Johnson & Johnson single dose vaccine approved for use in the US again

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Earlier this month, the US paused administration of the Johnson & Johnson vaccine upon the recommendation of the FDA and CDC. At the time, six women between the ages of 8 – 49 who’d received the J&J vaccine had developed blood clots. After further investigation, the CDC lifted the pause and advised that the J&J vaccine be administered once again.

Johnson & Johnson’s COVID-19 vaccine should be used in the U.S. again, the Centers for Disease Control said Friday, after they advised a pause in inoculations while they investigated six cases of a rare blood clotting condition in women who received the vaccine.

The benefits of the Johnson & Johnson vaccine outweigh the small risk of blood clotting, a CDC panel decided. Federal health officials are expected to quickly follow their recommendation and advise states to lift the pause on inoculations with the Johnson & Johnson vaccine.

The CDC has suggested adding a warning label to the vaccine stating that “most cases” of the condition, which they’re calling thrombosis with thrombocytopenia syndrome, or TSS, have been in women between the ages of 18 and 49. Anyone who receives the vaccine will be warned to look out for symptoms like blurred vision, fainting, seizure and coma that could indicate they have TSS.

The CDC’s Advisory Committee on Immunization Practices met for six hours on Friday to vote on updated recommendations for using the vaccine.

“This pause was essential to our ability to inform the public,” Dr. José R. Romero, the chair of the advisory panel, said at the meeting, The New York Times reported.

[From People]

Since the initial reporting, nine more women reported clots, bringing the total number to 15. 13 of those women were aged between 18 – 49. However, with 6.8M people receiving with the J&J vaccine, that number equates to 1 in 500,000, which is statistically very low. I’m not trying to dumb this down, but it reminds me of those drug commercials on TV when they claim that this drug will solve whatever health issue you have. Then the disclaimer lists the possible side effects, and they sound so horrible, you wonder how they sell a single pill. But doctors will explain how rare those possible side effects are. The top health officials in this country have weighed all the data and determined the risks are low enough to continue administering. The truly scary numbers are the COVID numbers, how easy it is to catch it when unvaccinated and the damage it can do if you have it. And remember, it’s not just you that you’re protecting when you receive your vaccine. In Kentucky, one unvaccinated nursing home staff worker set off a COVID-19 outbreak within the home, that ended up killing one of the residents.

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32 Responses to “Johnson & Johnson single dose vaccine approved for use in the US again”

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  1. SarahCS says:

    This sounds very similar to the conversations in Europe about Astra-Zeneca (which I’ll likely be getting a week on Saturday and I am SO excited, I cried a bit when I got my invitation to book it).

    The sister of a man who died of a clot here in the UK was in the news explaining that it’s tragic but still so important to be vaccinated. It’s an interesting lesson in statistics and probabilities and as you point out, we take so many other things without consciously thinking about all the potential rare side effects.

    • lucky says:

      I cried when I got my first dose. I literally cried. It was a little embarrassing, but I was so overwhelmed and just said, “wow this is surprisingly emotional,” and the kind nurses just said, “I know it is exciting!,” and clapped for me.

  2. Frida_K says:

    As someone who always gets the rare side effects, this topic hits home for me. My second shot was in March and I’m still dealing with the fallout from it. I never really recovered from my first shot.

    I avoid sharing the horrifying details so as not to (a) scare others or (b) give any lurking anti-vaxxer ammunition. It has been bad, and that’s all I will say.

    I am so grateful for the vaccines and I am grateful for being vaccinated. But it’s hard to be an outlier who always has the side effects and I don’t know that I’ll be able to get boosters. I can’t go through this again.

    I also feel that the CDC does not have good resources for people like me. Their list of side effects in not complete. I did, after much digging, find reports of other adverse events like mine and I know of two other cases in my area with one of my major adverse events. So I am not the only one, though it does seem relatively rare, like the blood clots.

    But if you’re the one with the blood clots, it’s not a rare adverse event. It’s you suffering that pain and fear, and it’s no kind of fun.

    So yes, this hits a nerve.

    • Persephone says:

      Wow…Frida_K I’m so sorry you went through that. I work in Pharma and often wish there were alternatives in drugs/vaccines for people like you. Please stay safe.

    • Watson says:

      FridaK I’m sorry this happened to you too. May your health get better soon!

