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Safety agencies issues statement on risks associated with AstraZeneca COVID-19 vaccine

DUBLIN: Safety agencies in Europe and Ireland have reiterated their stance on the continuing threat posed by AstraZeneca related to blood clotting. The Health Products Regulatory Authority (HPRA) has issued a detailed statement in the wake of concerns over blood clots following AstraZeneca vaccination.

The HPRA said it had conducted a scientific review with the European Medicines Agency (EMA) on the major safety issue of “unusual blood clots”. HPRA took part in the scientific review through participation in the EMAs Pharmacovigilance and Risk Assessment Committee (PRAC).

Here is a summary of their evaluations:

Although the combination of blood clots and low blood platelets is rare in those who have received AstraZeneca vaccine, there is a risk of both. The factors that caused this could not be identified. It requires more study and research.

The overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects. There is a causal link between vaccination and blood clotting. Such adverse reactions are very rare but more than normal. The highest incidence was in women under 60 years of age.

Seek immediate medical attention if you experience shortness of breath, chest pain, swelling of the legs, or persistent abdominal pain following vaccination. If serious or recurrent headaches or blurred vision occur after vaccination, or if skin bruising or pinpoint spots develop outside the site of vaccination after a few days, seek medical attention immediately.

The HPRA points out that suspicious side effects associated with the Kovid-19 vaccine should be reported through the COVID-19 Vaccine Adverse Reaction Report.

“As for all vaccines, it is possible to experience side effects, the majority of which are known to be mild to moderate. COVID-19 is a disease itself associated with blood clotting, as well as risk of hospitalisation and death. The overall benefit of vaccination in preventing COVID-19 disease outweighs the risks of known side effects,” according to a statement issued by the HPRA.

“As of 7 April, the HPRA has been notified of approximately 2,800 reports of suspected side effects associated with Vaxcevria®, in the context of 204,270 doses administered. Of these, 18 reports describe blood clots or events possibly associated with blood clots.” it said. It has been observed that platelets in the blood are reduced and blood clots form. These have been reported in people who have received the Vaxcevria® vaccination.

However, no specific risk factors have been identified at this stage. Based on the available evidence, it is not possible to draw conclusions about the factors that cause these side effects to develop in an individual.

The product information of Vaxcevria ® was recently updated to provide advice for healthcare professionals and those who have been vaccinated. The statement added that this safety issue will continue to be thoroughly reviewed with new studies and amendments to ongoing studies.

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