The European Medicines Agency (EMA) said it had found a "possible link" between the Johnson & Johnson COVID-19 vaccine and cases of blood clots. Nevertheless, it insisted that this product’s benefits outweigh the risks.
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"A careful review of the cases and other available evidence has led us to affirm that these blood clotting disorders are very rare side effects of the vaccine," said Sabine Straus, president of the EMA's safety committee.
On April 13, the European Union (EU) was informed of eight serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome. All the cases occurred in the United States, where over seven million people received the Johnson & Johnson vaccine.
EMA said its safety committee concluded that “a warning about unusual blood clots with low blood platelets should be added to the product information" for the Johnson & Johnson jab.
All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. These blood clots occurred mostly at unusual sites such as in veins in the brain and the abdomen and in arteries, together with low levels of blood platelets and sometimes bleeding.
The cases reviewed were very similar to the cases that occurred with the AstraZeneca vaccine, which EMA had also concluded that its benefits outweigh its risks. There have been almost 300 cases of blood clots worldwide linked with the AstraZeneca vaccine. Johnson & Johnson last week delayed the rollout of its single-shot jab across Europe pending the result of the EMA probe.
So far, the EU has given marketing authorization for four COVID-19 vaccines and three of them have been rolled out widely in the bloc. With a target of inoculating 70 percent of its adult citizens, the EU has administered over 100 million doses.