There is no evidence that the AstraZeneca vaccine caused blood clots to form

James Gathany / Centers for Disease Control and Prevention’s Public Health Image Library (PHIL) via Wikimedia Commons

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The National Medicines Agency reports that there is no evidence to conclude that the AstraZeneca vaccine caused blood clots in people who received this serum. Representatives of the institution also say that these conditions are not currently included in the list of side effects of this vaccine.

The Romanian National Agency for Medicines and Medical Devices presents information taken from the European Medicines Agency regarding the vaccine developed by AstraZeneca:

The Pharmacovigilance Risk Assessment Committee (PRAC) assesses cases of thromboembolic events.

The benefits of the vaccine continue to outweigh the risks.

The European Medicines Agency has been informed that the Danish Health Authority has discontinued the vaccination campaign with COVID-19 AstraZeneca in Denmark. This decision was taken as a precautionary measure, while a full assessment is being carried out on cases of blood clots in people who have been vaccinated with this vaccine, including a case of death in Denmark. Several other Member States have also stopped vaccinating with this vaccine.

Currently, there is no evidence that vaccination caused these conditions, which are not included as side effects of this vaccine. The position of the EMA PRAC Safety Committee is that the benefits of the vaccine continue to outweigh the risks and that the vaccine may continue to be administered during the assessment of cases of thromboembolic events. The EMA PRAC Committee is already assessing all cases of thromboembolic events and other blood clot-related conditions reported following vaccination with COVID-19 AstraZeneca.

The number of thromboembolic events in vaccinated persons is not higher than that observed in the general population. As of March 10, 2021, 30 cases1 of thromboembolic events have been reported among the 5 million people vaccinated with the COVID-19 AstraZeneca vaccine in the European Economic Area.

The European Medicines Agency will continue to provide information as the evaluation progresses.

The evaluation of thromboembolic events associated with the COVID-19 AstraZeneca vaccine is taking place in the context of a safety signal, at an accelerated pace. A safety signal is a set of information about a new or incompletely documented adverse reaction, possibly caused by a drug and requiring further evaluation.

The assessment is carried out by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency, which is responsible for assessing the safety concerns of medicinal products for human use. Once the evaluation is completed, the PRAC will issue the necessary recommendations to minimize the risks associated with the vaccine and to protect the health of patients.

The COVID-19 AstraZeneca vaccine is a vaccine indicated for the active immunization of people aged 18 years and over for the prevention of COVID-19 caused by the SARS-CoV-2 virus. The COVID-19 AstraZeneca vaccine is composed of another virus (from the adenovirus family), which has been modified to contain the SARS-CoV-2 protein gene.