CDC Advisers Recommend Continuing Pause on J&J COVID-19 Vaccine

By Amy Orciari Herman

Edited by Susan Sadoughi, MD

The CDC's Advisory Committee on Immunization Practices (ACIP) decided on Wednesday to continue recommending that vaccine providers pause use of Johnson & Johnson's adenovirus-vectored COVID-19 vaccine. The move comes a day after both the CDC and FDA recommended the pause amid reports of rare but serious venous thrombotic events in vaccine recipients.

The advisers said they needed more time to gather additional data to assess the vaccine's risk-benefit profile. They expressed a desire to meet again within 7 to 10 days.

At the ACIP meeting, the manufacturer described the six reported post-authorization cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia, all in white women under age 50, as well as one case in a 25-year-old white man who received the vaccine in the Johnson & Johnson clinical trial. Patients did not have known coagulation disorders. One of the women died.

Symptom onset ranged from 6 to 13 days after vaccination. Initial presenting features were generally mild, including headache, lethargy, and chills. Later features included severe headache, abdominal pain, limb weakness, and aphasia. Officials noted that over 3.7 million doses of the Johnson & Johnson vaccine were administered during the past 2 weeks, so additional cases of CVST with thrombocytopenia may occur.

CVST with thrombocytopenia has also been reported with the AstraZeneca COVID-19 vaccine — an adenovirus-vectored vaccine authorized in Europe. There have been no cases with either of the mRNA-based vaccines authorized in the U.S. (Pfizer-BioNTech and Moderna).

In the New England Journal of Medicine, a group from the University of Nebraska details one of the reported cases of CVST associated with severe thrombocytopenia and disseminated intravascular coagulation that occurred in a 48-year-old woman who received the Johnson & Johnson vaccine. The patient's symptoms, including abdominal pain and malaise, began roughly 2 weeks after vaccination. She was treated with unfractionated heparin, and her thromboses progressed, with hemorrhagic stroke. Latex-enhanced immunoassay for antibodies against platelet factor 4 (PF4)–heparin was negative, whereas enzyme-linked immunosorbent assay for PF4-polyanion antibodies was "strongly positive." Her treatment was switched to argatroban, as well as intravenous immune globulin, and her platelet count increased by roughly fivefold over 5 days. She was in critical condition at last report.