Monday, May 17, 2021

Of 11 mn AstraZeneca shots in UK thus far, rare blood clots reported in 5 cases

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Britain’s medicines regulator said there had been five cases of a rare type of blood clot in the brain among 11 million given AstraZeneca’s COVID-19 vaccine but said that it found the benefits of the shot far outweighed any possible risks.

Concerns about reports of blood clots, along with low platelet levels, have led to some European countries including Germany to pause the rollout of the shot while the cases are investigated by the European Medicines Agency (EMA), which is set to announce its findings later in the day.

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) said that use of the vaccine should continue while five reports were investigated, and one official said that the rollout would likely continue even if a link was proved.

“There is no evidence that blood clots in veins is occurring more than would be expected in the absence of vaccination, for either vaccine,” said June Raine, MHRA Chief Executive, referring to AstraZeneca and Pfizer shots.

Raine said there had been a very small number of reports of an extremely rare form of blood clot in the cerebral veins (sinus vein thrombosis, or CSVT) occurring together with lowered platelets soon after vaccination.

“Given the extremely rare rate of occurrence of these CSVT events among the 11 million people vaccinated (with AstraZeneca), and as a link to the vaccine is unproven, the benefits of the vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, continue to outweigh the risks of potential side effects,” she said.

One of the reported cases was fatal, MHRA Vaccine Safety Lead Philip Bryan said, adding that the cases were all among men aged between 19 and 59.

NO PAUSE NECESSARY

The MHRA said anyone with a headache that lasts for more than four days after vaccination, or bruising beyond the site of vaccination after a few days, should seek medical attention.

The regulator said there was an ongoing review into “five UK reports of a very rare and specific type of blood clot in the cerebral veins (sinus vein thrombosis) occurring together with lowered platelets (thrombocytopenia)”.

Munir Pirmohamed, Chair of the Commission on Human Medicines, in a statement suggested that even if a link between the clots and the vaccine was established, it likely wouldn’t halt Britain’s rollout.

“If we feel that there’s causal link then we may need to update the product information, but overall, I don’t think that would necessitate pause to any kind of vaccination programme,” he told reporters in a briefing.

The EMA is investigating reports of 30 cases of unusual blood disorders out of 5 million people who got the AstraZeneca vaccine in the EU, and is focusing on blood clots in the head.

Stephen Evans, at London School of Hygiene and Tropical Medicine, said that COVID-19 itself was associated with similar symptoms, making causality hard to establish.

“A major problem is discerning whether there is a possibility that this was caused by COVID-19,” Evans told Reuters.

“Exactly these sort of conditions have been seen in patients with COVID-19 prior to the vaccines being available.”

Related Stories

The crisis over vaccine side effects is just one of many playing out in the effort to inoculate populations.(AP)

Bloomberg

PUBLISHED ON MAR 18, 2021 09:51 PM IST

Several of Europe’s largest countries suspended use of Astra shots this month over reports of blood clotting, going against advice from the EMA and the World Health Organization.

WHO Europe director Hans Kluge during a press conference.(AFP)
WHO Europe director Hans Kluge during a press conference.(AFP)

Reuters, London

PUBLISHED ON MAR 18, 2021 04:12 PM IST

WHO’s European director Hans Kluge said that, at this point in time, the benefits of the AstraZeneca vaccine far outweigh its risks.

AstraZeneca said on Sunday a review of safety data of more than 17 million people vaccinated in the United Kingdom and European Union with its vaccine had shown no evidence of an increased risk of blood clots.(REUTERS)
AstraZeneca said on Sunday a review of safety data of more than 17 million people vaccinated in the United Kingdom and European Union with its vaccine had shown no evidence of an increased risk of blood clots.(REUTERS)

Reuters

PUBLISHED ON MAR 18, 2021 04:02 PM IST

The announcement came a day after the World Health Organization backed the vaccine and as more than a dozen European countries have suspended the use of it amid concerns over the risk of blood clots.

Vials labelled "Astra Zeneca COVID-19 Coronavirus Vaccine" and a syringe are seen in front of a displayed AstraZeneca logo, in this illustration photo taken March 14, 2021. (Reuters)
Vials labelled “Astra Zeneca COVID-19 Coronavirus Vaccine” and a syringe are seen in front of a displayed AstraZeneca logo, in this illustration photo taken March 14, 2021. (Reuters)

AP

PUBLISHED ON MAR 18, 2021 02:51 PM IST

Any time vaccines are rolled out widely, scientists expect some serious health issues and deaths to be reported, simply because tens of millions of people are receiving the shots.

WHO's vaccine experts said Wednesday it was still better to take the AstraZeneca vaccine than not -- adding that it was looking into available data on the jab.(Reuters)
WHO’s vaccine experts said Wednesday it was still better to take the AstraZeneca vaccine than not — adding that it was looking into available data on the jab.(Reuters)

Posted by Prashasti Singh | AFP

PUBLISHED ON MAR 18, 2021 06:15 AM IST

The WHO, Europe’s medicines regulator and AstraZeneca itself have repeatedly said the vaccine was safe after several countries reported feared links with blood clots or brain haemorrhages.

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