    • Jules says:

      My daughter had thrombocytopenia after getting the chickenpox vaccine. She also had a very serious reaction to an extremely common, widely used prescription medication. She had to go on steroid treatment and ended up in the ER three times in one week because of it. So she’s one of those people who always experiences the rare side effects. She spends a lot of time on SM and she’s heard of others who had similar reactions, so there may be under reporting.

      After the thrombocytopenia it’s been nearly impossible to get her an exemption. Some doctors simply refuse to tell me it was the vaccine, and even those who say it very likely was, tell us to continue vaccinating her hoping it’s a one-time occurrence. She was a teen when this happened, so she’s got all her vaccines but she’s had no boosters since.

      I understand the need to vaccinate most people, but when you’re slowly driving your child to the ER praying you don’t get in an accident and she bleeds to death, that really is all that matters.

      • Noodle says:

        My daughter, who was 4 at the time, developed shingles in her leg a week or two after receiving the chicken pox vaccine. It was wholly unheard of. Her pediatrician was shocked, and said it was likely a reaction to that vaccine, and not to give her that vaccine in the future. Shingles in a four year old was… awful. I know there are more awful diseases out there and I’m thankful she’s okay now, but those two weeks of just screaming, weeping pain I couldn’t do anything about, broke me.

    • pottymouth pup says:

      so sorry to hear @Frida_K. Like @Persephone, I also work in Pharma and have been encouraging everyone to make full use of v-safe to ensure adverse events are reported (I’m also obnoxious about telling friends to ensure any AEs they experience from marketed drugs are reported) because we need as much data as possible to be able to spot safety signals/identify populations at risk, etc.

      People who cannot be vaccinated or get boosters are the reasons we really need to combat the disinformation campaign and hysteria about the vaccines so we get enough people vaccinated to afford protection for those among us who aren’t because they can’t safely be vaccinated/get booster

  3. Jenns says:

    I had the J&J vaccine right before the pause. The news about the clots was concerning, but I also understood that there could be risks involved.

    As for side effects, I was pretty tired the day after. I also had that brain fog for about a week. Then, on day 8, I spiked a low grade fever that lasted about 24 hours(I took a COVID test which was negative). After that, I was fine.

  4. Watson says:

    This is a hard personal call. If you’re someone who’s experienced the 1% of terrible side effects of any drug or medical procedure I am sure that any new drugs are scary and terrifying. I know I was regarding AstraZeneca. But for me the risks of covid were higher than the risks of a potential side effect. I live in Canada and the third wave is real. The number of people i know who have gotten covid has risen exponentially and the idea that I could provide herd immunity to the people around me was/is a powerful draw. I feel better knowing I was part of a movement to try and save my kids who are unable to get the vaccine due to age from this pandemic.

    • derps says:

      My mom got that skin rash where your entire body sheds a layer after a shot just a few years ago and she is so terrified of getting it again. They know what ingredient caused it, and it’s not in any of the covid shots, but this is not a rational fear. She’s knows it isn’t, but she also just can’t shake it. So she still hasn’t gotten a shot even though she could have done back in January. We’re all just trying to listen to her and gently encourage. Hopefully, as the numbers of shots keep going up by way more than the adverse events she will calm enough to get it.

      That said, she still masks up and respects everyone else’s preferences for normal social distancing or extreme social distancing (we’ve got some in the family whose irrational fears go in the other direction) or whatever. I really feel for people who’ve had one of the rare side effects of any medication, it can be really terrifying.

  5. Sigmund says:

    Unfortunately, the built in “solution”, for lack of a better term, for people who can’t get the vaccine (or who are more likely to suffer side effects) is supposed to be everyone else getting widely vaccinated, which will still protect the vulnerable people who can’t get vaccinated. But thanks to the Republicans politicizing this, it’s become an issue of “choice” (and yeah, the irony of their use of the word is not lost of me).

    Anyone concerned should talk with their doctor. Get the vaccine if your doctor says to. Protect yourself and your family.

  6. sa says:

    They’re warning anyone who gets the J&J vaccine to to look out for symptoms that include coma? If it was J&J vaccine or no vaccine I would get it because it’s obviously lower risk than covid. But since there are other options that, as far as I’ve heard, don’t include the risk of a coma, and since I am a woman between 18 and 49, I’m good with getting one of the other vaccines.

