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FDA puts strict limits on Johnson & Johnson Covid-19 vaccine

<i>Frederic J. Brown/AFP/Getty Images</i><br/>The US Food and Drug Administration announced that it is limiting the emergency use authorization of the Johnson & Johnson/Janssen Covid-19 vaccine to people 18 and older for whom other vaccines aren't appropriate or accessible and those who opt for J&J because they wouldn't otherwise get vaccinated.
AFP via Getty Images
Frederic J. Brown/AFP/Getty Images
The US Food and Drug Administration announced that it is limiting the emergency use authorization of the Johnson & Johnson/Janssen Covid-19 vaccine to people 18 and older for whom other vaccines aren't appropriate or accessible and those who opt for J&J because they wouldn't otherwise get vaccinated.

By Katherine Dillinger, CNN

The US Food and Drug Administration announced Thursday that it is limiting the emergency use authorization of the Johnson & Johnson/Janssen Covid-19 vaccine to people 18 and older for whom other vaccines aren’t appropriate or accessible and those who opt for J&J because they wouldn’t otherwise get vaccinated.

The FDA said in a statement that the change is being made because of the risk of a rare and dangerous clotting condition called thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine.

“We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. “We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. … Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions.”

The agency confirmed to CNN that the updated authorization also applies to booster doses.

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

As of Thursday, more than 18.7 million doses of the J&J vaccine have been administered in the US, according to the US Centers for Disease Control and Prevention. Of those who are considered fully vaccinated, 7.7% got this vaccine.

After a meeting in December, the CDC’s vaccine advisory committee issued an updated recommendation on Johnson & Johnson’s vaccine, saying it makes a “preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen adenoviral-vectored COVID-19 vaccine in all persons aged ≥18 years in the United States.”

The committee cited the same concerns over TTS.

Both the CDC and the FDA previously recommended a pause in the use of this vaccine over reports of TTS. The pause was lifted, but that move came with a warning over the rare clotting events.

Johnson & Johnson said in a statement at the time, “The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. … We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public.”

In an updated fact sheet on the vaccine, the FDA says that 15% of TTS cases have been fatal.

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.

Cases of TTS typically begin one or two weeks after vaccination. Symptoms include shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms like headaches or blurred vision, or red spots just under the skin called petechiae beyond the site of vaccination.

The new warning on the vaccine’s fact sheet says “The Janssen Covid-19 vaccine can cause thrombosis with thrombocytopenia syndrome (TTS) which may be life-threatening.”

The-CNN-Wire
™ & © 2022 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.

CNN’s Brenda Goodman and Amanda Sealy contributed to this report.

CNN Newsource

Comments

57 Comments

  1. American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products. Go ahead and google Johnson&Johnson Talc Power Lawsuit…

    Does anyone wanna explain to me WHY We should trust Pfizer, Moderna or Johnson&Johnson considering their track record for lying, seriously injuring and even killing people all for cooperate profits? Their track record speaks for itself!!! Dont listen to Barn or any other “expert” listen to YOUR common sense and intuition.. The Vax manufacturers can not be trusted, the proof is crystal clear.. Your immune system has gotten you this far..

    1. Screaming into the wind MattS3rvrs. Intuition and common sense never had a hope in this scamdemic. And certainly not the vaccines. It became virtue signaling, a badge of honor to get the jab and wear the mask. Almost as fanatical as a religion, and equally used to shun those who believed differently. All of it now blows by the wayside as we approach midterms, leaving those duped into getting it wondering what long term effects may be. I for one am glad I don’t have to worry about getting “un-jabbed.”

  2. But….but….but….Barney and every politician told us these non fda approved experimental meds were “safe and effective”. How can this be. Barney and KTVZ has been promoting fake news for 2 years. Should be held accountable.

  3. And guess what, anyone that was injured from these clot shots can’t hold anyone accountable because they are not fda approved. By taking the med they consented to being part of the experiment. Enjoy the boosters.

  4. Remember when Biden said this last winter was going to be the “winter of death of the unvaccinated”? Yeah, more like winter of blood clots of the jabbed.

  5. Trust the settled science. From settled “safe and effective” science to “danger Will Robinson.” Trust the science. Obey the government. Science is settled and we must obey. The science would never lie to us and our government would never “disinform” we the serfs.

      1. And yet when a conservative said they wanted more time and research on the vaccines, liberals would yell at them that it is settled science and they should get the vaccine.

        1. I never saw someone saying “the science is settled.” As usual, memories are twisted like facts. They — the targeted experts whom folks used to trust before the spin — said the guidance on vaccines, masks, etc. was based on the best knowledge AT THE TIME and well could change as we learn more. And sure, some experts disagreed, too. But everything was weaponized by the critics who claimed the other side was “fear-mongering” as they spread fear of the vaccines, said masks are useless, etc. I recall many pointing out that the knowledge was evolving about the new virus, while the critics said “but you said last week/month/year” as if science is not supposed to evolve with studies/new info. Instead, folks were saying “where’s the long-term studies” as if we should wait to do anything for 5, 10, 20 weeks, months, years of studies.

