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Medicine United States

CDC Panel Recommends Using J&J COVID-19 Vaccine Without Restrictions, Saying Benefits Outweigh Risks (cnbc.com) 105

Posted by BeauHD from the safety-first dept.
A Centers for Disease Control and Prevention advisory panel on Friday recommended the U.S. resume using the Johnson and Johnson Covid-19 vaccine, saying the benefits outweighed the risk. CNBC reports: The recommendation, which was adopted 10-4 with one abstention, by the CDC's Advisory Committee on Immunization Practices, will pave the way for U.S. regulators to lift their recommended pause on using the J&J shot as early as this weekend. The committee, an outside panel of experts that advises the CDC, decided to postpone a decision on the vaccine last week while officials continued to investigate cases of six women, ages 18 to 48, who developed cerebral venous sinus thrombosis, or CVST, in combination with low blood platelets within about two weeks of receiving the shot.

The Food and Drug Administration and CDC on April 13 asked states to temporarily halt using J&J's vaccine "out of an abundance of caution" following reports of the rare blood clots. Within hours of the warning, more than a dozen states as well as some national pharmacies halted inoculations with J&J's vaccine, some replacing scheduled appointments with either the Pfizer or Moderna vaccine. Rare blood clots with low platelets are occurring at a rate of 7 per 1 million vaccinations in women ages 18 to 49 for the J&J shot and 0.9 per 1 million in women age 50 and older, according to a slide presented at the CDC panel meeting. CDC has confirmed 15 cases total of rare blood clot conditions, which includes 12 women who developed blood clots in the brain. Three women have died and 7 remained hospitalized, according to the slides. There are no confirmed cases in men, though officials have said they are reviewing potential additional cases.

A CDC model presented at the meeting showed not resuming the use of J&J's vaccine would delay immunizing all adults intending to get the shots by 14 days. J&J executives told the committee the benefits of its vaccine still outweighed its risks, adding that the shots would prevent deaths and hospitalizations. They suggested a new warning label for the vaccine that explains the risk of blood clots.
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CDC Panel Recommends Using J&J COVID-19 Vaccine Without Restrictions, Saying Benefits Outweigh Risks More

CDC Panel Recommends Using J&J COVID-19 Vaccine Without Restrictions, Saying Benefits Outweigh Risks

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  • Seems reasonable (Score:3)

    by 93 Escort Wagon ( 326346 ) on Friday April 23, 2021 @06:28PM (#61306960)

    I mean it's literally one-in-a-million odds of having the issue at all - it's hard to argue that the benefits don't far, far outweigh any risks.

    Plus, only having to get one shot rather than two does seem to matter to a few people in my circle.

    • I know people that prefer the single shot too, but I never really understood why. If you get better protection, damn close to perfect, from two Moderna or Pfizer jabs, why wouldn't you go that route? (Clotting issue aside.) I'd like whatever allows me to worry the least about getting sick.

      • Comment removed (Score:5, Insightful)

        by account_deleted ( 4530225 ) on Friday April 23, 2021 @06:37PM (#61306992)
        Comment removed based on user account deletion

        • Re:Seems reasonable (Score:5, Informative)

          by WaffleMonster ( 969671 ) on Friday April 23, 2021 @06:50PM (#61307022)

          It's not quite that simple. Part of the reason the J&J vaccine appeared to be less effective than the Pfizer/Moderna vaccines, is that the J&J trials were done later. Hence their trials contained more people with variants, most of which appear more resistant to the vaccines. My guess is that if you repeated the Pfizer/Moderna trials under the same conditions as the J&J one, you would probably get less impressive numbers for Pfizer/Moderna vaccines.

          This theory is easily disproven. We now have a shit-ton of data compared to initial trials.

          Later Israeli data starting from mid Jan thru early March shows 97% against SYMPTOMATIC infection in an environment where B.1.1.7 (UK) is dominate.

          JJ's 72% figure from trials for the US (57% ZA) begin with "SEVERE infections" the efficacy of two clearly are not even close in these categories.