    • FHMom says:

      Absolutely. If the two other vaccines are available, chose one of them.

    • Watson says:

      Im guessing that people opt for the j&j due to time and money. Not many people can take paid time off for medical appointments and a lot of Americans have not taken their second shot.

      • FHMom says:

        My daughter is a college student. I got her the J&J because is was the fastest route to immunity, and college students are bad at social distancing and wearing masks.

      • Watson says:

        FHMOM: that’s a solid reason to get the J&J shot. Good for you for getting the most logical vaccine did your kid!!

      • anon says:

        I opted for the J&J because I have a phobia of needles and given the choice of one shot or two I will choose one. I had it before the new of potential blood clots came out but if given the same choice today I think I’d make the same decision.

  7. Sayrah says:

    Hopefully vaccine hesitant people will opt for Pfizer and moderna instead of nothing. I work in pharma and you’re right that companies have to list all possible side effects. We even had a broken ankle as a possible side effect for a blood pressure drug because someone in the study happened to have one during the clinical trial.

    • derps says:

      Yes! You can always ask and see what the latest shipment has been at the various pharmacies, clinics, et al. in your area. We were specifically trying for the Pfizer bc at that time it was doing much better than others against the variants and we have a vulnerable person in our home who can’t get the shots. We were able to establish that the local Kroger was doing Pfizer shots for the next 2-3 weeks while the county health centers were working through a Moderna shipment. No one tried to obfuscate or refuse us the info, they answered straight out when we asked. Medical professionals want to help us all to feel comfortable getting the shot and to be protected. So if anyone is concerned just ask, and a get a shot, whichever it is.

  8. Lauren says:

    I’m in the age group at risk, but I’m hoping to get the J&J shot. I’m terrified of needles. Going in for one shot is going to be traumatic enough, I really don’t even want to think about going in for a second dose, but at this point, I’ll take whatever they give me.

    • Chicken Tetrazzini! says:

      Good for you being brave enough to go get your shot still! I don’t know if it’ll help lessen your anxiety, but as someone who had hundreds of shots for allergy relief (1000% worth it by the way) I feel like I’m an expert in shots and the vaccine shot felt like nothing. It’s over very quickly and there’s a good chance you’ll barely feel it. My 66 yo mother is terrified of needles as well and she said it was fine. I hope you get yours soon so you can be done with it and not have it looming ahead of you all scary but necessary!

    • Summergirl says:

      Lauren, I’m here in Canada, and my only option for getting vaccinated now is Astra-Zeneca, which carries the same risk as J&J. And even getting AZ was hard! Our booking system in Ontario is a mess. I’m prone to medical anxiety so I was really anxious about getting it and still am anxious. But I keep reminding myself that the risk of COVID is so much greater (I’m in Toronto and things are terrible here, we have field hospitals), and the risk of getting clots is so much greater with so many things people don’t think twice about: being on birth control, taking a flight longer than 4 hours, and of course having COVID itself. You can do it, Lauren! Good for you for having the strength to confront your fears. By the way, the shot itself barely hurt at all. (I understand that knowing that won’t necessarily lessen your anxiety about it). Soon you will be on your way to immunity!

    • KPS says:

      @LAUREN – I’m extremely needle-phobic as well! When I filled out the online vaccine through our state site (CA.gov) alI added this to the “Other” – Special Needs. Unfortunately, it didn’t transfer to the Med Clinic. However, when I got there, spoke to the nurse and they set me up in a special area. I always tell any healthcare professional – “I’ll either be HORIZONTAL during the shot or after the shot – get it. Take your pick.” That, they understand. DEMAND what you need! The nurse then moved me to a special area where I was able to lie down during the shot and the 15 waiting period afterwards. NO ANXIETY ATTACK.

    • Lauren says:

      Thank you so much for your comforting words ladies! I am a big believer in vaccines and I’ll get it regardless of my fear. I start hyperventilating and crying when someone is coming at me with a needle. I go once per year to get my blood drawn for tests and such and I explain to the nurses beforehand and they are such darlings. They start talking and keep my eyes away from the needles, even when I try to look they say “eyes on my face” and keep talking calmly to me. I know logically that there is nothing to be afraid of, but tell that to my fears. I will be getting my vaccine for sure, I just hope that it is soon.

