EU safety regulators clear J&J COVID shot despite tiny clot risk

The benefits of Johnson & Johnson’s COVID-19 vaccine outweigh a tiny risk of unusual blood clots forming, Europe’s drugs regulator has said.

In a decision that will allow the rollout of vaccines in certain EU states, the European Medicines Agency’s safety committee said there appears to be a link to unusual blood clots combined with low blood platelets.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) confirmed that the overall benefit-risk balance remains positive, in a decision that is similar to the one it reached regarding AstraZeneca’s rival vaccine earlier this month.

The PRAC was reviewing eight cases of thromboembolism with thrombocytopenia following vaccination in the US, one of which had a fatal outcome.

As of last Tuesday, more than seven million people had received the vaccine developed by J&J’s Janssen unit in the US.

Last week the FDA also advised states to pause use of the J&J vaccine while it reviewed the safety data and is expected to issue advice on Friday.

After the reports of the very-rare side effects emerged over the past weeks, a handful of EU countries have paused the rollout of the first batches of the single-shot jab.

The Netherlands was one of those countries and announced it would begin start using the jab following the ruling from the PRAC.

Belgium has also suspended use and officials are reviewing the advice, according to press reports.

European Commissioner for Health and Food Safety Stella Kyriakides urged member states to follow the advice in a tweet shortly after the PRAC published its findings.

https://twitter.com/SKyriakidesEU/status/1384527131158458370

All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women.

The EMA has not been able to identify risk factors based on the currently available evidence.

Blood clots occurred mostly at unusual sites such as in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.

The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca and Oxford University.