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Sweden halts J&J vaccine rollout till EU regulator critiques US studies of ‘very uncommon’ blood clot circumstances

Sweden gained’t begin vaccinating folks with Johnson & Johnson’s Covid-19 shot till the European Medicines Company (EMA) critiques studies of uncommon blood clots presumably brought on by it within the US, the Swedish Well being Company stated.

On Tuesday, the US Meals and Drug Administration (FDA) advisable that states pause their use of the J&J vaccine after six of its recipients developed a “uncommon and extreme kind of blood clot.” Over 6.8 million doses have been administered.

Johnson & Johnson reacted to the event by delaying supply of its Covid-19 vaccine to the EU. The well being issues have been comparable to people who earlier sparked the suspension of the AstraZeneca vaccine in a number of international locations, and which has seen age limits imposed on its use after UK and EU well being regulators posted up to date critiques of it.

The EMA stated on Wednesday that it was investigating the reported circumstances of “very uncommon” blood clots, whereas working in shut contact with the FDA and different worldwide companies.

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The EU regulator, which greenlighted the usage of the J&J vaccine inside the bloc in March, stated it was expediting its analysis of the reported circumstances and “expects to difficulty a advice subsequent week.”

“Whereas its overview is ongoing, EMA stays of the view that the advantages of the vaccine in stopping Covid-19 outweigh the dangers of unwanted effects,” it added.

The Swedish Well being Company stated it wanted extra knowledge from the European and American investigations earlier than deciding to make use of the US-made vaccine.

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“We are actually seeking to the EMA overview in addition to data from the US earlier than we take into account the suggestions in Sweden,” Anders Tegnell, Sweden’s chief epidemiologist, stated on Wednesday.

“Till then, the advice is to not use the [Johnson & Johnson] vaccine doses,” Tegnell introduced, including that he couldn’t present a forecast on when the ultimate determination will probably be made.

Sweden has already been equipped with the primary batch of 31,000 doses of the J&J vaccine, however hasn’t but administered a single shot of it.

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