1. Issue 1 Does the avg. recipient benefit? The avg. recipient of the vaccine was not going to die of covid, nor going to have a rare AE from vaccine, so the first Q I have is does the avg. person benefit?
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I am the biggest advocate of adult vaccination, and took the first opportunity I could get to get mRNA, but I am stunned that so many smart people are so eager to embrace EUA for 12 to 15 without closer scrutiny of the data. There are 7 issues, as I see it [thread]pic.twitter.com/esdZbQtFZK
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The answer to this question is to consider the adverse event profile against the typical case of covid in this age group The typical AEs are worth noting..pic.twitter.com/JFovdjEfT8
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You have a 2% of severe chills, headache, muscle pain, and fatigue And the average person lowers their risk of covid by ~2% in this time period (as covid had higher spread in USA back then) That second 2% will be lower today, and it is unclear how severe these cases were
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So does the avg kid benefit from this vaccine? I dunno for sure; but I have some questions Hopefully ACIP tells us how severe the 16 infections were
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2 Do the rare events favor vaccination? The mortality of COVID19 among an infected kid is very very low in this group; the study's sample size is too small to prove a mortality reduction, though I am willing to infer it. The size also can't exclude rare AEs Which is bigger?
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What were the 0.3% SAEs seen on vaccine arm? We will need to know that. As far as I can tell, one should not be convinced that the balance of rare events favors vaccination with these data. That is uncertain.
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3 Do we vaccinate kids because of adults who refuse to be vaccinated? Many on twitter cite adults, particularly those over 50, who refuse to be vaccinated as a reason to vaccinate kids... is this correct?
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First, what is the added protection to such an adult in the next few weeks, as rates of covid19 decline from vaccinating kids? v. low Second, are we incentivizing these adults from not getting vaccinated by offering kids in their stead? Concerning This is novel territory
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4. What concerns me the most about this debate is that we are confusing a rational appraisal of a vaccine with classic virtue signaling. Doctors have already offered their kids to the vaccine... but we have yet to have the ACIP!
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5. I continue to believe that this is truly unprecedented to use the EUA authority to push this vaccine through, there are grave risks to doing this detailed herehttps://blogs.bmj.com/bmj/2021/05/07/covid-vaccines-for-children-should-not-get-emergency-use-authorization/ …
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If an un-anticipated safety signal emerges (perhaps like the still under investigation myocarditis/ israeli data) you will have an existential crisis in the USA People are too divided on this issue; we need to be sure of net benefit to kids.
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6. Some say Kids need this to 'return to normal' I would humbly suggest that is because adults have deprived them of normalcy irrationally, and beyond the risk posed to them by the virus. The solution to that issue is not expedited authorizationhttps://www.statnews.com/2021/02/03/kids-dont-need-covid-19-vaccines-to-return-to-school/ …
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7. Many people refuse to comment on this issue because of the daily insults and epithets that they are anti-vax I am a cancer doc, who takes care of post BMT pts, I promise, I have given more vaccines than you. I also have 2 books on drug regulation & policy So spare me
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My answer is who are we decreasing transmission to? If the answer is adults who are choosing not to vaccinate, I am not sure that justifies EUA If the answer is younger kids, I am not sure they need it & what will covid rates be in 1 mo? (ala Israel)https://twitter.com/cso1893/status/1391923283646353414?s=20 …
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Some argue that the 16 cases in the control arm will grow and grow and grow were not for vaccination. To some degree yes, but problem is the base rate is already lower than 16. The other problem is the aforementioned problem which is are these cases as severe as the AEs?
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Over a long time horizon, with good adult vaccination what will the percent of kids suffering from covid (with symptoms) be. And Will it be bigger, and worse than the upfront AEs? The answer is these are uncertain questions not slam dunks
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Others argue that you need to do this to reopen schools "safely" Unfortunately that is not and was not ever a prerequisite to opening schools with very safe outcomes Now the teachers are vaccinated, Not opening is unforgivable
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Some argue that all kids will eventually get the virus were it not for vaccination. But that is an argument for a safe and effective vaccine at some point, and not an argument for a relaxation of approval standards and an EUA now with the remaining uncertainty
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A way to split the difference would be to roll out the vaccine in the safe group slowly. Let's not do 5 million in one week, let's spread that over time, and couple it with a surveillance system that is capable of adjudicating AEs
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This thread should not be misconstrued to mean that under no conditions is a vaccine acceptable but rather under the current conditions there are residual questions that are non-trivial
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And here is H. Cody Meissner from Tufts saying the same thinghttps://twitter.com/VPrasadMDMPH/status/1392196964675067906?s=20 …
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One difference btw this age group and the adult age group is that the adult data shows a reduction in severe infections, but here it cannot be shown as these occur too infrequently in this population, and the sample size is smallerpic.twitter.com/i5cb13yuwe
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End of conversation
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