Federal agencies will call to temporarily suspend the use of Johnson & Johnson coronavirus vaccines, after six recipients of the vaccine developed a blood clotting disorder.
Almost seven million Americans have received the Johnson & Johnson vaccine, which is administered in a single dose. Six recipients, all of them women between ages 18 and 48, developed an extremely rare clotting disorder, known as cerebral venous thrombosis.
The Food and Drug Administration and the Centers for Disease Control and Prevention will temporarily halt distribution of the vaccine at federal vaccination sites while an investigation is conducted into a possible link between the Johnson & Johnson vaccine and the clotting disorder, the New York Times reported.
The agencies will also urge states to temporarily halt distribution of the vaccine and will debate whether to continue FDA emergency authorization.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” the CDC and FDA said in a statement. “This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”
European regulators discovered a similar issue with the AstraZeneca coronavirus vaccine. Out of 34 million people to receive the AstraZeneca vaccine, 222 developed blood clots due to low platelet counts as a rare side effect.
However, in that case regulators said that the AstraZeneca vaccine should continue to be administered because the benefits outweighed the very low risk of side effects.
Johnson & Johnson was dealt a separate blow in late March after a mistake by factory workers in Baltimore ruined 15 million doses. None of those doses were administered to Americans, and current Johnson & Johnson vaccines are shipped to the U.S. from the company’s factories in the Netherlands. The Baltimore plant was set to take over production of the vaccine pending regulatory approval from the FDA.
Most of the vaccines used in the U.S. were produced by Pfizer and Moderna.