The Latest: Europe agency suggests updating J&J shot label

The Latest: Europe agency suggests updating J&J shot label

SeattlePI.com

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AMSTERDAM — The European Medicines Agency 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.

In a statement on Friday, the EU drug regulator says 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 also analyzed more than 1,180 cases of people who reported dizziness and tinnitus, or ringing in the ears, after receiving the one-shot J&J vaccine and concluded they were linked to the vaccine’s administration.

The agency, which regulates drugs across 27 European countries, says its assessment of the J&J vaccine was unchanged and the benefits of protection from COVID-19 still outweigh the small risk of side effects.

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MORE ON THE PANDEMIC:

— United Airlines will require US employees to be vaccinated

— China pledges 2 billion COVID-19 vaccine doses

— Italy requires ‘Green Pass’ f or museums, indoor dining

— In New York City, impending vaccination rules prompt concern

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— Find more AP coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/hub/coronavirus-vaccine

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HERE’S WHAT ELSE IS HAPPENING:

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