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Danish Medicines Agency warns of new mRNA side effect

Source: TKP.at, Thomas Oysmüller, 25 March 2024

Nobody has been talking about “safe and effective” for a long time. Denmark warns that chronic hives are a possible side effect of Moderna mRNA injections. The EU also agrees.

A new study from Denmark has come to the conclusion that chronic hives can come along with the Moderna mRNA injection. The European Medicines Agency (EMA) agrees with the Danish findings, but is not questioning the authorisation of the drug.

Updated side effect

The study found that the likelihood of developing chronic hives was highest 7-13 days after the third dose of the Moderna vaccine. Swedish journalist Peter Imanuelsen reports on this. He writes on Sunday:

“It was found that people who received the injection were three times more likely to develop chronic hives than the rest of the population. They also say that young men in particular are more likely to be affected by this side effect.

Interestingly, the Danish authorities warned back in 2021 that they had found evidence that chronic hives could be a consequence of the Moderna vaccine, but there was not enough data to confirm this.

In Norway, the Moderna vaccine has even been discouraged for men under the age of 30 because of the risk of myocarditis. Have you heard anything about this in the news?”

Imanuelsen sees the new study as a “bombshell”. It is a clear admission that the mRNA injection is unsafe. On 20 March, the Danish Medicines Agency reported on the “newly discovered” side effect.

So what exactly did the authority write?

The European Pharmacovigilance Risk Assessment Committee has reassessed whether chronic urticaria (hives, note) can be an adverse reaction following vaccination with Moderna’s Spikevax vaccine. This is based on a review by the Danish Medicines Agency, which analysed data and reports from patients in all EU countries.

In 2022, the Pharmacovigilance Risk Assessment Committee concluded that an allergic reaction in the form of non-chronic hives can very rarely occur as an adverse reaction to the two COVID-19 vaccines used in Denmark, Spikevax from Moderna and Comirnaty from Pfizer/BioNTech. At the time, however, there was insufficient evidence that the vaccines could also cause chronic urticaria.

The Danish Medicines Agency then conducted further studies on chronic urticaria as a possible side effect. Throughout 2023, the Pharmacovigilance Department has investigated all reports of chronic urticaria received by the Danish Medicines Agency and collected and analysed data from other sources, including data from the Danish health registers and reports from other EU countries.

The review of these cases has resulted in the Danish Medicines Agency submitting a so-called safety signal to the European Pharmacovigilance Risk Assessment Committee (PRAC) because it considers that there is sufficient evidence that chronic urticaria may be an adverse reaction to the Spikevax vaccine. The Danish Medicines Agency’s work is not limited to Spikevax, but also to the much more widely used Comirnaty vaccine, for which there is no evidence of a link.

In January, the PRAC reviewed the Danish safety signal and, based on the conclusions of the Danish Medicines Agency, decided to update the product information so that chronic hives would be listed as a side effect of Spikevax in the future.

Correlation found in 286 out of 360 cases[…]

“We have investigated a total of 360 European cases, the vast majority of them in Denmark, but there are also a large number of cases in Germany, Switzerland and Italy. In 58 of these cases, we assume a probable link between the vaccine and the development of chronic urticaria, and in 228 cases a possible link,” explains Martin Zahle Larsen, team leader at the Danish Medicines Agency[…}

The Danish study shows that the vast majority of cases of chronic urticaria occurred 7-13 days after the third dose of vaccine in people who had been vaccinated with the Spikevax vaccine. The study also shows that people vaccinated with Spikevax are three times more likely to develop chronic urticaria than the general population, and that younger men are at particularly high risk of developing chronic urticaria after vaccination with Spikevax.

What are the consequences of this new finding, you ask? The Danish authorities have an answer to that question too:

Chronic hives will be included in the package leaflet

The PRAC’s assessment was reviewed by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which agreed that the product information for the Spikevax vaccine should be updated to include chronic urticaria as a possible side effect. The next step is final authorisation by the European Commission. After that, the company behind the vaccine will update the product information and package leaflet of the vaccine.

The package leaflet for the Moderna product will therefore be updated. That seems to be the end of the story. So the substance is not quite so “safe”.

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