Johnson & Johnson’s coronavirus vaccine will be made accessible to the public again, ending an eleven-day gap initiated after a rare blood clotting disease was associated with the vaccine.
Centers for Disease Control and Prevention and The Food and Drug Administration determined the benefits of the J&J vaccine overweighed the risks of keeping it off the market. Out of nearly 8 million who got the vaccine, 15 people have developed the disease, and three have died.
The two companies held a joint news conference Friday morning to announce their verdict to resume the distribution of the J&J vaccine.
“Both companies have full confidence that this vaccine’s known and unknown benefits outweigh its known and unknown risks in individuals who are 18 years or more,” said Dr. Janet Woodcock, the FDA’s commissioner.
The J&J vaccine should be prepared almost immediately, “by tomorrow morning even,” said the director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks.
Everyone who gets the shot should receive an information sheet specifying the rare clotting problem and the indications to look out for, officials said. Providers also will be given data about the condition and the appropriate treatment for controlling it.
The rare disease includes a combination of blood clots, many in unusual locations such as the abdomen or brain, and low levels of platelets, which help injuries heal. It has been named thrombosis with thrombocytopenia syndrome or TTS.
The unexpected side effect, seen six to fourteen days after receiving the J&J vaccine, seems to strike women under age 50 usually.
The result has not been seen with the two other vaccines approved for use in the U.S., by Moderna and Pfizer-BioNTech, which have been delivered to about 130 million Americans.