Home » Aifa report on vaccines: eleven cases of thrombosis with four deaths in Italy

Aifa report on vaccines: eleven cases of thrombosis with four deaths in Italy

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Some cases of vaccine-related thrombosis have also been recorded in Italy. This was reported by the latest report on pharmacovigilance by the Italian Medicines Agency (Aifa). As of March 26, among the people who received AstraZeneca, “7 cases (with two deaths) of intracranial venous sinus thrombosis (CSVT) were reported up to March 22, 2021 and 4 cases (with two deaths) of thrombosis more blood vessels in atypical sites, out of the 24 included in the European surveillance network in the same period “.

The AstraZeneca vaccine remains recommended above 60 years of age, where no cases of thrombosis have been observed, “held account of the low risk of adverse reactions of tipo thromboembolic in the face of high mortality from COVID-19 in the most advanced age groups “. The AIFA also confirms that those who received the first dose with the English vaccine can also receive the booster.”n virtue of data available to date, those who have already received a pra dose of the Vaxzevria vaccine, can complement the vaccination cycle with the same vaccine “.

Most of the side effects, however, are recorded as not serious. In 92.7% of the reports it was fever, pain at the injection site, fatigue, muscle aches. The AIFA report covers a period in which just over 9 million doses had been administered. The two RNA vaccines (Pfizer and Moderna) showed more allergies and anaphylactic reactions than AstraZeneca, which uses the viral vector method.

Most of the reports, explains the report, concern Pfizer Comirnaty vaccine (81%), “so far the most used in the vaccination campaign (68% of doses administered), with an increase in reports for the AstraZeneca Vaxzevria vaccine (17 %) following the increase in the use of this vaccine (27% of the doses administered). The reports relating to the Moderna vaccine instead represent 2% of the total and are proportional to the more limited number of doses administered (5%). reported events occur mainly on the same day of vaccination or the day after (87% of cases) “.

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As for the thrombosis cases, they are all related to AstraZeneca. “The investigation at national level of these reports – continues the report – is conducted with the support of a” Working Group for the evaluation of thrombotic risks from anti-COVID-19 vaccines “, made up of some of the leading national thrombosis experts and hemostasis “.

In Europe, according to data dating back to March 22, the Agency for Medicines EMA has examined 62 cases of thrombosis potentially related to vaccines, out of the 222 reported in total and 25 million AstraZeneca vaccines administered. Within this database (partial with respect to all suspected cases) eleven cases came from Italy and 51 from the United Kingdom, the country most used the Vaxzevria vaccine. Two of the Italian deaths were caused by venous thrombosis in the brain associated with a decrease in platelets (the rare form of thrombosis which was hastily given the name Vitt), two others in different locations in the body.

The AIFA in its report reiterates that cases of vaccine-related thrombosis remain extremely rare. As the EMA has clearly documented, the benefits of the anti-Covid shield far outweigh the risks. There are still no clues as to who might be the most predisposed to the problem. “Anchand if most of the cases have occurred in women under the age of 60ni – explains the drug agency – it was not possible to confirm predisposing risk factors related to age and sex, bearing in mind that this vaccine it was mainly administered in people under the age of 60 and predominantly female. It was also not possible identify specific predisposing conditions to these very rare adverse events“.

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The mechanism linking vaccine and thrombosis is unclear. “It is hypothesized – suggests Aifa – un type i phenomenonmmunit similar to that very rarely observed during treatment with heparin (thrombocytopenia induced by heparin or HIT) “.

Apart from cases of thrombosis, Aifa has linked another death to vaccination. This is a 79-year-old man who had received an RNA-based product (it is not specified whether Pfizer or Moderna), already had many heart problems and suffered from a high fever, which worsened his condition until he died three days after the first dose.

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