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Federal officials on Tuesday pulled the brakes on the use of the Johnson & Johnson shot after reports of six patients experiencing blood clots and a “stroke-like illness.”
The Food and Drug Administration and the Centers for Disease Control and Prevention said they’re using the pause to look into whether the episodes are linked to the single-dose vaccine as well as educate patients and health professionals about the condition.
“We’re recommending this pause while we work together to fully understand these events, and also so we can get information out to healthcare providers and vaccine recipients,” Acting FDA Commissioner Janet Woodcock said.
Here’s what to know about the cases so far:
Who is being affected by the blood clots?
Six women, whose ages range from 18 to 48, experienced a “severe stroke-like illness” an average of nine days after receiving the J&J vaccine, officials said.
The FDA said the cases involved rare blood clots known as cerebral venous sinus thrombosis (CVST), which draws blood from the brain, along with low platelet counts, a condition known as thrombocytopenia.
One woman died and a second was hospitalized in critical condition.
Not all — if any — of the women have pre-existing conditions, officials said.
What are the symptoms of the blood clots?
Symptoms can include severe headaches, abdominal pain, leg pain or shortness of breath.
“The headache is the very common component of it because the sinus thrombosis that they have is the draining of the blood in the brain and it will cause enough symptomatology to make you notice it,” Dr. Anthony Fauci, the White House Chief medical advisor, said on Tuesday.
But health officials stressed that the warning signs shouldn’t be confused with the common symptoms associated with receiving the vaccine.
“We know that for these vaccines for the first several days after vaccination, there are flu-like symptoms which can include headaches,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“So, I think, for the internist out there and the primary care providers who are caring for patients, if they’re seeing flu-like symptoms and headache for the first few days after a vaccination that is likely just what has been seen in the common adverse events.”
Severe symptoms experienced after the first few days would have more cause of alarm, Marks said.
“With these vaccines, it would be more important that if somebody presented to an emergency room with a very severe headache or with blood clots” that doctors ask about vaccination history and check their platelet count, Marks said.
How common are the blood clots?
The six reports are among at least 6.8 million doses of the J&J vaccine that have been administered in the US since regulators approved the shot in late February.
“These events appear to be extremely rare. That said, COVID-19 vaccine safety is a top priority for federal government and we take all reports of adverse events following vaccination very seriously,” Marks said.
What are the risks associated with the condition?
Health professionals are urged to be on alert for warning signs of cerebral venous sinus thrombosis since it can be “dangerous” if the condition is treated like other forms of blood clots.
“Treatment of this specific type of blood clot is different from typical treatments for other types of blood clots, which usually involve an anticoagulant called heparin,” Marks said.
“With cerebral venous sinus thrombosis, heparin may be dangerous and alternative treatments need to be given, preferably under the guidance of physicians experienced in the treatment of blood clots.”
What type of patients are most at risk for the blood clots?
Despite all of the impacted patients being women, regulators said it’s too early to tell if a certain subset of the population is more at risk for the blood clots.
“We’re working right now from a small number from the six events that have been recorded here in the US,” CDC principal deputy director Dr. Anne Schuchat said.
“And so while we’re seeing that in women under 50, I think we are going to need to take some time and have our Advisory Committee on Immunization Practices take additional time to review.”
All of the women who experienced the medical episodes are child-bearing age. Do regulators know if birth control played a role in the blood clots?
Hormonal birth control can increase women’s risk of blood clots, but regulators at this time don’t know if contraception played any role in the medical episodes.
“At this time, it’s not clear that there’s any association with the oral contraceptive pill, birth control in the individuals who had these blood clots,” Marks said.
What is the difference between the J&J vaccine with the ones from Pfizer and Moderna?
J&J’s shot is unique from Pfizer and Moderna’s in that it is a viral vector vaccine.
With the vaccine, a gene for the virus’ spike proteins is attached to a virus for the common cold that has already been “disabled,” so it can’t infect the person.
The cold virus then helps to deliver the spike-protein gene — which prompts the development of a small amount of COVID-19 spike proteins, which trigger antibodies.
Pfizer and Moderna’s vaccines are specially manufactured mRNA, or genetic material, is injected into cells.
The mRNA directs the body to create a tiny amount of coronavirus spike proteins, which triggers an antibody response that will protect someone if they’re infected later on.
Regulators on Tuesday said they haven’t seen the blood clot trend with the Pfizer or Moderna vaccines.
“There have been over 180 million doses of these vaccines administered and at this time we’ve not found any reports of cerebral venous sinus thrombosis combined with thrombocytopenia,” Marks said.
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