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The link you provided explains it pretty well: “ Regulatory precedent with other preventive vaccines provides a basis for inference of vaccine effectiveness in

The link you provided explains it pretty well: “ Regulatory precedent with other preventive vaccines provides a basis for inference of vaccine effectiveness in pediatric populations based on immunobridging to a young adult population in which clinical disease endpoint vaccine efficacy has been demonstrated for the same prototype vaccine. The immune marker(s) used for immunobridging do not need to be scientifically established to predict protection but should be clinically relevant to the disease. […] A secondary objective is to evaluate efficacy of BNT162b2 against laboratory-confirmed symptomatic COVID-19 occurring from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection and in participants with or without evidence of prior SARS-CoV-2 infection. A descriptive analysis was conducted once 19 confirmed cases had accrued.“ The 19 confirmed cases were part of a secondary analysis. The primary plan was to compare immune markers and verify the vaccine was working similarity to the adult one which has been repeatedly proven to work.

angelzen 5y ago
Rofl. From the paragraph you just quoted: "The immune marker(s) used for immunobridging do not need to be scientifically established". What is the health benefit they are claiming for kids? Look at table 14: assuming we buy all their assumptions, maybe 1:1,000,000 deaths. How about vaccine adverse effects (by their own projections 1:10,000 excess miocarditis) and long term OAS risks?
- javagram 5y ago
  What about the higher risks of viral myocarditis, MIS-C, hospitalization to the children? Not to mention the quarantines and loss of school / social life that happen when you are sick with covid because you’re a danger to others.
  - vibrato2 5y ago
    Danger to whom? The adults have their vaccine and the kids aren’t susceptible
    - javagram 5y ago
      Many adults in USA have refused the vaccine due to anti-vax propaganda. It’s far from a safe assumption, without something like a vaccine passport scheme in place, that every or even most adults a sick child meets would be vaccinated. Perhaps some ethical systems would argue that anti vax adults have made their choice and should be exposed to the virus without care though. Personally if I was sick with covid I wouldn’t take that approach and would stay home though…
      - vibrato2 5y ago
        Or they have refused due to their own personal reasons. Such as science or demanding accountability and adequate testing from pharma companies. They (we) don’t need you to babysit us. We’re adults.
  - angelzen 5y ago
    What about them? It's Pfizer's job to quantify how their vaccine prevents these in kids, not mine. Perhaps redo the trials with a larger population? One more note. The vaccines effectiveness agains infection fades over time, going even in negative territory. There is the US veteran 6 months study (55% Pfizer, -3% J&J). There is the UK PHE data showing negative VE against infection (up to -50% for certain age groups), but there were some arguments about the denominator. A preprint of a Swedish total population study just dropped, and VE against symptomatic infection after 9 months is in negative territory (-15%). Everybody that quotes VE against infection is quoting outdated data, either original trials or studies with a cutoff <6 months since vaccination. Worse, VE against severe disease also significantly drops over time, the Swedish study looks bad :( (Not happy about any of this, btw) https://www.medrxiv.org/content/10.1101/2021.10.13.21264966v1.full https://www.medrxiv.org/content/10.1101/2021.10.13.21264966v... https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1027511/Vaccine-surveillance-report-week-42.pdf https://assets.publishing.service.gov.uk/government/uploads/... https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410
    - angelzen 5y ago
      Errata: The Sweden study only breaks down VE against severe infection in <80 and >=80 age groups. VE in <80 holds at 82% at 6 months point, no data for 9 months in the respective table.
    - javagram 5y ago
      > What about them? It's Pfizer's job to quantify how their vaccine prevents these in kids, not mine. Perhaps redo the trials with a larger population? It’s not their job to do that, though. They have passed the standards of the FDA. It sounds like what you actually want is for the FDA to increase their standards and require more than they have for past vaccines. There are multiple studies from outside Pfizer showing MIS-C, hospitalization, and illness in general affecting children as a result of COVID-19. If the vaccine can reasonably be believed to prevent illness then it follows that it will prevent or reduce all three of those. Vaccine waning is a bit of a different story, but keep in mind the studies you’ve linked are only part of the picture. Other studies claim the vaccines remain effective at some % after 6 months. Personally, I just got a booster to deal with the issue.

angelzen 5y ago

Rofl. From the paragraph you just quoted: "The immune marker(s) used for immunobridging do not need to be scientifically established". What is the health benefit they are claiming for kids? Look at table 14: assuming we buy all their assumptions, maybe 1:1,000,000 deaths. How about vaccine adverse effects (by their own projections 1:10,000 excess miocarditis) and long term OAS risks?

javagram 5y ago
What about the higher risks of viral myocarditis, MIS-C, hospitalization to the children? Not to mention the quarantines and loss of school / social life that happen when you are sick with covid because you’re a danger to others.
- vibrato2 5y ago
  Danger to whom? The adults have their vaccine and the kids aren’t susceptible
  - javagram 5y ago
    Many adults in USA have refused the vaccine due to anti-vax propaganda. It’s far from a safe assumption, without something like a vaccine passport scheme in place, that every or even most adults a sick child meets would be vaccinated. Perhaps some ethical systems would argue that anti vax adults have made their choice and should be exposed to the virus without care though. Personally if I was sick with covid I wouldn’t take that approach and would stay home though…
    - vibrato2 5y ago
      Or they have refused due to their own personal reasons. Such as science or demanding accountability and adequate testing from pharma companies. They (we) don’t need you to babysit us. We’re adults.
- angelzen 5y ago
  What about them? It's Pfizer's job to quantify how their vaccine prevents these in kids, not mine. Perhaps redo the trials with a larger population? One more note. The vaccines effectiveness agains infection fades over time, going even in negative territory. There is the US veteran 6 months study (55% Pfizer, -3% J&J). There is the UK PHE data showing negative VE against infection (up to -50% for certain age groups), but there were some arguments about the denominator. A preprint of a Swedish total population study just dropped, and VE against symptomatic infection after 9 months is in negative territory (-15%). Everybody that quotes VE against infection is quoting outdated data, either original trials or studies with a cutoff <6 months since vaccination. Worse, VE against severe disease also significantly drops over time, the Swedish study looks bad :( (Not happy about any of this, btw) https://www.medrxiv.org/content/10.1101/2021.10.13.21264966v1.full https://www.medrxiv.org/content/10.1101/2021.10.13.21264966v... https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1027511/Vaccine-surveillance-report-week-42.pdf https://assets.publishing.service.gov.uk/government/uploads/... https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410
  - angelzen 5y ago
    Errata: The Sweden study only breaks down VE against severe infection in <80 and >=80 age groups. VE in <80 holds at 82% at 6 months point, no data for 9 months in the respective table.
  - javagram 5y ago
    > What about them? It's Pfizer's job to quantify how their vaccine prevents these in kids, not mine. Perhaps redo the trials with a larger population? It’s not their job to do that, though. They have passed the standards of the FDA. It sounds like what you actually want is for the FDA to increase their standards and require more than they have for past vaccines. There are multiple studies from outside Pfizer showing MIS-C, hospitalization, and illness in general affecting children as a result of COVID-19. If the vaccine can reasonably be believed to prevent illness then it follows that it will prevent or reduce all three of those. Vaccine waning is a bit of a different story, but keep in mind the studies you’ve linked are only part of the picture. Other studies claim the vaccines remain effective at some % after 6 months. Personally, I just got a booster to deal with the issue.