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CDC Principal Deputy Director Dr. Anne Sccuchat and FDC Director for Biologics Evaluation and Research Peter Marks released a statement calling for the Johnson & Johnson (Janssen) vaccine administration to be paused as of April 13, 2021.
They made this determination out of an abundance of caution after six cases of a rare and severe type of blood clot were reported.
“In these cases, a type of clot is called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).
Those affected with these rare clots were women between 18 to 48; symptoms occurred 6 to 13 days after they were vaccinated.
The CDC is planning to call a meeting for the Advisory Committee on Immunization Practices (ACIP) on Wednesday, April 14. The committee will further review the cases and determine their potential significance. The FDA will review the CDC’s analysis while it also investigates these cases.
At this time, these six adverse reports appear to be extremely rare. As of April 12, over 6.8 million doses of the Johnson & Johnson vaccine have been administered in the United States.
COVID-19 vaccine safety is a top priority for the CDC and FDA, and all reports of adverse reactions are carefully reviewed.
Those who have received the Johnson & Johnson Janssen vaccine who develop a severe headache, leg or abdominal pain, or experience shortness of breath within three weeks after inoculation should contact a trusted health care provider.
The CDC and FDA ask health care providers to file a report on the HHS website: Vaccine Adverse Event Reporting System.¹.
Written by Cathy Milne-Ware
CDC: Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
Images by Sgt. Sebastian Rothwyn Courtesy of New York National Guard’s Flickr Page – Creative Commons License