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Government Response To The Coronavirus


James Daulton

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16 minutes ago, IvanKaramazov said:

I remember the good old days of five minutes ago, when we were talking about the importance of police reform and not criminalizing every little thing.  

I mean what a complete joke. 

We are working with the city of Berkeley to determine whether outdoor exercise may be permitted

 

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33 minutes ago, The Dude said:

Fox trying to make a story out or red states doing better at vaccinating than blue - then compares South Dakota to California 

People here in Florida have been comparing us to California for some time....never understood why.

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1 hour ago, The Dude said:

Fox trying to make a story out or red states doing better at vaccinating than blue - then compares South Dakota to California 

I don't get it.  I live in South Dakota, and we're actually doing a pretty decent job at vaccination, at least the last time I saw any numbers on this.  (I tried Googling for something more recent just now but the first few sites I came across were paywalled and I got lazy and gave up).

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1 minute ago, IvanKaramazov said:

I don't get it.  I live in South Dakota, and we're actually doing a pretty decent job at vaccination, at least the last time I saw any numbers on this.  (I tried Googling for something more recent just now but the first few sites I came across were paywalled and I got lazy and gave up).

They're probably trying to juxtapose the two rather than compare. California is not doing a good job rolling out the vaccine. There's a serious effort afoot to recall the governor. I don't happen to agree with it, but even the left-leaning folks are out with pitchforks, as it were. Especially public health officials speaking off of the record. Just read an article about it last week.

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3 minutes ago, rockaction said:

They're probably trying to juxtapose the two rather than compare. California is not doing a good job rolling out the vaccine. There's a serious effort afoot to recall the governor. I don't happen to agree with it, but even the left-leaning folks are out with pitchforks, as it were. Especially public health officials speaking off of the record. Just read an article about it last week.

Okay, fair enough.  I don't know much about vaccination efforts in California, or most states really.  I just know that the last time I checked my state was doing comparatively well.  (With the usual caveat that all of our states are behind the timeline that I would have preferred).  

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1 minute ago, IvanKaramazov said:

Okay, fair enough.  I don't know much about vaccination efforts in California, or most states really.  I just know that the last time I checked my state was doing comparatively well.  (With the usual caveat that all of our states are behind the timeline that I would have preferred).  

I read a prominent libertarian on Twitter say that he thought Amazon should be in charge of distributing the vaccine to people. A week later, they offered to help the government. I wonder what the end result of that was. I don't think it got any traction. I sort of support that effort, actually, even if I'm usually against public-private arrangements. I think Amazon would do better than the states are doing administering it.

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Just now, rockaction said:

I read a prominent libertarian on Twitter say that he thought Amazon should be in charge of distributing the vaccine to people. A week later, they offered to help the government. I wonder what the end result of that was. I don't think it got any traction. I sort of support that effort, actually, even if I'm usually against public-private arrangements. I think Amazon would do better than the states are doing administering it.

If there's one thing I've learned from covid-19, it's that our society is filled with people who will scream to high heaven about "multiple jumbo jets crashing every day" and how crucially important it is that the we put the country on wartime mobilization footing to solve this problem, and then in the very next breath insist that of course we can't act until the Associate Undersecretary of Compliance signs off on Form 574C pursuant to USC 4.292.59(b).II.  

I've learned a lot in the past year about state capacity and bureaucratic intransigence. 

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Just now, IvanKaramazov said:

If there's one thing I've learned from covid-19, it's that our society is filled with people who will scream to high heaven about "multiple jumbo jets crashing every day" and how crucially important it is that the we put the country on wartime mobilization footing to solve this problem, and then in the very next breath insist that of course we can't act until the Associate Undersecretary of Compliance signs off on Form 574C pursuant to USC 4.292.59(b).II.  

I've learned a lot in the past year about state capacity and bureaucratic intransigence. 

Sort of breathtaking, the whole thing.

