April 13, 2021 — After receiving studies of a uncommon blood clot in individuals 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 it’s essential know:
Why was the pause recommended?
After reviewing knowledge, the businesses 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 had 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?
Based on a joint assertion issued by the CDC and FDA, all six circumstances had 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 lady died; one other was in essential situation.
Remedy of the sort of clot is completely different from that for different sorts, the CDC and FDA say. Sometimes, an anticoagulant drug, heparin, is used. However for the sort of clot, different therapy could also be wanted.
Why does it occur?
“We do not have a definitive reply right now, nevertheless it seems to contain an immune response associated to the J&J vaccine that adversely impacts the operate of the platelets, which in flip prevents the conventional 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 finally 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’s not but recognized, 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 effectively and their blood clot points,” he says. Whether it is an immune-related problem, ladies do are likely to have extra of these points than males, generally, he says.
What ought to individuals who received the J&J vaccine know and do?
Remember the fact that the studies of blood clots had 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 truly a testomony to the sensitivity of our vaccine security system,” he says, that these few studies can be detected out of tens of millions of doses.
Individuals who have gotten the vaccine needs to be vigilant of signs, the FDA and CDC say. Should you 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 also be not but recognized. The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on Wednesday to additional evaluate the circumstances and ”assess their potential significance.” FDA can also be reviewing the info additional.