EU medicines regulator finds 'possible link' between J&J vaccine and rare blood clots

Authorities say benefits of shot still outweigh risks

The EU medicines regulator has found a possible link between Johnson & Johnson’s vaccine and rare blood clots. Reuters

Europe’s medicines regulator has found a “possible link” between the Covid-19 vaccine developed by Johnson & Johnson and rare blood clots in adults who received the shot in the US.

The European Medicines Agency said on Tuesday its safety committee concluded that a warning about unusual blood clots with low blood platelets should be added to the vaccine’s labels as a “very rare side effect”.

It said all reported blood clot cases occurred in adults aged under 60 – mostly women – within three weeks of vaccination.

All available evidence, including eight reports of cases in the US, were part of its assessment, it said.

The EMA said most blood clots had occurred in the brain and abdomen, but reiterated that the vaccine’s overall benefits outweigh the risks.

Concerns over J&J’s vaccine follow similar reports of blood clots in a minute number of people who received the AstraZeneca shot.

The ruling allows European governments to make their own decisions on whether to restrict use of the vaccine to a certain age or patient groups, as countries such as Germany and France have chosen to do with AstraZeneca.

Last week, J&J halted its European distribution of the vaccine after US officials recommended a pause when six blood clot cases were identified among about seven million people immunised with the shot.

The company advised European governments to store their doses until the EU drug regulator issued advice on their use.

Widespread use of the vaccine has not started yet on the continent, but EU officials had hoped the one-shot vaccine could be used to boost inoculation rates. The vaccine, which uses similar technology to AstraZeneca’s vaccine, does not need to be stored at ultra-low temperatures, unlike the Pfizer-BioNTech vaccine, and can therefore be delivered to remote communities.

The EU ordered 200 million doses of J&J’s Covid-19 vaccine for 2021.

The US medicines regulator is due to make its own ruling on Friday. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, said the watchdog may still allow the use of the shot with some form of restriction or warning.

J&J said earlier on Tuesday it was “very confident” in its vaccine and hopeful for a quick resolution from regulators over its status.