FDA restricts use of Johnson & Johnson COVID vaccine due to blood clot risk

[MdRef]

The Food and Drug Administration put rigid limits on who can receive Johnson & Johnson’s one-dose COVID-19 vaccine on Thursday, saying the vaccine should only be given to people who cannot receive a different vaccine or those who specifically request it.

After the single-dose vaccine was authorized in February 2021, the FDA and Centers for Disease Control and Prevention temporarily paused administering the shot in April after reports of blood clots in a small number of people who received it. The pause was lifted 11 days later, with the health agencies determining the benefits of the J&J vaccine outweighed the risks.

But the FDA has reversed course, ruling the risks of the side effect, called thrombosis with thrombocytopenia syndrome, outweigh the benefits. The condition, also known as vaccine-induced thrombatic thrombocytopenia, is the combination of a blood clot with low platelet count. The blood clots form in unusual places, such as veins that drain blood from the brain.

FDA restricts use of Johnson & Johnson COVID vaccine due to blood clot risk

According to the FDA, the J & J COVID-19 vaccine should only be given to people who can't receive other vaccines or those who specifically request it

www.usatoday.com

Has the FDA been taking lessons from Anthony Fauci?

 

[bluehende]

The Food and Drug Administration put rigid limits on who can receive Johnson & Johnson’s one-dose COVID-19 vaccine on Thursday, saying the vaccine should only be given to people who cannot receive a different vaccine or those who specifically request it.

After the single-dose vaccine was authorized in February 2021, the FDA and Centers for Disease Control and Prevention temporarily paused administering the shot in April after reports of blood clots in a small number of people who received it. The pause was lifted 11 days later, with the health agencies determining the benefits of the J&J vaccine outweighed the risks.

But the FDA has reversed course, ruling the risks of the side effect, called thrombosis with thrombocytopenia syndrome, outweigh the benefits. The condition, also known as vaccine-induced thrombatic thrombocytopenia, is the combination of a blood clot with low platelet count. The blood clots form in unusual places, such as veins that drain blood from the brain.



Edited to add information on the halt. From the CDC

The agency's updated analysis of the vaccine includes cases reported to its Vaccine Adverse Events Reporting System (VAERS) database through March 18. The FDA says it has confirmed 60 cases of TTS, including nine deaths.
Overall, the risk of TTS is extremely rare: about three cases for every million doses of vaccine administered. The highest rate of TTS has been in women 30 to 49 years of age. About eight cases per 1 million doses of vaccine administered have been in women in this age group.

FDA restricts use of Johnson & Johnson COVID vaccine due to blood clot risk

According to the FDA, the J & J COVID-19 vaccine should only be given to people who can't receive other vaccines or those who specifically request it

www.usatoday.com

Has the FDA been taking lessons from Anthony Fauci?

Man Faucci is never out of your mind.

Noticed you did not quote this part.

"If there’s an alternative that appears to be equally effective in preventing severe outcomes from COVID-19, we’d rather see people opting for that,” Marks said. “But we’ve been careful to say that — compared to no vaccine — this is still a better option.”

 

[emeryjre]

If he quoted it all, it would not have the spin he wanted to put on the story.

As for Fauci, those in the know understand how Fauci caused embarrassment to "he whose name shall not be spoken, written or otherwise referenced" lest this become a political statement.

"He whose name shall not be spoken, written or otherwise referenced" should never be embarrassed by a mere mortal like Fauci, lest he earn the spite of "He whose name shall not be spoken, written or otherwise referenced" and his devoted follower.

 

[bluehende]

For real info. This from the CDC.

Overall, the risk of TTS is extremely rare: about three cases for every million doses of vaccine administered. The highest rate of TTS has been in women 30 to 49 years of age. About eight cases per 1 million doses of vaccine administered have been in women in this age group.

