FDA, CDC Recommend Temporary Pause On Johnson & Johnson Vaccine Out Of 'Abundance Of Caution'
Photo Credit: MARK RALSTON

FDA, CDC Recommend Temporary Pause On Johnson & Johnson Vaccine Out Of 'Abundance Of Caution'

The New York Times shared breaking news from federal health agencies early Tuesday morning (Apr. 13) recommending that the United States put a temporary halt on administering the Johnson & Johnson COVID-19 vaccine following reports that six individuals developed a rare disorder involving blood clots within two weeks of vaccination.

CNN reports that a joint statement from Dr. Peter Marks — director of the Food and Drug Administration’s Center for Biologics Evaluation and Research — and Dr. Anne Schuchat — principal deputy director of the Centers for Disease Control and Prevention (CDC) — was released stating, the following:

“[The] CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. [The] FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”

Immediately following the joint statement, ABC News reports that Johnson & Johnson also issued its own statement saying, “The safety and well-being of the people who use our products is our number one priority. We share all adverse event reports about individuals receiving our COVID-19 vaccine, along with our assessment of these reports, with health authorities in compliance with regulatory standards.”

It adds, “We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine. We continue to work closely with experts and regulators to assess the data and support the open communication of this information to healthcare professionals and the public.”

According to The New York Times, close to seven million people in the U.S. have already received the Johnson & Johnson vaccine, and roughly nine million more doses have been shipped out to the states, according to data from the CDC.

News of this temporary pause comes after reports shared that a factory error in Baltimore contaminated close to 15 million doses of Johnson & Johnson’s vaccine.

More details to come as this breaking news story develops.