ALERT FDA recommends pause of Johnson & Johnson COVID-19 vaccine after blood clot cases

There have been six reported cases of a rare and severe blood clot in over 6.8 million Johnson & Johnson COVID-19 vaccine recipients
By Alexandria Hein | Fox News

FOX News medical contributor Dr. Marc Siegel joins 'Fox News @ Night' with the latest

The Food and Drug Administration together with the Centers for Disease Control and Prevention (CDC) is recommending a pause in the rollout of the Johnson & Johnson COVID-19 vaccine after several instances of a severe blood clot in recipients.
According to the FDA, there have been six reported cases of the rare and severe type of blood clot in over 6.8 million Johnson & Johnson COVID-19 vaccine recipients.

"Right now, these adverse events appear to be extremely rare," the agency said on Twitter. "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."

However, until that review is completed, the FDA is "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," the FDA said on Twitter.
Fox News has requested comment from Johnson & Johnson regarding this recommendation.

The company had told the White House it would deliver 100 million doses by the end of May, but faced a recent production blunder at a Baltimore plant and saw several vaccination sites shut down early over the last week due to potential adverse reactions.
In Georgia, eight people experienced lightheadedness, but officials could not rule out whether heat was a factor. In North Carolina, four people were taken to the hospital for reactions "consistent with known common side effects." In Iowa, three people experienced extreme lightheadedness, and in Colorado 11 people experienced dizziness and nausea.

The FDA has planned a 10 a.m. press conference for Tuesday.
This is a developing story, please continue to check back for updates.

It's interesting that the J&J vaccine is the only one in the United States the media is reporting on regarding side effects when we know the other two have had side effects too. However, when you realize that the NHI owns half of the patent on the Moderna vaccine, it kind of makes you question motivation here.

A heck of a lot more than 6 cases. I have an employee whose dad in Florida died 72 hours after his second shot when he threw a massive blood clot that killed him in under a minute. There was no autopsy as he was elderly and his death never made it into the vaccine adverse events database. You can probably take these six deaths and multiply it by thousands.

A cousin recently died in his sleep of a blood clot that went from his leg to his heart. No one could say if he had his covid shot. Put him in the maybe column.

I am VERY susceptible to blood clots

taking coumidin

I have had them in my lungs and my leg

no vax for me

Hfcomms said:

A heck of a lot more than 6 cases. I have an employee whose dad in Florida died 72 hours after his second shot when he threw a massive blood clot that killed him in under a minute.

Click to expand...

THERE IS NO SECOND SHOT WITH J&J. He didn’t get that vax.

I just got the J&J yesterday. Got it just under the wire. I already do the vit. D, lots of water, fish oil thing, I will up it a bit.

Dennis Olson said:

THERE IS NO SECOND SHOT WITH J&J. He didn’t get that vax.

Click to expand...

Dennis obviously doesn't know about the double-secret, probationary J&J second shot...

Best
Doc

homepark said:

I just got the J&J yesterday. Got it just under the wire. I already do the vit. D, lots of water, fish oil thing, I will up it a bit.

Click to expand...

Did you have any after-effects? I do the same as far as vitamin D and other supplements. I have an appointment for the day after tomorrow to get the J&J but now will be surprised if it doesn't get cancelled.

Wow. Stopping an emergency vaccine after 6 out of 6.8 million show issues?

"Right now, these adverse events appear to be extremely rare," as in 0.0000882 % of the 6.8 million noted. How does that compare to the 'safe' vaccines approved for normal use?

Someone wants this non-mRNA vaccine stopped.


What to Know About Blood Clots, Anaphylaxis and Other Vaccine Fears

snip from the article linked:

Reports that some vaccine recipients developed blood clots prompted several countries, mainly in Europe, to suspend use either of all AstraZeneca Plc’s Covid vaccine or doses from a particular batch, or to restrict its use in younger people. The European Medicines Agency concluded April 7 that unusual blood clots with low blood platelets should be listed as a very rare side effect of the vaccine; the same day, officials of the U.K.’s medicines regulator said evidence of the connection was firming up. Among 86 cases the EMA examined up to March 22, there were 18 deaths. U.K. regulators put the overall risk of the clots at about 4 in a million people who receive the vaccine. Most reported cases occurred within two weeks of vaccination, according to the EMA. Symptoms include shortness of breath, chest pain, leg swelling, persistent belly pain, severe headaches, blurred vision and tiny blood spots under the skin beyond the vaccine injection site. European regulators stressed that the overall benefits of the AstraZeneca vaccine outweigh the risks of side effects. U.K. health authorities noted that preliminary evidence suggests the clots occur more often in young people and recommended that those younger than 30 be offered an alternative vaccine, if available.

