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The Covid-19 vaccines from Moderna and Biontech / Pfizer are the first approved vaccines based on mRNA. That worries some people. But wrongly, as a study shows.

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Fee Anabelle Riebeling

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Get vaccinated against Covid-19 or not? That question still arises for some people.

20min/Celia Nogler

While a few are against vaccination in principle, ... (In the picture: Coronademo from 08/21/2021 in Olten)

While a few are against vaccination in principle, … (In the picture: Coronademo from 08/21/2021 in Olten)

20min/Matthias Spicher

... others struggle with the type of vaccine.  You are not entirely at ease with the mRNA vaccines: Are the vaccines really as safe as the manufacturers and regulatory authorities claim?

… others struggle with the type of vaccine. You are not entirely at ease with the mRNA vaccines: Are the vaccines really as safe as the manufacturers and regulatory authorities claim?

REUTERS

  • After the Covid-19 vaccinations from Moderna and Biontech / Pfizer, there are no direct, i.e. immediate, serious side effects.

  • This has been shown by the ongoing security monitoring in the USA.

  • The data from 6.2 million mRNA-vaccinated persons were included in this.

  • The investigation continues.

To date, more than 6.5 billion vaccine doses have been administered worldwide to protect against Covid-19. A large part are so-called mRNA vaccines, which are being used for the first time against the Sars-CoV-2 coronavirus. The mRNA technology has been researched for a long time, but it was only the urgency of the pandemic and the money brought in that ensured that the development could be accelerated to such an extent that it was approved after a few months.

Still, some people have doubts: Are the vaccines really as safe as manufacturers and regulatory authorities claim? A study published in the journal “Jama” now provides the answer. It turns out positive.

Certain serious medical conditions in focus

It is now well known that vaccination reactions can occur after vaccination, which can be unpleasant but usually disappear again quickly. Also that after receiving one of the two mRNA vaccines, in rare cases side effects such as inflammation of the heart muscle (myocarditis) or pericardial sac (pericarditis) can occur, which – recognized in good time – can be treated well.

According to Swissmedic, a total of 7571 reports of suspected adverse effects after a Covid 19 vaccination had been received in Switzerland by September 21, 2021. Around 65 percent are not serious effects. However, the remaining 2601 cases were classified as serious. The next report on side effects of Covid-19 vaccines in Switzerland will be published on October 15, 2021. You can find it here.

How it looks with more serious and life-threatening side effects, researchers from various private and government US institutions have now evaluated using data from 6.2 million people who had received either the vaccine from Moderna or Biontech / Pfizer. In doing so, they focused on serious health problems that have occurred before in connection with a Covid-19 vaccination. These include heart attacks, strokes, blood clots, facial paralysis (Bell’s Palsy), severe allergic reactions (anaphylaxis) and Guillain-Barré syndrome (see box).

For the study, Nicola P. Klein’s team from the Kaiser Permanente Northern California Division of Research in Oakland (California) compared the health events of the mRNA-vaccinated people in the first three weeks after vaccination with health events in similar patient types in the three to three six weeks after mRNA vaccination. This is in order to compare patients who are as similar to one another as possible in order to reduce the number of factors that could affect the results. In a supplementary analysis, the authors added a comparison group of unvaccinated patients.

The total number of subjects studied was 6.2 million for the first dose of either mRNA vaccine and 5.7 million for the second dose.

Protection outweighs the risks

Result: Compared to unvaccinated people and people who had been vaccinated with an mRNA vaccine more than three weeks previously, those who had received their vaccination in the past few weeks showed no more serious health effects. It is true that in some cases the persons whose data were included in the investigation experienced serious problems. However, there was no evidence that these were caused by the vaccine. “The signal threshold above which a side effect occurs statistically significant has not been exceeded,” said the researchers.

Accordingly, the authors come to the conclusion that serious side effects after the mRNA vaccination are very rare and that the protection provided by the vaccinations outweighs the risks. In addition, the Covid-19 vaccines from Pfizer and Moderna are much safer than the infection with Sars-CoV-2 itself. “The results of our safety monitoring are really reassuring,” said lead author Klein in a press release.

Heart muscle inflammation and allergic shocks

Also with regard to vaccination and myocarditis and pericarditis cases, which are currently the hot topic of discussion, the researchers did not find anything worrying: The study found only 34 cases of myocarditis in young people between the ages of twelve and 39, which are usually appeared within a week of vaccination. Almost all those affected had fully recovered by the end of the evaluation. According to the researchers, every million doses administered lead to 6.3 additional cases of myocarditis in the age group.

The verdict is also positive with regard to anaphylactic shocks: Severe allergic shocks occurred in only 55 cases in millions of participants. According to the researchers, that is around five additional cases. And most of them occurred in the first 30 minutes after the vaccination – that is, the period in which people with a history of allergies are still under medical supervision.

The CDC-funded study considers data through June 26, 2021. The research continues: with more data. In addition, all vaccinated persons are monitored for two years in order to be able to make statements later about long-term or possibly later side effects. Experts consider it unlikely that this will happen.

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