Can vaccines kill you
What is known about the side effects after a Covid-19 vaccination
You have to know that
- Injection site pain, fatigue, headache and muscle pain are the most common short-term side effects.
- The rare side effects observed so far include allergic reactions.
- Possible long-term consequences cannot yet be ruled out. However, experts consider this to be unlikely.
Last update: May 11th
Several hundred million people worldwide have already received a vaccination against the new coronavirus. In Switzerland, by May 5, 2021, over three million vaccine doses had been administered and one million people were fully vaccinated. The two mRNA vaccines from the manufacturers Biontech / Pfizer and Moderna were used. The vaccine from Johnson & Johnson is also approved in this country. However, this has not yet been inoculated because Switzerland has not ordered any cans from the manufacturer. In the rolling approval process, the approval authority Swissmedic is currently also examining the vaccines from Astrazeneca and Curevac. In addition, Biontech / Pfizer has submitted another application for approval to Swissmedic, which is intended to expand approval of the mRNA vaccine to 12 to 15 year olds. Because so far the mRNA vaccine from Biontech / Pfizer has only been approved for people aged 16 and over.
Here we answer the most important questions about classic harmless and undesirable side effects as well as possible long-term consequences of the various corona vaccinations.
How are side effects recorded?
Whether and which side effects occur after vaccination is recorded in clinical studies. Medical specialists actively ask the test subjects about side effects that occur or the test subjects record them themselves using an electronic diary. After a vaccine has been approved, the approval authority - in Switzerland called Swissmedic - monitors suspected adverse effects. Vaccinated people should contact their doctor or pharmacist if symptoms are severe or unusual. These forward the reports to Swissmedic. As of May 4, 2021, 1953 reports were received in this regard.
In addition, the manufacturers themselves have to keep a database.
The manufacturers then evaluate all reported events in a follow-up study. This so-called phase 4 study usually lasts two to four years - or until several million people have received the vaccine. It can be checked whether there are very rare but serious undesirable side effects. It is also used to determine how people or age groups who were not part of the clinical studies - children or pregnant women, for example - react to the vaccine.
However, not all post-vaccination events can be traced back to the vaccination itself. Because serious illnesses or deaths occur independently of a study or vaccination campaign. Therefore, the health history of those affected is also important for an assessment of the reported events. For example in the case of the 91-year-old person from the canton of Lucerne, who suffered from some previous illnesses and died a few days after a Covid-19 vaccination. Neither the medical history nor the acute course of the disease suggested a direct causal relationship between the vaccination and death.
In order not to confuse an accidental occurrence of a complaint with the vaccination with a side effect, experts in the clinical studies in phases 1 to 3 compare those people who received the active ingredient with the control group who were only injected with a placebo. It is analyzed how often certain events within the two groups, but also in the population, normally occur purely statistically. If there are significantly more events in the group of vaccinated people, these are considered to be a consequence of the active substance. In phase 4 studies, there are usually no longer any control groups, so experts compare vaccinated people with the general population.
What are the common side effects of the Covid-19 vaccinations prior to approval?
The most common side effects are pain at the injection site, fatigue, headache, muscle pain, and chills, as demonstrated in the clinical trials of the Biontech / Pfizer mRNA vaccines. The study enrolled over 40,000 people, half of whom received the vaccine and the other half received saline as a placebo. 8183 subjects were included in the evaluation of the common side effects. The percentage of these people who complained about the above-mentioned side effects differed depending on the age group and whether it was the first or second vaccination dose. Overall, the symptoms were more common in younger subjects and more severe after the second dose than after the first. The placebo group also complained of side effects such as headache or fatigue. Nevertheless, the symptoms were more common among those vaccinated with the active ingredient. For example, in the 16 to 55 age group, 83 percent of those vaccinated and only 14 percent in the placebo group reported pain at the injection site within seven days of the first dose. In contrast, 47 percent of those vaccinated felt tired and weak - but so did 33 percent of the placebo group.