The FDA says it has determined that the benefits of the J&J vaccine outweigh the risks for certain people. Examples of people who may still get the vaccine include:

• Those who had a severe allergic reaction to an mRNA vaccine such as those from Pfizer/BioNTech or Moderna
• Those with personal concerns about the mRNA vaccines who would remain unvaccinated without the J&J vaccine
• Those with limited access to mRNA Covid-19 vaccines

 

[MdRef]

Thank you Dr. Phil.

However you wish to spin this tragic news is up to you. Are we sticking to the, what's best for the greater good spiel? Each of these were rushed to distribution not knowing and/or apparently not caring which test subjects would be lost.

Bring to market and then February 2021, temporarily pause administering in April 2021. Start administering 11 days later. Then using what little compassion they could muster the FDA reversed course yet again. Knowing that the risks of the side effect, called thrombosis with thrombocytopenia syndrome and this is very important, outweigh the benefits.

And never forget, this is but the beginning. So let's review and pick your poison, so to speak. Don't inject Johnson & Johnson’s one-dose COVID-19 vaccine and risk getting COVID-19, perhaps with a hospital stay. Another option is to have injected the J&J vaccine and still risk getting COVID-19, as well as, the listed and now known side effects. Seems to me you've doubled your risks.

 

[emeryjre]

Probability theory is not the strong point of many people. Trying to make people that understand probability theory look bad is the strong point of many people.

 

[Cornell]

For those who were reluctant to get the vaxx or were forced to by an employer, university, etc, the Janssen vaxx was often the vaccine-of-choice.

 

["Roger"]

First the numbers: 60 cases, 9 deaths, 18,000,000 doses administered.

If this had been the only vaccine out there, there would have been no hesitation recommending it. Doctors, however, have to fear lawsuits if they do not choose what has proven to be the safest option. Thus, the FDA warning.

I should mention that drug companies (if they are on the winning end) love the fact that if their drug shows to have even a minimal advantage, they no longer have to promote its use. Doctors, out of fear of lawsuits, are forced to use their alternative. This can be counter good medicine in that at times a cheaper or more available alternatives are driven off the market with the result that fewer people benefit from a potential cure. This is one of the unintended consequences of our legal system.

 

[bluehende]

Thank you Dr. Phil.

However you wish to spin this tragic news is up to you. Are we sticking to the, what's best for the greater good spiel? Each of these were rushed to distribution not knowing and/or apparently not caring which test subjects would be lost.

Bring to market and then February 2021, temporarily pause administering in April 2021. Start administering 11 days later. Then using what little compassion they could muster the FDA reversed course yet again. Knowing that the risks of the side effect, called thrombosis with thrombocytopenia syndrome and this is very important, outweigh the benefits.

And never forget, this is but the beginning. So let's review and pick your poison, so to speak. Don't inject Johnson & Johnson’s one-dose COVID-19 vaccine and risk getting COVID-19, perhaps with a hospital stay. Another option is to have injected the J&J vaccine and still risk getting COVID-19, as well as, the listed and now known side effects. Seems to me you've doubled your risks.

Like I said. Completely ignoring the outstanding perforance of these vaccines. Every extremely rare side effect magnified. Always pointing out it is not perfect as no medicine or vaccine ever is. Always pointing out how quick they came to market with zero evidence that caused even the slightest problem. Always magnifying the stop for safety but then admonish the same organizations for not looking at safety data....etc etc. Then they ignore the sheer magnitude of suffering they have stopped.

 

[bluehende]

Are we sticking to the, what's best for the greater good spiel

Are we still sticking with the 9 deaths are a problem but over 1 million is ok spiel?

The agency's updated analysis of the vaccine includes cases reported to its Vaccine Adverse Events Reporting System (VAERS) database through March 18. The FDA says it has confirmed 60 cases of TTS, including nine deaths.

 

[bluehende]

Knowing that the risks of the side effect, called thrombosis with thrombocytopenia syndrome and this is very important, outweigh the benefits.

