The Food and Drug Administration and the Centers for Disease Control and Prevention called for an immediate pause of the Johnson and Johnson coronavirus vaccine after six recipients developed a rare blood clot disorder within two weeks of the shot, The New York Times reports.
The move underscores high levels of precaution at the federal health agencies. About 6.8 million people have already received the Johnson & Johnson shot.
The six recipients who developed clotting disorders were all women between 18 and 48.
One of the women died and a second woman has been hospitalized in critical condition.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” the FDA and CDC said in a joint statement on Tuesday. “Right now, these adverse events appear to be extremely rare.”
All federal J&J vaccines paused:
All federal vaccination sites will immediately halt the use of the vaccine and state health agencies are expected to follow. New York, Ohio, and Connecticut have already announced they will pause the use of the vaccine.
The pause will allow the FDA and CDC to examine the possible link between the vaccine and the disorder and determine whether the vaccine should continue to be available for all eligible groups or whether its authorization should be limited.
The Johnson & Johnson vaccine was the latest one to get an emergency use authorization but makes up a relatively small number of vaccines available. Most of the vaccines available in the US are from Pfizer and Moderna.
The move, however, could cut up to 30 million vaccinations from the country’s supply.
Jeffrey Zients, the White House Covid-19 response coordination, predicted the pause “will not have a significant impact” on the Biden administration’s goal to open vaccine access to all adults by May 31.
Concerns over vaccine hesitancy:
The news comes after AstraZeneca’s coronavirus vaccine, which has not been authorized in the US, came under scrutiny in Europe over links to blood clots. Medical health experts worry that an abundance of caution is understandable but could worsen vaccine hesitancy.
The FDA and CDC said they are particularly concerned that the “treatment of this specific type of blood clot is different from the treatment that might typically be administered” for blood clots.
Johnson & Johnson said there is “no clear causal relationship has been established between these rare events” and its vaccine.