          • Comment removed based on user account deletion

          • Re: (Score:3)

            by cowdung ( 702933 )

            I don't think the comparison can be done so clearly.

            Israel closed itself off quite effectively.

            I think a better test would be Brazil.. so they can compare JJ w/ Pfizer in Sao Paolo and see what the differences are.

            I don't think there's enough data out there yet and apples to apples comparisons.

        • The J&J vaccine was tested later, and in some places with different variants, but it was also tested in places with the same variant mix as Pfizer/Moderna. In the US, the vast majority of people sick during (and with) the J&J vaccine had the same variant as the Moderna/Pfizer people had. The overall efficacy goes down, but they also reported per-location effiacy.

          The Pfizer vaccine (at least) seems to be 90% effective against the variants.

          • Re: (Score:2)

            by rikkards ( 98006 )

            The irony is my inlaws are in an longterm care and everyone has gone through their double dose of Pfizer and yet they are in a lockdown because both a resident and one of the doctors there has now tested positive.

            • Breakthroughs happen. Lockdowns (well, really quarantining) will continue. The idea is they should be much rarer and more localized. The US government should do what the South Korean government did. If you are told to quarantine you get a two weeks supply of yummy goodies to stay inside and eat. Hell, the government should spring for 2 weeks of HBO too.

        • It's really not an apples to apples when comparing the calculated efficacy numbers of the trials because they were done in different environments. Not just the different locations in the different trials and that the variants were more prevalent during the J&J trial, but perhaps the biggest issue at all was the timing of the trials. The Pfizer & Moderna trials were done earlier - when the virus was much less prevalent in the trial population. J&J was done later when there was greater exposure.

        • Hence their trials contained more people with variants, most of which appear more resistant to the vaccines.
          One would assume in a vaccine trial they test first if the test person has anti bodies already ....

          But well, who am I to come to such an unscientific wicked idea ...

      • . If you get better protection, damn close to perfect, from two Moderna or Pfizer jabs, why wouldn't you go that route?

        p>I have no idea. I think the media blitz of "you cannot compare shots, they're all great get whatever you can" has made people think that you cannot compare shots. All the nonsense about "you cannot compare efficacy numbers" is true in that you cannot just look at the topline numbers. But of course you can. The mRNA ones are better. This is counterbalanced by any shot now is b

        • Yep. Even if you've been previously exposed to the virus, but you're not certain that you've had it, having your immune system react to it a second and third time makes it substantially less likely you'll catch a severe case.

          I'm just simple, but that math is enough for me.

      • Re:Seems reasonable (Score:4, Interesting)

        by redmid17 ( 1217076 ) on Friday April 23, 2021 @07:02PM (#61307062)
        Because it's one shot versus two and the the JJ vaccine totally prevented severe Covid. Why wait an extra weeks or months to get a second shot for another 10% chance to prevent what will most likely be a mild covid bout, if you get it.

        Full disclosure: i did the JJ trial but would have gone the JJ route anyway because I'm not in the vulnerably population nor very patient.

        • The J&J one is only one shot, but it takes the same amount of time from first injection to measured immunity as Pfizer takes. There's just only one shot in that period. That is, fewer injections, same timeline.

      • I know people that prefer the single shot too, but I never really understood why. If you get better protection, damn close to perfect, from two Moderna or Pfizer jabs, why wouldn't you go that route? (Clotting issue aside.) I'd like whatever allows me to worry the least about getting sick.

        Because perfect can't be the enemy of good enough in a time when many people don't have the luxury of choice. I want the Pfizer vaccine. I'm almost certainly going to get the J&J vaccine which has proven to have a 100% efficacy of keeping people out of hospital. If we had a drug to reduce COVID to becoming little more than a common cold, then that is very much a definition of "good enough". And experts have determined even with the lower efficacy that herd immunity can still be achieved.

    • I mean it's literally one-in-a-million odds of having the issue at all - it's hard to argue that the benefits don't far, far outweigh any risks.

      Plus, only having to get one shot rather than two does seem to matter to a few people in my circle.