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13 minutes ago, rockaction said:

I read a prominent libertarian on Twitter say that he thought Amazon should be in charge of distributing the vaccine to people. A week later, they offered to help the government. I wonder what the end result of that was. I don't think it got any traction. I sort of support that effort, actually, even if I'm usually against public-private arrangements. I think Amazon would do better than the states are doing administering it.

We'd be crazy to not to that when the J&J vaccine comes out that only needs regular refrigeration.    Won't happen.

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29 minutes ago, IvanKaramazov said:

I don't get it.  I live in South Dakota, and we're actually doing a pretty decent job at vaccination, at least the last time I saw any numbers on this.  (I tried Googling for something more recent just now but the first few sites I came across were paywalled and I got lazy and gave up).

I've seen a lot of shade thrown at South Dakota during this pandemic and frankly I don't see why. The state has roughly 1,800 deaths over the course of the pandemic, and current hospitalizations and deaths are at fairly low levels. I get "per capita" arguments, and of course per capita is the correct measurement. But I think it's also important to look at the raw numbers. South Dakota is doing fine, IMO. Could they have fewer deaths? Sure I guess, but at what cost economically and otherwise? 

South Dakota Numbers per Worldometers

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8 minutes ago, tonydead said:

We'd be crazy to not to that when the J&J vaccine comes out that only needs regular refrigeration.    Won't happen.

Johnson & Johnson requested FDA authorization last week.  The FDA won't even bother to discuss it until February 26.  

But remember, it's very important that everybody else put their lives on hold for the forseeable future because this is a public health emergency and we all need to make sacrifices.

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Just now, Grace Under Pressure said:

I've seen a lot of shade thrown at South Dakota during this pandemic and frankly I don't see why. The state has roughly 1,800 deaths over the course of the pandemic, and current hospitalizations and deaths are at fairly low levels. I get "per capita" arguments, and of course per capita is the correct measurement. But I think it's also important to look at the raw numbers. South Dakota is doing fine, IMO. Could they have fewer deaths? Sure I guess, but at what cost economically and otherwise? 

South Dakota Numbers per Worldometers

I'm a big supporter of mask mandates and lockdowns.  Our state very pointedly did not go that route, and I disagree with our governor's policy on that dimension.  But we're doing pretty well on vaccination.  It's like we're the UK of the US, only with better food.

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2 hours ago, IvanKaramazov said:

I don't get it.  I live in South Dakota, and we're actually doing a pretty decent job at vaccination, at least the last time I saw any numbers on this.  (I tried Googling for something more recent just now but the first few sites I came across were paywalled and I got lazy and gave up).

It’s a logistics issue. South Dakota and other smaller population states can more efficiently get the vaccines out. Not to downplay the great job SD has done, it’s just not a fair comparison. Right now most states are doing health care workers and elderly.

Any problem gets compounded as you increase in size. And when you’re talking about elderly, technology and transportation cause major issues. Small states can do a lot to get around those issues that large states can’t. For example my mom works at a hospital in SD. The day they received the vaccine they vaccinated everyone who wanted it within a couple hours. In Arizona, health care workers needed to sign up if interested and wait for an email invite to sign up for an appointment.

Comparing two vastly different sized states, even per capita, is tough to do. Not saying California is doing good, they’re not, but it’s not a fair comparison.

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8 minutes ago, Biff84 said:

It’s a logistics issue. South Dakota and other smaller population states can more efficiently get the vaccines out. Not to downplay the great job SD has done, it’s just not a fair comparison. Right now most states are doing health care workers and elderly.

Any problem gets compounded as you increase in size. And when you’re talking about elderly, technology and transportation cause major issues. Small states can do a lot to get around those issues that large states can’t. For example my mom works at a hospital in SD. The day they received the vaccine they vaccinated everyone who wanted it within a couple hours. In Arizona, health care workers needed to sign up if interested and wait for an email invite to sign up for an appointment.

Comparing two vastly different sized states, even per capita, is tough to do. Not saying California is doing good, they’re not, but it’s not a fair comparison.

