FDA

The FDA's 'Safety Pause' Predictably Lowered Americans' Confidence in Safety of J&J COVID-19 Vaccine

Who could possibly have known that that would happen?

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Food and Drug Administration (FDA) bureaucrats imposed a "safety pause" on administering Johnson & Johnson's one-shot COVID-19 vaccine on April 12. The agency recommended that inoculations of the vaccine come to a stop after six women out of nearly 7 million people who received the shot reported experiencing dangerous blood clots. At the time, various public health experts insisted that this safety-first response was taken in order to "maintain public trust" and could "actually build confidence in people" in the vaccine.

Other commentators pointed out that this highly risk-averse regulatory action would backfire and would instead make Americans more worried about the safety of the vaccine.

Last Friday, after 10 days, the FDA lifted its pause. The agency concluded that "the available data show that the vaccine's known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older."

So did the pause bolster the confidence of Americans in the vaccine as predicted? Not quite. "Fewer than 1 in 4 Americans not yet immunized against the coronavirus say they would be willing to get the vaccine made by Johnson & Johnson, according to a Washington Post-ABC News poll that finds broad mistrust of the shot's safety after federal health officials paused its use," reports the The Washington Post.

"If I hear the phrase 'abundance of caution' one more time, I'm going to jump out of my window," Paul A. Offit, a vaccine expert at Children's Hospital of Philadelphia, told the Post. "In the name of transparency, in the name of openness, we scare people."

Scaring people away from being inoculated with a very safe and effective vaccine means that more will die from, become hospitalized by, and suffer the miseries of the COVID-19 infections that would otherwise have been prevented.

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  1. “If I hear the phrase ‘abundance of caution’ one more time, I’m going to jump out of my window,” Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia, told the Post.

    “Philadelphia Vaccine Expert Dies From Covid”

    1. How did he react when he heard “nursing homes have to take in Wuhan virus patients, and I’m pulling my parents out of the home”?

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      2. About the same as he reacted when he heard “vaccine makers have no liability for vaccine damage and are able to release a vaccine with less than 6 months of trials under emergency use authorization even though vaccine trials typically take 5-10 years”

    2. Unstated: his office is on the first floor.

  2. Being told to wear a mask after getting vaccinated lowers the confidence in vaccines even more.

    1. As does the need for booster shots.

      1. The booster shots aren’t the issue–the polio vaccine required three when it was first released, for example.

        The biggest problem is these assholes aren’t providing guarantees that all this shit is going to end when people get vaccinated. They’re telling people who are vaccinated that they need to wear masks indoors and at large events like concerts, like the OP stated. They finally decided that you didn’t need to wear a mask if you were outdoors at a park, even though there’s never been any evidence for months that the coof spreads through casual, incidental contact AND getting people outside in the fresh air instead of huddled inside likely would have cut down on infections.

        If getting the vaccine still comes with all these caveats, then what’s the point in getting it?

        1. If getting the vaccine still comes with all these caveats, then what’s the point in getting it?

          So when you flee to a free country in a year they won’t make you quarantine for a month.

          1. If you find a free country let me know. I’m looking.

    2. Confidence and fear are all part of a balancing act. When perception of risk of illness/death and the fear from risk that are off the charts, confidence in the vaccine becomes secondary and people are willing to do just about anything. People will take huge risks to avoid a bee sting or a dog bite.

      However, when perception of risk of illness/death goes down, people start reevaluating their options in terms of confidence in the solution and perceived necessity to risk the unknown. One can argue that they start making more rational decisions [regardless of whether they are right or wrong in the conclusion].

      We were hearing about people getting sick 5000/day in my city, and now it’s basically down to 200/day, most of which are millennials hooking up at the bar. We are all taking a look at this and realizing that despite all the hype, 9/10 of us still haven’t gotten sick in 14 months of threats of near certain death and only 1/10 of 1% died of COVID, most of whom would have died of the next thing that hit them anyway.

      The media was driving the fear that led to the rush to vaccinate, but now that Biden is in office, they don’t want to push that fear button anymore. The numbers are down, the people who were vaccine crazy have been satisfied, people are tired of the bullshit, and now the question of confidence for the remainder becomes a far bigger deal.