      It is reasonable, and it also appears that one has a greater chance of developing blood cloths *from* COVID than from the vaccines. It's scary no matter what, but it's all a matter of looking at the numbers.

    • I mean it's literally one-in-a-million odds of having the issue at all - it's hard to argue that the benefits don't far, far outweigh any risks.

      Well... 7-in-a-million. Also noting that the risk is a possibly fatal brain clot - hmm... I'd have reservations if I were a woman ages 18-49, especially if one of the other vaccines were available or I could wait for one.

      • Well, plus it’s admittedly easy for me to say that since I’d already gotten the Pfizer vaccine before this hit the news. If I were younger and hadn’t had a shot yet, would I still look at it as dispassionately?

      • It has been conjectured that the blood clots are correlated with taking birth control pills. The pills can also cause clotting.

        I don't know if further data has supported the conjecture. But if the 7 dead women were on the pill, then that looks like a major risk factor.

    • What seems more reasonable is to recommend against using it on women under 50 unless and until it is determined that the risk in older women and in men is comparable.

    • The risk of getting clots with the J&J vaccine are lower than the risk of getting clots with no vaccine because the risk of clots from having coronavirus is heavily reduced by the vaccine. The only reason there is a question is because the risk of getting clots with the J&J vaccine is not lower than the risk of getting clots with the other vaccines as opposed to with no vaccine.

  • Warning label? Umm... no. (Score:5, Insightful)

    by dgatwood ( 11270 ) on Friday April 23, 2021 @06:31PM (#61306968) Homepage Journal

    You see, this right here is why folks don't trust the government. The U.S. has about 70 million people in that age group. That's about 490 projected deaths caused by this vaccine. There are other vaccines. The problem does not happen in men at all, as far as we know, nor in older people.

    So the right thing to do is to stop giving out the J&J vaccine to women under 50. Use it on people who aren't at significant risk of blood clots from the vaccine. Given that J&J is providing only about 26M doses per month (enough for 26M people), Moderna is providing about 40M doses per month (enough for 20M people), and Pfizer is providing about 52M per month (enough for 26M people), it should not be at all difficult to ensure that no young women are asked to take that unnecessary risk.

    The current approach is just plain stupid.

    • Re: (Score:2)

      by Tupper ( 1211 )
      This risk is extremely low. For a 20yo, a 1x10^-6 risk of death costs about a half an hour of life expectancy. That's less than the marginal time required to get a second shot.

      A warning label is sufficient, let individuals decide.

      • Re: (Score:2)

        by dgatwood ( 11270 )

        A warning label by itself is the wrong approach. Here's the harsh reality: Most folks don't get to decide which vaccine they receive. They get whatever that particular distribution location uses. Some use Moderna, some use Pfizer, some use J&J. A *few* have access to more than one. So arriving at the vaccination center and being told, "BTW, there's a seven in a million chance you'll die from a blood clot" is a great way to guarantee that either A. young women ignore it and we have several hundred

        • Re:Warning label? Umm... no. (Score:4, Interesting)

          by chill ( 34294 ) on Friday April 23, 2021 @08:48PM (#61307336) Journal

          Your statistics are off. As of April 23 there are a reported 8,040,727 [usatoday.com] people vaccinated with the Johnson & Johnson vaccine. The latest numbers show [businessinsider.com] 15 reported blood clots resulting in 3 deaths.

          That isn't 7 in a million, it is 3 in 8 million or about 1/3 of what you were stating. I do agree that scheduling around this could possibly alleviate concerns and increase the uptake.

          On the other hand, my wife didn't want the J&J because "that's the company that was poisoning people with baby powder and I don't trust them".

          We both got our 2nd dose of Moderna yesterday.

          • Re: (Score:2)

            by dgatwood ( 11270 )

            The 7 in a million is literally straight out of the summary. But you're right that I misread cases as deaths.

