FDA and CDC recommend pausing Johnson & Johnson vaccine due to rare blood clots

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In shocking news, the FDA and CDC are calling for an immediate temporary halt in use of the Johnson & Johnson coronavirus vaccine as they investigate the occurrence of a rare type of blood clot. In 6.8 million doses administered in the US, only 6 cases have occurred, all in women from 18 to 48. The treatment is different for this rare type of blood clot, and they want to get the word out that the typical treatment of heparin is contraindicated. Representatives from the US agencies will be meeting on Wednesday to examine the cases and make a more permanent recommendation about the vaccine. So far Ohio, NY and Connecticut have halted doses and it is expected that the government will temporarily stop using the J&J vaccine at federal vaccination sites.

The US Centers for Disease Control and Prevention and the US Food and Drug Administration are recommending that the United States pause the use of Johnson & Johnson’s Covid-19 vaccine over six reported US cases of a “rare and severe” type of blood clot.

The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States.

All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to a joint statement on Tuesday from Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“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,” the statement said. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”

The statement also noted that these adverse events “appear to be extremely rare.”

“It’s a very rare event. You’re talking about 1 per million, and when you give millions of doses of vaccines, you will see events like this that you couldn’t see in the clinical trial just because you didn’t have millions of people enrolled,” Dr. Carlos del Rio, executive associate dean of the Emory University School of Medicine at Grady Health System, told CNN’s John Berman and Poppy Harlow on Tuesday morning.

“But I want to congratulate the CDC and the FDA for very quickly jumping on it, halting the vaccinations until we know more, and really trying to understand what’s going on,” del Rio said. “I think vaccine safety has always been a priority — and I think this is exactly the right move until we understand what’s going on and what’s the way forward.”

[From CNN]

I feel so bad for people who had J&J vaccines scheduled and now have to wait. While over a quarter of US adults have been fully vaccinated and 40% have received at least one dose, there are still so many people waiting to get their shot. Incidentally my ex husband got his first shot in Germany with the AstraZeneca vaccine, which requires two doses. Due to incidents of rare blood clots, they stopped giving the AstraZeneca vaccine in Germany to anyone under 60. They’re now recommending that people under 60 get their second shot from Moderna or Pfizer.

It makes sense that the FDA and CDC would investigate these rare side effects from the J&J vaccine. From a layperson’s perspective a 1 in a million severe side effect doesn’t seem to outweigh the benefits of getting more people vaccinated against a deadly virus. I’m sure they know what they’re doing though.

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photos credit: CDC and Alex Mecl on Unsplash

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42 Responses to “FDA and CDC recommend pausing Johnson & Johnson vaccine due to rare blood clots”

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  1. Rapunzel says:

    My dad got the J&J vax. He only wanted a one shot. He’s 72 and had no side effects. Said it actually increased his appetite.

  2. nicegirl says:

    Portland saved & administered J&j vaccines to many houseless individuals. Hoping they are safe & receive all necessary care. We’re sending out street teams now in attempts to locate some previously given the J & J vaccine.

  3. fluffy_bunny says:

    I wonder if any of these women have a gene mutation for Factor V Leiden? It causes clots. My sister has a 2 gene mutation and suffered multiple miscarriages because of it. My other sister and I only have 1 mutation. I’m so glad none of us for the J&J vaccine in case there’s a link.

    • LBB says:

      I have it as well and wondered the same thing about the women. I also think it may be a combo of Factor V Leiden and they take birth control pills on top of that? My soon to be husband got the J and J and I would have but ended up getting Pfizer first.

    • pitch says:

      With AstraZeneca it is said that the cause is an autoimmune reaction and that there is no connection with other reasons for incereased thrombophilia. I don´t know about J&J though

    • LWT00 says:

      That’s very interesting. I’ve been told to not get vaccinated for now because I recently gave birth and developed HELLP Syndrome in the process, which also causes thrombocytopenia. I just asked my doctor if she can order some blood tests to see if I have autoantibodies and if I’ll ever be able to get one of these vaccines!?

  4. faithmobile says:

    Why not halt the vaccine just for women? It seems wasteful to halt it for both genders.

  5. Amelie says:

    They did the same with Astrazeneca in Europe but I think they have resumed letting people get it? Hopefully they are able to figure out from the small group of women getting blood clots any similarities in health and predisposition. Like maybe they’re all taking a similar type of medication or birth control? I hope they don’t completely halt J&J in the US because I know people really want to be just one and done. I’m fully vaccinated now but I honestly wouldn’t want to get two separate shots from two different vaccine manufacturers because one of them was temporarily paused. That’s too much of a gamble in my mind.

    • AlpineWitch says:

      In UK you can only have the AstraZeneca if you are over 30 now. We had 79 cases of blood clots, of those 7 died. It’s a rare incidence but I am worried as I have hereditary issues with blood clots already…..

