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Corona vaccines: it doesn't get any safer


Many vaccine skeptics consider the corona vaccines to be unsafe because of their rapid approval. But the exact opposite is the case.

The corona vaccination still triggers skepticism in too many people.

A concern of the hesitant: The corona vaccines were developed and approved faster than previous vaccinations.

They therefore fear that the vaccines established in the urgent procedure are not safe.

Some felt vindicated when the first reports of previously unknown possible side effects came up with the AstraZeneca vaccine in the spring.

The opposite is the case: there are hardly any better-reviewed vaccines than the coronavirus, the high level of publicity and the large number of doses administered ensure that undesirable side effects are quickly noticed. "Since hundreds of millions of people were vaccinated within a few months in the EU alone, it can be assumed that extremely rare serious side effects will also be recognized," explains Klaus Cichutek, President of the Paul Ehrlich Institute (PEI). Experience over the last few decades has shown that side effects usually occur within a few weeks or months. Therefore, all side effects should have been recognized by now.

The many reports of suspected side effects contributed to this.

For example, this: an adult woman is diagnosed with sinus vein thrombosis and a lack of platelets in the blood at the beginning of the year.

She had previously been vaccinated with the AstraZeneca corona vaccine.

There is suspicion that the vaccination may have blocked the blood vessels.

A corresponding notification will be received by the European Medicines Agency (Ema) on March 14th.

Even after this point in time, there have been dozens of similar suspicious transaction reports.

At the end of March, Ema added sinus vein thrombosis in combination with thrombocytopenia to the list of rare side effects of the AstraZeneca preparation.

Different number of suspicious transaction reports

Such reports are important so that the side effects that are not recognized in the approval studies are also noticed.

Because in each of these studies, only up to 18,000 people received the vaccine.

But when millions of people get a vaccination, the rarest side effects are also noticed.

A Europe-wide comparison shows that not all countries report the same number of suspected cases.

In relation to the doses administered, the Netherlands, Austria and Iceland report more possible side effects to Ema than Germany.

In its current safety report, the PEI itself reports a somewhat higher rate of 16 reports per 10,000 vaccinations.

If you compare the Ema database with the PEI figures, it is noticeable that the PEI actually has almost 50,000 more German reports than the Ema.

PEI President Cichutek explains the different numbers if it is not about serious suspected cases, the PEI has 90 days to forward the reports to the Ema.

Most of the reports are about comparatively harmless vaccination reactions such as headaches or pain at the injection site, which usually disappear after a few days.

For the safety of the vaccines, however, the serious reactions are particularly important, said Cichutek.

Enter the PEI in the Ema database within 15 days.

Different reporting cultures

Even if you take the PEI rate of 16 reports per 10,000 vaccine doses as a basis, there is still a clear difference to the Netherlands, Iceland and Austria. "The differences could be due to different reporting cultures in the respective countries," said Ema on request. Campaigns, media discussions and easily accessible reporting tools could raise public awareness - and ultimately lead to more reports. There are also such differences with other drugs, not just with the corona vaccines.

The Dutch Ministry of Health ran campaigns on social media and hung posters in vaccination centers, according to a spokesman for the ministry. In Austria, after the vaccination, every person received a card with a QR code that led directly to the registration form, says Erwin Forster, spokesman for the Austrian Federal Office for Health Safety. Forster adds that transparent communication about side effects is particularly important. So people would see "that something is done with the reports, that it makes sense to share the information."

It is questionable whether the German population knows how well they can report suspicious activity.

In this country, vaccination reactions and suspected side effects can be reported using an online form or with the SafeVac smartphone app.

But according to the PEI, it was used by just over 712,000 people by the end of September - with around 57 million people vaccinated at the time.

However, many reports also come from medical practices and hospitals.

According to the PEI, the reporting process is "well known to all those affected".

The suspicious transaction reports submitted give an "excellent picture of the situation".

Package inserts have grown

Since the start of the vaccination campaign, Ema has received over a million suspicious transaction reports from all over Europe.

Many of them have mild, known side effects or are not related to the vaccination at all.

But certain rare side effects have been rediscovered thanks to the reports and have been included in the package insert.

Fever, chills and other flu-like symptoms are among the expected vaccine reactions known from the approval studies.

They show that the body is dealing with vaccination.

Inflammation of the pericardium and heart muscle were identified as a very rare side effect with the Biontech product Comirnaty in July.

The collected reports are not yet sufficient to determine the exact frequency.

One thing is certain: the inflammations are very rare.

Another prominent example of a side effect that was only recognized after approval: cerebral vein thrombosis in connection with a lack of blood platelets after an AstraZeneca vaccination.

In Germany, seven reports of this in March led to vaccinations being temporarily stopped.

After a European panel of experts gave the all-clear, the vaccination continued.

The German Standing Vaccination Commission only recommended it for people over 60.

From the first occurrence of a side effect to a reaction by the authorities, the suspicious transaction reports go through several steps:

The individual suspicious transaction reports do not yet allow any statement to be made about actual side effects.

Only after scientific analysis is it clear whether it is a side effect or simply a coincidence.

This is particularly evident when looking at the reported deaths. By the end of September, the PEI had received 8002 reports of suspected deaths related to a corona vaccination. Some of those affected were infected with Covid-19 shortly before or after the vaccination and died from it. For others, death is due to previous illnesses - especially very old people who were initially vaccinated as a priority. According to its analysis, the PEI considers it probable or at least possible that there was a connection between vaccination and death in only 73 of the reported cases.

"Every report should be seen as part of a puzzle," explains Ema.

Together with clinical data, epidemiological studies and toxicological investigations, an overall picture emerges.

This explains why fever, muscle pain, nausea and diarrhea are side effects of the vaccination, but a stiff neck, for example, is not.

The frequently reported cycle shifts after a corona vaccination were also not recognized as a side effect.

According to Ema, they actually occurred less often after vaccination than would have been statistically expected.

The fear that the corona vaccination could lead to infertility was dispelled, at least in animal experiments, before approval - and also not plausible from a scientific point of view.

Source: spiegel

All tech articles on 2021-11-27

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