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FDA authorizes use of Pfizer's Covid vaccine for 5- to 11-year-olds
- sieabahlpark 5y agoCool tech article, hope it gets flagged.
- angelzen 5y agoIn the clinical trial underlying the decision there were ZERO severe covid cases or deaths in vaccinated or unvaccinated 5-11 kids. There were a grand total of 19 covid cases altogether out of 1,450 treatment and 736 control groups, over 6 months. What exactly is the claimed health benefit?! "The evaluable efficacy population included 1,450 participants randomized to BNT162b2 and 736 participants randomized to placebo." "All cases of COVID-19 occurred in children without prior history of infection. None of these cases met the criteria for severe infection. Most of the cases occurred in July-August 2021. Comorbidities at baseline (including obesity) were present in total of 20.1% of cases" https://www.fda.gov/media/153447/download https://www.fda.gov/media/153447/download
- jdhn 5y ago>What exactly is the claimed health benefit?! Easing parental anxiety.
- javagram 5y agoThe 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 agoRofl. 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 agoWhat 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 agoDanger to whom? The adults have their vaccine and the kids aren’t susceptible
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- sjg007 5y agoJust look at the pediatric hospitalization/ICU and death rate over the pandemic. These are all unvaccinated kids. We know the same vaccine formulations at higher doses reduce hospitalization/death in older populations. It's not hard to see the benefit.
- angelzen 5y agoThat's a bit of an odd argument, as no kids are vaccinated to compare, and especially no kids are vaccinated a year ago to see how well VE holds over time. The point is the Pfizer's own trials failed to prove vaccine health benefits in kids, mainly because covid in kids is a minor health risk, and the trial was too small to capture any severe case. Odd that the FDA went with it, no wonder that some FDA officials are choosing to resign than to partake in the charade.
- sjg007 5y agoIt’s not odd at all. And the vaccine is safe. Your only plausible argument would be that it’s useless, which we know is not true generally.
- ThunderSizzle 5y ago> And the vaccine is safe. Are you willing to stake liability on that? Is anyone willing to stake their liability on that point? The answer is no. No one has liability, which means theirs no incentives for honesty, accuracy, or transparency. Without the threat of lawsuits and bankruptcy, why would a vaccine company be more transparent and honest, than say Microsoft?
- sjg007 5y agoHuh? I don’t get your point? No vaccine provider has ever taken liability which is why we have the vaccine National Vaccine Injury Compensation Program. The threat of lawsuits is not the only nor the best way to enforce quality. In fact we have regulations and the FDA for this reason.
- limeblack 5y agoPlease correct if I am wrong but schools can start to require them similar to immunizations. Won’t help now but years later we have basically everyone vaccinated.
- peteradio 5y agoYears later the vaccinations effect will be long gone. Unless you are suggesting we implement a 2-3 times per year immunization cycle for our children to attend school, that certainly is unprecedented.
- cft 5y agoShould authorize and mandate it for dead people too.