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Medicine

Kids 5-11 Appear Safely Protected By Small Doses of COVID Vaccine, Pfizer Says (arstechnica.com) 156

An anonymous reader quotes a report from Ars Technica: Small doses of Pfizer's COVID-19 mRNA vaccine in children ages 5 to 11 appeared to produce strong antibody responses and comparable side effects to those seen in older age groups, according to the first top-line results from a Phase 2/3 clinical trial released by Pfizer and its partner BioNTech early Monday. The trial data involved 2,268 children ages 5 to 11 years, and these children were given a series of two 10-microgram doses of the vaccine, 21 days apart. The dosage is just a third of the 30-microgram doses given to people ages 12 and above. One month after the second dose, researchers measured the children's levels of antibodies able to neutralize the SARS-CoV-2 virus in a lab experiment. The geometric mean titer of antibody in the 5 to 11 year olds was 1,197.6 (95 percent confidence interval of 1,106.1 to 1,296.6), which is comparable to the geometric mean titer of 1,146.5 seen in people ages 16 to 25. Pfizer described the vaccine as being well tolerated in children, with side effects generally comparable to what's seen in people ages 16 to 25. But the company did not provide further data on the side effects. It also did not provide any further data on vaccine efficacy, though experts expect that comparable neutralizing antibody levels will provide comparable levels of protection against infection, hospitalization, and death. The company said it plans to submit the data to the FDA as soon as possible. It also aims to submit the data for emergency use authorization to the FDA by the end of the month. "Once data is submitted to the FDA, it will take regulators several weeks to review the data and make a decision," the report adds. "That places the earliest estimates for vaccine authorization and availability for the 5-to-11 group at the end of October."
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Kids 5-11 Appear Safely Protected By Small Doses of COVID Vaccine, Pfizer Says

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  • 1200 is way the fuck too high.

    For reference, adult average peak was around 600. Natural infection gives around 100, which is by all indications plenty to prevent infections.

    Note 1: I'm quoting those numbers from memory, based on a study I read a while back. Month ago? Two? I might be remembering them wrong, or different/better data may be out there.

    Note 2: I'm not saying that 1200 is bad or dangerous, it is just WAY overshooting the target. It strongly suggests that they could halve the dose again at

    • 1200 is way the fuck too high.

      Perhaps. But that is a geometric mean. So some kids may be much lower.

      It strongly suggests that they could halve the dose again at least 1 or 2 more times.

      Everyone would be better off with smaller doses in multiple jabs, but that means more admin overhead.

    • Re:huge (Score:5, Insightful)

      by Whateverthisis ( 7004192 ) on Monday September 20, 2021 @07:31PM (#61815477)
      Given the level of attention on this by the FDA and the CDC, and the commercial opportunity for Pfizer to getting it right along with the massive fallout if they get it wrong, I'm going to trust the study folks know what they're doing.

      I don't think it's right to compare adults to children on this either. Kids' immune systems are developing, and kids are at very different stages, and vary quite a lot in terms of mass, immune development, etc. even when the same age, let alone the age category of 5 to 11, and much much more variation than adults in various age categories.

      Not to mention that the article and summary compare to adults 16 to 25 (a more relevant figure), which are at 1,146. Seems to me they're right on the money and going in the right direction.

      • by quenda ( 644621 )

        which are at 1,146. Seems to me they're right on the money and going in the right direction.

        Yes, but its all a bit of guesswork.
        The Moderna vaccine is almost identical to Pfizer, but they went with 100 micrograms, compared to 30 for Pfizer with adults.

        https://www.webmd.com/vaccines... [webmd.com]
        > Moderna vaccine averaged 2,881 units per milliliter, as compared with those who got the Pfizer vaccine, who averaged 1,108 units per milliliter.

        and yet both have very similar efficacy, and similar low risk.

        Kids' immune systems are developing, and kids are at very different stages,

        What does that even mean?

        • Kids' immune systems are developing, and kids are at very different stages,

          What does that even mean?

          It means he has no clue.

        • by hawk ( 1151 )

          >and yet both have very similar efficacy, and similar low risk.

