On March 25, 2021 in Los Angeles, California, doses of a shot of Johnson & Johnson’s COVID-19 vaccine are being prepared at a clinic aimed at members of the immigrant community.
Mario Tama | Getty Images
The European drug regulator said it is reviewing reports of rare blood clots in four people who received the Johnson & Johnson Covid-19 vaccine and has expanded its investigation into AstraZeneca’s shot to include reports of a disease bleeding.
Of the four severe cases of clotting and low platelets, three occurred in the United States during the deployment of the J&J 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 from the EMA probe on the J&J vaccine, while AstraZeneca’s coronavirus vaccine has been haunted for weeks by possible links to rare blood clots in the brain and abdomen, which the EMA has confirmed.
J&J, based in the United States, said it was aware of reports of blood clots possibly related to its Covid-19 vaccine and others, and that it is working with regulators to evaluate 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 an emailed statement.
The EMA also said it was still unclear whether there was a link between the two vaccines and the conditions communicated and that its safety committee would decide whether regulatory action was needed, such as label changes.
Some countries in Europe and Asia have restricted the use of AstraZeneca vaccine, Vaxzevria, in younger people following a week-long update from EU and UK regulators that found a link between facts and the shot.
Regulators have said the benefits of the vaccine outweigh the risks.
The J&J single-dose vaccine has been approved for use in the EU, but its launch has not yet begun. It is currently used primarily in the United States.
The EMA also reported that five cases of capillary leak syndrome related to AstraZeneca vaccine were reported.
The condition, in which blood comes out of the smallest vessel into the muscles and body cavities, is characterized 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 four vaccinations approved against Covid-19 in Europe.