The European medicines regulator has found a “possible link” between Johnson & Johnson’s Covid-19 vaccine and very rare blood clots.
The Johnson & Johnson vaccine is yet to be approved for use in the UK.
The European Medicines Agency said in a statement on Tuesday its safety committee had concluded a warning should be added to the vaccine’s product information.
The safety committee of the European Medicines Agency concluded that unusual blood clots with low blood platelets should be listed as a “very rare” side effect of the vaccine.
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But the EMA concluded the overall benefits of the Janssen vaccine “outweigh the risks of side effects”.
A statement read: “Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination.
“Covid-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of [the vaccine] in preventing Covid-19 outweigh the risks of side-effects."
Johnson & Johnson’s chief financial officer, said before the EMA’s announcement the company was “very confident”.
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Officials reviewed eight cases reported in the United States, where more than seven million people have received the jab.
They said these cases were “were very similar to the cases that occurred with the Covid-19 vaccine developed by AstraZeneca”.
The UK has 30 million doses of the vaccine on order, but it has not yet been signed off for use by the Medicines and Healthcare products Regulatory Agency (MHRA).
The doses are expected to arrive in the second half of 2021 if approved by the regulator.
The Department of Health and Social Care (DHSC) has previously insisted Johnson & Johnson’s decision to delay the rollout of its vaccine in Europe would not derail the UK’s programme to offer a jab to all adults by the end of July.
Regulators in the UK said that they will examine “any safety reports” during their considerations on whether or not to approve the jab.
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