There have been multiple reports posted here from people who received the J&J vax. No ill effects from any of them.

zeker said:

I am VERY susceptible to blood clots

taking coumidin

I have had them in my lungs and my leg

no vax for me

Click to expand...

Same here. PE's are no joke. I was 32 when I had the first one (and several since then, even on blood thinners) so no shot for this old gal.

mistaken1 said:

Wow. Stopping an emergency vaccine after 6 out of 6.8 million show issues?

"Right now, these adverse events appear to be extremely rare," as in 0.0000882 % of the 6.8 million noted. How does that compare to the 'safe' vaccines approved for normal use?

Someone wants this non-mRNA vaccine stopped.

Click to expand...

Thats where the term “abundance of caution “ comes in to play.

/sarc

See, I WONDERED if this wasn't going to be the case. It's the only one that isn't mucking about with RNA, so of course the feds were going to try and yank it.

mistaken1 said:

Someone wants this non-mRNA vaccine stopped.

Click to expand...

From what I understand - this is also an mRNA vaccine, but the mRNA is delivered in a different way.

adgal said:

From what I understand - this is also an mRNA vaccine, but the mRNA is delivered in a different way.

Click to expand...

I had heard the Johnson & Johnson version attacks the VIRUS' mRNA as opposed to the recipient's.

A large proportion of those who died 'with' Covid developed blot clots from the disease. It stands to reason, if a person who is prone to this immunological 'response' receives any vaccine, then they may develop blood clots. What the immunologists really need to be focusing on is identifying what condition exists in those who develop the clots (ie: blood type, genetic markers, etc) and focus on that subset of persons to mitigate death due to cardio-pulmonary embolisms and stroke.

Hfcomms said:

A heck of a lot more than 6 cases. I have an employee whose dad in Florida died 72 hours after his second shot when he threw a massive blood clot that killed him in under a minute. There was no autopsy as he was elderly and his death never made it into the vaccine adverse events database. You can probably take these six deaths and multiply it by thousands.

Click to expand...

I’m on several groups that were developed just report whether people have had positive or negative short term effects post injection. There’s no name calling, just people reporting if they’ve experienced symptoms or not. While there’s quite a few that have reported they are fine, I can’t count all the reports I’ve seen on strokes and blood clots coming in daily. I read 6 a day. And it’s not just J&J, it’s Moderna and Pfizer too.

All the talk about how the mRNA vax specifically works against covid, but no info what other functions it may disturb. Can the messenger interfere with blood clotting, with suppressing tumors, or regulation of any other bodily functions? I think we are in the stage of finding out now just exactly what else in the body it interrupts.

Here’s some examples what I’m reading daily:

“My dear dad had the Pfizer vaccine a week or so ago. Today he had to go to the hospital because of severe pain in his leg. He has a blood clot. I feel so certain it's because of the vaccine. ”

“Family member, took vaccine, 70’s but healthy, 3 days later dies suddenly. Maybe coincidence but needs tuled out.”

“My mom passed away four days after her Moderna vaccine she was in the kitchen and collapsed I did cpr my daughter called 911 my mom died in the hospital, In the hospital they said she had a blood cot around her lung, after her passing they decided to send her to coroner and do autopsy, not only loosing her has been devastating but not knowing exactly what happened is very difficult. She was 72”

“My sister-in-law's mother got pfizer last tuesday. 3 days later she arrived at the hospital with an infection in her body, which they do not find out. Is still in hospital.”

“It’s been 3.5 weeks since my Pfizer shot. When will the random muscle spasms stop? Has anyone experienced this and they stopped?”

