April 13, 2021 — After receiving studies of a uncommon blood clot in folks receiving the Johnson & Johnson COVID-19 vaccine, the FDA and the CDC have really useful a pause in the usage of the vaccine, pending additional investigation.
Right here, what you should know:
Why was the pause prompt?
After reviewing information, the companies discovered six studies of people that skilled uncommon blood clots together with low platelets, that are the smallest blood cells and concerned in clotting. The six studies have been discovered of greater than 6.8 million doses given. The FDA and CDC initiated the pause ”out of an abundance of warning.”
What else is thought?
In keeping with a joint assertion issued by the CDC and FDA, all six circumstances have been in ladies between ages 18-48. Signs occurred 6-13 days after vaccination. The kind of clot is thought medically as a cerebral venous sinus thrombosis (CVST) and was seen together with low ranges of blood platelets. Go right here to be taught extra about these types of blood clots.
Of the six circumstances, one girl died; one other was in vital situation.
Therapy of this sort of clot is totally different from that for different varieties, the CDC and FDA say. Usually, an anticoagulant drug, heparin, is used. However for this sort of clot, various remedy could also be wanted.
Why does it occur?
“We do not have a definitive reply right now, but it surely seems to contain an immune response associated to the J&J vaccine that adversely impacts the perform of the platelets, which in flip prevents the traditional clotting course of from occurring,” says Robert Glatter, MD, emergency physician at Lenox Hill Hospital in New York Metropolis.
He says that the reason “could in the end be associated to the adenovirus vector [used in the vaccine] itself.”
Why does it appear to have an effect on ladies greater than males?
That isn’t but identified, says William Schaffner, MD, professor of preventive drugs and infectious illness specialist at Vanderbilt College Medical Heart in Nashville. “This has been true for the AstraZeneca [vaccine] as nicely and their blood clot points,” he says. Whether it is an immune-related concern, ladies do are inclined to have extra of these points than males, usually, he says.
What ought to individuals who bought the J&J vaccine know and do?
Remember that the studies of blood clots have been uncommon, Schaffner suggests. The probabilities are about 1 in one million, based mostly on the six studies out of 6.8 million doses given. “That is truly a testomony to the sensitivity of our vaccine security system,” he says, that these few studies could be detected out of hundreds of thousands of doses.
Individuals who have gotten the vaccine needs to be vigilant of signs, the FDA and CDC say. In the event you obtained the Johnson & Johnson vaccine and develop extreme headache, abdominal pain, leg ache, or shortness of breath inside 3 weeks of vaccination, contact your their well being care supplier.
How lengthy will the pause final?
That can also be not but identified. The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on Wednesday to additional overview the circumstances and ”assess their potential significance.” FDA can also be reviewing the information additional.