          That depends upon your value of "similar".

          Pretty much every comparison I've seen, from early on to the major one on long term effectiveness, has found that Moderna has an edge.

          In particular, effectiveness wanes faster for Pfizer.

          And today, J&J is claiming to be as effective as the others if served with a second dose at 21 days . . . so why in the world didn't they test for this at stage 1 & 2 in the first place???

      • The best markets are where the product does nothing: vague, minor or no benefit but no harm. Pfizer wants to sell and the vaccine appears to be reasonably safe. The benefits for children are also minor though.

        They are measuring titers, not real world benefits. Previously titers have been used to argue that the protection from vaccination was better than the protection from actual infection . That was wrong. Not to be confused with the comparison 'counting on infection to protect you' vs 'counting on vaccin

        • It was reported that an FDA scientist testified before the FDA board making the booster decision that the slight risk of heart inflammation (1 in 5000, 1 in 6000 from Israeli data) makes the Pfizer vaccine of no personal benefit in relation to the risk from COVID disease in males under age 40.

          Mind you, this is from FDA, not from Robert Kennedy Jr or some flaming anti-vaxers among the Trump crowd, unless someone here can convince me that this is Fake News?

          There may be a social benefit of reduced chance

          • Someone said a common feature of covid is high dispersion: a lot of stuff happens far from the average. Some people are superspreaders ,many people spread little or nothing. So it is to expected that while for old people the choice for vaccination is easy it is less straightforward for young people.

            The simple approach is, if the individual choice is not straightforward it does not make a big difference which you choose, so what is the problem with going along with the official advice which has the advantage

            • The official advice, right now, is not to give booster doses of vaccine to those under 65 or without certain high-risk medical conditions.

              The evidence behind that advice, coming from FDA itself, is that the risk/benefit, which is the FDA's stock-and-trade, is not clear cut for giving vaccines to males under age 40.

              So is this a case of the government (FDA) not trusting the government (Biden Administration, CDC)?

              • I don't know, but can't it be reduced to different risk calculus? The government focuses on getting the epidemic under control and is willing to take more risks to get maximum vaccination. The argument you give about the FDA is 'not clear cut' meaning if the benefit is clear cut then we support it, otherwise not. What about the opposite: if the downsides of the vaccines are clearcut stop recommending them, otherwise keep going. That is a wide middle ground.

          • by BranMan ( 29917 )

            Yeah, that's an unfortunate factoid about the *personal* benefit of vaccines for males under 40. Another straw for anti-vaxxers to grasp at.

            YES - there is huge social benefit to the vaccine. There is also the fact that there is little to no *personal* benefit to wearing a mask. But huge, proven, social benefits - as seen by the drastic differences in transmission rates, hospitalizations, and deaths between regions that HAVE good mask-wearing stats vs. those that do not.

            Like any good military defense, de

        • > Previously titers have been used to argue that the protection from vaccination was better than the protection from actual infection . That was wrong.

          Citation needed.

          • of what? There has been a whole period where people who had been infected were still exhorted to take the vaccine.
            This article shows a change of mind: https://www.science.org/conten... [science.org]

            The coarse grained deduction is this: whichever way you got your immunity , you're pretty safe now and don't have to bother about extra shots.

      • I don't think it's right to compare adults to children on this either. Kids' immune systems are developing, and kids are at very different stages, and vary quite a lot in terms of mass, immune development, etc. even when the same age, let alone the age category of 5 to 11, and much much more variation than adults in various age categories.

        Not to mention, kids of that age group are far less likely to suffer serious consequences as a result of COVID-19 infection. That raises the bar for safety in terms of "net benefit" of the vaccine.

    • by ceoyoyo ( 59147 )

      Slashdot poster "1200 is way too high, adults were only 600. I'm quoting that from memory."

      Summary: "comparable to the geometric mean titer of 1,146.5 seen in people ages 16 to 25"

      • by gweihir ( 88907 )

        Indeed. Some people are incredibly stupid and incapable, yet believe they are smarter than everybody else. This one is a good example. Dunning-Kruger effect at work.

