In a joint statement released on Tuesday, April 13, the CDC and FDA recommended the United States “pause” the use of Johnson & Johnson’s COVID-19 vaccine. The statement was made in response to six confirmed cases of rare blood clots in the two weeks following the single-dose vaccine.
As of April 12, close to 7 million doses of the J&J vaccine have been administered in the United States, with millions more ordered and awaiting further use. The six reported cases of blood clots, a type of clot known as cerebral venous sinus thrombosis (CVST), were all seen in combination with low levels of blood platelets (thrombocytopenia) and were observed between 6 to 13 days following vaccination.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” said Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, in a joint statement. “Right now, these adverse events appear to be extremely rare.”
All six cases of CVST occurred in women between the ages of 18-48, one of which died as a result, and another in Nebraska who is currently in critical condition. These types of clots are extremely rare, according to the statement, and further research is needed to establish a definitive link between the two.
The CDC will meet with the Advisory Committee on Immunization Practices (ACIP) on Wednesday to discuss the six cases and review further information on the J&J vaccine and its potential link to CVST. In the meantime, the FDA will conduct investigations into the vaccine, and until results are clear, both are recommending a halt on all J&J vaccinations.
“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.”
Following the release of the joint statement, White House COVID-19 Response Coordinator Jeff Zients issued a statement in which he stated, “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.”
Johnson and Johnson have stated in response, “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,” and added, “We have made the decision to proactively delay the rollout of our vaccine in Europe.”
The complications with the J&J vaccine closely mimic the concerns raised over the Oxford-AstraZeneca vaccine, which has been administered in large capacities in both the U.K. and Europe, with health officials stating the benefits outweigh the risks.
Per the CDC’s guidelines, anyone who has received the J&J vaccine and who develops a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of vaccination should contact their health care provider.
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