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Johnson & Johnson’s single-injection COVID-19 vaccine is linked to cases of low platelet counts, the European Medicines Agency said on Friday.
The regulator’s drug safety committee, the PRAC, said it came to a conclusion after assessing the available evidence in the scientific literature, as well as cases of suspected side effects reported to the drug manufacturer and regulators. European and American. He did not note in his statement the number of cases he observed.
This specific condition, known as immune thrombocytopenia, occurs when the number of blood platelets – which are needed for clotting – decreases because the immune system mistakenly attacks them.
The committee recommended updating the vaccine information to include immune thrombocytopenia as a possible side effect and warning healthcare workers and vaccinees of this risk.
In addition, the committee called for adding dizziness and tinnitus to the list of possible side effects after concluding that some reported cases are also related to the vaccine.
Separately, the PRAC requested additional data from AstraZeneca to assess whether its two-dose adenoviral vaccine is linked to cases of Guillain-Barré syndrome, a rare immune disorder causing nerve inflammation, pain and difficulty walking.
At its last meeting, the committee recommended warning doctors and recipients to be aware of this disease, but requested additional data from the drug manufacturer “to clarify if further updates to the information. on the product and the risk management plan are necessary “.
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