The Biden administration put a cautionary pause on the use of Johnson & Johnson’s coronavirus vaccine Tuesday after a handful of recipients developed “rare and severe” blood clots.
Only 6 out of the nearly 7 million Americans who received Johnson & Johnson’s vaccine developed the blood clots, and the Centers for Disease Control and Prevention and Food and Drug Administration recommended the pause “out of an abundance of caution” in a joint statement Tuesday morning. (RELATED: Germany Reports More Blood Clot Cases Associated With AstraZeneca Vaccine)
“In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia),” Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research said in the statement. “All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.”
Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.
— U.S. FDA (@US_FDA) April 13, 2021
As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare
— U.S. FDA (@US_FDA) April 13, 2021
The statement added that the CDC will convene an advisory meeting on Wednesday to discuss the six cases and offer a determination regarding future use of the Johnson & Johnson vaccine. (RELATED: China Says Its COVID-19 Vaccines Don’t Work Well, Then Backtracks)
The White House issued an additional statement to reporters in which coronavirus coordinator Jeff Zients claimed the pause would not interrupt the administration’s pace of vaccinations, as Johnson & Johnson vaccines make up “less than 5 percent of the recorded shots in arms in the United States to date.”
He added that the government would further surge the distribution of Pfizer and Moderna vaccines to make up for the pause and pledged work with “state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine”
Adm. Brett Giroir — one of the Trump administration’s top officials on the Operation Warp Speed vaccine initiative — also called the decision “an appropriate step.”
“Such clots occur regularly in the population, so this MAY or MAY NOT be related to the vaccine,” he tweeted Tuesday morning. “That is why the investigation and pause is appropriate.”
This is an appropriate step – a pause – while the data can be evaluated. Such clots occur regularly in the population, so this MAY or MAY NOT be related to the vaccine. That is why the investigation and pause is appropriate. https://t.co/Q5YUAVEd7Y
— Brett Giroir (@DrGiroir) April 13, 2021
As they note, this is out of “an abundance of caution.” Risk of a clot is still very low (less than 1 in a million) but like the AZ vaccine which uses a similar platform, they seem to be most common in women under 50. https://t.co/pLPEKOFx1X
— Dr. Tara C. Smith (@aetiology) April 13, 2021
AstraZeneca’s coronavirus vaccine, which has not been granted a U.S. Emergency Use Authorization by the FDA, faced similar blood clotting concerns in recent weeks. The European Union briefly paused that vaccine’s use in March, and the United Kingdom has sought to find alternative vaccines to provide to low-risk individuals.
This is a developing story and will be updated with more information as it becomes available.