On April 13, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) made a joint recommendation that administration of the Johnson & Johnson vaccine be paused. At that point more than 6.8 million Americans had received the single-dose vaccine. The pause was recommended so the two agencies could review the cases of six women who received the vaccine then developed rare and serious blood clots that could not be treated as usual. All six cases were in women ages 18-48, and the blood clots formed 6 to 13 days after receiving the vaccine.
Now, following a thorough data assessment, the FDA and CDC have determined that the blood clot risk is very low, while the Johnson & Johnson vaccine is safe and effective.
Although the agencies lifted the pause on April 23, they remain committed to monitoring the vaccine for safety.