Johnson & Johnson has delayed the rollout of its COVID-19 vaccine in Europe.
The company says it has made the decision 'proactively' after US authorities recommended pausing the rollout there.
It comes as the first doses of the one-shot vaccine were due to arrive in Ireland this week.
The US CDC and FDA today said they were recommending the pause after six people developed a “rare & severe type of blood clot” after receiving the jab.
They said the “adverse events appear to be extremely rare” - noting that they were recommending the pause "out of an abundance of caution".
In a statement, Johnson & Johnson said: "We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine.
"The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.
"In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe."
They added that they 'strongly support' open communication of the information to healthcare professionals and the public.
The Acting Chief Medical Officer is due to be briefed on the situation with Johnson & Johnson this afternoon.
Dr Ronan Glynn says the European Medicines Agency (EMA) has been closely monitoring the situation.
Ireland is expecting to receive around 605,000 doses of the Johnson & Johnson vaccine over the next three months.