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BREAKING: FDA Limits Use of Johnson & Johnson COVID-19 Shot Due to Risk of Blood Clots


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The U.S. Food and Drug Administration has limited the authorized use of the experimental Johnson & Johnson COVID-19 shot to individuals 18 years of age and older for whom other authorized or approved ‘vaccines’ are not accessible or clinically appropriate due to the risk of a potentially life-threatening side effect.

What is that side effect?

Thrombosis with thrombocytopenia syndrome (TTS), a blood disorder that results in blood clots.

Per the FDA:

Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

Key Points:

  • After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine.
  • The FDA has determined that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and for individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
  • The Fact Sheet for Healthcare Providers Administering Vaccine  now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS. Additionally, information on the revision to the authorized use of the vaccine and updated information on this risk of blood clots with low levels of blood platelets has been added to the Fact Sheet for Recipients and Caregivers.

But this isn’t the first time we’ve read reports of blood clots associated with the Johnson & Johnson COVID-19 shot from the horse’s mouth.

The CDC’s Advisory Committee on Immunization Practices (ACIP) released this report in April 2021.



 

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