Octopus Overlords

Unagi wrote: ↑Wed Sep 29, 2021 1:18 pm

Unagi wrote: ↑Tue Sep 14, 2021 4:49 pm So, my 11 yr old daughter had a small headache this morning and went into the nurses office.
I guess 'just a headache' is indeed how a majority of kids experience COVID, so the nurse was alarmed (I didn't even know she had one).

She's pulled from school now, I got her tested, and she's now home until the results of a lab test come back negative... (none of that fancy rapid-test crap).
We should know in 48 hours.

Her headache is basically gone now... but, it's indeed rare that she even has a headache, so I'm only 50/50 I guess on what to expect.

So, my (vaccinated) 14 yr old reports to have lost most of their sense of taste this morning and went into the nurses office... So, we are now home together - waiting to get the results of their test.

I lost my sense of taste a few months ago due to allergies. Fingers crossed.

Anyone know what the holdup is on Moderna getting approval for 12-18 year olds? Didn't they submit data back in June?

stessier wrote: ↑Wed Sep 29, 2021 1:37 pm Anyone know what the holdup is on Moderna getting approval for 12-18 year olds? Didn't they submit data back in June?

It was approved in Canada for 12-17 about a month ago, not sure what's happening here.

My kids are chomping at the bit to get vaccinated, but now it seems like it's going to be after Football and Turkey Day. Which means we can't host a Football and Turkey Day feast again this year.

My daughter had her kindergarten physical last week. This included 4 vaccines. She believes them to all be flu vaccines, but that's not the case. She really wants the Covid one, though.

Smoove_B wrote: ↑Wed Sep 29, 2021 12:47 pm In other news, the antiviral developed by Merck seems to be working:

Laboratory studies show that Merck & Co's (MRK.N) experimental oral COVID-19 antiviral drug, molnupiravir, is likely to be effective against known variants of the coronavirus, including the dominant, highly transmissible Delta, the company said on Wednesday.

Since molnupiravir does not target the spike protein of the virus - the target of all current COVID-19 vaccines - which defines the differences between the variants, the drug should be equally effective as the virus continues to evolve, said Jay Grobler, head of infectious disease and vaccines at Merck.

Molnupiravir instead targets the viral polymerase, an enzyme needed for the virus to make copies of itself. It is designed to work by introducing errors into the genetic code of the virus.

Data show that the drug is most effective when given early in the course of infection, Merck said.

No word on if it's apple flavored, but here's hoping it's available soon.

Ars also did an article on this.

Pretty interesting strategy.

stessier wrote: ↑Fri Oct 01, 2021 1:51 pm

Smoove_B wrote: ↑Wed Sep 29, 2021 12:47 pm In other news, the antiviral developed by Merck seems to be working

No word on if it's apple flavored, but here's hoping it's available soon.

Ars also did an article on this.

Pretty interesting strategy.

Saw that this morning; awesome all-around! Hopefully approval comes swiftly. This seems to close a large treatment gap that presently exists: we have great vaccines, and we have some treatments (eg monoclonals), but once you have COVID, there's not a ton to do until you have bad COVID and are hospitalized and racking up the big bills. An over-the-counter antiviral that you can take as soon as you have confirmed COVID symptoms, with a ~50% effectiveness? Seems huge.

Also huge is that I saw that Merck has already licensed this drug out to several other manufacturers for speedy ramp-up, and has talked of a tiered pricing based on a country's ability to pay.

Am I reading too much into this all?

Also, it's October. Where's my Pfizer EUA application for my kids, Mr. Pfizer CEO? You're now past your self-imposed deadline, but I haven't seen any news as to why. Smoove, any insight?

So, a few weeks ago, vaccine passports came into effect in Ontario. Probably not a good idea then for a local business owner to publicly state that they won't abide by it and screen for vaccines. This was formerly a hip and trendy place, selling expensive cheese plates ($20-30, and even moreso now I heard). Also likely not good business sense to focus on the 20% who haven't been vaccinated, given that we have an 80% rate now. Now exactly a week later she's selling her business. She was sabotaging herself, but I didn't expect her to give up so soon.

Zaxxon wrote: ↑Fri Oct 01, 2021 2:31 pm Also, it's October. Where's my Pfizer EUA application for my kids, Mr. Pfizer CEO? You're now past your self-imposed deadline, but I haven't seen any news as to why. Smoove, any insight?

NEW: The FDA's independent advisory committee has announced 3 upcoming meetings for vaccine discussions:
- October 14: Moderna booster
- October 15: J&J booster
- October 15: Mix-and-match boosters
- October 26: Pfizer vaccine for kids 5-11

I feel like maybe they need to reverse the order there.

Uuuugfgghhhhh.

Reading the link, this doesn't sound bad to me. I take it as they are expecting to receive Pfizer's application any day now, so they are proactively setting a date to hold their review.

https://www.fda.gov/news-events/press-a ... d-covid-19

The FDA anticipates receiving a request from Pfizer to amend its emergency use authorization to allow the use of its COVID-19 vaccine in children 5 through 11 years of age. In anticipation of the request, the FDA is moving forward with scheduling an advisory committee meeting on Oct. 26 to inform the agency’s decision-making.

