EU monitor says J&J jab requires warning label

The EU drug regulator said a condition where the immune system mistakenly attacks and destroys blood cells needed for clotting, or immune thrombocytopenia, is an “important identified risk” and health workers and people receiving the vaccine should be informed of this possible side effect.

The European Medicines Agency (EMA) has recommended updating the information label for the coronavirus vaccine made by Johnson & Johnson, saying it should include warnings that a rare immune condition, tinnitus and dizziness are possible side effects.

The EMA’s expert group analysed more than 1,180 cases of people who reported dizziness and tinnitus, or ringing in the ears, after receiving the J&J jab and concluded they were linked to the vaccine’s administration. (AFP)

In a statement, the EU drug regulator said a condition where the immune system mistakenly attacks and destroys blood cells needed for clotting, or immune thrombocytopenia, is an “important identified risk” and health workers and people receiving the vaccine should be informed of this possible side effect.

The EMA’s expert group analysed more than 1,180 cases of people who reported dizziness and tinnitus, or ringing in the ears, after receiving the J&J jab and concluded they were linked to the vaccine’s administration.

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