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The European Medicines Agency (EMA), through its Committee for the Evaluation of Risks in Pharmacovigilance (PRAC), has updated this Friday the information available on the safety of vaccines against covid-19, and especially the by Janssen.

It considers that there is a causal relationship between its administration and reported cases of

immune thrombocytopenia, dizziness and tinnitus

.

The EMA recommends that these risks be included in the package leaflet and technical sheet of the vaccine to serve as a warning to healthcare professionals and patients, and emphasizes that

the benefit-risk balance of the vaccine remains positive

.

The PRAC has also recommended updating the risk management plan with this vaccine to reclassify thrombocytopenia, which is currently considered "a significant potential risk", and would become "

a significant identified risk

".

In immune thrombocytopenia, the immune system mistakenly attacks and destroys platelets, increasing bleeding and bruising.

To conclude that this disorder is related to the vaccine, the EMA reports that all available information has been evaluated, including scientific studies published in journals, and the cases reported in the European database on suspected adverse effects. EudraVigilance, the American System for Vaccine Safety (Vaers) and the laboratory database.

Dizziness and tinnitus

In the case of dizziness, the committee states that

1,183 cases identified in spontaneous reports

on suspected adverse reactions to vaccination, which were related to

anxiety

, have been analyzed

.

In addition, the EMA has investigated

6 cases of tinnitus

that were detected during clinical trials, and 108 more identified by Janssen during follow-up to notifications about adverse effects.

'Vaxzevria', the British option

Furthermore, the EMA committee has announced that it has asked AstraZeneca for more information and that it continues to review the relationship between the administration of its

Vaxzevria

vaccine

and

Guillain-Barré syndrome

.

The PRAC has already recommended including a warning in the information that accompanies the vaccine about this possible association.

Guillain-Barré is a rare immune system disorder that causes inflammation of the nerves and can lead to pain, numbness, muscle weakness, and difficulty walking.

The EMA advises those vaccinated with AstraZeneca to

seek immediate medical attention

if they develop weakness and paralysis in the extremities that can progress to the chest and face.

Another of the latest risks that have been associated with covid-19 vaccines are

menstrual cycle disorders

.

The experts of the European agency consider that at the moment, a cause-effect relationship cannot be established, but they point out that they have asked the laboratories of the four vaccines authorized in the European Union (Pfizer, Moderna, AstraZeneca and Janssen) to contribute more information in this regard.

According to the criteria of The Trust Project

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