EMA publishes report on AstraZeneca coronavirus (COVID-19) vaccine

EMA publishes report on AstraZeneca coronavirus (COVID-19) vaccine

The European Medicines Agency (EMA) has published a report contextualising the risks and benefits of the AstraZeneca coronavirus (COVID-19) vaccine. The agency maintained that the benefits of the vaccine outweigh the risks in all age groups, while there exists a small risk of blood clots with low blood platelets following vaccination. The EMA human medicines committee has undertaken further analysis of available data to contextualise the risk of blood clots by age group and has also considered the effect of the second dose.

The EMA has determined that the blood clot side effect has an occurrence of one in 100,000 people following administering of the vaccine. To ascertain the risk to benefit analysis of the vaccine by age group, the EMA considered prevention of hospitalisations, intensive care unit admissions, deaths and side effects. It has determined the vaccine is increasingly beneficial as the age of the patient increases.

The agency has said that there was insufficient data to determine if the benefit of the vaccine is different based on the sex of the patient. Furthermore, the EMA recommended continuing the roll out of the second dose, and that it had insufficient data to determine if a second dose had any correlation with an increase in the likelihood of developing blood clots.

The EMA has said that the source of the data used in these studies is the European Centre for Disease Prevention and Control and EU Member States, to determine the risk of side effects, the agency used data from the European database for side effects.

The European Medicines Agency stressed that there is a degree of uncertainty in its analysis, and that estimates of benefits and risks will be updated as new data becomes available.

 

Source: AstraZeneca’s COVID-19 vaccine: benefits and risks in context

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