South dakota is spread out and rural. I dont see how they have a logistics advantage. 

Eta: rhode island this argument makes sense. 

Edited by parasaurolophus
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26 minutes ago, parasaurolophus said:

South dakota is spread out and rural. I dont see how they have a logistics advantage. 

Eta: rhode island this argument makes sense. 

It is spread out and that makes it difficult but if you take a box of doses, drop it off at the local hospital or pharmacy, you can have most of the health care workers and elderly immunized within a few days. That’s just not happening in bigger states. No doubt SD has done a great job but it’s not an equal comparison.

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9 hours ago, IvanKaramazov said:

Johnson & Johnson requested FDA authorization last week.  The FDA won't even bother to discuss it until February 26.  

But remember, it's very important that everybody else put their lives on hold for the forseeable future because this is a public health emergency and we all need to make sacrifices.

Really wish this got more air time.   Literally every day they delay the decision....they are signing people's death warrants.   Does anyone really believe the FDA review will be meaningful?   Why couldn't they do the review.....today?  Or tomorrow?   It's hard to imagine that the data isn't already prepared.

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13 minutes ago, Alex P Keaton said:

Really wish this got more air time.   Literally every day they delay the decision....they are signing people's death warrants.   Does anyone really believe the FDA review will be meaningful?   Why couldn't they do the review.....today?  Or tomorrow?   It's hard to imagine that the data isn't already prepared.

I think they need a certain amount of post-trial safety data.

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8 hours ago, Biff84 said:

I think they need a certain amount of post-trial safety data.

I'm pretty sure they had to demonstrate safety before moving on to large-scale efficacy trials.  Regardless, it doesn't take three weeks to analyze these data.  Essentially all you're doing is testing for a difference in means between two populations.  It's not literally just one difference-in-means, of course -- you're looking at mean rates of asymptomatic infection, symptomatic infection, hospitalization, intubation, death, as well as well as the incidence of various side effects.  But each of those is the sort of thing that takes literally seconds.  I'm no longer research active, but if I was this is the sort of thing I would outsource to a grad student and expect results back the next day.

Edit: It's also kind of wild that everybody just knows that this vaccine is going to be approved.  I mean, there doesn't seem to be any real question about that.  But for some reason it's really important that we go through the motions even though that means killing another hundred thousand people or so.  If somebody came forward and said "Yes, I know this delay is going to kill a hundred thousand people who had family members and hopes and dreams for the future, but following standard procedure is worth that cost," I could at least respect that position even if I think it's kind of evil.  My bigger problem is that people refuse to even acknowledge that there's a tradeoff involved.  It is literally the case that the people making life-and-death policy decision either don't understand or choose not to understand that their decisions involve costs.  That's terrifying.

Edited by IvanKaramazov
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52 minutes ago, IvanKaramazov said:

 It is literally the case that the people making life-and-death policy decision either don't understand or choose not to understand that their decisions involve costs.  That's terrifying.

It's also, sadly, one the things that make autocrats appealing. When government is so sideways that its bureaucracies are literally killing its own people, and democratic means will not only not solve executive branch malfeasance in this sense but speak sideways about their own culpability in untold deaths, people will turn to autocrats to abolish that branch of government that is responsible for killing its own citizens. It will trade the less-understood evil of encroaching autocracy for the result of razing the more immediate threat.

I'd be lying if I didn't say that some of the last autocrat's program weren't appealing in this way in the beginning, though I never supported him (I never trusted him. After he mocked the disabled journalist, it was completely over). You can bet that there would be people fired, the heads of the agency stripped of power, and then publicly embarrassed by an admittedly ranting loon, but at least a loon on the people's side. That's how all those autocrat governments get that "people's" moniker. Because they'll actually do a thing or two like we're asking to happen to the FDA.

Just a cautionary tale for those running into apologize for the FDA. Careful what you wish for when it comes to bureaucratic decision-making in the name of "protection" of the public. 