In most people, these symptoms lasted a few days and were mild to moderate, but in a few cases they were severe. These side effects are not unusual and are to be expected from a vaccination, as immunologist Steve Pascolo from Zurich University Hospital told higgs. Because this is primarily a reaction of the immune system, which usually lasts several days to weeks.
Test subjects who received the active ingredients from Moderna, Astrazeneca, Johnson & Johnson and Curevac also frequently reported these classic side effects such as pain at the injection site, fatigue, headache and muscle pain. More than 30,000 people took part in Moderna's phase 3 clinical trial. The interim results of the phase 3 study based on over 30,000 and over 40,000 people, respectively, are available for the active ingredient from Astrazeneca and those from Johnson & Johnson. The phase 3 clinical trial of Curevac's vaccine with approximately 36,000 people has not yet been completed.
What are the side effects of the mRNA vaccination?Read the whole article
What rare serious side effects occurred with the Covid-19 vaccinations prior to approval?
In addition to these classic vaccination reactions, however, individual serious adverse events occurred with all three vaccines, both in the vaccine group and in the placebo group. In the case of Biontech / Pfizer, experts came to the conclusion that three of these events were causally linked to the vaccine: a shoulder injury, swelling of the lymph nodes and an abnormal heart rhythm. The evaluation of these undesirable side effects is based on all over 40,000 test subjects.
The Astrazeneca study reported three cases of transverse myelitis in the UK - two in the vaccine group and one in the control group. It is a rare inflammatory disease of the spinal cord that can occur without a known cause, through other inflammatory diseases such as multiple sclerosis, or through infectious diseases. How exactly an infection or a vaccination can trigger this disease has not yet been fully clarified.
The three cases in the UK were reviewed by a committee of independent neurologists. Such a committee accompanies every clinical study on humans. They came to the conclusion that two of the three events are unlikely to be linked to the vaccination: One of the people vaccinated with the active ingredient was diagnosed by doctors with previously undiscovered multiple sclerosis, which very likely triggered the myelitis. Why there is no connection in the person from the control group who had received a vaccination against meningococci is not explained further in the study. The transverse myelitis of the second vaccinated person, on the other hand, may be related to the vaccination, according to the expert report. According to the study authors, all three subjects have now recovered.
In the Moderna vaccine clinical study, three people from the vaccine group and one person from the control group developed transient facial paralysis. At the moment, it cannot be ruled out that this event is a consequence of the vaccination.
In all three studies, there were individual deaths among the vaccinated and in the control group that were not due to Covid-19. With the Biontech / Pfizer vaccination, for example, there were two deaths in the vaccination group and four deaths in the placebo group. As such deaths are similarly common in the general population in the corresponding age groups, none of the events were due to vaccination of the active substances or the saline solution.
What are the rare side effects of the Covid-19 vaccinations after approval?
The majority of vaccination-related side effects usually occur within two to three months after the last vaccination dose, as Carlos Guzmán, head of the vaccinology department at the Helmholtz Center for Infection Research in Braunschweig Guzmán, told science.lu. The manufacturers' clinical studies cover this period, but very rare side effects are only discovered after a few million people have been vaccinated. With corona vaccines, it could go relatively quickly until rare side effects are known. In the USA alone, over 130 million people had received a vaccination from Biontech / Pfizer or Moderna by April 21, 2021. Only after the start of a vaccination campaign does it become apparent how certain groups not included in the studies, such as pregnant women, people with previous illnesses, and very old or young people, react to the vaccine. Because the clinical studies always include a selection of people and are not representative of the entire population.