“My father (73 years old) went to the cardiologist mid- December. Called me to say his heart was super healthy. Got the vaccine (moderne) Jan 16th I believe and dropped dead January 20th. I’m still heart broken. We’re Jewish and do not do autopsies but it just doesn’t feel right. ”

“I had a massive adverse reaction on my second Moderna shot. I was transported by ambulance. For about 2 1/2 weeks afterwards, I had tachycardia and extremely high blood pressure resulting in three more trips by ambulance. I have MS. Whatever immunological response I had triggered my MS; I traveled to Johns Hopkins to the immunology neurology department. They’re unsure exactly what happened except now they’re just saying I cannot take a shot with mRNA. Has anyone else with an auto immune disease experienced anything similar?”

adgal said:

From what I understand - this is also an mRNA vaccine, but the mRNA is delivered in a different way.

Click to expand...

No, the J&J vaccine utilizes the traditional disabled adenovirus method of vaccination. Pfizer and Moderna "vaccines" contain an nMRA code segment that "teaches" or "instructs" your cells to recognize the virus that causes COVID;

On the "maybe there's a real vaccine out there" front, I noticed this news blurb today about Regeneron (which was part of the cocktail given to President Trump):

Regeneron to Seek FDA Approval for Its COVID-19 Antibody Cocktail to Be Used for Prevention

Regeneron Pharmaceuticals is pursuing FDA approval for its antibody cocktail to be used as a preventative treatment for COVID-19 after its latest study showed positive results.

The company announced in a release that its phase three prevention trial for REGEN-COV—a combination of casirivimab and imdevimab—showed that the drug reduced the risk of symptomatic infections by 81 percent.

The findings are drawn from the 1,505 people who were not infected when they entered the trial.

The double-blind, placebo-controlled trial also found that the drug cocktail “rapidly protected” people from exposure to the CCP (Chinese Communist Party) virus in households where someone else has the virus. It provided 72 percent protection against symptomatic infections in the first week and 93 percent after that, the company announced.


Among people who developed symptoms of COVID-19, the disease caused by the CCP virus, those who were treated with REGEN-COV cleared the virus faster and their symptoms were resolved faster—within one week compared to three weeks with a placebo, according to trial data.

The drugmaker said that it will share data with the U.S. Food and Drug Administration and request an emergency use authorization (EUA) for the combo therapy “to include COVID prevention for appropriate populations, using a 1,200 mg subcutaneous dose.”

“These data suggest that REGEN-COV can complement widespread vaccination strategies, particularly for those at high risk of infection,” Myron Cohen, who leads monoclonal antibody efforts for the U.S. National Institutes of Health-sponsored COVID Prevention Network, said in a statement.

“Despite standard precautions to reduce transmission, nearly 10 percent of unvaccinated individuals living with an infected person developed symptomatic infections if they did not receive REGEN-COV,” he said, adding that if authorized, the therapy “could help control outbreaks in high-risk settings where individuals have not yet been vaccinated, including individual households and group living settings.”


A scientist works in Regeneron Pharmaceuticals’s Infectious Disease Lab in New York state, for efforts on an experimental CCP virus antibody cocktail, in this undated image from video provided by the company on Oct. 2, 2020. (Regeneron via AP)

The company noted that after 29 days in the study, 11 people developed COVID-19 symptoms in the group that received a single 1,200 mg dose of the REGEN-COV treatment, compared to 59 people who received a placebo.

In the study, adverse events occurred in 20 percent of people who received the combo therapy, compared to 29 percent of those who got the placebo. Serious adverse events occurred in one percent of either group. In the 29 days, four placebo participants were either hospitalized or went to the ER because of COVID-19, compared to zero in the treatment group. No deaths in the trial—two in the treatment and two in the placebo groups—were due to COVID-19 or the drug.

REGEN-COV is currently FDA-approved for EUA to treat non-hospitalized people at least 12 years old who have contracted COVID-19 with mild or moderate symptoms and are at high risk for developing severe symptoms. The currently authorized dosage is a 2,400 mg dose composed of 1,200 mg of casirivimab and 1,200 mg of imdevimab, to be administered in a single infusion within 10 days of becoming symptomatic.


