Monday, April 12, 2021

Infarmed maintains AstraZeneca and “updates information when necessary”


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Hannibal Hanschke / AFP

After the European Medicines Agency (EMA) assessment of AstraZeneca was known, Infarmed decided to keep the vaccine, “will continue to monitor the situation and update the information when necessary”.

According to ECO, Infarmed decided to continue to administer the AstraZeneca vaccine, which has been suspended in some European countries, and recalled the “importance of notifying the National Pharmacovigilance System of any suspected adverse reaction”.

According to the national authority responsible for medicines and health products, the possibility of the appearance of this type of clots is “very low”.

However, Infarmed recommends that vaccinated people seek “immediate medical assistance” if they detect symptoms such as lack of air, chest pain, swelling in the legs, abdominal pain persistent, neurological symptoms (severe and persistent headaches or blurred vision) or small blood stains under the skin at locations other than the injection site.

The EMA identified this Wednesday a “possible link” between the AstraZeneca vaccine and the “very rare” cases of clot formation associated with a low level of platelets. However, the European agency reiterates that the benefits of vaccination continue to outweigh the risks.

In this evaluation, a “detailed review of 62 cases of thrombosis of the cerebral venous sinuses and 24 cases of splanchnic venous thrombosis, 18 of which were fatal, occurred in the European Economic Area and the United Kingdom, and were notified by the national pharmacovigilance systems based on European database of adverse reactions, until March 22, 2021 ”.

According to the conclusions, these reactions can be explained by “an immune response similar to that occasionally seen in heparin treated patients”.

The reported cases occurred “mainly in women under 60, in the two weeks following vaccination ”, but“ the definition of specific risk factors ”is not yet possible.

The Portuguese Minister of Health, Marta Temido, called an emergency meeting this Wednesday to coordinate the positions of the 27 member states in relation to the administration of the vaccine of AstraZeneca, but there seems to be no consensus among the ministers of Health of the European Union ( HUH).

Several countries, such as Belgium, Italy and Spain, have decided to limit the ages of the people to whom these vaccines will be administered. While Belgium will only administer the vaccine to people over 55, Italy and Spain will give priority to adults over 60.

Portuguese keep confidence

A study by Deco Proteste reveals, according to ECO, that the majority of Portuguese people still want to be vaccinated with the AstraZeneca drug, despite the fact that confidence has been shaken by the reported blood clots.

The survey was carried out in four countries – Portugal, Spain, Italy and Belgium – and concluded that confidence in vaccines against covid-19 is higher in the Portuguese.

According to the study, confidence in the AstraZeneca vaccine decreased to 63% of the Portuguese, but it was not enough to decide not to take the drug. Among the respondents, only 5% are sure that they will not get the vaccine and 10% hesitate. On the contrary, 59% of Portuguese who have not yet taken the first dose of the vaccine would be sure to take it and 26%, despite their doubts, would probably also go.

Of the Portuguese who have already taken the first dose of the vaccine in question, more than half of those who reported negative effects (55%) are willing to take the second dose.

In Spain, only 52% would get the vaccine without hesitation, in Belgium the figure goes up to 47% and in Italy it drops to 45%.

Maria Campos Maria Campos, ZAP //


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