FDA and CDC Recommend Pausing Johnson & Johnson COVID-19 Vaccine After Reported Blood Clots

The Centers for Disease Control & Prevention and the Food and Drug AdministrationFederal have recommended pausing the use of Johnson & Johnson’s COVID-19 vaccine, after six reported U.S. cases of a rare and severe type of blood clot in individuals who received it.

On April 13, the CDC and FDA issued a statement regarding the 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,” the announcement said.

According to the organizations, “treatment of this specific type of blood clot is different from the treatment that might typically be administered.” While an anticoagulant drug called heparin is used to treat blood clots, an alternative treatment would need to be provided, since administration of heparin in this case may be dangerous. The statement also said that the CDC would convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review the reported cases, in addition to assessing their potential significance. A pause of administering the vaccine was recommended until this process was completed.

“People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html,” the statement said.

Back in January, WBAL reported that the vaccine would be made just outside Baltimore, MD, at Emergent BioSolutions near Johns Hopkins Bayview Medical Center

The Maryland Department of Health tweeted an advisory as well.

ADVISORY: Based on the federal government’s recommendation and out of an abundance of caution, @MDHealthDept directs all Maryland COVID-19 vaccine providers to pause the administration of Johnson & Johnson vaccines until further federal guidance is issued: https://t.co/jaesglfaHZ

— Maryland Department of Health (@MDHealthDept) April 13, 2021

As of Tuesday, there have been more than 31 million reported cases of COVID-19 in the United States, and 563,000 deaths.