EMA investigation finds AstraZeneca's Covid-19 vaccine to be "safe and effective" 1 month ago

EMA investigation finds AstraZeneca's Covid-19 vaccine to be "safe and effective"

It comes after a number of countries, including Ireland, temporarily suspended use of the vaccine.

The European Medicines Agency (EMA) has said that AstraZeneca's Covid-19 jab is a "safe and effective vaccine" following an investigation by the body's safety committee.

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Last weekend, the National Immunisation Advisory Committee (NIAC) in Ireland recommended that the administration of the AstraZeneca vaccine be temporarily deferred.

This recommendation was made after the Norwegian Medicines Agency reported four serious blood clotting events in adults after receiving the jab from AstraZeneca.

Ireland's Deputy Chief Medical Officer Dr Ronan Glynn issued a statement at the time which read: "It has not been concluded that there is any link between the Covid-19 Vaccine AstraZeneca and these cases.

"However, acting on the precautionary principle, and pending receipt of further information, the NIAC has recommended the temporary deferral of the Covid-19 Vaccine AstraZeneca vaccination programme in Ireland."

Various countries including Denmark, Iceland and the Netherlands also halted their use of the vaccine.

However, the EMA on Thursday issued a statement confirming that:

    • the benefits of the 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 in those who receive it;
    • there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites.
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That said, the body added: "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)."

According to the EMA, around 20 million people in the UK and EEA had received the vaccine as of 16 March and the body had reviewed only seven cases of blood clots in multiple blood vessels and 18 cases of CVST.

They wrote: "A causal link with the vaccine is not proven, but is possible and deserves further analysis."

The EMA concluded that the vaccine’s proven efficacy in preventing hospitalisation and death from Covid-19 outweighs the "extremely small likelihood" of developing clotting problems.

Patients should, however, be aware of the remote possibility of such syndromes, the EMA also noted.

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Steps are already being taken to update the product information for the vaccine to include more information on these risks.

If you present symptoms suggestive of clotting problems after getting a Covid-19 jab, you should seek immediate medical attention and inform healthcare professionals of your recent vaccination.