Johnson & Johnson said it will “proactively delay” the rollout of its Covid-19 vaccine in Europe after US regulators announced an investigation into the risk of blood clots among people who receive the jab.
In a statement released by the company on Tuesday, Johnson & Johnson said it will pause the rollout of the vaccine in Europe “out of an abundance of caution” after the US Centers for Disease Control (CDC) and Food and Drug Administration (FDA) announced an investigation into the risk of blood clots as a potential side effect.
While cases of blood clots reported among its recipients in the US have been very rare – with only six cases detected after more than 6.8 million were given a dose of the vaccine – the FDA recommended that its use be paused while the side effects are investigated.
The decision to “proactively delay the rollout” of the vaccine in Europe also comes before a decision from the European Medicines Authority (EMA) and despite the Dutch regulator (CBG) declaring that the positive benefits outweigh any potential risks.
“We are monitoring the situation very closely. For now, the benefits of the vaccine outweigh the possible risks,” the CBG said on Tuesday.
It is not clear how long the delay of the vaccine’s use will be, with neither the CDC, FDA, or Johnson & Johnson providing a timescale for establishing how safe the vaccine is.
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Concerns about the Johnson & Johnson vaccine come as regulators assess similar worries about the effects of the AstraZeneca Covid jab. A number of countries have altered their rollout of the AstraZeneca vaccine following a small number of reports of blood clots in people who have had a dose, with the EMA identifying a possible link and declaring the manufacturer should list the issue as a very rare side effect.
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