J&J vaccine under EU review over after four cases of blood clotting
The European Medicines Agency says there is, as yet, no causal link and J&J is working with regulators to assess the data more thoroughly
Bengaluru/London — Europe’s drug regulator has said it is reviewing reports of rare blood clots in four people who received Johnson & Johnson’s (J&J) Covid-19 vaccine and has expanded its probe into AstraZeneca’s shot to include reports of a bleeding condition.
Of the four serious cases of clotting and low platelets, three occurred in the US during the rollout of J&J’s vaccine from its Janssen unit, the European Medicines Agency (EMA) said on Friday, adding that one person had died and that one case was reported in a clinical trial.
It was the first news of the EMA’s probe of the J&J vaccine, while AstraZeneca’s coronavirus vaccine has been dogged for weeks over possible links to rare blood clots in the brain and abdomen, which the EMA has confirmed.
US-based J&J said that it was aware of the reports of blood clots possibly related to its vaccine and others, and is 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 EMA also said that it is not yet clear if there is a link between the two vaccines and the reported conditions, and that its safety committee will decide if regulatory action, such as label changes, is needed.
Some countries in Europe and Asia have restricted the use of AstraZeneca’s vaccine, Vaxzevria, in younger people following an update by EU and UK regulators this week that found a link between the events and the shot. Regulators have said the benefits of the vaccine outweigh the risks.
J&J’s single-dose vaccine has been approved for EU use, but a rollout is yet to begin. It is mainly being used in the US.
The EMA also said five cases of capillary leak syndrome in people who received AstraZeneca’s vaccine were reported.
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. AstraZeneca did not immediately respond to a request for comment.
The J&J and AstraZeneca shots are two of the four approved Covid-19 vaccinations in Europe.
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