European Medicines Agency begins review to assess blood clots in people who received Johnson and Johnson Covid-19 jab

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April 09 2021 03:32 PM

The European Medicines Agency (EMA) is investigating a potential causal link between four “serious cases of unusual blood clots” with a low platelet count and the Johnson & Johnson coronavirus vaccine.

The first supplies of the one-shot vaccine are due here the week after next.

It is currently only being used in the United States where the cases were reported.

The European medicines' watchdog said that one case occurred in a clinical trial and three cases occurred during the vaccine rollout in the USA. One of them was fatal.

The EMA said “currently not clear whether there is a causal association” between the shot and the adverse event.

The drug company said it was working with experts and regulators to assess the data.

“Our close tracking of side effects has revealed a small number of very rare events following vaccination.

“At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.”

Earlier this week, the EMA said that blood clots in the brain, coupled with low platelet counts and bleeding, should be listed as a very rare side effect of the Oxford/AstraZeneca vaccine.

The National Immunisation Advisory Committee here which advises on vaccines is meeting again today to decide if there should be new guidelines around the jab.

An investigation is underway into a case where a Dublin woman developed a clot in the brain after getting AstraZeneca vaccine.

The woman is is aged around 40 was treated successfully in the Mater Hospital.

The J&J and AstraZeneca vaccines use the same type of technology, using a viral vector to spur the immune system to fend off the virus that causes Covid-19.

The EMA said it has also started examining whether capillary leak syndrome, in which fluid leaks from blood vessels causing a drop in blood pressure and tissue swelling, was causally linked to the AstraZeneca vaccine. It received reports of five such cases.