by Brian Shilhavy
Editor, Health Impact News
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 [1]:
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.
They later held a conference call regarding the J&J vaccine that was recorded on YouTube.
ZeroHedge News [2] 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 [2].
Dr. Meryl Nass, MD [3] commented on the decision to halt the vaccinations today raising questions about which lab actually made these batches that have been distributed in the U.S.:
After many clinics in 4 states closed down, due to a high number of adverse reactions to the J and J vaccine (which were not described but which included many hospitalizations) the US CDC and FDA has halted use of these vaccines while it takes a closer look at what is happening. I heard this am that a local person had been hospitalized with a serious blood clot.
My question has been, is this J and J vaccine truly made by Janssen in the Netherlands, or was it perhaps Emergent BioSolutions-made vaccine that snuck out the back door before it was authorized, got bottled elsewhere and was comingled with the vaccine made in Europe? Why so many reactions suddenly?
I have been warning against using the EBS-made vaccine for over 6 months. OTOH, it could be that the design of the vaccine is what is causing problems. Maybe the adenovirus vector is the problem. Maybe the spike. Maybe something else. Please be careful! We are so close to herd immunity in most of the US. We can successfully treat this virus.
Whenever public health officials use the term “abundance of caution” you know what that means: “we’re screwed!”
Read the full blog post here [3].
Donald Trump Angry with the FDA – Shows No Concern for Vaccine Victims
Former President Donald Trump issued a statement expressing his displeasure with the FDA for halting the J&J shots. This was reportedly sent out by email from his Save America PAC (Source [4]):
The Biden Administration did a terrible disservice to people throughout the world by allowing the FDA and CDC to call a pause in the use of the Johnson & Johnson COVID-19 vaccine.
The results of this vaccine have been extraordinary but now it’s reputation will be permanently challenged.
The people who have already taken the vaccine will be up in arms, and perhaps all of this was done for politics or perhaps it’s the FDA’s love for Pfizer.
The FDA, especially with long time bureaucrats within, has to be controlled.
They should not be able to do such damage for possibly political reasons, or maybe because their friends at Pfizer have suggested it.
They’ll do things like this to make themselves look important.
Remember, it was the FDA working with Pfizer, who announced the vaccine approval two days after the 2020 Presidential Election. They didn’t like me very much because I pushed them extremely hard. But if I didn’t, you wouldn’t have a vaccine for 3-5 years, or maybe not at all. It takes them years to act!
Do your testing, clean up the record, and get the Johnson & Johnson vaccine back online quickly.
The only way we defeat the China Virus is with our great vaccines!
Comment on this article at HealthImpactNews.com [5].
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