        • A warning label by itself is the wrong approach. Here's the harsh reality: Most folks don't get to decide which vaccine they receive. They get whatever that particular distribution location uses. Some use Moderna, some use Pfizer, some use J&J. A *few* have access to more than one. So arriving at the vaccination center and being told, "BTW, there's a seven in a million chance you'll die from a blood clot" is a great way to guarantee that either A. young women ignore it and we have several hundred easily preventable deaths, B. a bunch of people freak out and don't get vaccinated, or C. some combination of the above. All of these are considered bad outcomes.

          The right way to do it is to handle this at the scheduling level. Ensure that people are scheduled at centers on days when the best vaccine for them is available. That means scheduling younger women for centers and at times when the Pfizer or Moderna vaccine is available unless they specifically request a single-dose vaccine, in which case you read them the warning label and get their affirmative consent at scheduling time and accept their decision...

          I'm not sure how the rollout compares state by state & could be that my state (Wisconsin) is really that far out in front of the rest of the country, but we're really already there in scheduling. You've been very easily able to check & select which vaccine you wanted for at last least a week, probably more. As far back as I got my first shot (March 23) I was able to see which one I was registering for (at a grocery store pharmacy). And now the big clinics are doing it by days of the week. As of the

        • The right way to do it is to handle this at the scheduling level. [...] That means scheduling younger women for centers and at times when the Pfizer or Moderna vaccine is available

          No, the right way to do this is to vaccinate anyone based on the effective vaccine available. Not increase complexity in scheduling administration in order to increase the possibility of saving one life per 7 million, and choose to kill one life per million, because they can't be bothered with the hassle of appointed time periods.

          • Re: (Score:2)

            by dgatwood ( 11270 )

            The right way to do it is to handle this at the scheduling level. [...] That means scheduling younger women for centers and at times when the Pfizer or Moderna vaccine is available

            No, the right way to do this is to vaccinate anyone based on the effective vaccine available.

            Which one? There are three effective vaccines available. You have to schedule an appointment for the vaccine no matter what. It takes negligible effort to route younger women to a vaccination center that uses one of the other vaccines, and to reserve most of the appointments at those centers for women so that most men will be routed to a vaccination center that uses the J&J vaccine. This really should not be hard. If it is, something is wrong.

            Not increase complexity in scheduling administration in order to increase the possibility of saving one life per 7 million, and choose to kill one life per million, because they can't be bothered with the hassle of appointed time periods.

            No idea what you're getting at here. There's no reason

      • For a 20yo, a 1x10^-6 risk of death costs about a half an hour of life expectancy.
        You are an idiot.
        The risk is 60 years life expectance.
        You are mixing up risk with chance.

        • Re: (Score:2)

          by sfcat ( 872532 )

          For a 20yo, a 1x10^-6 risk of death costs about a half an hour of life expectancy. You are an idiot. The risk is 60 years life expectance. You are mixing up risk with chance.

          Nope, the OP got it right. It is what statisticians call an expected value. The half hour is an estimated drop in life expectancy. 60 years / 1,000,000 = E(drop in life expectancy). Maybe you never had a stats class? Of course if it happens to you, the difference is academic but the expected value calculation remains the same.

    • That's more or less what the CDC just said, but sure

    • The U.S. has about 70 million people in that age group. That's about 490 projected deaths caused by this vaccine.

      You're assuming that the vaccine actually caused those blood clots, which is not a fair assumption.

      • Re: (Score:1)

        by dgatwood ( 11270 )

        In that age group? It's pretty likely to be the cause (unless they got COVID).

    • Re: (Score:3)

      by sjames ( 1099 )

      Actually 98 projected deaths. Only 1 in 5 people who developed the clotting problem died.

      All the same, I was happy that the appointment I finally got was for Moderna.

      • Re: (Score:2)

        by gTsiros ( 205624 )

        holy shit

        a 4digiter

        are you people still alive?

        silliness aside, i was waiting for my turn with great anticipation, until the news about the clotting issues surfaced. I have genetic predisposition to blood clots and have already survived one brain aneurysm due to a clot. I'm not exactly eager to roll the die again so i'll prefer the one that *so far* hasn't shown to be as risky, to me at least

        • Re: (Score:2)

          by sjames ( 1099 )

          Given your history, I'd say that's a good idea.