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3 hours ago, IvanKaramazov said:

I'm pretty sure they had to demonstrate safety before moving on to large-scale efficacy trials.  Regardless, it doesn't take three weeks to analyze these data.  Essentially all you're doing is testing for a difference in means between two populations.  It's not literally just one difference-in-means, of course -- you're looking at mean rates of asymptomatic infection, symptomatic infection, hospitalization, intubation, death, as well as well as the incidence of various side effects.  But each of those is the sort of thing that takes literally seconds.  I'm no longer research active, but if I was this is the sort of thing I would outsource to a grad student and expect results back the next day.

Edit: It's also kind of wild that everybody just knows that this vaccine is going to be approved.  I mean, there doesn't seem to be any real question about that.  But for some reason it's really important that we go through the motions even though that means killing another hundred thousand people or so.  If somebody came forward and said "Yes, I know this delay is going to kill a hundred thousand people who had family members and hopes and dreams for the future, but following standard procedure is worth that cost," I could at least respect that position even if I think it's kind of evil.  My bigger problem is that people refuse to even acknowledge that there's a tradeoff involved.  It is literally the case that the people making life-and-death policy decision either don't understand or choose not to understand that their decisions involve costs.  That's terrifying.

A couple of weeks ago they scheduled the 2/26 date for the hearings/discussion and then the approval will come after that. They should have said we're going to analyze this data ASAP and then schedule the discussion/hearing for the day after completing the analysis. It feels like this could have been handled with greater urgency. Every day matters.

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35 minutes ago, Grace Under Pressure said:

A couple of weeks ago they scheduled the 2/26 date for the hearings/discussion and then the approval will come after that. They should have said we're going to analyze this data ASAP and then schedule the discussion/hearing for the day after completing the analysis. It feels like this could have been handled with greater urgency. Every day matters.

Can someone make the argument that the FDA would make for this? What would be their response to Ivan's criticism? Is it really just that that's the way they've always done it?  What is their justification for not scheduling the hearing till 2/26?  Ivan's argument makes complete sense but I have to think that there is at least some reason they are not expediting the whole thing even if that reason is questionable at best.

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19 minutes ago, pokin said:

Can someone make the argument that the FDA would make for this? What would be their response to Ivan's criticism? Is it really just that that's the way they've always done it?  What is their justification for not scheduling the hearing till 2/26?  Ivan's argument makes complete sense but I have to think that there is at least some reason they are not expediting the whole thing even if that reason is questionable at best.

I asked a good friend that does regulatory affairs for pharma this question.  She's a PhD neuroscientist that worked on the recent EUA for an Ebola treatment.  She also has good stories about giving cocaine to mice and then cutting their skulls open with scissors (for research, of course).

Edited by The Z Machine
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2 hours ago, pokin said:

Can someone make the argument that the FDA would make for this? What would be their response to Ivan's criticism? Is it really just that that's the way they've always done it?  What is their justification for not scheduling the hearing till 2/26?  Ivan's argument makes complete sense but I have to think that there is at least some reason they are not expediting the whole thing even if that reason is questionable at best.

From my friend that does this for a living (paraphrasing):

The justification for not scheduling the hearing sooner is that the analysis will not be completed until then.  "Normal" process from FDA submission to non-EUA discussion is 9 mo.  Priority review is 6 mo.  Before online submission of the data and summaries, the data was submitted in binders brought in by UHAUL trucks.  Yes, literal truckloads of printed materials.  Now the submissions are done digitally, so that's better.  All summaries have hyperlinks to the underlying data set, methodology, and certificate of analysis.

The FDA read ALL summaries, and repeats the analysis of the underlying data, cross checks every protocol and every sub-report to ensure that the analysis provided by the company was accurate.  They do not trust the company to do it correctly, as private industry has proven to be sneaky and not transparent (by the way, she works for one of these companies, not the FDA).  Any questions on why certain analyses were performed to certain levels are fed back to the submitter for proper answers or to re-run analyses in another way.

The work is not simply data analysis, but rather a data integrity evaluation.