      What I notice missing here is confidence in the JJ version vs other versions. Funny that it’s just not mentioned.

    3. It should be temporary. Already they said you don’t need to outdoors even if it is a gathering.

      At the current rate we are vaccinating 10% of the population a month. When we get to 60% or more and most double dosed we should get to a rate where we can open back up as we see happening in Israel.

      Vaccines are the way out of this. It is really up to the people now.

      1. Or, how about this you bootlicking piece of shit state worshipping faggot: we could not do any of that and tell you and your brownshirt buddies to go fuck a tree stump because natural rights are not secondary to a virus that causes the same symptoms as the common cold or seasonal influenza.

        “If you stop being so stubborn I wouldn’t have to keep hitting you, baby!”

  3. Let not forget that J&J screwed up a large batch of the vaccine at the production plant. There is more than one party culpable for the loss of confidence in this company.

    1. J&J didn’t make the mistake.
      “ The plant is run by Emergent BioSolutions, a manufacturing partner to both Johnson & Johnson and AstraZeneca, the British-Swedish company whose vaccine has yet to be authorized for use in the United States. Federal officials attributed the mistake to human error.”

      1. To be fair, when I first heard the story snippet on CBS, they made it sound like a J&J manufacturing plant had botched millions of doses.

        It wasn’t until I read more about it online that I heard that it was a 3rd party partner.

        1. Fortunately we have plenty of the two best ones and they give better protection.

          It seems to be the topic when we talk with people now. Team Pfizer or team Moderna and did you have any side effects. I haven’t met any never vaxxers yet, or nobody who would admit it. My wife knows someone but she is a truly nutty winger to the point of Q anon.

          Good point Minadin. Most people don’t know that J&J is actually dozens of companies making all kinds of things.

          1. There’s a difference between not taking an experimental vaccine only authorized under emergency use provisions for which the vaccine maker has special exemption from legal liability for damages which is protective against a virus with a 1/10 of 1% fatality rate and a less than 1% rate of hospitalization for people under 70 years old and being “never vaxxer” you pathetic piece of shit state worshipping faggot. As long as you’re slithering around on your knees, feel free to suck my nuts.

    2. I was talking with a buddy over the weekend. His mother doesn’t trust J&J because they “lied about baby powder and cancer” back in the ’80s. I missed that particular scandal but it shows how easy it is to lose trust and how long it can take to earn it back.

      On the other hand, the bright sparks at the CDC were between a rock and a hard place. Either they call a pause, knowing that will undermine confidence or don’t pause and risk another “but you _knew_ this was dangerous” situation.

      In a sane world, they could have just announced “we’re heard of clotting issues, we don’t see a problem yet, we’re carefully looking into it to make sure there’s nothing there, in the mean time, you’re better off getting jabbed than not.”

      1. “you’re better off getting jabbed than not.”

        Unsupported assertion.

      2. In a sane world we wouldn’t be forced by the government to take a vaccine that their own drug-approval agency has not studied long-term and has only authorized under emergency use provisions all to address a virus that causes mild flu symptoms for 99% of people.

        1. Or hey, if J&J wants to prove how safe their vaccine is and how much they trust its safety and efficacy, they could waive their exemption from legal liability for vaccine injury. That might win the public’s trust.

  4. Perhaps a small refresher in reality – – –
    All vaccines currently administered in the USA are under an EMERGENCY USE approval.
    None have been under a scientific trail on fertile females.
    None have been under a scientific trial on children/youth.
    None have had a long term study on effects.
    Those being vaccinated at this time are in fact the long term study subjects.

    1. Those being vaccinated at this time are in fact the long term study subjects.

      Pretty much–that’s why these companies are exempt from being litigated if something goes wrong down the line. That’s the hedge in case this turns out to be like every other attempt to produce a coronavirus vaccine.

      1. turns out to be like every other attempt to produce a coronavirus vaccine.

