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 advisable a pause in using the vaccine, pending additional investigation.
Right here, what it is advisable know:
Why was the pause instructed?
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 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 thought?
In accordance with a joint assertion issued by the CDC and FDA, all six instances have been in girls 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 study extra about these types of blood clots.
Of the six instances, one girl died; one other was in crucial situation.
Remedy of any such clot is totally different from that for different varieties, the CDC and FDA say. Usually, an anticoagulant drug, heparin, is used. However for any such clot, various remedy 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 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 finally 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 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 properly and their blood clot points,” he says. Whether it is an immune-related problem, girls do are likely to have extra of these points than males, typically, he says.
What ought to individuals who acquired 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 really 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. In case 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 be not but recognized. The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on Wednesday to additional evaluate the instances and ”assess their potential significance.” FDA can be reviewing the information additional.