Finally, there are crap-ton of cross tabulations that need to be examined for efficacy for all the sub-groups.  Those subgroups are by demographics, existing drug regimen, pre-existing conditions, etc.  It's a lot of sub-groups to work through.   There are ethical implications to approving a vax that has 98% efficacy for those 65+ but only 45% efficacy for male smokers under 40. You won't know that unless you execute the data analysis for the sub-groups / cross-tabulations.

In addition to the efficacy data and data quality work, there's also a bunch of work to look at the manufacturing site and their processes.  Are they making the same thing that they tested?  Is it contaminated? Etc. 

-------

I asked if 2x more people doing the work would speed things up or whether full transparency from J&J on the data would help or whether the FDA should just run the whole damn thing themselves from a data analysis standpoint and not repeat work from J&J, and she said, those things might help a little but not cutting the time significantly more than it already is.  The FDA moved a bunch fo staff over to assist with COVID analysis already as they knew the urgency in the matter.  Going from 6 mo. to 3 weeks is no small feat.

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23 hours ago, Biff84 said:

It is spread out and that makes it difficult but if you take a box of doses, drop it off at the local hospital or pharmacy, you can have most of the health care workers and elderly immunized within a few days. That’s just not happening in bigger states. No doubt SD has done a great job but it’s not an equal comparison.

Florida is a larger state and they're doing great with vaccinating.  All indications are that the issues in NY are being created by the government.  I suspect the government is a bigger issue than the size/density of the state.

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4 minutes ago, The Dude said:

Does anyone know what the suggested lower end age range is for the shot?

ie are 16 year olds in general supposed to get the shot?  What is the age suggestion?

I think both approved vax are for 16+.  Therefore, I would think everyone aged 16 or older should get it unless there's a compelling medical reason not to do so.  (note: I am not a physician, nor vaccine researcher).

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26 minutes ago, The Z Machine said:

I think both approved vax are for 16+.  Therefore, I would think everyone aged 16 or older should get it unless there's a compelling medical reason not to do so.  (note: I am not a physician, nor vaccine researcher).

Moderna is just 18+. We accidentally immunized at 17 year old employee in a rush to use some doses before they expired and the insurance shot us down.

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Just now, Biff84 said:

Moderna is just 18+. We accidentally immunized at 17 year old employee in a rush to use some doses before they expired and the insurance shot us down.

I hope you pooled some $ together to pay for the cost of the vax so the kid didn't have to eat it.

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42 minutes ago, The Dude said:

Report today that everyone that wants vaccination might have it by end of April.

I mean, we're up to 2.5 million vaccinations a day, if I understand right. If that's sustainable, those are gonna add up fast, especially after subtracting all those willfully refusing the vaccine.

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13 minutes ago, The Z Machine said:
14 minutes ago, Biff84 said:

Moderna is just 18+. We accidentally immunized at 17 year old employee in a rush to use some doses before they expired and the insurance shot us down.

I hope you pooled some $ together to pay for the cost of the vax so the kid didn't have to eat it.

Huge ethical violation, I'm sure ... but:

"My bad, insurance company! We gave the kid a flu shot, not a COVID shot. We had to schmidt-can that last Moderna dose. Yeah ... that's the ticket!"

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12 minutes ago, The Z Machine said:

I hope you pooled some $ together to pay for the cost of the vax so the kid didn't have to eat it.

Nah billing was done after the fact. She got the shot, we just didn’t get reimbursed for it. No one gets charged regardless of insurance coverage.

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1 hour ago, The Z Machine said:

From my friend that does this for a living (paraphrasing):

The justification for not scheduling the hearing sooner is that the analysis will not be completed until then.  "Normal" process from FDA submission to non-EUA discussion is 9 mo.  Priority review is 6 mo.  Before online submission of the data and summaries, the data was submitted in binders brought in by UHAUL trucks.  Yes, literal truckloads of printed materials.  Now the submissions are done digitally, so that's better.  All summaries have hyperlinks to the underlying data set, methodology, and certificate of analysis.

