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 beneficial a pause in using the vaccine, pending additional investigation.
Right here, what you could know:
Why was the pause instructed?
After reviewing knowledge, 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 came upon of greater than 6.8 million doses given. The FDA and CDC initiated the pause ”out of an abundance of warning.”
What else is understood?
In accordance with a joint assertion issued by the CDC and FDA, all six circumstances have been in girls between ages 18-48. Signs occurred 6-13 days after vaccination. The kind of clot is understood medically as a cerebral venous sinus thrombosis (CVST) and was seen together with low ranges of blood platelets. Go right here to study extra about these types of blood clots.
Of the six circumstances, one girl died; one other was in crucial situation.
Therapy of this sort of clot is totally different from that for different sorts, the CDC and FDA say. Usually, an anticoagulant drug, heparin, is used. However for this sort of clot, different therapy could also be wanted.
Why does it occur?
“We do not have a definitive reply at the moment, however it 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 girls greater than males?
That’s not but identified, says William Schaffner, MD, professor of preventive medication and infectious illness specialist at Vanderbilt College Medical Middle in Nashville. “This has been true for the AstraZeneca [vaccine] as effectively and their blood clot points,” he says. Whether it is an immune-related subject, girls do are likely to have extra of these points than males, usually, he says.
What ought to individuals who bought the J&J vaccine know and do?
Needless to say the studies of blood clots have been uncommon, Schaffner suggests. The possibilities are about 1 in 1,000,000, based mostly on the six studies out of 6.8 million doses given. “That is really a testomony to the sensitivity of our vaccine security system,” he says, that these few studies could be detected out of thousands and thousands of doses.
Individuals who have gotten the vaccine ought to be vigilant of signs, the FDA and CDC say. If you happen to acquired 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 be not but identified. The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on Wednesday to additional evaluation the circumstances and ”assess their potential significance.” FDA can be reviewing the info additional.