12 ms·

The biggest reason the under 5s vaccine is taking so long is that they don't suffer severe enough symptoms that they can easily test the efficacy of the virus.

The biggest reason the under 5s vaccine is taking so long is that they don't suffer severe enough symptoms that they can easily test the efficacy of the virus. The same issue was there with the 5-11s but pharma, CDC, & FDA just glossed over that to approve the vaccines.

dataflow 5y ago
> that they can easily test the efficacy of the virus I think you meant to type 'vaccine'
throw6622 5y ago
The success we’re talking about was an analytical measurement of the antigen response in the body. It wasn’t lack of symptoms which ruled that phase a failure.
- Sparyjerry 5y ago
  That is incorrect, the decision making numbers used to test vaccine effectiveness having nothing to do with lab antigen numbers, they are based on how much symptomatic illness is avoided. All of the results such as as 95%-96% efficacy for Phizer and Moderna and 66% for J&J are based on the % reduction of symptomatic illness only. Not the reduction in actual illness or based on lab tests of antigen response.
  - hammock 5y ago
    I believe you are incorrect. What you say was true for the initial adult trials but many recommendations for boosters and lower age groups have been based on antibody response, not clinical outcomes.
    - beerandt 5y ago
      Correct or incorrect is sort of irrelevant, because it's a problem itself if they aren't including severity of symptoms in the study. If they are ignoring symptoms to approve a vaccine who's primary remaining benefit is ... reducing severity of symptoms ... then how exactly has the trial proved anything? Since antibodies are no longer a reliable indicator of immunity or of preventing transmission, then reduced severity is the primary remaining benefit. Ideally they'd be looking at a cumulative risk/prevention assessment, but I don't see how they do that while excluding observed symptoms. If they are using antibody levels as a proxy for this when they could just ... directly observe symptoms... then there would be a bigger problem with the study than just a failure to show sufficient efficacy.
      - hammock 5y ago
        Take it up with the FDA. You're preaching to the choir
        beerandt 5y ago
        I get it. It's just a fine line between arguing what would justify FDA "approval" vs what merits have changed that actually increase the risk-versus-reward assessment. Put another way, when the biggest excuse for not getting vaccinated was "it's experimental and not approved", it became a straw-man-esque "gotcha-trap" of a battle to achieve "approval", even though that approval process looked nothing like any before it (no matter how many times "full fda approval" is repeated). When the metric becomes the goal, it's no longer a metric, and all that. We get bogged down arguing whether criteria of a definition or standard are being met, while the regulators end up just redefining things. And we're supposed to pretend the teacher applying a curved grading scale actually represents a difference in the students performance.
  - cik2e 5y ago
    I've read that the pfizer study compared rates of positive test cases between the two groups. BUT, the tests were administered based on self-reported symptoms which were then evaluated by a staff member to decide whether a test was warranted. This absolutely blew my mind. This kind of avoidable subjective decision making should not be happening in a clinical trial. All participants should have been tested at regular intervals.
    - beerandt 5y ago
      Equally... that when they repeat it and get different numbers, the failed trial will be ignored in favor of the passing trial, without first invalidating the previous results[0], and without using any increased burden of proof. Passed+Failed = "Passed!" [0] There will be a reason given to ignore that first trial, it just likely won't be a good one.
    - tekknik 5y ago
      How does one not self-report symptoms? Some will be externally obvious but how does someone know someone else has chest pain, or a sore throat?
beerandt 5y ago
>The biggest reason the under 5s vaccine is taking so long is that they don't suffer severe enough symptoms that they can easily test the efficacy of the virus. How does anyone convince themselves that this is actually a problem? Especially when the vaccine no longer prevents catching the virus or transmitting it. What remaining benefit are people so eager to confer upon their toddlers?
- notch656a 5y ago
  Well Virtue with a capital 'V' is one big one! And of course they're an excellent source of revenue for Pfizer et al. You wouldn't want to risk it would you? -- writing this while my toddler is banished from daycare for 10 days because a single kid there tested positive.
  - dpark 5y ago
    It’s not virtue signaling to be terrified for your children’s health. It might not be rational but it should be perfectly understandable.
    - walterbell 5y ago
      Terror is rarely coincident with clear decision making. Hopefully it's transient, soon followed by calm risk-benefit analysis.
- chithanh 5y ago
  Vaccines still lower disease severity. Also vaccines reduce risk of some post-acute COVID disorders like MIS-C (which can result even from asymptomatic COVID). https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e1.htm https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e1.htm And of course you don't want to infect your child with a disease that has long term consequences which we are still learning about. Diabetes hit the news recently in the US, but it is actually been known for a while in other countries. https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e2.htm https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e2.htm https://diabetesjournals.org/care/article/43/11/e170/35903/New-Onset-Type-1-Diabetes-in-Children-During-COVID https://diabetesjournals.org/care/article/43/11/e170/35903/N... (UK) https://adc.bmj.com/content/early/2021/05/27/archdischild-2020-321220.abstract https://adc.bmj.com/content/early/2021/05/27/archdischild-20... (Finland) If that wasn't bad enough, diseases that are associated with T1D like celiac disease are on the rise, and show stronger association in COVID patients: https://onlinelibrary.wiley.com/doi/10.1111/apa.16173 https://onlinelibrary.wiley.com/doi/10.1111/apa.16173
mritchie712 5y ago
Do you have a source for this?
tablespoon 5y ago
> The biggest reason the under 5s vaccine is taking so long is that they don't suffer severe enough symptoms that they can easily test the efficacy of the virus. Do you have a source on that? My understanding is the reason it's taking so long is 1) an abundance of caution because the risk/reward calculation is different and 2) young children's immune systems don't work the same as adults').

dataflow 5y ago

> that they can easily test the efficacy of the virus I think you meant to type 'vaccine'

throw6622 5y ago

The success we’re talking about was an analytical measurement of the antigen response in the body. It wasn’t lack of symptoms which ruled that phase a failure.

