The European Medicines Agency’s safety committee has also been looking at how AstraZeneca’s COVID-19 vaccine is associated with very rare cases of unusual blood clots and said it was now reviewing reports of capillary leak syndrome in people given AstraZeneca’s vaccine.
Johnson & Johnson (J&J) said it was aware of the rare reports of blood clots in individuals given its COVID-19 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.
Of the four serious cases of clotting and low platelets, three occurred in the United States during the rollout of J&J’s vaccine from its Janssen unit, the European Medicines Agency (EMA) said.
That was in addition to one person who died from a clotting disorder reported in J&J’s clinical trial.
The US Food and Drug Administration said it was aware of a few reports of individuals who had serious blood clots — sometimes linked with low levels of blood platelets — after they received the J&J vaccine, and noted that these conditions could have many different causes.
“We have not found a causal relationship with vaccination and we are continuing our investigation and assessment of these cases. Our analysis of the data will inform the potential need for regulatory action,” the agency said.