UPDATED: EMA investigating 4 'serious cases' of blood clots following J&J vaccinations
The European Medicines Agency’s safety committee said last Friday that it has initiated a review of 4 “serious cases of unusual blood clots with low blood platelets,” including one death, reported after people received the J&J vaccine in the US.
The agency offered an update on Wednesday that it is expediting this evaluation and currently expects to issue a recommendation next week. “While its review is ongoing, EMA remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects,” the agency said in a statement. J&J announced on Tuesday that it would pause the distribution of its vaccine across Europe until the investigations are complete.
The EMA said the cases point to a “safety signal” but it’s unclear if there is a causal association between the J&J vaccine and these conditions. One of the cases occurred in a clinical trial.
The J&J vaccine, which is given as a single shot and is currently on pause in the US while a separate investigation into 6 of the rare blood clots, has not been used in Europe yet, although the European Commission authorized its use on March 11.
The EMA’s and FDA’s review of the J&J vaccine follows a review of the AstraZeneca Covid-19 vaccine that concluded earlier last week, with the EMA recommending that the very rare but sometimes fatal blood clots should be listed as a side effect for the vaccine.
The EMA’s safety committee said the change to the vaccine label is part of an in-depth review of 62 cases of cerebral venous sinus thrombosis (CVST) and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database as of March 22. Eighteen of the cases were fatal.
The committee also said last Friday that it’s reviewing another safety signal that hasn’t been confirmed as causally linked to the AstraZeneca vaccine. This one is to assess 5 reports of capillary leak syndrome in people who were vaccinated with the AstraZeneca vaccine. Separately, the agency also said Wednesday that it’s investigating whether to update recommendations for a second dose of the AstraZeneca vaccine in those who have already received the first dose.