    • Lauren says:

      Only some European countries stopped using AstraZeneca for a few days until the EMA (the European FDA) decided that the risks were negligible. In Italy, the damage was already done by the time they decided. A lot of Italians are hesitant to be vaccinated with Astra, in Sicily 80% of the people that were to be vaccinated with Astra gave up on their turns. The fact that we were supposed to start using the J&J vaccine tomorrow means further delays until the EMA can reassess the risks, and it means that I will need to wait longer since I’m in my 30′s and considered low risk. This sucks.

  6. Down and Out says:

    I got J&J. No side effects. I understand the caution that they are taking (particularly due to the type of clot), but honestly birth control carries a greater risk of clotting than this. Also there are many studies out there on thrombosis in hospitalized & deceased COVID patients that are incredibly scary. I’ll take my chances.

    • anon says:

      I got the J&J and got sicker than I’ve been in years… body aches, fever, worse chills of my life (I was so cold), nausea, headache and vomitting. My arm also hurt for a week. That said I am glad I got it.

  7. Liz version 700 says:

    The thing is, it is good that they are looking at this and it needs to be done, but I sure hope this doesn’t derail the progress getting folks vaccinated. They need to make it clear the other vaccines are safe. This is such a small number out of 6 million shots. The percentage of women who get blood clots from birth control is so much higher, but that is just women so it’s ok?

  8. Sunday says:

    This is after the NY Times reported a few weeks back that 15 million J&J doses had to be trashed and future shipments paused from one factory because they “mixed up” the ingredients. I am 100% NOT an anti-vaxxer and was lucky enough to get my first shot last week, but I’ve been side-eyeing J&J because this is the same company that had to be sued into oblivion before they finally decided to pull their carcinogenic baby powder. The numbers for these clots seems really low, and I totally get why people would want any vaccine they could get their hands on; mostly it’s just the general state of healthcare and having to put your health in the hands of shady corporate overlords that’s depressing.

  9. dawnchild says:

    It’s creating a huge logistical mess. My daughter works in Covid response in Philly. Thousands of cancelled appointments at the FEMA sites and others. And this after they spend days on the phone answering questions about J&J…
    Still…hopefully they’ll have good information going forward

  10. Emm says:

    Read this this morning and just ugh. My very trumpy very weary of the vaccines parents JUST got the j&j last Friday and now….I’m waiting for the texts about how I shouldn’t have pressured them to get this and “see this is why we didn’t want tooooo!!” When I never actually pressured them, I just told them they should do it and not to believe the insane conspiracy theories about microchips in it. They are both in their mid/late 60s but both are on medications for various things and my dad has had a couple of strokes from blood clots from high blood pressure. My husband and I thankfully are now fully vaccinated with the Pfizer.

    • Kebbie says:

      You should just reassure them that it was six cases out of 7 million, all in women under 48.

      It is so, so much more likely that they would die of covid than the J&J vaccine. They made the right choice and so did you for telling them they should get vaccinated.

      • Liz version 700 says:

        Exactly! And in a normal population there is a resting incidence of blood clots so that needs to be looked at. 6 out of 7 million vs 570,000 dead just in the US. No drug is 100% safe but the odds are sure better with the vaccine. I just hope the press handles this calmly and doesn’t blow it up and make people afraid to get vaccinated. The results of that would be horrific

      • Emm says:

        Oh I totally agree with you but convincing them of anything is next to impossible which is why I was shocked when they texted me that they had scheduled their appt for that day for the j&j. I mean these people only watch faux news and are on the FB echo maga chamber all the time which is how they get their “information” and why they are the way they are right now. They will believe some rando on FB ranting about bill gates trying to control the population and make you stop believing in Jesus before they believe me when I come with facts and reason. Because at this point they, especially my dad, is fully immersed in the crazy right wing conspiracies that are out there because everyone is out to get him and he is a victim just like faux news tells him.

  11. Midge says:

    I’m working as a medical evaluator at the largest vaccination site in the country. (Well over 400,000 doses given so far.) We are giving JnJ today. This is not a statistically significant event and less prevalent than in the general population.

  12. Lunasf17 says:

    Ugh, this is going to add so much fuel to the anti vax fire and I think many people on the fence about the vaccine are going to refuse it. I hope everyone is safe. I got the Moderna and the second one was rough so I was kind of jealous about the J and J being one shot. I hope people can get the other ones easily!

  13. Dana says:

    I got the Johnson & Johnson on Sunday. I know it’s too soon to tell about the clots, but I felt no side effects except for a mild body ache (a little intense less than a hard workout). I’ll be cautious because of the clotting but I’m not too worried.

  14. Tanya says:

    Ugh. I expected better of this administration. More people will get sick and die from getting COVID due to this decision than will be saved. The J&J vaccine is the only one that can be taken into the community, as opposed to making the community come to you. Plus the EU just studied this!

