The Food and Drug Administration and the Centers for Disease Control and Prevention recommend a “break” in the administration of the Johnson & Johnson single dose COVID-19 vaccine to review cases of blood clots.
The agencies said in a statement Tuesday that the CDC would convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to look at six cases of “a rare and severe type of blood clot” in people who have received the vaccine. The FDA will then review this analysis as it investigates the cases as well.
“By the end of this process, we recommend a break in the use of this vaccine with plenty of caution,” said Dr. Anne Schuchat, CDC’s deputy principal, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research shows in the statement.
The White House said Tuesday that the break “will not have a significant impact” on the U.S. vaccination plan
As of Monday, more than 6.8 million single-dose vaccine doses had been administered across the country, a small portion of the 190 million COVID vaccines administered nationally – mostly from Pfizer and Moderna.
A handful of cases that the FDA and CDC are investigating have occurred in women and involved a blood clot called cerebral venous sinus thrombosis, which was seen along with low levels of platelets in the blood, according to their statement. Symptoms were observed 6-13 days after vaccination in women aged 18 to 48 years.
“The treatment of this specific type of blood clot is different from the treatment that could usually be given. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this context, the administration of heparin can be dangerous, and alternative treatments must be given, “they said.
The agencies said that “adverse events” seem to be extremely rare, but that the break is important so that healthcare providers can be aware of the reactions and recognize and manage cases correctly, given the unique treatment required.
Following the announcement, a growing list of states and cities has announced that it is suspending the use of the Johnson & Johnson vaccine.
Ed O’Keefe contributed to the reporting.