Food and Drug Administration and Centers for Disease Control and Prevention Recommend “Pause” in Single Dose Administration of Johnson & Johnsonvaccine to examine 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 “rare and severe type of blood clot” in people who received the vaccine. The FDA will then review this analysis as it is investigating the cases as well.
“Until this process is complete, we recommend a pause in the use of this vaccine as a precaution,” Dr. Anne Schuchat, CDC senior assistant director, and Dr. Peter Marks, director of the FDA’s Center for Assessment and research on organic products, said in the statement.
The White House said on Tuesday that the hiatus “will not have a significant impact” on the vaccination plan in the United States.
As of Monday, more than 6.8 million doses of the single-dose vaccine had been administered across the country, a small portion of the 190 million COVID vaccines administered nationwide – most from Pfizer and Moderna.
The handful of cases investigated by the FDA and CDC have occurred in women and involved a blood clot called cerebral venous sinus thrombosis, which has been seen alongside low levels of blood platelets, according to their statement. Symptoms were seen 6 to 13 days after vaccination in women aged 18 to 48.
“The treatment for this specific type of blood clot is different from the treatment that might usually be given. Usually a blood thinning 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.
Agencies said “adverse events” appear to be extremely rare, but that the break is important so that healthcare providers can be informed of reactions and properly recognize and manage cases, given the unique treatment required.
After the announcement, a growing list of states and cities announced it was suspending use of the Johnson & Johnson vaccine.
Ed O’Keefe contributed reporting.