        Oh do tell us about the previous attempts re a coronavirus vaccine. If you know, you’ll know that those were near irrelevant to this one

        1. Yeah, fuckface, “we’ll get it right this time.”

          1. Oh – so you actually don’t know the first thing about those previous attempts.

            SARS and MERS went extinct before the vaccine could be tested. We didn’t have that problem because we don’t do public health in the US and because politicizing the virus encouraged it to grow/mutate.

            The ‘cold’ virus vaccines would have to include about 200 different viruses. All of which are relatively (compared to say influenza where annual vaccine includes three strains of ONE virus) inconsequential anyway. So the problem there is more along the lines of ‘ok rub your belly. Now pat your head. Now pat your belly. Now rub your head. Now do all that at the same time’

            1. SARS and MERS went extinct before the vaccine could be tested.

              Guess what you retarded fuck: COVID-19 is called SARS-COV-2. Know why it’s called SARS-COV-2? Because it’s a fucking SARS variant. COVID 19 posed no more risk to the pubic than the first SARS scare and would have faded into the background in the exact same way, except that it was politically expedient to use it an excuse to collapse the world’s economy and manipulate a presidential election.

              Kinda funny how you’re so on board for a government-mandated vaccine for a virus of no appreciable to risk to anyone under 70 years old who isn’t 300 pounds overweight and yet latch onto batshit conspiracies about how Hugo Chavez was poisoned by the CIA. You should really consider shutting the fuck up and/or killing yourself.

            2. Literally nothing you said here refuted my comment.

    2. This is true. All the clinical trials were focused mainly on retirement age folks where long-term effects just don’t matter. The JnJ vaccine was based on the work they have done re an Ebola vaccine – a hemorrhagic disease where clotting is GOOD. Anyone who had that particular problem would have been seriously harmed by the regular way that blood clots are treated. And what was missing was actual information about any of this.

      It would have been obscene negligence to just keep jabbing people and in effect covering this all up because events were in rapid motion. This is exactly the sort of situation where a clinical trial itself would have been suspended until more information was known.

      Getting pissy about the wording of the pause is the height of fucking stupid.

    3. At least there’s one sane person on this fuckhole of a website.

  5. Same Americans who probably masked up and cowered in their homes.

  6. One often hears the word ‘literally’ misused, as in “my head literally exploded!” In this case, of seven million J&J vaccines used, seven women reported blood clots – literally a million to one risk. One died, making the risk of death seven million to one, literally.
    If some people were struck by lightning within a two week period following vaccination, would we fear J&J thunderstorms? There is at present no real way to tie the clots to the vaccine other than that they followed the vaccination.

    1. Exactly. This is people that get a blood lot after getting the vaccine. At a lower rate than people get blood clots as a normal part of life.

      1. Yeah, I think I remember hearing that it was something like a 5 in a million chance that women in this age range would develop these rare sorts of blood clots without the vaccine, which means the J&J vaccine is potentially 80% effective at preventing these blood clots.

        Which is higher than its efficacy rate against covid-19.

        1. It’s whatever lines someone wishes to draw. How many people got pregnant, lost their job, had a car accident or got a job within a month after getting the vaccine? Once again, correlation doesn’t equal causation.

      2. Something like 1 in 1,000 develop clots from birth control pills and we don’t even think about that.

        Don’t quote that stat without a caveat: I don’t know the source and don’t know the timeframes.

      3. They developed low platelets for some reason. Same thing can rarely happen from heparin which is actually a blood thinner.

    2. In this case, of seven million J&J vaccines used, seven women reported blood clots

      No. In LITERAL fact, those seven million are not tracked or monitored after they get the vaccine. So in fact you have no idea how many of them had – or will have – blood clots but were successfully treated. What happened to those seven women is that the treatment for the clotting went bad – with a similar and rare clotting problem – and in all likelihood the JnJ vaccine was what they had in common.

      Further, the clotting issue is gonna likely be a problem that first manifests with pre-menopausal and pregnant women because they have many more clotting proteins/factors in their blood. How many of those seven million injections were given to young pregnant women?

      1. This was a specific unusual type of clot which occurs in the dural sinuses that drain the brain. Also they had low platelets for some reason.

