A year of vaccination in review: Serious side effects after the corona vaccination are extremely rare
Created: 12/27/2021 Updated: 12/27/2021, 5:31 PM
According to the PEI, serious side effects are very rare with the approved corona vaccines and do not change the positive benefit-risk ratio.
© Paul Zinken / dpa
Shortly after Christmas 2020, the first people in Germany were vaccinated against the corona virus.
What do we know today about the side effects?
Thromboses in women, heart muscle weakness in adolescents: for a year now, reports about possible
side effects of
the corona vaccines * have been
unsettling
many people.
The vaccination campaign officially started on December 27, 2020.
Because the number of people vaccinated was initially low, it was initially difficult to classify such reports.
Millions of people have now been immunized: time to take stock.
Corona vaccination: great benefit, low risk
The vaccinations not only prevented hospital admissions and deaths, but also made a large part of social life possible again
, write US authors in the journal “Jama”.
In order for people to trust the vaccines, it is important to clearly communicate "the great benefits and the low risks", but also to monitor the safety of the vaccines, emphasize the experts from the CDC.
Germany had "from the beginning observed the reports of suspected vaccine side effects and complications with the highest priority, recognized very rare side effects at an early stage and initiated measures to minimize risk," write the bosses of the Paul Ehrlich Institute (PEI) and the Federal Institute for Drugs and Medical Devices (BfArM), Klaus Cichutek and Karl Broich, in their
balance sheet one year after the start of the vaccinations.
The most frequent reactions quickly subside
According to the German Society for Immunology (DGfI), typical complaints after a vaccination are
pain at the injection site, exhaustion and headache, muscle pain, chills and fever
. "These reactions are an expression of the desired confrontation of the immune system with the vaccine and usually subside completely after a few days," writes the Robert Koch Institute (RKI).
The PEI, which is responsible for the safety of vaccines, regularly publishes so-called safety reports on the Covid-19 vaccines. The most recent dates from December 23 and relates to over 123 million vaccinations administered nationwide by the end of November. Up until then, 1.6 suspected cases per 1000 doses had been reported -
this corresponds to 0.16 percent.
If one only looks at the serious reactions, the reporting rate is 0.2 suspected cases per 1000 vaccine doses - 0.02 percent.
The German Medicines Act defines side effects as "serious" that are fatal or life-threatening, require inpatient treatment or lead to permanent damage.
According to the Infection
Protection Act
,
serious side effects
must be reported
if they “go beyond the usual extent of a vaccination reaction”.
The latest PEI safety report lists the following as "very rare risks of Covid-19 vaccines":
allergies (anaphylactic reactions), inflammation of the heart muscle (myocarditis) and pericarditis, nerve inflammation Guillain-Barré syndrome and blood clots (thrombosis-with- Thrombocytopenia Syndrome, TTS).
Serious side effects after corona vaccination: what do we know about it so far?
In general, the PEI points out that “undesirable reactions are reported in the temporal, but not necessarily in the causal, connection with a vaccination.
Only studies could prove whether a reaction is actually a consequence of the vaccination.
The PEI works with probabilities: it compares how often an undesirable reaction is reported and relates this to how often it occurs statistically in a comparable, unvaccinated population.
"According to the current state of knowledge, serious side effects are very rare and do not change the positive risk-benefit ratio of the vaccines," emphasizes the latest safety report.
Heart muscle inflammation after corona vaccination
"Myocarditis is a relevant side effect," says the chairman of the board of the German Heart Foundation, Thomas Voigtländer.
But that shouldn't be a reason to decide against a Covid-19 vaccination: "
Those who do not get vaccinated against Covid-19 run a much higher risk due to the dangers of a severe Covid-19 disease course.
"
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Myocarditis or pericarditis as vaccine reactions are very rare.
“We're talking about five cases for
every
100,000 vaccinations.” In
addition, they were usually mild and healed in almost all cases.
The suspicious transaction reports mainly concerned the two mRNA vaccines and mostly male adolescents.
According to the safety report, 15 deaths were named in connection with the Covid-19 vaccination.
In three of these, the PEI considers a causal relationship to be possible, in the other cases the authority does not assume this “on the basis of the current data situation”.
Thromboses after corona vaccination
In the spring, reports of very rare thromboses caused a stir -
thrombosis-with-thrombocytopenia syndrome * (TTS).
These blood clots often appear in unusual places, such as in the brain, and people also have low platelet counts. "This disease is a rare but potentially dangerous side effect of vector-based Sars-CoV-2 vaccines," emphasizes the Society for Thrombosis and Hemostasis Research (GTH).
Most of the reports concerned the vector vaccines from Astrazeneca and Johnson & Johnson.
Women were affected more than average
.
According to the safety report, 43 deaths from TTS were linked to the vaccinations.
According to the PEI, 29 of them meet the special criteria for a TTS: They therefore relate to the preparations from Astrazeneca and Johnson & Johnson.
Astrazeneca is no longer used in Germany, Johnson & Johnson plays a subordinate role.
Allergic reactions after immunization
Anaphylactic reactions
occurred with all four approved vaccines, but they were also very rare.
The reporting rate was less than one case per 100,000 vaccine doses by the end of November.
It is slightly higher in women than in men and higher for the first dose than for the follow-up vaccinations.
Nerve damage after vaccination
Guillain-Barré Syndrome (GBS) is a very rare
autoimmune disease of
the nervous system.
According to the safety report, the reporting rate after vaccination with one of the two vector vaccines was lower than one report per 100,000 vaccine doses.
What about long-term consequences?
"There are two possibilities of what the term" long-term effects "means," writes the PEI.
“
Something that takes a long time to happen, or something that lasts for a long time.
"The fact that very rare vaccination complications persisted over a long period of time is" the absolute exception, "writes the authority.
“Concerned citizens understand long-term effects - often also called late effects - to be side effects that only occur after a delay of many months or years after the vaccination,” it continues.
“
These concerns are unjustified.
We are not familiar with such late-onset side effects of vaccines
. "
And how many “vaccine deaths” are there now?
According to the latest safety report, suspected deaths following vaccination were reported in 1919
.
But only in 78 individual cases did the PEI “rate the causal connection with the vaccination as possible or likely”.
A comparison of the number of reported deaths with the statistically expected number of deaths in the same period "did not result in a risk signal for any of the four Covid-19 vaccines previously used in Germany," writes the PEI.
What are actually side effects?
A side effect is an effect that occurs in addition to the intended main effect of a drug.
Alternatively, the terms “undesirable reaction” and “complication” are used.
Side effects of drugs or vaccines are listed in the package insert, the specialist information for doctors and the manufacturer's product information.
For this, a causal relationship must be known or at least plausible.
“Unforeseen side effects” are reactions that have not been observed before and are not yet described in the product information.
"Serious side effects" are reactions that are fatal or life-threatening,
require inpatient treatment, or cause permanent or serious harm.
You only see “rare side effects” when a large number of people have received the product
.
The number of people taking part in phase 3 studies of a new drug is often too small to see side effects that occur, for example, once in a million people.
The term says nothing about the severity of the side effects.
It ranges from harmless side effects such as tiredness to risks, the harm of which exceeds the benefits of the drug.
(dpa) * Merkur.de is an offer from IPPEN.MEDIA.