  9. ThatgirlThere says:

    I think I shared this here already, but there was an abundance of the J&J vaccine at one of the vaccination sites. I jumped on that so fast and signed up for a slot two weeks ago. I am very, very grateful to have gotten my one and done shot.

  10. Gigi says:

    Hubby and I received our J&J vax in mid-March by sheer luck (read: stalking the vax appt website); a few days later, our middle school (unvax’d) daughter tested + for C19 (she was staying with her mom for the week prior to her test). My husband tested + a few days after her (before the 2 week period for vaccines to take full effect). I quarantined with both, even had close contact with both during our 3 week quarantine and I did not test + at all (took 4 rapid & PCR tests in those 3 weeks). Moral of the story: vaccines work in preventing transmission and protects your loved ones. GET VAXXED!!!

  11. Karen says:

    I have never posted before. I usually just lurk and devour the royal soap opera as a distraction from my serious government job, but I know how emotional this whole topic can be, so I wanted to add that I got the J & J before I knew about any of the side effects, and I would get it again. I was outside gardening when a friend called to say her husband had just gotten word from a medical colleague that a mass vaccination site was nearly empty and to please send anyone he could so the doses wouldn’t go to waste. I was home with two of my young kids, my husband wasn’t home, and I don’t own a car. I bike everywhere, but the vaccine site was several miles away up some very large hills along routes that are dangerous for traffic conditions, and I knew I couldn’t get my two daughters up those on our cargo bike by myself. I threw down my gardening tools, ran down the street to get a car share, installed my daughters’ car seats, and packed a snack bag and a car sickness kit for my youngest, and was on the road, all within the span of five minutes. That’s how excited and determined I was to get a vaccine as soon as I could.

    My husband got his J&J vaccine a few days later through his work.

    FWIW, I am in the age bracket identified for clot risk, I am in very good health, not prone to adverse side effects beyond an allergy to one class of antibiotics, what you would probably call slim or skinny, and not on hormonal birth control.

  12. equality says:

    Got the J&J shot 18 days ago and everything is fine.

  13. Christina says:

    I had Covid in November and I got an antibodies test done this week to see if I had anything left and I didn’t. So, today I got my first dose of Pfizer. I live in Romania and the vaccination process is moving along quite well. Almost everyone I know got their vaccine. I think most of the people left are the ones that are still hesitant about getting the vaccine or they don’t want it.

  14. Frida_K says:

    On edit: I meant to reply to the responses to my comment, above.

    Thank you, @Watson, I truly appreciate your well wishes!

    I’m glad that your pediatrician didn’t try to gaslight you, @Noodles. And @Jules…I feel you. What makes me angry about trying to deal with MDs is the “It can’t be the vaccine…” response, which to me is gas lighting. I TRULY understand that some things are not a straight line from vaccine to health problem. But if the vaccine set something in motion that secondarily becomes a very serious health problem, then whether or not it’s a direct result of the vaccine is irrelevant.

    I did report to the VAERS site, @pottymouth pup, and thank you for your kind words, @persephone and @pottymouth pup.

    What I find distressing about my situation is that I actually found a report written for pharmacists by pharmacists and it clearly stated that three people in clinical trials had one of my alarming adverse events. You have to be willing to read a long, dry, densely-written professional report, but it is there. I also found another study in which researchers gathered data on another, related, alarming adverse event I experienced. This was a compilation of post-vaccine advents of the specific sort that I experienced. They clearly stated that this is a very rare adverse event, but that they do occur post-vaccine, and they compiled and presented all the data.

    So to pretend like this never happens is not convincing and to not list it as a potential side effect is rotten, I think. Scientists know that it happens. It’s just very small-scale, about on the level of the blood clots, and I guess not as news-worthy. Unless you happen to be one of the unlucky ones to experience it.

    Again, I am so glad to be vaccinated and so grateful for the vaccines. But I cannot do this again. I cannot.

  15. Sam says:

    The J&J news was concerning , but I had a friend who got it the day before the pause. Her doctor just asked to see her that week, but everything was fine. I’m a very anxious person and was dreading the side effects from the 2nd Pfizer shot since my partner was very sick 2 days after his. I tried my best to eat well leading up to it and take anti inflammatory supplements. The side effects for me were not so bad. The day after felt maybe like I took benadryl and sort of slept most of the day and listened to meditations in bed. I was shocked , since I usually get weird side effects from medications.