        So very low risk far outweighed by the benefits but maybe something going on there.

        1. The treatment problems for blood clotting had the combination of CVST and low platelet. For both the JnJ and AZN vaccines – both of which are also viral vector vaccines where the research was done on hemorrhagic viruses. In both those cases, the treatment problem that pops up is clinically similar to heparin-induced thrombocytopenia (HIT). Heparin is the treatment for well over a million clotting problems (strokes, heart, and lung) each year. If the JnJ and AZN vaccines instead tend to lead to heparin being the proximate cause of a clotting problem, then there’s a potential big problem there. And possibly more long-term than short-term if the problem is less about the vaccine creating the clot than about the combination of vaccine and heparin and virus itself creating the brain clot.

          And the JnJ stuff is now at 11 women – average age just over 30. Personally, I would advise pre-menopausal women (and possibly under-60’s who have had stroke/etc clotting problems without other co-morbidities) not to take either the JnJ or AZN or Russian (another viral vector) vaccine. Course I’m not a doctor either – but statistically there’s a scope-yet-unknown problem with the viral vector vaccines.

          1. there is also a property-rights issue here. JnJ has asked the other vaccine producers for info regarding clotting issues in their clinical trials. Maybe for sleazy whatabout reasons. But there’s also highly legitimate issues here that can’t be resolved in our current system where the clinical trials data is considering purely proprietary (and national when not proprietary).

            1. That kind of cooperation is not uncommon. There are certainly trade secrets but sharing information when you are talking about a complication is something else.

              It has nothing to do with work done on other pathogens. These vaccines are highly specific. They are copies of specific parts of the viral spike protein. If there is anything going on it is some kind of autoimmune response which rarely occurs in certain individuals.

              The similarity with heparin is that they may be related in cause. Some people may be at risk due to something like a genetic mutation. Also they found out not to treat it with heparin.

              1. I hope so. But purely rationally – there is little to no upside in private sector sharing of clinical trial data. It would be more likely for regulators across countries to share clinical trials data in order to speed up drug approval. But of course they’d have to own that data themselves. And there’s a ton of pharma/medical nationalism that prevents that.

                What’s going on with this vaccine may be a rare occurrence. It may be more common than you think merely because data is not likely being gathered or analyzed in the rush to jab. What is known is that for one year now we’ve known that people with coronavirus are at risk of blood clots and strokes. And it means that there has been some element of ‘preventive blood thinning’ – using heparin – for people who are admitted to hospital who will be bed-bound for awhile.

                this is not a side-effect that comes out of the blue. It’s a side effect that is overlooked because we’ve been obsessed with the notion that this is a respiratory disease rather than a vascular disease.

        2. So very low risk far outweighed by the benefits

          A 1 in 100,000 risk of dying from a clot caused by the vaccine vs a 1 in 10,000 risk of dying from the virus the vaccine protects again. You’re really counting angels on the head of a pin in evaluating the risk/reward here since your chances of dying in either case are dwarfed by things like driving a car, taking a bath, or using power tools.

          1. You can’t take a gross statistic like that and apply it to individuals. Depending on the individual’s age, weight, overall health and other risk factors, a particular individual may have a chance much less than 1 in 100,000 of dying from the virus.

    3. One good way to tell if it’s coincidence or causation is to conduct double-blind clinical trials that last longer than 3 months and involve participants that are representative of the population you will be forcing a compulsory vaccine onto. Maybe we could try that?

  7. federal bureaucracy reduces confidence in federal bureaucracy. bueno.

  8. Are we sure demand isn’t dropping because everyone who really wanted to be vaccinated already got their supply? Demand is low enough now in some places, you can now have your pick.

    1. When I went for my first jab 3 weeks ago, the (socially-distanced) line was about 45 minutes long, so about 100 or so people in front of me. People getting their first shot as opposed to their 2nd were split about 75/25.

      Today, when I went back for my 2nd, there was no line, and it appeared that almost everyone was there for their 2nd shot.

    2. Some of that is convenience for some people. They can get it but don’t want to drive 20 miles. If they could just walk into the local pharmacy they would. Eventually a lot of those folks will end up getting it.