          Yes, we're still around :-) Back in the day, we didn't have all this NotSee crap, just a bunch of people pouring hot grits down their pants...

      • Re: (Score:2)

        by dgatwood ( 11270 )

        Actually 98 projected deaths. Only 1 in 5 people who developed the clotting problem died.

        All the same, I was happy that the appointment I finally got was for Moderna.

        Thanks for that statistic; I misread cases as deaths; sorry about that.

        Interestingly, the normal fatality rate for that type of clotting disorder is only about one in twelve. So that high fatality percentage is curious in and of itself.

        • Re: (Score:2)

          by sjames ( 1099 )

          Also interesting that both vaccines that have been suspected of causing blood clot problems are based on a modified adenovirus. Possibly useful info here [webmd.com]

          • Re: (Score:2)

            by dgatwood ( 11270 )

            Yeah, not entirely surprising. Viruses (and specifically, adenovirus, among many others) are known to cause blood clots in some people, under some circumstances. We've known that for a long time [nih.gov].

            About a year ago, I made a comment on this forum that there was a small possibility that the vaccines might cause precisely the same clotting as the actual virus, but hopefully at a lower rate. At the time, I was more concerned about immune overreaction to the spike protein, but in hindsight, it stands to reason

    • Re: (Score:2)

      by cowdung ( 702933 )

      So the right thing to do is to stop giving out the J&J vaccine to women under 50. Use it on people who aren't at significant risk of blood clots from the vaccine. Given that J&J is providing only
      about 26M doses per month (enough for 26M people), Moderna is providing about 40M doses per month (enough for 20M people), and Pfizer is providing about 52M per month (enough for 26M people), it should not be at all difficult to ensure that no young women are asked to take that unnecessary risk.

      The current approach is just plain stupid.

      The problem is thinking about this as a national problem.

      Worldwide the pandemic is growing at ever faster rates. The virus is also mutating and could develop variants that are vaccine resistant.

      The best way to stop this pandemic is to implement a SWIFT and WORLDWIDE vaccination program.

      This quibbling about AstraZeneca and Johnson & Johnson, this obsessing about a small number of deaths is irresponsible. Why?

      Because there are countries with 5-10 million people where about 100 people are dying EACH DAY fr

      • Re: (Score:2)

        by dgatwood ( 11270 )

        So the right thing to do is to stop giving out the J&J vaccine to women under 50. Use it on people who aren't at significant risk of blood clots from the vaccine. Given that J&J is providing only about 26M doses per month (enough for 26M people), Moderna is providing about 40M doses per month (enough for 20M people), and Pfizer is providing about 52M per month (enough for 26M people), it should not be at all difficult to ensure that no young women are asked to take that unnecessary risk.

        The current approach is just plain stupid.

        The problem is thinking about this as a national problem.

        Worldwide the pandemic is growing at ever faster rates. The virus is also mutating and could develop variants that are vaccine resistant.

        The best way to stop this pandemic is to implement a SWIFT and WORLDWIDE vaccination program.

        This quibbling about AstraZeneca and Johnson & Johnson, this obsessing about a small number of deaths is irresponsible. Why?

        Because there are countries with 5-10 million people where about 100 people are dying EACH DAY from the pandemic.

        If you gave this vaccine to 100% of the population you'd have 5-10 deaths TOTAL. But by pausing vaccination for just ONE WEEK you've already allowed 700 PEOPLE to die.

        In theory, sure. In practice, the U.S. isn't going to give up a single dose, because it needs as many as it can get. So sending those doses to a country that might have a higher death percentage isn't going to happen, even though yes, that would be the optimal outcome. Sending pretty much all the vaccines to the countries with the highest case count per capita would be the smartest approach, rather than hoarding them in the U.S. But again, no way is that going to happen, realistically.

        So pausing vaccina

    • The U.S. has about 70 million people in that age group. That's about 490 projected deaths caused by this vaccine.

      You think that's bad, just wait until you tally up the number of people who will die in car accidents driving to a vaccination centre.

