AstraZeneca vaccine ‘safe and effective’, says European Union

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The European Medicines Agency has ruled that the AstraZeneca coronavirus vaccine is safe and effective, despite some concerns over possible side effects.

The announcement Thursday comes after more than a dozen EU nations decided to halt the use of the AstraZeneca shot, which was developed with the University of Oxford, after around 30 cases of blood clots. A few other countries have stopped using individual batches of the vaccine.

The EMA said Thursday that the benefits of the vaccine outweighed the risks.

“This is a safe and effective vaccine,” EMA Executive Director Emer Cooke said Thursday at a press briefing.

“Its benefits in protecting people from Covid-19 with the associated risks of death and hospitalization outweigh the possible risks. The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots …. We still cannot rule out a definitive link between these cases and the vaccine.”

The regulator said it would continue to study possible links between rare blood clots and the vaccine. It will also update its guidance for the vaccine to explain the potential risks.

Austria was the first country to suspend the use of a specific batch of AstraZeneca shots last week, following the death of a 49-year-old woman who had received the vaccine.

This was followed by reports of blood clots elsewhere, although in a very small number of individuals, which led other heads to state to pause its use and wait for a new assessment from the region’s health authority.

The EMA said in its review that the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets, including rare cases of clots in the vessels draining blood from the brain, known as CVST.

“These are rare cases — around 20 million people in the U.K. and EEA (European Economic Area) had received the vaccine as of March 16 and EMA had reviewed only 7 cases of blood clots in multiple blood vessels and 18 cases of CVST. A causal link with the vaccine is not proven, but is possible and deserves further analysis,” the EMA added in a statement.

AstraZeneca’s vaccine is being widely used in the U.K., but has not yet been approved by authorities in the United States.

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