Johnson & Johnson vaccine paused over rare blood clots
The US, South Africa and European Union will temporarily stop the rollout of the Johnson & Johnson (J&J) COVID jab, after reports of rare blood clotting.
Six cases were detected in more than 6.8 million doses of the vaccine, the US Food and Drug Administration (FDA) said. Johnson & Johnson has paused its EU rollout, which started this week.
The FDA said it was recommending the temporary pause "out of an abundance of caution". It confirmed that one patient died from blood clotting complications, and another is in a critical condition.
All six cases were in women aged between 18 and 48, with symptoms appearing six to 13 days after vaccination.
Following the advice, all federal sites in the US have stopped using the vaccine until further investigations into its safety are completed. State and private contractors are expected to follow suit.
Johnson & Johnson is a US health care company, but the vaccine was developed mainly by a pharmaceutical branch in Belgium, and unlike some of the other jabs, it is given as a single shot and can be stored at normal refrigerator temperatures, making it easier to distribute in hotter climates or more remote areas.
While many countries have pre-ordered millions of doses, it has only been approved in a few nations.
The J&J vaccine has been administered to nearly seven million people in the US, which is around 3% of the total immunisations given so far.
Dr Anthony Fauci, the country's top COVID-19 adviser, said it was too early to comment on whether it could have its authorisation revoked.
In a joint statement, the FDA and the Centers for Disease Control and Prevention (CDC) said they were "reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine".
It said the clotting was called cerebral venous sinus thrombosis (CVST). The statement said that this type of blood clot needed a different treatment than usual.
Johnson & Johnson issued a statement saying that it shared "all adverse event reports" with the health authorities. It added: "We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen (J&J) COVID-19 vaccine."