Former President Donald Trump previously described the drug as key to his recovery from having been infected with the CCP virus last year.

Regeneron also announced on Monday that a separate trial showed that REGEN-COV reduced the overall risk of progressing from asymptomatic to symptomatic COVID-19 by 31 percent, and by 76 percent after the third day. This trial involved 204 people who had the CCP virus but did not show any symptoms.

The combo therapy also nearly cut in half the total number of weeks that patients experienced COVID-19 symptoms—a reduction of 45 percent. The viral burden—the amount of virus present—was also reduced by more than 90 percent.

Six placebo participants were either hospitalized or went to the ER because of COVID-19, compared to zero in the treatment group.

“These phase three data provide even more evidence that REGEN-COV, this time given to asymptomatic patients via convenient injections, can change the course of COVID-19 infection in non-hospitalized patients,” George Yancopoulos, president and chief scientific officer at Regeneron, said in a statement.

Blacknarwhal said:

I had heard the Johnson & Johnson version attacks the VIRUS' mRNA as opposed to the recipient's.

Click to expand...

One of the other members had more information about it - but this is all I could find:


The first COVID-19 vaccines given emergency use authorizations (EUAs) from the FDA — the Pfizer and Moderna vaccines — rely on mRNA vaccine technology. But the next vaccines most likely to receive EUAs use a different vaccine template called viral vector technology.

These COVID-19 vaccine candidates, from Johnson & Johnson and Oxford/AstraZeneca, have been studied since summer 2020, though viral vector vaccines in general have been studied since the 1970s. Viral vector vaccines were used recently to respond to Ebola outbreaks, and human clinical trials have tested viral vector vaccines against Zika, influenza, HIV and malaria, among other viruses.

Technology used in viral vector vaccines

Viral vector vaccines use a modified, harmless version of a different virus as a vector, or carrier, to deliver immunity instructions to cells in the body. The body then follows those instructions to build an immune response to the intended virus (in this case, SARS-CoV-2, which causes COVID-19.)

The virus vector being used in the Johnson & Johnson and AstraZeneca vaccines is an adenovirus, a common type of virus that typically causes mild cold symptoms when it infects someone.

COVID-19 viral vector vaccines inject a harmless adenovirus vector, which carries unique genetic information from the COVID-19 virus to human cells. Once it reaches human cells, the vector uses that genetic information with the cell’s machinery to produce a COVID-19 spike protein (a small piece of SARS-CoV-2) on the cell’s surface. That spike protein triggers a response from the body’s immune system to start producing antibodies to COVID-19.

The antibodies created are specific to the virus that causes COVID-19, meaning the body is then prepared to protect against any future infections of the SARS-CoV-2 virus.

Pros and cons of viral vector vaccine technology

Viral vector vaccines work well in pandemics because they’re easy to produce quickly and in large volumes. Decades of clinical data show that adenoviruses in particular can trigger a strong immune response in humans, making them especially effective.

However, if a viral vector vaccine uses a virus that you’ve already been exposed to and, therefore, have pre-existing immunity for, the vaccine won’t be as effective for you. That’s why scientists creating these vaccines try to choose versions of viruses that we’re unlikely to encounter naturally — in the Johnson & Johnson and AstraZeneca vaccines, the adenovirus is a strain that is found only in chimpanzees.

ETA - links from the other members' comments:

Regeneron
I think our existing cocktails will beat that.

Pharmaceutical research numbers.

Economic reports with charts and graphs.

Santa Claus and the Easter Bunny.

Unicorns.

Color me cynical.

Hfcomms said:

A heck of a lot more than 6 cases. I have an employee whose dad in Florida died 72 hours after his second shot when he threw a massive blood clot that killed him in under a minute. There was no autopsy as he was elderly and his death never made it into the vaccine adverse events database. You can probably take these six deaths and multiply it by thousands.

Click to expand...

Couldn't be the J&J vaccine that he had since it is a one-dose only vaccine. The other two are two doses.

If you notice, all the news stories the last week or so have been solely about J&J. Why? Because there are way, way fewer doses of the vaccine in the country, however, many people are gravitating to taking J&J because it isn't mRNA. They are going out of their way to find suppliers to specifically give that maker's vaccine, foregoing the abundance of other doses that are now sitting and waiting for someone to give it to. In the meantime, people are waiting for appointments for J&J.

