The condition occurs when the number of blood platelets falls because the immune system mistakenly attacks them.
- Johnson & Johnson’s single-shot COVID-19 vaccine is linked to cases of low blood-platelet counts, the European Medicines Agency said on Friday.
The regulator’s drug safety committee, PRAC, said it reached the conclusion after assessing available evidence from scientific literature, as well as cases of suspected side effects reported to the drugmaker and to European and U.S. regulators. It didn’t note in its statement how many cases it had observed.
This specific condition, known as immune thrombocytopenia, occurs when the number of blood platelets — which are needed for clotting — falls 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 health care staff and vaccine recipients 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 linked to the vaccine.
Separately, PRAC has requested further data from AstraZeneca to assess whether its two-dose adenovirus 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 medics and recipients to be aware of this disease, but it has requested further data from the drugmaker “to clarify whether further updates to the product information and the risk management plan are necessary.”
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