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J&J COVID-19 Vaccinations to Resume in U.S.

Recommendation from the U.S. CDC Advisory Committee followed rigorous evaluation of data relating to very rare adverse event involving blood clots.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Johnson & Johnson’s COVID-19 single-shot vaccination will resume for all adults 18 and older in the U.S., under Emergency Use Authorization (EUA), following a decision from the CDC and FDA.
 
The decision was based on a recommendation from the U.S. CDC Advisory Committee on Immunization Practices (ACIP), which followed a rigorous evaluation of data relating to a very rare adverse event involving blood clots in combination with low platelet counts (thrombosis with thrombocytopenia) observed within approximately one to two weeks following vaccination.
 
“As the global pandemic continues to devastate communities around the world, we believe a single-shot, easily transportable COVID-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere. We will collaborate with health authorities around the world to educate healthcare professionals and the public to ensure this very rare event can be identified early and treated effectively,” said Paul Stoffels, Chief Scientific Officer of Johnson & Johnson.
 
J&J has updated the EUA Fact Sheets for Healthcare Providers and Recipients for the vaccine to include information about the diagnosis and treatment of thrombosis with thrombocytopenia. The revised EUA fact sheets is available at: www.janssencovid19vaccine.com.
 
The health authorities advise that people who have received the COVID-19 vaccine and develop severe headache, chest pain, swelling in the leg, abdominal pain, tiny blood spots under the skin or excessive bruising within two weeks after vaccination should immediately contact their health care provider.

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