FDA Lifts 11-Day Pause of the Johnson & Johnson COVID-19 Vaccine – ‘Potential Benefits Outweigh Potential Risks’
By Fox News // April 23, 2021
FDA recommends warning on label risk of blood clots upon receiving the single-dose vaccine
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(FOX NEWS) – Federal health officials lifted an 11-day pause on use of the Johnson & Johnson COVID-19 vaccine on Friday following a review and the recommendation of a panel of experts who determined it met safety standards despite rare instances of severe blood clots.
The Food and Drug Administration and the Centers Disease Control and Prevention lifted the pause shortly after a CDC advisory panel recommended a resumption of its use.
The panel recommended inclusion of language warning the public of a risk of blood clots upon receiving the single-dose vaccine.
“We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older,” Acting FDA Commissioner Janet Woodcock said in a statement. “We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality.”
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