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E.U. Regulator Argues to Continue J&J Vaccine With a Warning Label
The European Union’s drug regulator said that the Johnson and Johnson vaccine should carry a warning of potential risk for rare blood clots on the label, but did not recommend stopping the vaccine, saying the benefits of the vaccine outweighed the risks.
After a careful review of the cases of blood clots combined with low platelets reported after vaccination with Johnson’s Covid-19 vaccine, the PRAC has concluded that there is a possible link between the occurrence of these blood clots, combined with the low levels of blood platelets, thrombocytopenia, and the vaccination with the Covid-19 vaccine, Johnson. The product information will be updated to reflect this information, and will include a warning and an update of the side effects. The reported cases occurred mostly in women under 60 years, and within the first three weeks after the vaccination. A fatal outcome has been reported. The careful review of the cases, and other available evidence, have led the committee to the conclusion that these blood-clotting disorders are very rare side effects of the vaccine. However, our work does not stop here. We will analyze any new data and any new evidence as it becomes available, and provide updated guidance as needed. At this moment, it’s not possible to identify clear risk factors for the occurrence of these very rare events, such as gender or age.
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