ZAGREB, 13 March 2021 - The head of Croatia's Agency for Medicinal Products and Medical Services (HALMED), Siniša Tomić, said on Saturday that according to preliminary data he did not believe that there was a connection between the death of a 91-year-old woman and her inoculation with AstraZeneca vaccine against COVID.
The HALMED regulator and the Croatian Institute of Public Health (HZJZ) are supposed to adopt their joint conclusion on this matter next week; he told the national broadcaster HTV on Saturday evening.
HALMED is looking into a 7 March report of a fatal pulmonary embolism in the 91-year-old woman three days after receiving a shot of AstraZeneca.
According to Tomić, this case will also be on the agenda of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA).
Tomić said that to date, 14 reports had been submitted in Croatia about side effects with death outcome after inoculations against coronavirus. In nine cases, the reports were sent after the inoculation with the Pfizer vaccine and in five with AstraZeneca.
In six cases, it has been ruled out that the death might be associated with inoculation. In two cases, this relationship does not seem probable, and in another six cases, the authorities are waiting for more supporting documents.
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