Link between single-dose Johnson & Johnson Covid vaccine and rare blood clots 'possible', EU regulators say
REGULATORS in Europe have said that there is a possible link between rare blood clots and the Johnson & Johnson coronavirus vaccine.
The European Medicines Agency (EMA) today concluded that a warning should be added to the product description.
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It comes after rollout of the jab was last week paused in the US.
The rollout of the jab in Europe was also delayed last week and the EU had been due to receive 55 million doses of the jab.
The EMA today concluded that unusual blood clots associated with low levels of blood platelets would be listed as a rare side effect.
Side effects are common with all medications and vaccines including the coronavirus jabs.
Most people won't have any side effects, but people suffering them have mainly reported pain at the site of injection and fatigue.
Over 7 million people in the United States have been given the J&J jab.
Out of seven million, there have been just eight reports from the US of the serious blood clots.
Specific risk factors have not yet been confirmed but all patients were under the age of 60 and all cases were confirmed within three weeks of vaccination.
The majority of those affected were women.
The cases had typically occurred in unusual sites such as the veins in the brain – this is also known as cerebral venous sinus thrombosis (CVST).
They also occurred in the abdomen – also known as splanchnic vein thrombosis and in arteries, with low levels of blood platelets and sometimes bleeding.
Symptoms of a rare blood clot
Experts at the EMA say that you should seek medical help in the three weeks after receiving the J&J vaccine if you experience any of the following symptoms:
- shortness of breath
- chest pain
- leg swelling
- persistent abdominal (belly) pain
- neurological symptoms, such as severe and persistent headaches or blurred vision
- tiny blood spots under the skin beyond the site of the injection
The experts today said that the cases reviewed were of a similar nature to those that occurred in patients having had the Oxford/AstraZeneca vaccine.
The UK has 30 million doses of the J&J jab on order and it uses the same technology as the AstraZeneca jab.
In a statement the EMA said that healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination.
The statement read: "Covid-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of Covid-19 Vaccine Janssen in preventing Covid-19 outweigh the risks of side effects."
Dr Anthony Fauci yesterday confirmed that the US pause on the US-made jab would end next week, but it's not yet clear when the EU will receive the doses it already has on order.
Fauci said that it was possible for the Johnson & Johnson vaccine to return with some restrictions.
"My estimate is that we will continue to use it in some form. I doubt very seriously if they just cancel it.
"I don’t think that’s going to happen," he said on NBC News’s "Meet the Press."
"I do think that there will likely be some sort of warning or restriction or risk assessment. I don’t think it’s just going to go back and say, ‘Okay, everything’s fine. Go right back.’
"I think it’ll likely say, ‘Okay, we’re going to use it, but be careful under these certain circumstances.'
The Department of Health in the UK had previously said that the issued with the J&J jab would not interfere with the rollout for Brits.
So far in the UK over 32.9 million Brits have had a first dose of either the Oxford/AstraZeneca, the Pfizer/BioNTech or the Moderna offering with over 10.1 million having had a second.
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