Covid-19: EU declares AstraZeneca vaccine safe and effective for use
Posted by FN Editor | 3 years ago | 1,011 times
AstraZeneca Vaccine
THE European Medicines Agency, EMA, which is the European Union’s most authoritative regulator of medicinal products, has declared that the AstraZeneca vaccine is safe and effective for use.
Making the declaration on Thursday after the meeting of its safety committee, PRAC, concluded its preliminary review of a signal of blood clots in people who received the shot, the EU regulator said it found that the jab was not associated with a higher risk of clots.
Addressing a press conference,Emer Cooke, the agency’s executive director, said: “This is a safe and effective vaccine. Its benefits in protecting people from COVIDovid-19 with the associated risks of death and hospitalisation outweigh the possible risks.” Cooke said the EMA’s expert committee on medicine safety, found that “the vaccine is not associated with an increase in the overall risk of blood clots”.
The EMA’s safety committee said that the benefits of the AstraZeneca jab still outweigh its risks despite possible link to rare blood clots associated with low levels of blood platelets. It said individual EU states could decide whether and when to re-start vaccinations using the AstraZeneca shot.
The committee recommended raising awareness of possible risks, ensuring they are included in the product information. It also advised healthcare providers and the public should be educated about the signs and symptoms to look out for.
Peter Arlett, head of safety monitoring for the EMA, said: “The primary assessment is a vigorous scientific assessment, looking at all the available evidence, to see whether the evidence would suggest a causal link between these very rare but serious events that we’ve seen and vaccination, or whether they are coincidental.”
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