Do vaccines actually cause negative effects
Side effects of the mRNA vaccinations: Not so completely "without"
At the moment, the willingness to be vaccinated against Covid-19 in Austria does not seem to be overwhelmingly high. Even people who have been immunized against many other diseases have reservations about the Covid vaccination. The reasons are understandable: the vaccinations were developed at a record pace, and in some cases it is a fairly new type of vaccine, namely vaccination with mRNA.
In addition, nothing is known about theoretically possible long-term consequences - except for the immunization, which is likely to last longer than initially feared. After all, reports are known about the short-term side effects of the two mRNA vaccinations: on the one hand, the official ones from the manufacturers and, on the other hand, those from test persons who have had themselves vaccinated. Of course, it is not known whether they actually received the vaccine or just the placebo.
Severe symptoms subside quickly
But these case reports suggest that - similar to other vaccinations - a small percentage of those vaccinated could have severe symptoms, even if they would soon subside. One of those subjects who volunteered in Moderna's mRNA vaccine study is Massachusetts Institute of Technology (MIT)-trained bioinformatician Luke Hutchinson. The 43-year-old reported for the online edition of the journal "Science" that his right arm swelled briefly to the size of a goose egg at the puncture site after the second vaccination.
This was followed by bone and muscle pain, and Hutchinson also had a fever of 38.9 degrees Celsius. Then came hot and cold episodes. After twelve hours, however, the ghost, for which he was not really prepared, was over again.
The Germanized technical term for this is reactogenicity and describes the - sometimes more severe - side effects that vaccinations can trigger. In the case of the mRNA vaccinations developed by Biontech / Pfizer and Moderna, fewer than two percent of the people had a fever between 39 and 40 degrees Celsius, as is known from the phase 3 studies. In the case of the Moderna vaccination, fatigue (9.7 percent), muscle pain (8.9 percent), joint pain (5.2 percent) and headache (4.5 percent) were also recorded.
With the vaccination from Biontech / Pfizer, these side effects were lower: 3.8 percent were affected by tiredness and two percent by headache. (In the phase 1 study, these side effects were apparently ten times more common.)
"Mild to Moderate"
"Serious side effects have not yet been observed," says infectiologist Bernd Salzberger (Uniklinikum Regensburg), who knows the data that Biontech / Pfizer sent to the US FDA: "The side effects are more likely to be mild to moderate, both locally as well as systemically. "
But even this mRNA vaccine, which is manufactured for Europe in Belgium, is likely to have more "side effects" in a few people, as a case report published on Monday by volunteer Kristen Choi in the journal "JAMA Internal Medicine" suggests. (However, it is also unclear whether she received the real vaccination or the placebo.) Choi, a doctor of nursing from UCLA, complains of rather severe side effects after the second vaccination.
At first it was pain in the arm, then a stabbing headache and a fever that reached 40.5 degrees the night after the vaccination. The following day, she still had a body temperature of 37.5, and all symptoms did not go away until the morning after. Choi also notes in her autobiographical report that she was not informed about the possible side effects of the vaccination - which she has now made up for for her colleagues and the public.
Two allergic reactions in the UK
After the UK vaccination campaign began on Tuesday (with the Biontech / Pfizer vaccine), incidents occurred among two NHS employees who received the first "shot": the two people with a long history of allergies showed allergic reactions after vaccination and had to be treated.
"Both are recovering well," said NHS boss Stephen Powis on Wednesday. According to him, the two sufferers are so susceptible to allergies that they always carry an emergency kit with adrenaline with them. However, the British drug regulatory authorities have advised against injecting the Biontech / Pfizer vaccine into anyone with a "significant" history of allergies for the time being. The warning was purely a precautionary measure, Powis added.
Peter Openshaw, ex-president of the British Society for Immunology and professor at Imperial College London, points out that - as with many foods and medicines - there is also a low probability of intolerance with vaccinations. But it is important to put this low risk in relation. With the Biontech / Pfizer vaccination, there were minor allergic reactions in the phase 3 study in the vaccination group, but also in the placebo group (0.63 and 0.51 percent, respectively). (Read more reactions from UK experts here.)
Study phase 3 without "special allergy sufferers"
Pfizer said in a statement that the MHRA had notified the company of the allergic reactions. At the same time, the manufacturer confirmed that the vaccine was generally well tolerated during the last clinical study with more than 40,000 subjects. No serious safety concerns were reported.
However, according to the study protocol published by Pfizer, the pivotal study did not include participants with a history of severe adverse reactions associated with a vaccine and / or severe allergic reactions to any ingredient in the study.
The British MHRA was the world's first regulatory authority to give the vaccine an emergency approval a week ago. Several hundred people were vaccinated on the first day. The vaccine is expected to be approved in the US on Thursday. (Klaus Taschwer, APA, December 9, 2020)
The article was updated at 3:37 p.m. to include the two allergic reactions in the UK.
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