We just went through days of a bunch of shit I couldn’t even follow the thread of why people were arguing causing so much traffic in the thread and now FDA approves EUA for 5-11 and nothing?
https://twitter.com/KevinMKruse/status/1454174813942059009?s=20
It is freakin awesome!
Think it’s anticlimatic because we all knew it was coming, we were just waiting for when.
At this point, I’m fairly confident that it’s going to be approved and available next week. So the FDA approval wasn’t a shock at all. But I’m also not going to feel any real excitement until my youngest has a shot in his arm.
In terms of the FDA approval process, I thought this was interesting:
The FDA conducted an extensive benefit/risk assessment through a series of six models. Because we can’t see into the future, biostatisticians ran different scenarios based on varying three variables: COVID19 cases (pandemic could get worse or better); real world effectiveness of vaccines (we think this will be high, but could vary depending on waning and variants); and rate of vaccine-induced myocarditis among this age group (we think it will be lower than adolescents but we don’t know). All of these risks are deliberately conservative. In other words, they looked at worse case scenarios for myocarditis risk and vaccine efficacy. This is what they found…
• For five scenarios, the benefits of a vaccine clearly outweigh the risks of myocarditis:
• Scenario 1: Used number of COVID19 cases on Sept 11, 2021
• Scenario 2: Used number of COVID19 cases at the Delta peak (worse case scenario)
• Scenario 4: Used a high real-world effectiveness of the vaccine
• Scenario 5: Used high COVID-19 death rate
• Scenario 6: Used a lower estimate of myocarditis rate than adolescents (this is the likely scenario given the impact of hormones on myocarditis and given classic myocarditis among this group is so low)
• There was one scenario (#3) where benefits didn’t outweigh risks. In this model, the FDA used the lowest level of COVID19 cases like we saw in June 2021. Using this, the model predicts more excess hospitalizations due to vaccine-related myocarditis compared to prevented hospitalizations due to COVID-19 in males and in both sexes combined. It’s important to keep in mind that there are benefits to the vaccine beyond hospitalization.
Much longer discussion of the meeting here:
Anyone who’s interested in COVID-related stuff should probably be signed up - she’s great.
I’m really not sure what I’m going to be feeling once the last member of my household is vaccinated. I though that I’d experience an overwhelming sense of relief when my wife and I were fully vaccinated several months ago, but obviously that didn’t really happen. Did we wait all this time for the kid vaccine, only to be stuck in the “well, we still need to worry about breakthrough infection” mode forever? God, I hope not.
Yeah the real relief will be once appointment is booked and shot is in arm.
For us we need to find out if we need the shot or not, but unfortunately the clinical trial doesn’t have hours left today so we have to wait till at least Monday to find out of our 7 year old got the real deal or not. We may have been a fully vaxxed family for a while now TBD.
If we’re going to talk about the FDA approval, let’s talk about this quote from the advisory council that voted in favor earlier this week:
But Dr. Michael G. Kurilla, an official at the National Institutes of Health who abstained from the vote, said the government was embracing a “one-size-fits-all” approach.
“I think for many children who have experienced Covid already, they’re probably more than adequately protected. One dose may be sufficient,” he said. “I think for the high-risk children, it’s very different.”
Maybe I’m misinterpreting this quote, but it sounds like this dude didn’t vote to approve the vaccine for any children because he feared that some governments might mandate the vaccine for everyone? That seems like a really poor way to evaluate the safety and efficacy of a drug.
Are you guys just showing up to get boosters? Pretty sure I’m not eligible but I doubt anyone cares
Got boostered on Tuesday. J&J in April and Moderna on Tuesday (thanks to poll feedback). Symptoms this time were like a very mild cold/flu on the day after. Felt a lot worse after the shot in April.
Made an appointment on the Safeway (grocery chain) website and they had checkboxes to indicate my status and eligibility for booster.
Walked into wal-mart (texas) today and got the booster.
They asked me for underlying condition. This did’nt happen for first 2 shots.
I commented and tech said they had to ask for booster.
He checked a chart, and hypertension didn’t qualify but tachycardia did.
However there is/was no way for them to verify my condition.
So you might get asked.
I’m gonna have to try walking in, because I can’t find a booster appointment within 90 miles of me through November.
Walgreens had me sign a photocopied sheet of paper that listed all the eligible categories saying “I am one of these”, but that was it.
tachycardia isn’t really a condition, lol. nice work on the upgrade.
Depends on your state. Generally I think you just attest to being eligible (NY is like this, TX apparently not).
Nice subtle humble brag about not being fat tho :)
wow, even if you are only “overweight” on the BMI scale you are eligible.
Is there any reason not to get an 8-YO vaccinated as soon as possible?
not that I can think of
Only eligible because JNJ.
Don’t jump the gun on getting a booster shot imo. From what I read it’s best to wait until six months after the 2nd shot before hitting the turbo boost.
I could schedule a booster online if I checked one of the boxes. (I said high-risk work environment, which is 1000% true for me and probably somewhat true for most anyone)
Aren’t we at or near that point for just about everyone in the US that wanted the shot ASAP earlier this year?