    • Who are you, really? You are making way too much sense to visit here often. You can't in any way, any time have been even NEAR a guv'mt organization. You can't be a J&J employee, as they'd say anything to peddle their "vaccine". Ooooh, so here is another bit of evidence about dropoffs from UFOs. You are one of THEM! Welcome. Hope you have a nice time while here. Is there any way I can apply for asylum?

  • Shouldn't something like this be unanimous? Maybe not, being a game of statistics and all.

    • There are always going to be a difference of opinions, even among doctors. There is a conflict of "do no harm" with "this could kill a small number of people but will save many more from dying" that not everyone sees eye-to-eye on.

      Some people would never agree to allow the vaccine even if it only killed one in a million despite so many more being killed without it.

  • The US is swimming in Pfizer and Moderna vaccines. What is the real world benefit of a vaccine with way lower efficacy?

    • Re: (Score:3, Insightful)

      by olsmeister ( 1488789 )
      I think some of the thinking was that since the storage requirements for the J&J vaccine are simpler, it could be used in more rural areas that might not necessarily have the specialized freezers required to store the mRNA vaccines.

      • Re:What benefits? (Score:5, Insightful)

        by Kernel Kurtz ( 182424 ) on Friday April 23, 2021 @06:49PM (#61307012)

        I think some of the thinking was that since the storage requirements for the J&J vaccine are simpler, it could be used in more rural areas that might not necessarily have the specialized freezers required to store the mRNA vaccines.

        A single shot is also better for transient populations who may not ever show up or be contactable for a second one.

        • Re:What benefits? (Score:5, Informative)

          by WaffleMonster ( 969671 ) on Friday April 23, 2021 @06:58PM (#61307046)

          A single shot is also better for transient populations who may not ever show up or be contactable for a second one.

          Real world efficacy data for single shot Pfizer/Moderna is BETTER than full vaccination with single shot J&J.

          • Follow questions include how long single-dose mRNA vaccine immunity would last. I don't remember that having been tested.

            Another is how comparable the numbers are. The clinical trials for Johnson & Johnson took place after variants were in wide circulation.

            Notice I'm not pushing a conclusion. I'm ready to believe the mRNA vaccines are intrinsically superior and would win an even competition, just because of that utter brilliance of transfecting dendritic cells and turning the wanted poster billboards in

          • Real world efficacy data for single shot Pfizer/Moderna is BETTER than full vaccination with single shot J&J.

            The problem with that statement is we only have a narrow window of data for Pfizer/Moderna - the few weeks between the first and second dose - representing the single shot case. The idea that people who receive a single dose would still have strong immunity outside of that window is an unconfirmed hypothesis.

            Beyond that, we are grossly behind in the billions of vaccines that we need to vaccinate *everyone,* so even if you decided to switch to single doses for Pfizer/Moderna, you would still want the additio

            • The problem with that statement is we only have a narrow window of data for Pfizer/Moderna - the few weeks between the first and second dose - representing the single shot case. The idea that people who receive a single dose would still have strong immunity outside of that window is an unconfirmed hypothesis.

              There is reams of data from countries who wisely chose to stagger second doses by several months rather than going with CDCs 'tested' three/four week strategy.

              Of course there is no long term efficacy data to speak of either way.

              Beyond that, we are grossly behind in the billions of vaccines that we need to vaccinate *everyone,* so even if you decided to switch to single doses for Pfizer/Moderna, you would still want the additional J&J/AstraZeneca vaccines. Any delay at all in vaccinating the population will cost lives and provide time for variants we can't handle to emerge.

              My comments are limited to US situation only. CDCs failure to delay second doses has already cost lives.

          • Real world efficacy data for single shot Pfizer/Moderna is BETTER than full vaccination with single shot J&J.

            Being in Canada and looking at the data I absolutely agree. I've had one Pfizer shot myself. Next one certainly will not be on the manufacturers schedule, but I'm good with that. Most first doses for the win.

            The ones that don't need freezers will still get more places though. Places they need to be. And one shot with easy transport and storage is going to get as far into impoverished or marginalized societies as can be had.

