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Johnson & Johnson (Janssen) vaccine pause: Physician leader available for interviews

On Tuesday April 13, 2021 the Food and Drug Administration and the Centers for Disease Control recommended that states pause using Johnson & Johnson’s COVID-19 vaccine while they investigate six cases of a rare but serious blood clot disorder reported in women ages 18-48. As of Monday April 12, 2021 more than 6.8 million doses of this vaccine have been given, the vast majority with no or mild side effects. Yale New Haven Health, in accordance with these recommendations paused administering Johnson and Johnson COVID-19 vaccines.

“The recommendation to pause the Johnson & Johnson vaccine was done out of an abundance of caution,” said Ohm Deshpande, MD, vice president of Population Health who oversees Yale New Haven Health’s vaccine program. “It gives health care providers time to be educated on recognizing and managing this rare condition and allows the FDA to better understand the connection between these adverse events and the Johnson & Johnson vaccine so they can make appropriate recommendations moving forward.”

The type of blood clots reported after vaccine administration are called cerebral venous sinus thrombosis (CVST). In all cases, the clots were seen in combination with low levels of blood platelets, a condition known as thrombocytopenia. This rare combination was seen in the AstraZeneca vaccine which employs a similar vaccine technology as the Johnson & Johnson vaccine and is approved in Europe for people over 50. It is not yet known whether that technology causes the problem.

CVST, which without the low platelet levels occurs in about 2-14 cases per million people annually, cannot be treated with the same blood thinners that are the mainstay for treating most blood clots. Clinicians are being educated to ask about vaccine history when a blood clot is presented or suspected so they can treat it safely and report it.

These types of blood clots have not been seen in the mRNA vaccines made by Moderna and the Pfizer-BioNTech partnership of which over 180 million doses have been administered in the United States.

If people experience severe headache, abdominal pain, shortness of breath, blurred vision, fainting or leg pain or swelling a few days to three weeks after vaccination, they should seek medical care and disclose their vaccine history, according to the CDC and the FDA.

“Vaccines remain one of the most important tools to get the pandemic under control,” said Dr. Deshpande. “The process we are seeing of surveillance and swift action shows our regulatory bodies are prioritizing safety and transparency,” said Dr. Deshpande.

Yale New Haven Health is notifying all patients who need to reschedule their Johnson & Johnson vaccine appointments to one of the mRNA COVID-19 vaccines.