  9. In the past, Reason has run quite a few stories criticizing child protection agencies for not taking a child away from its parents “despite numerous warning signs”. And they have also run numerous stories criticizing child protection agencies for taking kids away for no good reason. In other words, government agencies should be able to predict the future. Imagine the public reaction if it had turned out that the J&J vaccine led to even one fatal blood clot. Imagine how the public would have reacted if dozens died. Doesn’t Reason pay more attention to one police arrest that results in the death of black man rather than the thousands that don’t? Funny how that works out.

    1. There are always trade offs but the FDA historically errs on side of caution. More have died from delay in approving treatment than have died from treatment too hastily approved.

  10. It was a terrible mistake to pause the J&J vaccine administration, and lower confidence. Glad Bailey agrees with former POTUS Trump on that specific topic. He was right.

    1. Well the news of the possible complication got out and was blasted all over the place so they had to have some kind of response.

      They could have just said they were looking into it but whatever damage was done was already done. I suspect it will just affect people who were not really planning to get the vaccine anyway.

      1. I am less certain about that. The loss of confidence is not good.

        I have two twenty-something children who just refuse to get vaccinated. When we talk about it, they simply point to the data.

        1. I have two twenty-something children who just refuse to get vaccinated. When we talk about it, they simply point to the data.

          Good for them. They obviously got their wits from their other parent.

        2. Only two? You are doing well.

  11. “You should go ahead and get the vaccine because the risk of adverse side effects are very low.”

    Left out of the equation – what are my chances of getting the ‘rona and suffering any bad effects from it if I don’t get the vaccine? I’m not yet old, I’m reasonably healthy, I’m anti-social, I live out in the country away from other people, I work by myself – where am I gonna get the ‘rona from?

    1. You’ll slip up and catch it one of these years. It’s probably here to stay.

    2. Wandering bands of city squirrels looking for food?


  12. “If I hear the phrase ‘abundance of caution’ one more time, I’m going to jump out of my window,” Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia, told the Post. “In the name of transparency, in the name of openness, we scare people.”

    And yet, where was that opinion when they were busy telling everyone the world was about to die and the only answer was putting you out of business, confiscating your rental properties, and curtailing people’s rights?

    Oh, I see now. This is the ‘one step too far’ after all the other steps that led us here.

    Well, that or they think lying to people is better than scaring them with the truth. Just one random guy, of course, but still a scary ass position to take.

  13. How can you say this “lowered confidence” when you don’t know what the confidence was prior? Who knows, maybe it increased from 18% to 22%.

    Come on, be the science guy!

    1. The polls I have seen indicate that those saying no way have been steady. Around 20%. What has happened is that more maybes are now planning to. Some of that is probably peer pressure. I suspect some of those are in no hurry or just will never get around to it.

      I do not think this is going to change anyone’s mind on this.

  14. I must say it’s entertaining to see all the science-worshipping progtards have cognitive dissonance attacks over this.

    -they have always believed that vaccines are 100% safe
    -they always believe that the government can do no wrong

    Now they’re forced to choose between their faith in vaccines (science) and faith in government

  15. With all due respect Mr. Bailey, You have no training or expertise in the psychology of vaccine skepticism. If you did, you would understand that a decrease in confidence in vaccines is actually an increase in confidence! After all, I am an expert, and if I say up is down, you must believe me, because I am an expert.

    Yours in science,
    Dr. Anthony Fauci, Expert

    PS – Be sure to check in next week when I will contradict everything I have just said and tell you it is what I truly believed all along. Because I am an expert.

    1. To be fair, Ron’s education ended with an undergraduate degree in philosophy. He has literally no training or education in any scientific field. He just regurgitates whatever paid experts the Koch Foundation needs him to amplify at any given time. That’s how he went from a global warming skeptic to a global warming fearmonger in the space of a couple of years, then went from a technoutopian transhumanist predicting post-scarcity and eternal life to a TEOTWAWKI panic-stricken pants-shitter over a bad flu.

  16. And the peoples’ confidence in the safety of the vaccine is much more important than the *actual* safety of the vaccine!

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