The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are recommending a “pause” in the use of the single-dose Johnson & Johnson COVID-19 vaccine out of an “abundance of caution” while a review of reports of rare, potentially dangerous blood clots is conducted.
In a joint statement, the agencies said they are “reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.”
Following the recommended pause in vaccination with the Johnson & Johnson vaccine, Jeffrey Zients, the White House coronavirus coordinator, said, “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.”
In a statement sent to NPR, Johnson & Johnson said it was “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.”
More than 6.8 million doses of the Johnson & Johnson vaccine have already been administered in the U.S., alongside tens of millions of doses of vaccines produced by Pfizer-BioNTech and Moderna. The Johnson & Johnson vaccine received FDA emergency authorization for distribution in February. Similar concerns over rare blood clots have been raised over the Oxford-AstraZeneca vaccine, which has been widely administered in the U.K., European Union and many other countries. Last week, the European Union’s drug regulator said the benefits of the vaccine outweigh its risks.
Governor Janet Mills, Maine Department of Health and Human Services Commissioner Jeanne Lambrew and Maine Center for Disease Control and Prevention Director Dr. Nirav D. Shah issued the following statement in response:
“This morning, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) recommended a pause in the use of the Johnson & Johnson COVID-19 vaccine out of an abundance of caution following reports of six cases of a rare and severe type of blood clot in recipients in the United States. Maine CDC is not aware of any reports of these cases in Maine residents. Given this recommendation, the State of Maine is advising that providers pause administration of the Johnson & Johnson vaccine until the U.S. CDC’s scientific advisory committee has further reviewed the safety data.”