          • In the real world a single shot of J&J is better than a mythical shot of Pfizer that I can't get due to supply shortages.

      • Re: (Score:3)

        by bjwest ( 14070 )
        Or given to third world countries that have a more difficult time meeting the cold storage requirements of the other two.

        • Or given to third world countries that have a more difficult time meeting the cold storage requirements of the other two.

          CDC recommendations are for US consumption.

          • Re: (Score:3)

            by bjwest ( 14070 )

            Or given to third world countries that have a more difficult time meeting the cold storage requirements of the other two.

            CDC recommendations are for US consumption.

            Do you really think I was suggesting we give our CDC recommendation to third world countries?

            • As you are talking about "third world countries" which do not exist since 30 or 40 years anymore, it is pretty unclear what you want to suggest. Ah, well, there still is Somalia, I nearly forgot about that. Was that not again a country bombed back into stone age by the US of Awesomeness?

              • Re: (Score:2)

                by bjwest ( 14070 )

                As you are talking about "third world countries" which do not exist since 30 or 40 years anymore...

                Just because you change the name from third world countries to less developed countries does not make them magically disappear. They're still around, and pretty much the same list as was 30 or 40 years ago.

        • Even if it is a morally rational and ethical thing to do, it will not look good at all. We would be accused of all kinds of things if we sent them vaccines we do not want ourselves. All the made up controversy about vaccines will not help.

      • Re:What benefits? (Score:5, Interesting)

        by WaffleMonster ( 969671 ) on Friday April 23, 2021 @06:56PM (#61307038)

        I think some of the thinking was that since the storage requirements for the J&J vaccine are simpler, it could be used in more rural areas that might not necessarily have the specialized freezers required to store the mRNA vaccines.

        Moderna has reasonable cold chain requirements and does not require specialized freezers.

    • What is the real world benefit of a vaccine with way lower efficacy?

      The idea was that J&J could be distributed to the homeless or at colleges before the students went home, since it only requires one shot. Basically populations that may have trouble returning for a second dose.

      • The idea was that J&J could be distributed to the homeless or at colleges before the students went home, since it only requires one shot. Basically populations that may have trouble returning for a second dose.

        A reference to support my earlier claim just a single dose of Pfizer/Moderna is better than one shot J&J.

        https://www.thelancet.com/jour... [thelancet.com]

        • I believe that your statement is factually true. However, there have been insufficient clinical trials to support such a use. If we had no other choice, I can see using the vaccines off-label. That's a huge additional risk of vaccine hesitancy and potentially people thinking they are vaccinated when they aren't.

          I would expect the US Government to listen to what's been verified, not what seems to be true.

          • However, there have been insufficient clinical trials to support such a use
            How can that be the case when all vaccines approved at the moment went through all the three trial phases?

            • The mRNA vaccines (Pfizer and Moderna) went through a three-trial phase with two shots as the treatment. My point is specifically we don't have a three-phase trial showing efficacy of one Pfizer/Moderna dose, so the US government isn't going to give only one mRNA vaccine shot and call you "all good". The only vaccine approved for one-and-done, like you might use for itinerant populations/the homeless/college kids about to go home, is J&J. This is true even if early evidence indicates one Pfizer or Mo

    • Re: (Score:3)

      by hey! ( 33014 )

      This is a common misconception. Yes, the Johnson and Johnson Phase 3 trial reported a lower efficacy figure, but we don't actually know if it is any less effective at preventing symptomatic COVID. That's because you can't compare data between trials run at different points in the pandemic and in different countries.

      J&J ran its Phase 3 trial at a later date than Pfizer and Moderna, when there was more COVID circulating and more new strains of COVID to contend with. Even if the vaccine were *exactly the

      • That's because you can't compare data between trials run at different points in the pandemic and in different countries.
        True.
        However it is mostly because to determine if it lowers the chance to cause a server case: the trial person needs to get infected. And that is one thing the vaccine is supposed to prevent, or lower the risk of. Secondly that person needs to behave or work under circumstances that have a risk of infection.

