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April 13, 2021
Christa Hyson, MPH
Asst. Director, Emergency Response
Public Information Officer
FDA and CDC Recommend Pause for Johnson & Johnson Vaccine
Out of an abundance of caution, the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) recommended a temporary pause in the use of the Johnson and Johnson (Janssen) vaccine following an extremely rare blood-clotting event in six people. Vaccination safety is a top priority, and all reports of adverse events are taken seriously.
As of April 12, more than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S. The CDC and FDA are reviewing data involving a rare and severe type of blood clot, CVST (cerebral venous sinus thrombosis) in combination with low levels of platelets in blood (thrombocytopenia), reported in six people after receiving the Johnson & Johnson vaccine. All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination.
Individuals who received the Johnson & Johnson vaccine that are experiencing severe headache, chest pain, abdominal pain, lower extremity pain, shortness of breath or unexplained bruising or bleeding within three weeks of vaccination, should reach out to their healthcare provider.
“The CDC and FDA are acting in a very cautious manner,” said Tom Lamarre, MD, Medical Director for Infectious Diseases at The Christ Hospital Health Network. “These actions underscore the overall commitment to vaccine safety. The complications being reported are very, very rare. We will be closely monitoring the federal review process and use that information to help guide our efforts in the days ahead.”
The CDC will convene a meeting of its Advisory Committee on Immunization Practices (ACIP) tomorrow, April 14th, to further review these cases and assess their potential significance. Meanwhile, Governors of Ohio, Kentucky and Indiana are advising all vaccine providers to temporarily pause using the Johnson and Johnson vaccine.
This rare blood-clotting event has not been reported with Pfizer or Moderna’s vaccines.
COVID-19 vaccine supply in Greater Cincinnati has become more abundant over time. This temporary pause will not adversely impact overall vaccination goals.
For more information on COVID-19 Vaccines please visit: http://testandprotectcincy.com/.