  15. Concern Fae says:

    What the articles seem to be missing, but doctors/researchers are talking about is that the normal treatment for blood clots can make vaccine caused clots worse, and this may be the cause of the fatalities. The pause may just be to let doctors know if someone has clots, to use treatment X rather than the norm, if they recently got a COVID vaccine shot.

  16. lucy2 says:

    NJ paused it here today too. I hope they are able to figure it out quickly, and no one else has such a serious side effect. A lot of the J&J supply here was being used for people who can’t easily get to a vax center, so I hope it is safe to resume as soon as possible.
    This is not going to help with all the anti-vaxxers and people spreading false info. Ugh.

  17. Kkat says:

    The 6 women got brain clots, and because of the low platelets we wouldn’t be able to use the typical clot busting treatments.
    Spot flood the clot with heparin to dissolve it or shrink it so it can be grabbed

    The JJ uses the same technology as the Astra Zeneca vaccine.

    They (vaccines) can all temp lower platelets in the first week of the immune response, but then it rebounds. There have been enough cases of heavier periods in the first period after the shots due to not clotting as well that OB/GYns have been noticing and collecting information.

    So one of the things to look at is why did these women get this type of brain clot, what do they have in common. And is it even related to the low platelets or is it a separate issue that is just compounded by it.

    I personally got the pfizer and my kids just did the same on Saturday. I wanted a mrna type that targeted the protein. The JJ and AZ vaccines do not target the protein.

  18. gabriella says:

    My daughter got the J&J last Wednesday. That night she experienced fatigue, muscle aches, nausea, vomiting and headache. Sunday she got a rash. Today she has symptoms of a blood clot and campus police are escorting her to the ER. I’m still pro-vaccine. I get my second Moderna next week.

    • User4355 says:

      I hope your daughter is okay! I got the J&J vaccine about 3.5 weeks ago, so I am not happy about the news coming out today. Luckily I have not experienced any adverse side effects.

      • gabriella says:

        Thank you! I’ll update when I hear anything else. As of right now they took her vitals and are doing blood work. Her reaction to the vaccine was within 7 hours.

    • Emm says:

      Oh my goodness, I hope she is ok!

    • Liz version 700 says:

      Holy cow I hope she is ok!!!

    • gabriella says:

      Update:
      Daughter was discharged from the ER. Blood tests showed no clots. She doesn’t feel that great but it looks like everything is ok. Thanks everyone for the well wishes!

  19. Emm says:

    This was meant as a response to @KKAT

    Thanks for this info. I also read an article about women who have been commiserating online about changes in their cycle after the shots. I for one got my period two days early, two days after my second Pfizer shot. I had some side effects from the second shot, like body aches, chills, headache, and just figured that’s why I got my period early, because my body thought I was sick.

    • phlyfiremama says:

      Ooh, I was playing Pokemon in my park & talked to another woman (also playing) who said that since her vaccine, her periods CAME BACK even though she is well past menopause age. Hmm, blood organs (uterus stores menstrual blood until it sloughs off) and blood related complications?? Sounds like some hormonal disruption. Let me check with my fellow Acupuncturists on FB and see what we have come up with regarding this!

      • Kkat says:

        People with endometriosis are having issues too.
        Covid is a vascular disease, that causes clots. So having platelets lowered to cause blood not to clot makes sense.

        My sister and I are on IR surgical teams and we have been seeing a HUGE upswing in covid related issues. Clots, lots of strokes, masses of micro clots in hears, lungs, kidneys. So many kidney failures and prepping people for dialysis.
        And this is in young people that shouldn’t be experiencing this.

        I think there will probably be some surprises with the vaccine

        But I don’t think we’ve seen anything yet with covid, the rate of secondary damage from mild to moderate covid cases is… Not good.
        And this is early short term damage, I dread what we will find out in 5-10-20 years

        I hope enough people get the vaccine, we need to stop the rapid spread and keep it from mutating further

  20. Snrub says:

    Utah just “paused” them too. I was supposed to get mine Thursday 😞

  21. Jay (the Canadian one) says:

    1 in a million might be rare, but if there’s another option (Pfizer/Moderna) that’s even safer, it can make sense to shelve the less safe option even if it’s marginal. The prime argument against that is if time is of the essence and this slows things down.

  22. Pocket Litter says:

    Had J&J on Sunday. Signed up for the app, and am basically charting myself daily. Keeping an eye on everything. Some side effects so far, but they’ve been more annoying than anything. I’m older than the clotting age range, but still, data is data.

  23. Carabella says:

    When this story about the brain clots first broke, it was reported that two men had them as well. It was also reported a 25-year-old male with no medical history died of a brain clot during trials but his death was dismissed as an anomaly. The story has been distilled throughout the media to “six women, one critical in hospital and one has died” but men have been affected, too.