In Switzerland, up to May 4, 2021, 1953 reports of suspected adverse effects after a Covid-19 vaccination were received from Biontech / Pfizer or Moderna. As the evaluation by the licensing authority Swissmedic shows, 64 percent of the reports were non-serious effects. However, the remaining 701 cases were classified as serious. The most frequent occurrences were fever, headache or migraine, shortness of breath, herpes zoster reactivation, exhaustion, muscle pain, malaise, hypersensitivity, anaphylactic reactions, nausea, chills, vomiting and increased blood pressure. In most cases, those affected reported more than one reaction. A total of 92 cases of herpes zoster have been reported so far. Whether this is causally related to the vaccination is currently not known and is being investigated. 76 people died at different intervals for the vaccination. All were on average 82 years old and the majority had serious previous illnesses. There is no concrete evidence that the vaccination led to death in any of the deceased. The cause of death appears to be from other diseases such as infections, cardiovascular events, or diseases of the lungs and respiratory tract. As Swissmedic writes in its communication, these latest reports largely confirm the side effect profile known from the approval studies.
After the Biontech / Pfizer vaccination, individuals in Great Britain and the USA have suffered an allergic shock immediately after the Biontech / Pfizer vaccination since the start of the vaccination. As an evaluation of the first nearly two million vaccinations in the USA by the US health authority CDC shows, most of those affected already had known allergies to other vaccines or drugs. The overreaction of the immune system was probably triggered by the so-called auxiliary polyethylene glycol - a substance that is also found in various everyday products such as deodorants, toothpaste or ointments. Therefore, experts from the German Paul Ehrich Institute, the Federal Institute for Vaccines and Biomedical Medicines, advise people with a proven polyethylene glycol allergy against vaccination with the Biontech / Pfizer vaccine. The same applies to allergies to any of the other ingredients. For allergy sufferers in general, however, the experts do not see an increased risk of having an allergic reaction after a Covid 19 vaccination. In general, severe allergic reactions after vaccinations are very rare, with an average of 1.31 cases per million vaccine doses. No serious side effects are known to date for the Moderna vaccine since its widespread use.
With regard to the Astrazeneca vaccine, cases of thrombosis - some of them temporal and fatal - have caused quite a stir. In Switzerland, the vaccine has not yet been approved due to a lack of data. Experts from the Paul Ehrlich Institute had noticed a noticeable increase in a special form of very rare cerebral vein thrombosis (sinus vein thrombosis) in connection with a lack of blood platelets (thrombocytopenia) and bleeding close to vaccinations with the Covid-19 vaccine AstraZeneca. The European Medicines Agency (EMA) has been recommending that thrombosis be listed as a very rare side effect since April 7th. The EMA examined a total of 62 cases of sinus vein thrombosis and 24 other thromboses in large veins of the abdominal cavity. These included 18 deaths. These complications come to around 25 million people vaccinated in the EU and the UK, according to the EMA. Behind the incidents there could be a special immune reaction that activates blood platelets and thus triggers thrombosis, as researchers from the Greifswald University Hospital said.
A first version of a study on thrombosis cases was published on March 28, but this has not yet been reviewed by specialist colleagues. “So far, the AstraZeneca vaccine AZD1222 has been approved for all groups of people. Based on the data in Germany, but also in the UK in particular, women up to the age of 55 are primarily affected by atypical thrombosis, ”Johannes Oldenburg, chairman of the German Society for Thrombosis and Hemostasis Research (GTH) told the Science Media Center. “Other age groups and men can also be affected, but this seems to be much less the case. For example, Great Britain saw cases of atypical thrombosis comparatively late, despite a much higher dose of vaccination. One possible explanation could be that the elderly groups were initially vaccinated and this complication is practically not observed there. One consequence of this could be that women up to the age of 55 should be vaccinated with a different vaccine in order to keep the number of atypical thromboses as low as possible. "
After vaccination with the Johnson & Johnson vector vaccine, eight people in the United States developed unusual blood clots associated with platelet deficiency. One person died from it. The European Medicines Agency EMA has examined the cases and announced on April 20, 2021 that the vaccine could cause blood clots in very rare cases and that blood clots should therefore be listed as very rare side effects in the package insert.
How likely are long-term effects?