        When I'm vaccinated, I most certainly do not change my distancing habits "just bec

  • Who's going to manufacture the vaccine for J&J?

    Hopefully it's not Emergent BioSolutions

    Baltimore plant with contaminated Johnson & Johnson vaccines had multiple failures, unsanitary conditions, FDA says [washingtonpost.com]

  • Absolute bungling of a decision (Score:4, Insightful)

    by physicsphairy ( 720718 ) on Friday April 23, 2021 @08:17PM (#61307294)

    It's hard to get a definitive and recent infection-mortality number for COVID but a low-end guess could be 0.05%, i.e., 5000 deaths per million infected. (And all the vaccines do tend to be ~100% effective in preventing COVID infection mortality.) It obviously has *never* made sense to pause the vaccine due to an observed incidence of 6 serious side effect cases/million. If, due to cancelled appointments, increased hesitancy, etc. the pause has caused just 1% of people to not get vaccinated before being infected, then that increases the number of deaths in that group by an order of magnitude.

    What's worse is that this already played out in Europe with the AstraZeneca vaccine, so we knew exactly what would happen. And this comes right as we have needed to shift the ground game to vaccinating people who are hesitant (everyone else being already at least partially vaccinated).

    • And 0.05% is very much on the low side of what experts find the true IFR to be based on actual studies. The IFR is quite variable with age, exceeding 10% above ages ~70 to ~80 years old, depending on the study. So the average IFR it is currently thought to be a bit over 1% in high income countries which have more older people, and lower in low-income countries with a lower proportion of older people.

      This is a good meta-analysis showing age-specific IFR: https://link.springer.com/arti... [springer.com]
      This report has a me

    • You are an order of magnitude off with your death rate, it is close to 0.4%.
      AZ vaccines are all again in use all over Europe: for older mostly male people.

      You are out of the loop regarding news.

    • Re: (Score:2)

      by djinn6 ( 1868030 )

      If, due to cancelled appointments, increased hesitancy, etc. the pause has caused just 1% of people to not get vaccinated before being infected, then that increases the number of deaths in that group by an order of magnitude.

      You have that completely backwards. Continuing the rollout of the problematic vaccine would cause more people to not get vaccinated. Where I live, the vaccination site doesn't tell you which vaccine you're getting until you've already spent an hour getting to the location and waited in line. Those who do not want that particular vaccine is going to cancel their appointment altogether.

      Many places don't have a problem with vaccine supply anymore, some that had thousands of people lining up a few weeks ago are

  • For an individual, the risk calculation is am I better of taking the vaccine? what is the probability of death for doing it and not doing it; covid has 5k per million death rate; while vaccine (JJ/blood clot) has 18 per million. Yes, on the outside it looks like 5k seems bigger than 18; BUT this 18 is like a sure kill as the immune system is turned against the body (ie hit the platelets, make them go into a massive feedback loop to clot n cause heart blockage or other blood issues to death).

    The 5k inclu

    • For some individuals, the risk calculation isn't purely self-centered, but also includes the risk he or she presents to others.

      Remember, getting vaccinated isn't only about protecting yourself, it's about protecting those around you.

      Preliminary evidence suggests that the vaccines are good at suppressing transmission: (this is not an unexpected result)

      https://www.healthline.com/hea... [healthline.com]

      https://www.healthline.com/hea... [healthline.com]

      Personally, I would take a far riskier vaccine than the one I got just for the sake

      • True, if you are altruistic then it's ok - take the 18 in a million risk than say 1 in a million risk. Surely vaccinating a vast population deprives the virus the time/space to mutate and become even more deadly.

        The point is when you already have vaccines which are far safer (the pfizer/moderna) why push for the one which can do a sure-kill thru blood clots? Yes, it may have features like easier transport (freezer needs) -- but these can be easily solved with technology (remember we can fly a helicopter
  • I remember the name of the company, which helps me to set up my digital marketing business. They helped me very much to set up my business. That company is - presentation design service https://slidepeak.com/ [slidepeak.com] . If you want an awesome pitch deck, you can contact them directly.

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