That quote is from the author of your post with no basis in fact. Note I posted the quote from the head of the FDA in context. Everything from the fda says the same thing. Because there are alternatives that do not have this 0.4 in a million risk of death you should go with those. Nowhere does it say that this rare risk outweighs vaccination....even with the J&J vaccine. But the antivax crew will never admit that.

 

[MdRef]

As wanna be media representative for J&J, spin the story however you wish. Dance around the facts all you want. Lo and behold the restriction remains. And why is that? It's true. I have little doubt that J&J's legal staff is anticipating yet another lawsuit. Something they've become quite accustom to.

 

[emeryjre]

Fauci is the greatest scientist of all time!!

 

[bluehende]

As wanna be media representative for J&J, spin the story however you wish. Dance around the facts all you want. Lo and behold the restriction remains. And why is that? It's true. I have little doubt that J&J's legal staff is anticipating yet another lawsuit. Something they've become quite accustom to.

Deflect and deny.

 

[MrockStar]

Dodge, duck, drop. Dodge ball anyone?

 

[easyrider]

Interesting is that the Danish study shows adenovirus vaccines like J&J and Astra Zenica a better vaccine than mRNA vaccines.

Bill

 

[bluehende]

Interesting is that the Danish study shows adenovirus vaccines like J&J and Astra Zenica a better vaccine than mRNA vaccines.

Bill

Nonsense

 

[easyrider]

Nonsense

Said the Pfizer investor.

Bill

 

[bluehende]

Said the Pfizer investor.

Bill

I wish. Although I assume they are in the s&p 500 so my SPDR s do make me a shareholder.

 

[Ralph Sir Edward]

Are we still sticking with the 9 deaths are a problem but over 1 million is ok spiel?

The agency's updated analysis of the vaccine includes cases reported to its Vaccine Adverse Events Reporting System (VAERS) database through March 18. The FDA says it has confirmed 60 cases of TTS, including nine deaths.

Question. Why is VAERS database data acceptable for the J&J vaccine, but considered utter garbage for mRNA vaccines?

Expiring minds want to know. . . .

 

[bluehende]

Question. Why is VAERS database data acceptable for the J&J vaccine, but considered utter garbage for mRNA vaccines?

Expiring minds want to know. . . .

Where in gods green earth did you get those words. It is acceptable...in fact indispensible for both. Conspiratory minds think differently.

 

[Ralph Sir Edward]

Where in gods green earth did you get those words. It is acceptable...in fact indispensible for both. Conspiratory minds think differently.

People here have pointed out all the mRNA vaccine adverse reactions on VAERS . They have been continually dismissed as not valid, political, ect., no cause to complain about the mRNA vaccines. Are you saying that those reactions should be taken as seriously as those claimed for the Adenovirus based vaccines?

I can take both of them being written off as unadmissible, or both being taken seriously; what I can't take is selectively saying one is valid and the other is not.

 

[bluehende]

People here have pointed out all the mRNA vaccine adverse reactions on VAERS . They have been continually dismissed as not valid, political, ect., no cause to complain about the mRNA vaccines. Are you saying that those reactions should be taken as seriously as those claimed for the Adenovirus based vaccines?

I can take both of them being written off as unadmissible, or both being taken seriously; what I can't take is selectively saying one is valid and the other is not.

Vaers reports are possible adverse reactions not vaccine adverse reactions. If you understood the vaers system you would know that. I have posted the explanation of this at least 5 times from the CDC. We dismiss the constant conspiracy theories generated by people who do not understand data. I know you will bluster but REAL experts look at this constantly to see reactions that are out of line. These real experts have spent their whole career looking at this data. They understand what is out of line and what would be expected. That is why I rely on them to watch for rare adverse reactions. Right wing media, youtube and facebook are not what I rely on. You do know each type of vaccine has had one rare adverse reaction identified so your one and not the other is completely ridiculous. You can build more strawmen but all adverse reactions should be taken seriously but not one is linked to the vaccine until the data is analysed by experts or do you honestly believe that everything reported to VAERS has been caused by the vaccine. Including zombies, turning into hulk, grocery shortages etc.