13th May 2021
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EU Medicines Agency: ‘clear scientific’ evidence that AstraZeneca vaccine safe

Latest: Coronavirus in Spain figures (25 Mar)

The European Medicines Agency (EMA) has concluded that there is ‘clear scientific’ evidence that the AstraZeneca vaccine is ‘safe and effective’ and that its benefits outweigh its risks. It has said that the vaccine is not associated with an increase in thrombosis or blood clots.

Speaking on Thursday afternoon, the Executive Director of EMA, Emer Cooke, said that the vaccine, developed jointly by AstraZeneca and Oxford University was ‘safe and effective’.

On Monday, the Spanish government suspended the use of the AstraZeneca vaccine for ‘at least’ 15 days, following decisions taken by several other EU states to temporarily suspend its use. The decision by Spain came just hours after Germany, France and Italy announced similar moves linked to fears that the vaccine could generate serious side effects such as blood clots.

Up until the AstraZeneca vaccine was suspended, figures showed that 980,126 people in Spain had received a jab of it. The EMA had previously said that it was ‘firmly convinced’ that the benefits of the vaccine outweighed potential risks, insisting there was no evidence linking it to blood clots.

It had decided, however, to look into ‘adverse events’ associated with all vaccines, and has delivered its conclusions on Thursday.

In a statement released by the EMA on Thursday, it said:

  • The benefits of the [AstraZeneca] vaccine in combating the still widespread threat of Covid-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects.
  • The vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it.
  • There is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites.
  • However, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST).

It went on to state that ‘these are rare cases – around 20 million people in the UK and EEA had received the vaccine as of 16 March 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.’

You can read the EMA’s full statement and conclusions by clicking here.

Click here for all reports on Coronavirus in Spain and for specific reports related to Covid-19 Vaccinations.

ALSO READ (15/3/21): Spain halts use of AstraZeneca vaccine for 15 days, following other EU states

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