The government paid for all these doses from all three companies. But most of the doses come from Moderna and Pfizer. They need to find some way to get people to take the other two, otherwise, they are going to be left with a lot of leftover vaccines, and not enough doses of J&J to give to everyone.

So the "Discredit" campaign begins, to try and use fear and propaganda to move people from wanting and seeking out J&J and going to take the other two.

No internet...we would know NONE OF THIS STUFF.

The tv and radio would just keep telling us it is the next best thing to a good jam sammich.

Just had the J&J vaccine yesterday. I have a mild headache, but I'm a chronic headache patient so I can't necessarily blame the vaccine for that.

I take lots of Vit D and Vit C daily.... I'm gonna go dig up the bottle of aspirin (blood thinner) and maybe take a little stroll around the garden...

mistaken1 said:

Wow. Stopping an emergency vaccine after 6 out of 6.8 million show issues?

"Right now, these adverse events appear to be extremely rare," as in 0.0000882 % of the 6.8 million noted. How does that compare to the 'safe' vaccines approved for normal use?

Someone wants this non-mRNA vaccine stopped.

How Safe Are Covid Vaccines? Here’s the Rundown on Reactions

Covid vaccines are designed to prevent a disease that has so far killed more than 5 million people worldwide. No pharmaceutical, however, is completely benign. The goal is to ensure the benefits outweigh the risks. So far, the vaccines have been connected to a relatively small number of cases of...

www.bloomberg.com

What to Know About Blood Clots, Anaphylaxis and Other Vaccine Fears

snip from the article linked:

Reports that some vaccine recipients developed blood clots prompted several countries, mainly in Europe, to suspend use either of all AstraZeneca Plc’s Covid vaccine or doses from a particular batch, or to restrict its use in younger people. The European Medicines Agency concluded April 7 that unusual blood clots with low blood platelets should be listed as a very rare side effect of the vaccine; the same day, officials of the U.K.’s medicines regulator said evidence of the connection was firming up. Among 86 cases the EMA examined up to March 22, there were 18 deaths. U.K. regulators put the overall risk of the clots at about 4 in a million people who receive the vaccine. Most reported cases occurred within two weeks of vaccination, according to the EMA. Symptoms include shortness of breath, chest pain, leg swelling, persistent belly pain, severe headaches, blurred vision and tiny blood spots under the skin beyond the vaccine injection site. European regulators stressed that the overall benefits of the AstraZeneca vaccine outweigh the risks of side effects. U.K. health authorities noted that preliminary evidence suggests the clots occur more often in young people and recommended that those younger than 30 be offered an alternative vaccine, if available.

Click to expand...

That's what I was thinking. Statistically that's "0". Someone really doesn't want the J&J vax to get a foothold at all.

adgal said:

From what I understand - this is also an mRNA vaccine, but the mRNA is delivered in a different way.

Click to expand...

THIS is why they want it stopped. It has nothing to do with blood clots or other things. It can't deliver the genetic garbage that the other two do. When it comes to boosters...they have something up their sleeves planned.

WRT J&J side effects.I am a bit tired today, but then, I am a bit tired most days. No sore arm. No other side effects of note yet.
HOWEVER, as I told a friend of mine, my balls fell off and I feel a sudden craving for a soy latte!

Hfcomms said:

A heck of a lot more than 6 cases. I have an employee whose dad in Florida died 72 hours after his second shot when he threw a massive blood clot that killed him in under a minute. There was no autopsy as he was elderly and his death never made it into the vaccine adverse events database. You can probably take these six deaths and multiply it by thousands.

Click to expand...

I thought the J&J vax was a one shot and done type thing?

