The Food and Drug Administration and Centers for Disease Control and Prevention recommend a “pause” when administering Johnson & Johnson’s single dose COVID-19 vaccine to evaluate cases of blood clots.
The agencies said in a statement Tuesday that the CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to review six cases of “a rare and serious type of blood clot” in people who have received the vaccine. The FDA will then review that analysis while also examining the cases.
“Until that process is complete, we recommend a break from the use of this vaccine out of an abundance of caution,” Dr. Anne Schuchat, the CDC’s chief deputy director, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.
Monday, more than 6.8 million single-dose doses of the vaccine had been administered nationwide.
Officials in multiple states said early Tuesday that they are in the process of determining how the decision affects current vaccine supply and distribution plans.
The cases investigated by the FDA and CDC occurred in women and involved a blood clot called cerebral sinus venous thrombosis, which, according to their statement, was seen alongside low platelets. Symptoms were seen 6 to 13 days after vaccination in women aged between 18 and 48 years.
“The treatment for this particular type of blood clot is different from the treatment that is usually administered. Usually an anti-coagulant called heparin is used to treat blood clots. In this setting, the administration of heparin can be dangerous and alternative treatments should be given,” said they.
Authorities said the “adverse events” seem extremely rare, but the pause is important so that healthcare providers can be notified of the reactions and properly recognize and manage the cases, given the unique treatment required.
Ed O’Keefe contributed to reporting.