Sparyjerry 5y ago
That is incorrect, the decision making numbers used to test vaccine effectiveness having nothing to do with lab antigen numbers, they are based on how much symptomatic illness is avoided. All of the results such as as 95%-96% efficacy for Phizer and Moderna and 66% for J&J are based on the % reduction of symptomatic illness only. Not the reduction in actual illness or based on lab tests of antigen response.
- hammock 5y ago
  I believe you are incorrect. What you say was true for the initial adult trials but many recommendations for boosters and lower age groups have been based on antibody response, not clinical outcomes.
  - beerandt 5y ago
    Correct or incorrect is sort of irrelevant, because it's a problem itself if they aren't including severity of symptoms in the study. If they are ignoring symptoms to approve a vaccine who's primary remaining benefit is ... reducing severity of symptoms ... then how exactly has the trial proved anything? Since antibodies are no longer a reliable indicator of immunity or of preventing transmission, then reduced severity is the primary remaining benefit. Ideally they'd be looking at a cumulative risk/prevention assessment, but I don't see how they do that while excluding observed symptoms. If they are using antibody levels as a proxy for this when they could just ... directly observe symptoms... then there would be a bigger problem with the study than just a failure to show sufficient efficacy.
    - hammock 5y ago
      Take it up with the FDA. You're preaching to the choir
      - beerandt 5y ago
        I get it. It's just a fine line between arguing what would justify FDA "approval" vs what merits have changed that actually increase the risk-versus-reward assessment. Put another way, when the biggest excuse for not getting vaccinated was "it's experimental and not approved", it became a straw-man-esque "gotcha-trap" of a battle to achieve "approval", even though that approval process looked nothing like any before it (no matter how many times "full fda approval" is repeated). When the metric becomes the goal, it's no longer a metric, and all that. We get bogged down arguing whether criteria of a definition or standard are being met, while the regulators end up just redefining things. And we're supposed to pretend the teacher applying a curved grading scale actually represents a difference in the students performance.
- cik2e 5y ago
  I've read that the pfizer study compared rates of positive test cases between the two groups. BUT, the tests were administered based on self-reported symptoms which were then evaluated by a staff member to decide whether a test was warranted. This absolutely blew my mind. This kind of avoidable subjective decision making should not be happening in a clinical trial. All participants should have been tested at regular intervals.
  - beerandt 5y ago
    Equally... that when they repeat it and get different numbers, the failed trial will be ignored in favor of the passing trial, without first invalidating the previous results[0], and without using any increased burden of proof. Passed+Failed = "Passed!" [0] There will be a reason given to ignore that first trial, it just likely won't be a good one.
  - tekknik 5y ago
    How does one not self-report symptoms? Some will be externally obvious but how does someone know someone else has chest pain, or a sore throat?

beerandt 5y ago

>The biggest reason the under 5s vaccine is taking so long is that they don't suffer severe enough symptoms that they can easily test the efficacy of the virus. How does anyone convince themselves that this is actually a problem? Especially when the vaccine no longer prevents catching the virus or transmitting it. What remaining benefit are people so eager to confer upon their toddlers?

notch656a 5y ago
Well Virtue with a capital 'V' is one big one! And of course they're an excellent source of revenue for Pfizer et al. You wouldn't want to risk it would you? -- writing this while my toddler is banished from daycare for 10 days because a single kid there tested positive.
- dpark 5y ago
  It’s not virtue signaling to be terrified for your children’s health. It might not be rational but it should be perfectly understandable.
  - walterbell 5y ago
    Terror is rarely coincident with clear decision making. Hopefully it's transient, soon followed by calm risk-benefit analysis.
chithanh 5y ago
Vaccines still lower disease severity. Also vaccines reduce risk of some post-acute COVID disorders like MIS-C (which can result even from asymptomatic COVID). https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e1.htm https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e1.htm And of course you don't want to infect your child with a disease that has long term consequences which we are still learning about. Diabetes hit the news recently in the US, but it is actually been known for a while in other countries. https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e2.htm https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e2.htm https://diabetesjournals.org/care/article/43/11/e170/35903/New-Onset-Type-1-Diabetes-in-Children-During-COVID https://diabetesjournals.org/care/article/43/11/e170/35903/N... (UK) https://adc.bmj.com/content/early/2021/05/27/archdischild-2020-321220.abstract https://adc.bmj.com/content/early/2021/05/27/archdischild-20... (Finland) If that wasn't bad enough, diseases that are associated with T1D like celiac disease are on the rise, and show stronger association in COVID patients: https://onlinelibrary.wiley.com/doi/10.1111/apa.16173 https://onlinelibrary.wiley.com/doi/10.1111/apa.16173

mritchie712 5y ago

Do you have a source for this?

tablespoon 5y ago

> The biggest reason the under 5s vaccine is taking so long is that they don't suffer severe enough symptoms that they can easily test the efficacy of the virus. Do you have a source on that? My understanding is the reason it's taking so long is 1) an abundance of caution because the risk/reward calculation is different and 2) young children's immune systems don't work the same as adults').