CDC and FDA pause Johnson & Johnson vaccine over rare blood clot concerns

(Photo by Luis Alvarez/Getty Images)(Picture by Luis Alvarez/Getty Pictures)

The Facilities for Ailment Control and Avoidance and the Foodstuff and Drug Administration on Tuesday advisable pausing the Johnson & Johnson vaccine owing to issues of quite a few scarce blood clotting circumstances in men and women who have received the vaccine.

The CDC and the Food and drug administration are reviewing data involving 6 reported U.S. circumstances of a scarce and extreme sort of blood clot in men and women. This is out of extra than six.8 million doses of the Johnson & Johnson Janssen vaccine that have been administered in the United States as of Monday.

All 6 circumstances occurred among gals between the ages of eighteen and 48, and signs or symptoms occurred six to 13 days just after vaccination. 

Ideal now, these adverse activities show up to be very scarce, according to Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Analysis and Research. 

CDC said it would convene a assembly of the Advisory Committee on Immunization Procedures on Wednesday to even more overview these circumstances and evaluate their potential significance. Food and drug administration will overview that investigation as it also investigates these circumstances. 

“Right until that method is total, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Schuchat and Marks said by assertion. “This is vital, in component, to guarantee that the health care provider local community is knowledgeable of the potential for these adverse activities and can plan for proper recognition and management owing to the exceptional therapy necessary with this sort of blood clot.

“COVID-19 vaccine protection is a prime priority for the federal govt, and we just take all reviews of overall health difficulties subsequent COVID-19 vaccination extremely seriously,” they said. 

People today who have acquired the J&J vaccine who produce extreme headache, belly discomfort, leg discomfort, or shortness of breath inside three months just after vaccination must get hold of their health care provider. Healthcare vendors are questioned to report adverse activities to the Vaccine Adverse Occasion Reporting System at https://vaers.hhs.gov/reportevent.html,

The blood clot, termed cerebral venous sinus thrombosis, was observed in combination with minimal degrees of blood platelets, or thrombocytopenia. Treatment of this specific sort of blood clot is different from the therapy that could normally be administered.

Normally, an anticoagulant drug termed heparin is made use of to treat blood clots. In this placing, administration of heparin may be dangerous, and option remedies will need to be provided, the CDC and Food and drug administration said.
 
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