View: https://twitter.com/Timcast/status/1381990155683237892

View: https://twitter.com/CosmicLord111/status/1382023581597589508


Fauci is at it again. "It’s still not ok for vaccinated Americans to eat and drink indoors."
RT 45secs
View: https://twitter.com/KVollero/status/1381630059719618562


RandPaul: “Dr. Fauci should be voluntarily removed from TV because what he says is such a disservice and such fear-mongering, and almost all of what he says isn’t even matched by the science of his own institute."
RT 2:18secs
View: https://twitter.com/SandraKathleen4/status/1382034682477477895

Been trying to tell you all the difference between the J&J DNA/adenovirus vaccine and the Pfizer and Moderna mRNA vaccines but everyone here kept insisting that the J&J was more like a normal vaccines. Silly people.

The J&J still eventually makes mRNA which then makes Covid spikes, but it does it through a much more complicated process, with more interaction with your cellular machinery, where it is more possible to have issues. AstroZenica in the UK and EU works the same way.

J&J vaccine is a DNA vaccine not a conventional vaccine. I laugh my ass off at those of you who believe taking it is more similar to a conventional vaccine. Next time don't listen to those who haven't got a clue to how DNA and RNA work.

Anyway its still a good vaccine, but perhaps more suited to those who are older and have less strong immune systems and therefore less of a possibility of a reaction/side effect.

Dennis Olson said:

THERE IS NO SECOND SHOT WITH J&J. He didn’t get that vax.

Click to expand...

For now there is no second shot. Just yesterday, Fauci hinted that there "may" be boosters coming in the next 6-18 months.

Translation: Will be boosters in the next 6-18 months. This was an easy one to predict.

@JordanSchachtel

Fun fact: April 20th will mark 400 days of 2 weeks to slow the spread.

Fauci yesterday: "Hang in there!”

homepark said:

HOWEVER, as I told a friend of mine, my balls fell off and I feel a sudden craving for a soy latte!

Click to expand...

No craving yet for a red flannel onesie and a cup of hot chocolate?

Dennis Olson said:

No craving yet for a red flannel onesie and a cup of hot chocolate?

Click to expand...

Well, it is early yet.

No sure which Vax was taken at the moment but trying to find out. Friend of my GF daughter volunteered their kids for one of the trials for kids . Their little girl received the second shot yesterday and died from blood clots to the lungs and brain just a short time ago today.

Omg. How awful!

Weps said:

No, the J&J vaccine utilizes the traditional disabled adenovirus method of vaccination. Pfizer and Moderna "vaccines" contain an nMRA code segment that "teaches" or "instructs" your cells to recognize the virus that causes COVID;

Johnson and Johnson vaccine How is it different | VCU Health

The Johnson & Johnson vaccine could mark a turning point in the pandemic.

www.vcuhealth.org

Click to expand...

I suggest you do some more learning and reading and not from some pseudo-science like Natural News or Epoch times.
J&J uses a adenovirus whose DNA has been modified. The virus goes into the cell and injects it's altered DNA into your cell nucleus.
You know the same damn nucleus that contains the rest of your DNA. Once in the nucleus this genetically modified DNA then produces,, wait for it...;..;;..... a mRNA strand. Surprise, surprise, surprise!!!
The mRNA strand then goes out into the cell cytoplasm where it produces Covid spike proteins, exactly how the directly injected mRNA vaccines (Pfizer and Moderna) do.. Only the Pfizer and Moderna vax don't use genetically modified DNA and don't ever enter your cell nucleus where your DNA resides.
The mRNA vaccines use mRNA directly and don't go through the convoluted process of injecting DNA which then makes RNA which then makes the covid spikes. mRNA vax are a one step process, where the J&J is a multistep process.
Both use genetically modified DNA or mRNA. In the end mRNA is what makes the spikes.
This knowledge is easily available online from University sources.

Finally any time you inject anything into your body there is a chance of a serious reaction. People with overactive immune systems seem to be more susceptible to these type of reactions.
Thats why J&J is more suited to older people. That recommendation will probably be coming out shortly.

Finally if you are subject to clotting you need to be careful with any of the vaccines.
Same if you have a history of severe allergic reactions to things.

Blacknarwhal said:

I had heard the Johnson & Johnson version attacks the VIRUS' mRNA as opposed to the recipient's.

Click to expand...

You heard wrong.
The J&J vaccine uses it's modified DNA to make mRNA in your cells, which then makes the Covid spike.
Something the Pfizer mRNA vaccine does directly without using the extra step of DNA making the mRNA.