    • The very next sentence reads "which is comparable to the geometric mean titer of 1,146.5 seen in people ages 16 to 25"

      So I'm wondering where you came up with that "adult average peak was around 600" besides from a "study [you] read a while back".

      Seems vague, and contradicted by the very next sentence of the article.

      You say you're not saying 1200 is bad, but you then go on to say that you "strongly suggest" they shoot for a lower target, and then that you suggest the adult 600 number that you "remember" is a

  • Why? (Score:1, Troll)

    by labnet ( 457441 )

    Here’s a quote from nature

    Of 3,105 deaths from all causes among the 12 million or so people under 18 in England between March 2020 and February 2021, 25 were attributable to COVID-19 — a rate of about 2 for every million people in this age range. None had asthma or type-1 diabetes, the authors note, and about half had conditions that put them at a higher risk than healthy children of dying from any cause.

    Why expose kids to a vaccine that doesn’t yet have long term health data and does have side effects when COVID is such a low risk to children?

    • Shareholder value, of course!

      we'd save more kids banning hot dogs.

    • Re:Why? (Score:5, Informative)

      by Anonymous Coward on Monday September 20, 2021 @07:25PM (#61815453)

      Why expose kids to a vaccine that doesn’t yet have long term health data and does have side effects when COVID is such a low risk to children?

      Your concern is valid but there are a couple of reasons to vaccinate children under twelve. First is the rise in short and long term pediatric neurological disorders. This doesn't get a lot of headline press because it isn't kids dying. The absolute numbers are low but the disease rate increase is startling. Sorry don't have links handy.

      The other issue is that kids may be asymptomatic but are carriers and herd immunity won't be achieved unless they are part of the vaccination program.

      A difficult issue and more information is definitely necessary.

      • So children need to be exposed to a (low risk) of an adverse effect to protect fat codgers?

        We have legislation that allows drafting 19-year-old men where they may lose their lives in furtherance of our common defense, so I guess this is OK?

    • Re: (Score:3, Insightful)

      by JoshuaZ ( 1134087 )
      Children are not just dying, they are getting long-term repercussions. And every child which gets seriously sick takes up one of our limited hospital beds. Also, every children which isn't vaccinated creates another risk of transmission to either unvaccinated people or people who are vaccinated but may have immune issues (such as people who have undergone chemotherapy recently).
      • by Jerry ( 6400 )
        "Every child which gets serious sick..."

        The CDC reported that over the last 21 months the total number of kids between the ages of 0-17 that have died of covid is 439. https://data.cdc.gov/NCHS/Prov... [cdc.gov]

        Probably most of those had extenuating medical circumstances. But, how many children would you be willing to give cardiomyopathy to in order to save them from death due to covid? As of June 10, 2021 there were 789 cases "reported" of myocarditis with 285 being under 30. Nice, obtuse figures. https://www. [aappublications.org]

        • I love how when it comes to vaccines, we need to worry about everything that might go wrong, including non-fatal cases of myocarditis, but when it comes to covid, we can just ignore the much higher rate of myocarditis because the only thing that matters is death.

          • by ceoyoyo ( 59147 )

            Not to mention someone can refute a post about kids getting sick, including quoting the line "every child which gets serious sick..." with the count of children who have died.

            There's some hard core wishful thinking going on.

      • by gweihir ( 88907 )

        Indeed. And the longer this crap goes on, the more other negative effects on children merely from a prolonged pandemic running.

    • Re: (Score:3, Insightful)

      Because there's a long span between "healthy child" and "dead child" and you don't want to find out where a monstrosity that attacks nearly every organ in the body, including the brain, is going to leave them? One third of all covid victims are still sick over two months after diagnosis. Usually with exhaustion/tireness due to horrendous lung damage.

      Because what right do you have to be a vector to forcibly subject others to these outcomes when a proven safe alternative exists?
    • Re:Why? (Score:5, Insightful)

      by Ksevio ( 865461 ) on Monday September 20, 2021 @08:22PM (#61815599) Homepage

      1. The kids won't catch it so won't have to worry about long term effects of COVID

      2. The vaccine is extremely safe. No deaths have been reported from it.

      3. The kids won't spread it to more vulnerable people.

      4. You can't reach a herd immunity if 20% of the population equally spread about that regularly comes in contact isn't immune.

