April 13, 2021 – After the FDA and CDC received reports of a rare blood clot in people who received the Johnson & Johnson COVID-19 vaccine, they recommended a pause in their use of the vaccine pending further investigation.
Here what you need to know:
Why was the break suggested?
After reviewing the data, the agencies found six reports from people who had rare blood clots combined with low platelets, which are the smallest blood cells involved in clotting. The six reports were found out of more than 6.8 million administered doses. The FDA and CDC have initiated the break out of caution. “
What else is known?
All six cases were in women between the ages of 18 and 48, according to a joint statement from the CDC and FDA. Symptoms appeared 6-13 days after vaccination. The type of clot is known medically as cerebral venous sinus thrombosis (CVST) and has been observed in combination with low platelet levels. You can learn more about these types of blood clots here.
Of the six cases, one woman died; Another was in critical condition.
Treatment for this type of clot is different from that for other types, say the CDC and the FDA. Typically an anticoagulant, heparin, is used. However, alternative treatment may be needed for this type of clot.
Why is this happening?
“We don’t have a definitive answer right now, but it appears to be an immune response related to the J&J vaccine that is affecting platelet function, which in turn prevents the normal clotting process from occurring,” says Robert Glatter, MD, Emergency doctor at Lenox Hill Hospital in New York City.
He says the explanation “may ultimately be related to the adenovirus vector [used in the vaccine] self.”
Why does it seem to affect women more than men?
That’s not yet known, says Dr. William Schaffner, Professor of Preventive Medicine and Infectious Disease Specialist at Vanderbilt University Medical Center in Nashville. “This applies to AstraZeneca [vaccine] Also and their blood clot problems, “he says. When it comes to an immune problem, women generally tend to have more of these problems than men, he says.
What should people who received the J&J vaccine know and do?
Remember, the reports of blood clots were rare, suggests Schaffner. The odds are about 1 in 1 million based on the six reports of 6.8 million doses administered. “This is actually evidence of the sensitivity of our vaccine safety system,” he says, that those few reports would be recognized out of millions of doses.
People who received the vaccine should watch out for symptoms, say the FDA and CDC. If you have received the Johnson & Johnson vaccine and develop severe headache, stomach pain, leg pain, or shortness of breath within 3 weeks of vaccination, contact your doctor.
How long is the break?
That is also not yet known. The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on Wednesday to further review the cases and assess their potential relevance. The FDA is also reviewing the data further.
WebMD Health News
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CDC: “CDC-FDA Joint Statement on Johnson & Johnson’s COVID-19 Vaccine.”
Johnson & Johnson: “Johnson & Johnson Statement Regarding COVID-19 Vaccine.”
William Schaffner, MD, Professor of Preventive Medicine and Infectious Disease Specialist, Vanderbilt University Medical Center, Nashville.
Robert Glatter, MD, Emergency Physician, Lenox Hill Hospital, New York City.
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