Possible long-term consequences cannot yet be ruled out at this point in time. The immunologist Steve Pascolo, who has been researching mRNA vaccines for many years, sees no great danger, however. In 2003 he and his team started injecting cancer patients with mRNA vaccines. In a self-experiment, he has already administered such vaccines to himself. "We never observed any serious side effects or any long-term consequences," says Pascolo. The components from Biontech / Pfizer and Moderna are new for the Covid-19 vaccines and, unlike in cancer patients, are injected into the muscle instead of under the skin. However, since all five components contained in the vaccination - one mRNA and four lipids - are natural and are excreted or broken down naturally, Pascolo does not expect any long-term problems from the very small doses of the injected products. The immunologist has slightly more concerns about the Astrazeneca vector vaccine, which is based on modified adenoviruses that cause colds in chimpanzees and introduce part of the Sars-CoV-2 genome into the human body.
This is also confirmed by Christian Münz, Professor of Viral Immunobiology at the University of Zurich. He rates the mRNA vaccines as having a little less side effects than the adenovirus vaccine, as he writes on request. In general, however, he considers the likelihood of long-term consequences with all three Covid 19 vaccinations to be low. “Since the vaccination triggers an immune response against the spike protein of Sars-CoV-2, which corresponds to part of the immune response against the actual Sars-CoV-2 infection, I also think that any long-term consequences from vaccination as well as infection would occur », so Münz.Since presumably everyone will either be vaccinated in the future or have gone through the disease, the vaccination is clearly preferable due to the comparatively low short-term side effects, the researcher continues.
How often have other vaccines experienced rare side effects or long-term effects in the past after approval?
Autoimmune reactions are among the rare reactions after vaccinations - but also after a viral infection. This can occur when virus proteins look similar to the body's own structures. In such a case, the antibodies not only fight the virus, but also these endogenous cells. In a few cases, depending on the genetic characteristics of the genome, such an autoimmune reaction can lead to an autoimmune disease
This could be observed, for example, with the Pandemrix vaccine against swine flu 2009. This triggered the autoimmune disease narcolepsy in some cases, especially in children and adolescents. Those affected are dead tired again and again during the day. Since the disease cannot be cured, it is referred to as vaccine damage. Although several studies from Finland and England have shown a causal relationship between the disease and the vaccine, both the manufacturer and the European Medicines Agency Ema reject this finding. This is shown in a report by the British Medical Journal investigation team.
According to this report, eight years after the swine flu pandemic, it also became apparent that at the beginning of the vaccination campaign for the Pandemrix vaccine used in Europe there were warning signs of other undesirable side effects such as facial paralysis or twitching. Such side effects occurred significantly more frequently than the Canadian counterpart of the vaccine, but this was ignored and did not reach the public. According to research by the weekly Woz, Swissmedic was more reluctant to use Pandemrix and did not recommend the vaccine for adolescents and children - precisely those groups who later developed narcolepsy. The reason for the reluctance was that too little data was available from the manufacturer to prove that the vaccine was safe for these groups. In general, autoimmune reactions and diseases cannot be completely ruled out with vaccinations, but also with virus infections - this is also the case with the new coronavirus.
An example of a long-term sequelae that can occur years after vaccination is known in dengue fever. So-called infection-enhancing antibodies do not fight the virus, but allow it to penetrate even better into cells where it can multiply. This means that those affected get more seriously ill with a second infection. The risk of such severe courses in vaccinated people who did not come into contact with the virus before vaccination is around twice as high as in non-vaccinated people. This is shown by a study of around 30,000 Brazilian and Filipino children between the ages of two and 16. Vaccination is therefore not recommended for such people who have not been infected by wild dengue viruses for the first time.
There are currently no indications that this side effect could also occur with the Covid 19 vaccines. However, the phenomenon occurred in some vaccine candidates against Sars-CoV and Mers-CoV in preclinical studies on animal models. That is why researchers keep an eye on this undesirable long-term consequence when vaccinating against the new coronavirus.
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