          1. That’s hilarious considering they said don’t wear a mask, wear a mask, don’t wear a mask, wear 2 masks. I guess it evolves, and devolves, lol.

          2. You’re correct, no one said that the science was settled. But when people were skeptical of the vaccines and the potential side-effects, they were directed to the “reputable sources” saying they were safe and affective. That’s the entire point that the media neglects to challenge… could it be possible that the “reputable sources” aren’t trustworthy? The government and media are no longer credible because it is obvious that both parties are incompetent in their duties.

          3. You’re so full of it, lol. I knew this type of response from people like you was coming but it’s still amazing to see. This is only beginning, I hope you and your family are fully vaxxed!

            1. Yes, we are, but I will never “LOL” about a very serious issue and those who do… folks can judge for themselves. What I said was the truth, and opinions prove nothing, even if repeated endlessly without proof.

              1. This platform restricts free speech- as you use your individual bias to determine “truth” and silence those you disagree with… FACT !

                1. I’m tired of letting you beat me up verbally and then attacking me offensively further when I defend myself. Your 1,000s and 1,000s of allowed comments here – the vast majority – disprove your repeated false claims about our moderation.
                  The First Amendment does not restrict, limit or prohibit private businesses from setting and enforcing minimal Terms of Service intended to promote civil dialogue and stop the offensive personal attacks.
                  I am not speaking to you – you show how useless that is every day, night and weekend – but to others with open minds and hearts who wonder why we allow you to continue to berate the moderator with falsehoods and personal attacks.

                2. Barney’s reboot of the First amendment reads like a manifest to promote censorship… just as long as it’s done by “private business”… You decide- “The First Amendment does not restrict, limit or prohibit private businesses from setting and enforcing minimal Terms of Service”… cripes people- imagine if Red Meyer decided on members only- and no-one was allowed to wear red-white-or blue attire because it denoted a political statement that some would find “offensive”…. that’s one slippery slope Barney- good luck with that.

                3. The First Amendment:
                  “Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.”
                  NO mention of anything but govt.’s role. You twist it, like everything – not what I say, but those who study the issues, such as:
                  ” In contrast, a private person or organization’s social media page is not a public forum and is not protected by the First Amendment.”
                  https://accessiblelaw.untdallas.edu/limits-free-speech-social-media

                4. No mention in the constitution about “Private Business” need not abide by the law as it is laid out in the First Amendment… You went to some on-line internet lawyer to defend your company policy to demand membership- then stifle free speech. You are arguing a communists platform… shameful !

                5. twisted as usual. Shameful, too. As usual, you twist everything upside down and backwards. What “law” says private enterprise has to let anyone say anything in an online platform? The Constitution sure doesn’t.

      2. Why did you report daily that this vaccine was safe and effective Barney? Pretty damn dangerous and you should personally be held liable.

        1. WE never said that. We quoted authorities by name in positions of authority who said that, and quite often pointed to the caveats involved. And we quoted critics as well. Not aware of any court rulings that support your allegations.

            1. Lack of unaccountability? Yep, the double-negative is true! I’m accountable to my employer, who may well decide to join others in deleting a comment system if the new platform can’t encourage more civil dialogue and less toxic hateful trolling (downvote into invisibility, Reddit’s great strength). Of course, predictable cries of censorship for those who have no clue how to keep a civil tongue. Nothing to do with your bogeyman “Big Pharma.” As far as I know, all the drug ads are in network programming, not ours.

          1. I’m trying to post ONE link of KTVZ saying the j&j is safe and effective from 2/24/21 but it won’t let me post the link. It’s clear that YOU reported this almost daily for 2 years.

        2. Not only did Barney personally promote these vaccines- he consistently ridiculed and bad mouthed the VAERS reporting system- which was highly utilized to make this decision- Barney would say that VAERS is untrustworthy- “not verified” where his exact words”… He was wrong then- VAERS observers were verifying reports and were making decisions based on them… he’s wrong now not to admit his personal bias and serious levels of what amounts to “dangerous misinformation”… the archives don’t lie !

          1. Nope, never promoted anything. Provided info from CDC, OHA, etc. Your misstatements and false memories stand on their own.
            You can repeat falsehoods about our work, 1,000s of times as you have and it’s nowhere near closer to true or changing any minds, except perhaps about you.
            ” Specifically, a report to VAERS does not mean that a vaccine caused an adverse event. But VAERS can give CDC and FDA important information. If it looks as though a vaccine might be causing a problem, FDA and CDC will investigate further and take action if needed.”
            https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html

      3. Yeah “wise folks know science evolves as new knowledge evolves from research”. OMG. That’s what I’ve been saying for 2 years These experimental vaxxes aren’t tested for safety. Not FDA approved. Pushed on the public. Coercion. Take the jab or lose your job, which I did. You are part of the problem KTVZ. DISGUSTING. Hope there are BIG lawsuits.

