The FDA announced today that it was recommending a pause in the use of the Johnson and Johnson experimental COVID vaccine “out of an abundance of caution.”
From their Twitter account:
Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.
As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare
Treatment of this specific type of blood clot is different from the treatment that might typically be administered.
CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases.
Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.
ZeroHedge News published some notes regarding the call:
The health officials who spoke on today’s call started by reiterating details about the decision to halt the J&J shared with the press earlier. Officials said they would update doctors with new vaccine “fact sheets” designated certain medications that could be associated with higher risks of blood clots.
After they said they were only seeing symptoms in patients who received the JNJ vaccine, the first question from the press (asked by an FT reporter) was: what about AstraZeneca? In Europe, governments have been imposing age limits on who can receive the AstraZeneca jab for similar reasons.
Officials responded by brushing the AZ question aside, before saying they hoped the halt would last for only a few days. Pressed about what’s causing the clots, doctors said that an extremely rare immune response triggers the blood clots by sending signals in patients’ blood to clot. While they said they hadn’t seen complications with other vaccines, Dr. Marks said the US believes the problem in the JNJ and AZ vaccines is “related” to the adenovirus platform, though he didn’t offer much in the way of details.
At one point, Dr. Marks said “the real thing that is so notable here is not just the cerebral blood clods…it’s their occurrence together that makes a pattern, and that pattern is very very similar to what was seen with another vaccine.”
A reporter for CNN mentioned that they were being told that this was something being “looked into” earlier, and Schuchat explained that the CDC had first looked into how best to advise the health-care community to treat and respond.
The FDA left open the possibility that new cases of blood clots could be brought to its attention. The FDA will actively search for vaccines. New guidance to be issued will help educate doctors and other health-care professionals about risk factors that could put patients at risk of the autoimmune reaction.
After offering examples of symptoms that would be on the list of potential warning signs, Dr. Marks was pressed to open up a bit more about symptoms after a doctor who was on the call asked him about specific symptoms seen by these patients. The doctor noted that listing “headaches” on a list of suspect symptoms or “abdominal pain” could lead to a lot more tests and doctor visits. At this, Marks seemed to have trouble putting a figure on the background rate of blood clots, and other questions about the prevalence of symptoms that could be seen on the FDA’s list.
“This is going to translate to a lot more doctors visits for people like me,” the doctor said.
The press briefing was ended soon after. Of course, it’s not difficult to understand why the FDA was starting to feel uncomfortable. A wave of patients being told to seek emergency care as a precaution could push ER occupancy rates higher again. Suddenly, the numbers will be telling us that we are back in the worst of the COVID pandemic.
Read the full article at ZeroHedge News.