U.S. health officials are recommending a pause in the use of the Johnson & Johnson COVID-19 vaccine as they investigate six cases of rare and severe blood clots.
In a joint statement released Tuesday morning, the Food and Drug Administration and the Centers for Disease Control and Prevention said the recommendation was made “out of an abundance of caution.”
The New York Times first reported on Tuesday that the six people who became sick are women between 18 and 48 years old. The Times reports one of the them died and another is in the hospital in critical condition.
U.S. health officials stress that “these adverse events appear to be extremely rare.” These six cases are out of 6.8 million doses that have been administered in the United States as of Monday.
KYW Medical Editor Dr. Brian McDonough said regulators are doing the right thing and should be as transparent as possible.
“It’s essential to keep building trust with the vaccines. What you don’t want to do is give even the perception that you’re hiding something or not looking at something totally and thoroughly,” McDonough said.
U.S. federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers are expected to follow.
CDC's Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the FDA has also launched an investigation of the cases.
"Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution," Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research said in a joint statement.