The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) on Tuesday morning recommended a pause on administering Johnson & Johnson’s COVID-19 vaccine in response to six reported cases of blood clotting in the U.S among those who received the vaccine.
The director FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, and CDC Principal Deputy Director Dr. Anne Schuchat released a joint statement stating that their agencies would begin reviewing the cases this week.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” the officials said. “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.”
Marks and Schuchat noted that “[r]ight now, these adverse events appear to be extremely rare.”
More than 6.8 million doses of J&J’s vaccine have been administered in the U.S., according to the officials.
J&J responded with a statement saying that the company is “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.”
“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” J&J said.
A number of states, such as Virginia and Michigan, have already announced a halt on administering the vaccine.