A committee of vaccine advisers to the CDC convened to discuss the risk of a rare blood clotting condition linked to the Johnson & Johnson COVID-19 vaccine.
The CDC’s Advisory Committee on Immunization Practices (ACIP) has voted to recommend resuming the use of the Johnson & Johnson (Janssen) COVID-19 vaccine following a brief safety pause.
The members came to the conclusion in a vote on Friday to recommend the continued use of Janssen COVID-19 vaccine for individuals aged 18 years and older under the FDA’s emergency use authorization. There were 10 votes in favor, 4 opposed, and 1 abstention to the motion.
Rollout of the Johnson & Johnson COVID-19 vaccine was temporarily halted last week after reports of a type of rare, but potentially lethal blood clotting condition called thrombosis with thrombocytopenia syndrome (TTS) in individuals who received the vaccine. A total of 15 post-authorization cases were reported, mostly in women under the age of 50 years, among nearly 8 million doses of the vaccine. Three cases were fatal.
During the meeting, vaccine advisers discussed the risks versus benefits of the Janssen vaccine in light of the recent reports. Despite the severity of TTS cases, the experts reaffirmed that the incidence of TTS following receipt of the vaccine is extremely rare. Based on the current available data, Johnson & Johnson officials at the meeting stated that the reported proportion of TTS associated with the vaccine is approximately 1.9 cases per million individuals.
In her presentation on the vaccine’s benefit-risk assessment, Sara Oliver, MD, MSPH, member of the CDC’s Epidemic Intelligence Service, cited several benefits to the continued use of the Janssen vaccine. In addition to the vaccine’s efficacy, the single-dose shot has simple shipping and storage requirements, making it easier to reach remote locations. Moreover, many jurisdictions report using the vaccine in disproportionately affected populations, such as in individuals experiencing homelessness, homebound populations, and incarcerated individuals.
Many of the advisers expressed the need to include nuanced language in clinical consideration to ensure that health care providers and the public are adequately informed. Johnson & Johnson officials indicated that they are working with the FDA on appropriate labeling.