents at the age of 12 up to 17 years of age, followed by men between 18 and 29 years of age.
The PEI also observes reports of menstrual cycle disorders such as intermenstrual bleeding and pain during menstruation. According to this, 310 individual reports had been received by the end of June, almost ten percent were classified as serious. So far, the PEI does not see this as a risk signal. The European Medicines Agency also currently sees “no causal connection between Covid 19 vaccines and menstrual disorders”. The British researcher Victoria Male recently called for a large-scale study of the vaccine’s effects on the menstrual cycle. But she doesn’t see any reason for concern either.
How the PEI collects the data
Doctors are obliged to report vaccination complications to the responsible health department, who pass the data on to the PEI in pseudonymized form. Such vaccination complications include health complaints that go beyond the usual extent of a vaccination reaction and cannot be attributed to other causes.
Reports also come from the drug commission of pharmacists and doctors, from authorization holders via the database of the European Medicines Agency, but also directly from doctors. Vaccinated persons or their relatives can also report suspected cases. The PEI also uses the SafeVac 2.0 app to conduct a survey on the compatibility of corona vaccines. This is a twelve-month observational study in which vaccinated adults can participate voluntarily.
The PEI therefore collects data from various sources, and duplicate reports are merged into one case. It is important with these data that the undesired reactions are reported “in the temporal, but not necessarily in the causal connection with a vaccination”.
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