Tag: Blood Clots

EU Regulator Says AstraZeneca Covid-19 Vaccine ‘Safe and Effective’, Not Linked to Blood Clot Risk

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A nurse prepares to administer a dose of the AstraZeneca COVID-19 vaccine at a health care centre. (Image: AP)

A nurse prepares to administer a dose of the AstraZeneca COVID-19 vaccine at a health care centre. (Image: AP)

EMA chief Emer Cooke said its benefits in protecting people from Covid-19 with the associated risks of death and hospitalisation outweigh the possible risks.

  • AFP Amsterdam
  • Last Updated:March 18, 2021, 23:26 IST
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The EU’s drugs regulator said on Thursday that it had found the AstraZeneca coronavirus vaccine was “safe and effective” and was not linked to an increased risk of blood clots.

Around a dozen countries had suspended the use of the vaccine and were awaiting the outcome of an investigation by the European Medicines Agency (EMA) safety committee.

“The committee has come to a clear scientific conclusion: this is a safe and effective vaccine,” Emer Cooke, the head of the Amsterdam-based EMA, told a press conference.

“Its benefits in protecting people from Covid-19 with the associated risks of death and hospitalisation outweigh the possible risks,” she said.

“The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots.” Cooke added: “If it was me I would be vaccinated tomorrow.” 

The EMA said however that it “could not rule out definitively” a connection to a particularly rare type of clotting disorder and would update the vaccine’s product information.

“During the investigation and review we began to see a small number of cases of rare and unusual but very serious clotting disorder and this then triggered a more focused review,” she said.

“Based on the evidence available, and after days of in depth analysis of lab results, clinical reports, autopsy reports and further information from the clinical trials, we still cannot rule out definitively a link between these cases and the vaccine.”

The new warning in the vaccine information would draw attention to the “possible rare conditions” to help patients and healthcare professionals “stop and mitigate any possible side effects.” The EMA was launching a further probe into the rare cases, she added.

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Amid AstraZeneca Concerns, WHO Official Calls Blood Clots ‘Very Rare’

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A nurse prepares to administer a dose of the AstraZeneca COVID-19 vaccine at a health care centre. (Image: AP)

A nurse prepares to administer a dose of the AstraZeneca COVID-19 vaccine at a health care centre. (Image: AP)

The current benefit-risk assessment from the European Medicines Agency and WHO is for countries to continue giving people AstraZeneca shots, WHO said.

  • PTI
  • Last Updated:March 17, 2021, 22:32 IST
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A top World Health Organisation expert on vaccines says people should feel reassured that even if health authorities turn up a link between blood clots and the AstraZeneca vaccine, such cases are very rare. Dr Kate O’Brien, who heads WHO’s department of immunisations and vaccines, said the UN health agency and the European Medicines Agency are trying to investigate the possibility of a link between blood clots and the AstraZeneca shots. The potential side effect has prompted some countries — mostly in Europe — to temporarily suspend use of the AstraZeneca vaccine. A WHO committee on vaccines is looking into the issue. I think the reassurance to the public is that regardless of whether or not the committee ultimately assesses that there may be an association between these events and the vaccine, that in any event, these are very rare events, O’Brien said during a Wednesday news conference.

The current benefit-risk assessment from the European Medicines Agency and WHO is for countries to continue giving people AstraZeneca shots, she said. Both WHO and EMA are expected to present updated recommendations on Wednesday or Thursday. O’Brien said in general vaccine recommendations are dynamic, and are reviewed over days, months, and years. She noted that blood clots occur regularly in the population.

What we don’t know is whether or not that experience would be related to having been vaccinated, she said. The important point is that if anybody is having symptoms, any serious medical symptoms, regardless of whether you’ve been vaccinated or not vaccinated, it’s important to seek medical care for the presence of those symptoms. The comments came at a news conference detailing how a WHO expert panel on vaccines recommended use of Johnson & Johnson’s one-dose COVID-19 vaccine, which has already been granted an emergency use authorisation from the UN agency. Dr Annelies Wilder-Smith, a technical adviser to the expert panel, noted that studies on the J&J vaccine involving some 42,000 people turned up 10 cases of blood clotting in the placebo group — slightly more than half of all participants — and 14 cases among those who were administered the vaccine. She called that difference not statistically significant.

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