FDA, CDC call for pause in use of Johnson & Johnson vaccine after six reported cases of rare blood clots

The CDC will hold a meeting Wednesday of its Advisory Committee on Immunization Practices to review the cases and assess their potential significance, the statement said. The FDA will continue to investigate the cases.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” the statement said. “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.”

Creating a new vaccine can involve thousands of people over several years. Here’s what it takes to produce a new FDA-approved vaccine. (John Farrell/The Washington Post)

The type of clot, called cerebral venous sinus thrombosis, was seen in combination with low levels of blood platelets, the agencies said. Treatment is different from what might typically be administered; while usually an anticoagulant called heparin is used to treat blood clots, it is dangerous to give heparin in this situation. Alternative treatments need to be given, they said.

The officials said the clots “appear to be extremely rare.” They said people who have received the Johnson & Johnson vaccine who develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their doctor.

The rare blood clots, paired with low levels of platelets, were first detected in people in Europe who had received the vaccine developed by AstraZeneca and the University of Oxford. European regulators said it was “plausible” that the clots were linked to that vaccination and have also been reviewing four similar clotting cases after vaccination with the Johnson & Johnson vaccine, which uses a similar technology.

In a statement, Johnson & Johnson spokesman Jake Sargent said the company shares all adverse event reports about individuals who receive the vaccine with health authorities.

“At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine,” Sargent said. “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.”

One of the cases happened in a Nebraska woman in her late 40s, who experienced a blood clot two weeks after receiving the Johnson & Johnson vaccine and received treatment at the Nebraska Medical Center in Omaha, according to state and federal health officials. The woman remains hospitalized, state officials said Monday.

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