COVID-19: EU regulator reviewing possible links between Johnson & Johnson jab and blood clots | World News
Europe’s drugs regulator is reviewing possible links between blood clots and Johnson & Johnson’s coronavirus vaccine.
The move comes after four serious cases of rare clots with low platelets were reported after the COVID-19 jab, one of which was fatal, according to the European Medicines Agency (EMA).
The Johnson & Johnson (also known as Janssen) vaccine, which has proved 67% effective in preventing infection and completely effective at preventing hospital admissions and death from the coronavirus during trials, is currently only used in the US, under an emergency use authorisation.
The jab was was authorised in the EU last month but has not started to be rolled out to members states yet, although this is expected in the next few weeks.
The vaccine stands out from the others being used because only one shot is needed, rather than two.
The UK has ordered 30 million doses, but it has not yet been approved by the regulator.
Both the EMA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have investigated links between rare clots and the Oxford-AstraZeneca vaccine, but this is the first formal disclosure that Janssen’s jab is also being looked into.
The EMA statement said: “These reports point to a ‘safety signal’, but it is currently not clear whether there is a causal association between vaccination with COVID-19 vaccine Janssen and these conditions.”
It said it was “investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information”.
US-based Johnson & Johnson said that it was aware of the reports of blood clots being possibly linked to its vaccine, and was working with regulators to assess the data and provide relevant information.
“At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine,” the company said in a statement.
The UK and some other countries in Europe and Asia have restricted the use of AstraZeneca’s vaccine in young people following an update by regulators this week, which found a link between the rare blood clots and the shot.
However, drugs watchdogs have stressed that the benefits of the vaccine outweigh the risks.
Meanwhile, analysis by Public Health England (PHE) showed coronavirus vaccines had prevented 10,400 deaths in people aged 60 and over.
The EMA also said five cases of a condition called capillary leak syndrome had been linked to AstraZeneca’s vaccine.
The condition, in which blood leaks from the smallest of vessels into muscles and body cavities, is characterised by swelling and a drop in blood pressure.
Earlier this week, Professor Anthony Harnden, deputy chairman of the UK’s Joint Committee on Vaccination and Immunisation (JCVI), said the Janssen vaccine was a similar type to the AstraZeneca jab.
He said the blood clots could be related to the vaccine “platform”, and said that if it was “then the same safety signals will arise with the Janssen vaccine”.
However, they were not currently being seen in the Pfizer or Moderna vaccines.
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