The LCO Community Health Center issued a statement on Tuesday, April 13, regarding the temporary pause the U.S. Food and Drug Administration (FDA) put on the Johnson & Johnson Covid vaccine. Last month the Health Center received 100 doses of this vaccine and to date, they have administered 25 doses on community members with little to no adverse reactions, according to Dr. Steve Miszkiewicz of the clinic.
"The utmost cautions are being taken and the severe reactions and causality have not been established as of yet," Dr. Miszkiewicz stated.
The following is the statement from the clinic:
As of Monday April 12th, LCO Community Health Center made the proactive decision to temporarily put a hold on administering the Johnson & Johnson (Janssen) Covid vaccine due to reports of adverse effects. Subsequently the FDA today also has urged providers to halt giving this version of the Covid vaccine. Below is a synopsis of known data and a review of the cases and symptoms any questions for those that have already been given the vaccine please understand that this is rare, and not fully understood. Should you have questions please contact the clinic and we will be happy to provide you with updated information.
As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
Cerebral venous sinus thrombosis (CVST) is the presence of a blood clot in the dural venous sinuses, which drain blood from the brain. Symptoms may include headache, abnormal vision, any of the symptoms of stroke such as weakness of the face and limbs on one side of the body, and seizures.
Nine in ten people with sinus thrombosis have a headache; this tends to worsen over the period of several days, but may also develop suddenly (thunderclap headache). The headache may be the only symptom of cerebral venous sinus thrombosis. Many patients have symptoms of stroke: inability to move one or more limbs, weakness on one side of the face or difficulty speaking. This does not necessarily affect one side of the body as in the more common "arterial" stroke.
40% of people have seizures, although it is more common in women who develop sinus thrombosis peripartum (in the period before and after giving birth). These are mostly seizures affecting only one part of the body and unilateral (occurring on one side), but occasionally the seizures are generalized and rarely they lead to status epilepticus (persistent or recurrent seizure activity for a long period of time).