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Sweden halts J&J vaccine rollout until EU regulator reviews US reports of ‘very rare’ blood clot cases Sweden halts J&J vaccine rollout until EU regulator reviews US reports of ‘very rare’ blood clot cases
(5 months later)
Sweden won’t start vaccinating people with Johnson & Johnson’s Covid-19 shot until the European Medicines Agency (EMA) reviews reports of rare blood clots possibly caused by it in the US, the Swedish Health Agency said.Sweden won’t start vaccinating people with Johnson & Johnson’s Covid-19 shot until the European Medicines Agency (EMA) reviews reports of rare blood clots possibly caused by it in the US, the Swedish Health Agency said.
On Tuesday, the US Food and Drug Administration (FDA) recommended that states pause their use of the J&J vaccine after six of its recipients developed a “rare and severe type of blood clot.” Over 6.8 million doses have been administered.On Tuesday, the US Food and Drug Administration (FDA) recommended that states pause their use of the J&J vaccine after six of its recipients developed a “rare and severe type of blood clot.” Over 6.8 million doses have been administered.
Johnson & Johnson reacted to the development by delaying delivery of its Covid-19 vaccine to the EU. The health complications were similar to those that earlier sparked the suspension of the AstraZeneca vaccine in several countries, and which has seen age limits imposed on its use after UK and EU health regulators posted updated reviews of it.Johnson & Johnson reacted to the development by delaying delivery of its Covid-19 vaccine to the EU. The health complications were similar to those that earlier sparked the suspension of the AstraZeneca vaccine in several countries, and which has seen age limits imposed on its use after UK and EU health regulators posted updated reviews of it.
The EMA said on Wednesday that it was investigating the reported cases of “very rare” blood clots, while working in close contact with the FDA and other international agencies.The EMA said on Wednesday that it was investigating the reported cases of “very rare” blood clots, while working in close contact with the FDA and other international agencies.
The EU regulator, which greenlighted the use of the J&J vaccine within the bloc in March, said it was expediting its evaluation of the reported cases and “expects to issue a recommendation next week.”The EU regulator, which greenlighted the use of the J&J vaccine within the bloc in March, said it was expediting its evaluation of the reported cases and “expects to issue a recommendation next week.”
“While its review is ongoing, EMA remains of the view that the benefits of the vaccine in preventing Covid-19 outweigh the risks of side effects,” it added.“While its review is ongoing, EMA remains of the view that the benefits of the vaccine in preventing Covid-19 outweigh the risks of side effects,” it added.
The Swedish Health Agency said it needed more data from the European and American investigations before deciding to use the US-made vaccine.The Swedish Health Agency said it needed more data from the European and American investigations before deciding to use the US-made vaccine.
“We are now looking to the EMA review as well as information from the US before we consider the recommendations in Sweden,” Anders Tegnell, Sweden’s chief epidemiologist, said on Wednesday.“We are now looking to the EMA review as well as information from the US before we consider the recommendations in Sweden,” Anders Tegnell, Sweden’s chief epidemiologist, said on Wednesday.
“Until then, the recommendation is to not use the [Johnson & Johnson] vaccine doses,” Tegnell announced, adding that he couldn’t provide a forecast on when the final decision will be made.“Until then, the recommendation is to not use the [Johnson & Johnson] vaccine doses,” Tegnell announced, adding that he couldn’t provide a forecast on when the final decision will be made.
Sweden has already been supplied with the first batch of 31,000 doses of the J&J vaccine, but hasn’t yet administered a single shot of it.Sweden has already been supplied with the first batch of 31,000 doses of the J&J vaccine, but hasn’t yet administered a single shot of it.
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