FDA, CDC Recommend Pausing Johnson & Johnson Vaccine Due To 'Extremely Rare' Clots

Six recipients in the U.S. out of more than 6.8 million doses developed a rare disorder involving blood clots about two weeks after getting the J&J shot.

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention called for a pause Tuesday in the use of Johnson & Johnson’s coronavirus vaccine “out of an abundance of caution” so they can review an “extremely rare” incidence of blood clots.

Six recipients in the U.S. developed a rare disorder involving blood clots and low blood platelets about two weeks after vaccination. One woman died and another was in critical condition. More than 6.8 million doses of the vaccine have been administered in the U.S., according to the CDC.

In a joint statement, the FDA and CDC said “a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).” All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after they received the shot.

Not all six of the affected women had preexisting conditions, said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, at a press conference Tuesday. He described the adverse reaction as an immune response that occurs “very rarely” after someone is vaccinated.

Health officials said they have not seen the same clotting events and low platelet counts with the two other vaccines in the U.S. from Pfizer-BioNTech and Moderna, which have been distributed at significantly higher rates than the one by J&J. Marks likened the rare incidents involving the J&J vaccine to blood clots reported in Europe involving the COVID-19 vaccine by AstraZeneca and Oxford University, saying both vaccines “are from the same general class of viral vectors.”

The FDA and CDC are recommending the pause, which is not a mandate, so that the CDC can convene an advisory committee on Wednesday and the FDA can investigate the cases. They want to ensure that health care providers can plan for the unique treatment required with this type of blood clot.

They ask that people who develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks of receiving the shot contact their health care provider and inform them of their recent vaccination.

Federal health channels, such as mass vaccination centers, will immediately stop administering the J&J vaccine, a health official told CNN.

Jeff Zients, White House COVID-19 response coordinator, assured that the U.S. has secured enough doses of the Pfizer and Moderna vaccines to continue the nation’s current pace of administering 3 million shots per day.

“We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine,” he said in a statement Tuesday.

The U.S. pause comes shortly after European authorities said they were investigating cases of the unusual blood clots.

“We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine,” J&J said in a statement emailed to HuffPost after the U.S. announcement. “Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.”

“In addition, we have been reviewing these cases with European health authorities,” the statement said. “We have made the decision to proactively delay the rollout of our vaccine in Europe.”

Vaccine hesitancy is an issue both in the U.S. and worldwide. The vaccine developed by AstraZeneca and Oxford University has come against similar issues and has been variously paused or suspended in different age groups in Europe. Britain has recommended that people under 30 be given alternative vaccines to AstraZeneca.

J&J has also faced manufacturing difficulties that have held back its rollout across the U.S. Workers at a giant plant in Baltimore accidentally mixed up the ingredients between the J&J and AstraZeneca vaccines, contaminating up to 15 million doses of the J&J vaccine. While the two use the same mechanism — a harmless version of a virus transmitted into cells to stimulate the immune system into producing antibodies — their ingredients aren’t interchangeable.

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