The Food and Drug Administration and Disease Control and Prevention Centers recommend a “break” in the administration of Johnson & Johnson’s single dose COVID-19 vaccine to review blood clots.
The agencies said in a statement on Tuesday that the CDC would convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to investigate six cases of “a rare and serious blood clot” in people who had received the vaccine. The FDA will then review the analysis as it also investigates the cases.
“Until the process is complete, we recommend the use of this vaccine out of sheer caution,” said Dr. Anne Schuchat, chief deputy director of the CDC, and dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.
As of Monday, more than 6.8 million doses of single vaccine had been administered across the country.
Officials in several states said early Tuesday they were scrambling to determine how the decision would affect the current supply and distribution plans for vaccines.
The cases investigated by the FDA and CDC occurred in women and were, according to their statement, a blood clot called cerebral venous sinus thrombosis, which was seen along low levels of platelets. Symptoms were seen 6 to 13 days after vaccination in women between 18 and 48 years of age.
“The treatment of this particular type of blood clot is different from the treatment that can usually be given. Usually, an anticoagulant called heparin is used to treat blood clots. they said.
The agencies said the “adverse events” seem extremely rare, but that the break is important so that healthcare providers can be made aware of the reactions and properly recognize and manage the cases, given the unique treatment required.
Ed O’Keefe reported.