April 13, 2021 — After receiving reviews 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 must know:
Why was the pause urged?
After reviewing knowledge, the businesses discovered six reviews of people that skilled uncommon blood clots together with low platelets, that are the smallest blood cells and concerned in clotting. The six reviews 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 understood?
In response to 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 understood 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 crucial situation.
Remedy of this sort of clot is completely different from that for different varieties, the CDC and FDA say. Sometimes, 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 right now, 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 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 “might 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 Middle in Nashville. “This has been true for the AstraZeneca [vaccine] as properly and their blood clot points,” he says. Whether it is an immune-related situation, ladies do are likely to have extra of these points than males, on the whole, he says.
What ought to individuals who obtained the J&J vaccine know and do?
Needless to say the reviews of blood clots had been uncommon, Schaffner suggests. The possibilities are about 1 in 1,000,000, based mostly on the six reviews 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 reviews could be detected out of hundreds of thousands of doses.
Individuals who have gotten the vaccine ought to be vigilant of signs, the FDA and CDC say. For those who 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 evaluate the circumstances and ”assess their potential significance.” FDA can be reviewing the information additional.