      • by gweihir ( 88907 )

        Indeed. But these are facts are too difficult for the utterly-dumb anti-vaxxers to understand. Hence they deny, lie and deride.

      • 1. The kids won't catch it so won't have to worry about long term effects of COVID

        A vaccine does not prevent infection. It merely minimizes the effects of it.

        And since #1 on the list is complete bullshit, I'm going to safely assume we can ignore the rest.

        • by Ksevio ( 865461 )

          That's an anti-vax talking point I've been seeing a lot lately. It is of course not true, vaccines do prevent infection in some people and overall they reduce the chance of infection. What they don't do is prevent spread from already infected people, though they do increase the recovery time which also reduces the spread

          But like most anti-vaxxers, your second comment about believing science is bs and ignoring everything also seems to be pretty common

    • Re:Why? (Score:4, Insightful)

      by dgatwood ( 11270 ) on Monday September 20, 2021 @08:26PM (#61815623) Homepage Journal

      Why expose kids to a vaccine that doesn’t yet have long term health data and does have side effects when COVID is such a low risk to children?

      Because kids are disease vectors. Ask any parent with kids what happens when school starts. The whole family gets sick. Every year.

      Because the risk for the vaccine is still way lower than the risk of getting COVID, even at that age.

      Because any long-term effects are provably no worse than getting COVID.

    • Re:Why? (Score:5, Insightful)

      by UnknowingFool ( 672806 ) on Monday September 20, 2021 @08:50PM (#61815681)

      Why expose kids to a vaccine that doesn’t yet have long term health data and does have side effects when COVID is such a low risk to children?

      From my risk analysis, death is a very bad side effect to getting CoVID. Also you neglected this part: "The studies did not evaluate rates of less-severe illness or debilitating ‘long COVID’ symptoms that can linger months after the acute phase of the infection has past". So you ignored the long term effects of CoVID while asking about the long term effects of the vaccine.

    • There isn't really such a thing as 'long term health data' for something that you take once, like a vaccine. That'd be more for, say, a maintenance medication. Waiting for vaccine safety testing to be complete is what we just did in waiting this long.
    • Why expose kids to a vaccine that doesn’t yet have long term health data

      Who says we don't have long term health data? For each component of the Pfizer vaccine we have long term health data with the exception of the effect of the anti-bodies being generated themselves. And any effect this would have would have shown up within months at the most, would be just as bad from getting even asymptomatic COVID, and above all we have over a years worth of data on this as well.

      More reading science and less reading antivax blogs.

    • by gweihir ( 88907 )

      There is more risk to COVID than death. For example, long COVID is a thing for children as well. Also, if a child infects an adult they are close to and _that_ one dies, do you think this has no adverse effect on the child? Right.

    • Because the side effects and health risks from the vaccine have evidence to show that they were lower than they were in comparison to COVID. Also note that the data from Nature were before the significant spread of the Delta (and any future variants) which are more pathogenic.

      Regardless, how many children would have to die before you would consider a vaccine? Three per million? Ten per million? One hundred per million? Maybe it would be useful to ask a parent who has lost a child to COVID whether a vacci
  • by XeLiTuS ( 2787743 )
    Study conducted by dairy farmer concludes.
    • Study conducted by dairy farmer concludes.

      Poor analogy. A better analogy is dairy farmers concluding you can get all the benefits of milk by drinking less.

    • If the study is well done, what's the problem with who did it and do paid for it? The study should be properly reviewed for sure, by independent specialists, but other than that, I see no problem.
  • https://www.fda.gov/emergency-... [fda.gov]

    Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act [fda.gov]), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and avai

    • They'll let them all EUA like they did for adults, I'd expect. Manufacturing capacity for vaccines is yet to saturate demand worldwide, they're not going to cut any of them off at this point, especially as one platform or another may end up easier to modify in the face of future waves of mutants.

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