  6. And there it is.
    Millions of Americans have done their own cost/benefit analysis and concluded that taking a vaccine that hasn’t been around for long using a new technology may not be in their best interest. Many of those people have been shamed and often coerced with the threat of losing their job into taking these vaccines.
    Now, the FDA is doing this with the JJ vaccine. What may come in time with the others? I can hear it now: “Did you or a loved one take the Pfizer Covid vaccine?”
    The last two years have been a shameful episode in American history. “The Science”TM is more like a religion, and “The Experts” are the clergy. Unfortunately, too many in the congregation drank the Kool Aid.

  7. From the article- “dangerous clotting condition called thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine.”… This condition is not “rare” ! In fact the writer of this article fails to show any data proving so… terms like “rare-hardly ever- sometimes- often- several times”… are subjective- and are used for opinion pieces only. Fact- if TTS was so rare- why this dramatic announcement !

    1. I am not going to allow you to continually lie about what I’ve done and we’ve over the past 2 years. I never made a “personal recommendation,” we quoted authorities in a position to make such recommendations. You have no evidence to disprove anything in this or other articles so you spin up falsehoods that thankfully most people now ignore.

  8. For those of you who have been extremely frustrated with Lertens heavy-handed participation rate on this board… here’s one he’ll never live down… as he got this about as wrong as wrong can be !

    “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.” …. This is absolute proof that the VAERS cases were being verified- while for two years Barney said they weren’t… he said it over and over every-time someone pointed out a death related to the vaccines. If I performed my job in such an arrogant and bull-headed manner- I woulda been out the door years ago. I’d really like to know who his supervisor is- the one that backs this nonsense !

          1. And as I said before- as a moderator- it is not your position to “add” any comment or attempt to bully pulpit the conversation in any direction… Mammabear123 did an excellent job of highlighting the concerns- you interfered with a sentence that has been proven wrong since the FDA pulled the first doses of the J&J because of what they found on the VAERS reports… so why would the CDC deny the validity of VAERS- yet- once again- back the findings of the FDA- based on the VAERS reports ??? Catch 22- good luck.

    1. Your lies are being deleted. I’ve NEVER blocked a SINGLE one of your or anyone’s comments. Even when you’re a jerk to me, WP Comments HAS no “block” capability – it can only delete users, but that gets rid of the comments that would buttress our defense of responsible moderation. Our new system might have such a capability, and we will rarely use it if so. But even when the issue rises in offensive manner like yours, I go back and look in the trash to see if the tech error you refuse to believe (and falsely believe is worth the time to fix) is there, and have approved them, many times, and you know it. Just did a few, 2-3 of random people, one yours. But yes, we delete offensive comments that violate Terms of Service, no matter the point on the political spectrum. That’s not a criteria – never has been, never will be. Your false spin won’t work, never has, never will.

      1. Nope- I re-posted a factual piece- quoting the article above and it’s been blocked from appearing twice now. So who’s the new moderator in charge of the TOS if its not you ?

  9. As readers can see- there appears to be a new moderator working this forum- I come to this conclusion by the term used above… “we” delete comments.

      1. So who checks your work ? Who is this mystery person that gives you that “atta-boys” to continue to provide misinformation about the VAERS program- which does indeed confirm and review cases- says so in this story ! Oh my- such a catch 22 !

              1. You didn’t answer the question- the FDA has used the VAERS reports to justify 2 shutdowns of the J&J vaccine- the CDC has agreed with these findings… so how does the CDC “not” believe these VAERS reports are reviewed or confirmed ??? What kind of government- colluding media mumbo jumbo is this doublespeak ?

                1. That’s because talking to you is useless. The VAERS statement linked to here makes clear they USE the data to investigate and make such calls, but not to let people like YOU who are NOT scientists to use/twist the raw reports to reach false/unproven conclusions.

          1. Quoting the CDC when you have to earthly clue to the validity of their statements is a travesty at best. KTVZ DOES NOT confirm the information quoted they just repeat it. That is NOT journalism at all.

  10. How can the CDC claim that VAERS is not reviewed or confirmed- then as we see in this article: “The agency’s updated analysis of the vaccine includes cases reported to its Vaccine Adverse Events Reporting System (VAERS) database through March 18.” !!! Stop arguing with me and admit that claiming VAERS is neither confirmed or reviewed is a factual falsehood… this isn’t difficult.

    1. You obviously misstate what CDC statement said! They said the data was uncorroborated but reviews and if patterns emerge, they are addressed.
      You seemingly can’t quote anyone without spinning into inaccuracies. You post falsehoods all the time. It’s quite a flaw in your character.

  11. Not one pro vaxx heckler on here? Where is tiozo and Martha or frog breath? Just a honest question to any of you that have received the J&J vaxx, are you upset or mad that it is now pulled because it is NOT safe after being told it was safe and effective for 2 years? If you or a loved one are harmed by it, are you upset that you can not hold any of these Pharma companies liable because they were never FDA approved? Would love a real conversation.

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