CDC, FDA to Resume J&J COVID-19 Vaccination Following Pause Over Rare Clots

By Kelly Young

Edited by André Sofair, MD, MPH

The CDC and the FDA said use of the Johnson & Johnson COVID-19 vaccine should resume in the U.S. The vaccine's label will now carry a warning about elevated, but rare, risk for thrombosis with thrombocytopenia syndrome (TTS).

The move came soon after CDC's Advisory Committee on Immunization Practices voted to lift the recommended pause of the vaccine on Friday. The committee voted 10 to 4 in favor of restarting vaccination, with one abstention.

The FDA and CDC recommended the initial pause on April 13, after six cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia were observed. The adverse events were similar to rare events in countries administering the AstraZeneca COVID-19 vaccine. Both vaccines use an adenovirus system.

Since then, a total of 15 cases of TTS — including CVST, other forms of rare clotting, deep vein thrombosis, pulmonary embolism, ischemic stroke, and myocardial infarction — have been identified in Johnson & Johnson vaccine recipients, all in women. Nearly 10 potential cases are still under review. Among the data presented:

• The rate of additional cases of TTS is estimated to be about 1.9 per million people vaccinated with the Johnson & Johnson vaccine.

• For women aged 18 to 49 years, the estimated TTS rate is higher, at 7.0 per million. Women in their 30s had the highest rate.

• In comparison, vaccinating 1 million adults with the Johnson & Johnson vaccine in the U.S. could be expected to lead to roughly 2100 fewer COVID-19-related deaths and roughly 6000 fewer COVID-19 hospitalizations, according to data from the manufacturer. Data on rates of long-term complications of COVID-19 were not provided.