The FDA read ALL summaries, and repeats the analysis of the underlying data, cross checks every protocol and every sub-report to ensure that the analysis provided by the company was accurate.  They do not trust the company to do it correctly, as private industry has proven to be sneaky and not transparent (by the way, she works for one of these companies, not the FDA).  Any questions on why certain analyses were performed to certain levels are fed back to the submitter for proper answers or to re-run analyses in another way.

The work is not simply data analysis, but rather a data integrity evaluation.

Finally, there are crap-ton of cross tabulations that need to be examined for efficacy for all the sub-groups.  Those subgroups are by demographics, existing drug regimen, pre-existing conditions, etc.  It's a lot of sub-groups to work through.   There are ethical implications to approving a vax that has 98% efficacy for those 65+ but only 45% efficacy for male smokers under 40. You won't know that unless you execute the data analysis for the sub-groups / cross-tabulations.

In addition to the efficacy data and data quality work, there's also a bunch of work to look at the manufacturing site and their processes.  Are they making the same thing that they tested?  Is it contaminated? Etc. 

-------

I asked if 2x more people doing the work would speed things up or whether full transparency from J&J on the data would help or whether the FDA should just run the whole damn thing themselves from a data analysis standpoint and not repeat work from J&J, and she said, those things might help a little but not cutting the time significantly more than it already is.  The FDA moved a bunch fo staff over to assist with COVID analysis already as they knew the urgency in the matter.  Going from 6 mo. to 3 weeks is no small feat.

Thanks for this.  At least there is work being done and it's not like they just scheduled it for the 26th because that was the next time they all had a break in the schedule.  I don't really know how I feel about this.  I totally understand not just trusting the corporations' analysis and taking their word for it but if it's already been proven safe and the analysis they are doing is more about it's 75% effective for this group and 73% effective for that group 3 weeks is a long time to wait to start giving shots.  

It'd be interesting to know what percent of these type of analyses don't get approved.  Also would be interesting to know how she'd answer the type of question from earlier in the thread of if waiting these 3 weeks means 10000 more deaths (totally made up number) is this review process important enough to accept that result?  Thanks again for the info. 

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11 minutes ago, parasaurolophus said:

Biden with another lofty goal. More than 50% of schools having in person instruction at least one day a week within 100 days. 

Lol, ummm.... mission accomplished! 

Schools here have had in-person learning all school year long (though with roughly 60% of the kids opting for virtual learning). We get texts from both my kids schools several times every week telling us that "a student or staff member tested positive" but that our child is not a close contact. My daughter told us today that during a recent biology test, one of the virtual students had COVID and asked to be excused from the test to go lie down.

Meanwhile, my son's teachers disappear for several days every now and then, sending messages to the kids that they're quarantining.

Seems like COVID is running buck-wild through these schools.

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29 minutes ago, parasaurolophus said:

Biden with another lofty goal. More than 50% of schools having in person instruction at least one day a week within 100 days. 

Lol, ummm.... mission accomplished! 

It just amazes me that people buy this stuff....way to go Joe!:lmao:

Promise made, Promise kept!!!!!

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32 minutes ago, Doug B said:

Schools here have had in-person learning all school year long (though with roughly 60% of the kids opting for virtual learning). We get texts from both my kids schools several times every week telling us that "a student or staff member tested positive" but that our child is not a close contact. My daughter told us today that during a recent biology test, one of the virtual students had COVID and asked to be excused from the test to go lie down.

Meanwhile, my son's teachers disappear for several days every now and then, sending messages to the kids that they're quarantining.

Seems like COVID is running buck-wild through these schools.

CDC says otherwise 

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4 hours ago, parasaurolophus said:

Biden with another lofty goal. More than 50% of schools having in person instruction at least one day a week within 100 days. 

Lol, ummm.... mission accomplished! 

:shrug:

My kids haven't had one day of in person instruction in almost a year. 

 

Do we have #s of how many kids or what percent are actually already in school?

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