Late October was the expectation for that meeting, right?

This is the first vaccine all over again. Everyone is so focused up on getting kids vaccinated, once it happens it will be Mission Accomplished again.

I really want my kids vaccinated but I'm not going to count the days. It will happen when it happens and when it does, they'll still wear masks and won't go to birthday parties or play dates. But I guarantee a lot of other kids will be having victory lap parties. Just like when their parents got vaccinated and kids were "low risk."

The problem is the other kids are already holding those victory laps, and they go to class with my kids.

J&J now asking for booster authorization:

J&J said it filed a request with the FDA to authorize boosters for people 18 and older who previously received the company's one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators.

At some point I'd like to read an official history of what's been happening behind the scenes because I honestly can't make sense of what's been going on. Between the disconnection between researchers and the approval committees (namely in what is appropriate) along with the extremely slow rollout for 5-11 year olds as we head into our second COVID winter and arguably the riskiest holiday / vacation season nationwide.

Smoove_B wrote: ↑Tue Oct 05, 2021 10:45 am J&J now asking for booster authorization:

J&J said it filed a request with the FDA to authorize boosters for people 18 and older who previously received the company's one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators.

At some point I'd like to read an official history of what's been happening behind the scenes because I honestly can't make sense of what's been going on. Between the disconnection between researchers and the approval committees (namely in what is appropriate) along with the extremely slow rollout for 5-11 year olds as we head into our second COVID winter and arguably the riskiest holiday / vacation season nationwide.

I'd like to read that official history now.

Smoove_B wrote: ↑Tue Oct 05, 2021 10:45 am At some point I'd like to read an official history of what's been happening behind the scenes because I honestly can't make sense of what's been going on. Between the disconnection between researchers and the approval committees (namely in what is appropriate) along with the extremely slow rollout for 5-11 year olds as we head into our second COVID winter and arguably the riskiest holiday / vacation season nationwide.

Not to quibble too much since I understand how frustrating it is considering the need, but the "extremely slow rollout for 5-11 year olds" will still be remarkably fast compared to any other vaccine ever.

Smoove_B wrote: ↑Tue Oct 05, 2021 10:45 am J&J now asking for booster authorization:

J&J said it filed a request with the FDA to authorize boosters for people 18 and older who previously received the company's one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators.

At some point I'd like to read an official history of what's been happening behind the scenes because I honestly can't make sense of what's been going on. Between the disconnection between researchers and the approval committees (namely in what is appropriate) along with the extremely slow rollout for 5-11 year olds as we head into our second COVID winter and arguably the riskiest holiday / vacation season nationwide.

As a non-expert who is nonetheless on the internet, it seems like J&J would have the strongest case for a general booster, right? I've seen a variety of stuff that suggests that J&J seems to give less protection than Pfizer / Moderna, but becomes comparable with two doses.

Ralph-Wiggum wrote: ↑Tue Oct 05, 2021 11:15 am Not to quibble too much since I understand how frustrating it is considering the need, but the "extremely slow rollout for 5-11 year olds" will still be remarkably fast compared to any other vaccine ever.

No, I'm totally with you - it's "fast" in the big picture. What I don't have an appreciation for is what their process is as it relates to an unfolding crisis. I understand the FDA process was never designed for what's currently happening (and that might be part of the oral history of what is unfolding right now), it's just difficult from a person that is arguably in a "tip of the spear" position to offer guidance and support to those currently struggling with what it means to live in a world where 5-11 year olds cannot be vaccinated.

El Guapo wrote: ↑Tue Oct 05, 2021 11:53 am As a non-expert who is nonetheless on the internet, it seems like J&J would have the strongest case for a general booster, right? I've seen a variety of stuff that suggests that J&J seems to give less protection than Pfizer / Moderna, but becomes comparable with two doses.

Yes, I think this is a good take. However, I'll be curious to see what the booster update rate is for J&J as I'm confident many (majority?) of the people opting for J&J (intentionally chose, not offered because of mobility/access issues) picked it because it was a single shot.

Regardless, this all goes back to the core argument over booster shots and if/how they should be used. My Twitter is filled with various infectious disease doctors and researchers saying they aren't going to get one, despite being technically eligible. It's not over fear but instead a belief that for the overwhelming majority of people they're just not necessary. It's also coming from a place that believes we're collectively better off making sure everyone has at least one shot vs a spectrum across the population that includes 0-3 shots.

Smoove_B wrote: ↑Tue Oct 05, 2021 12:02 pm Yes, I think this is a good take. However, I'll be curious to see what the booster update rate is for J&J as I'm confident many (majority?) of the people opting for J&J (intentionally chose, not offered because of mobility/access issues) picked it because it was a single shot.

I got J&J because it's the first one I could get when I could get one. The only other person I know who got J&J had a break thru case 2 weeks ago and now has long covid... so I think I'll probably get a booster when I can.
I'd much prefer the rest of the world to get shots first, but that's not going to happen.

I had Moderna. If allowed to take a booster, I'll take it.

My kids are still asking all the time when are they going to get the vaccine. My 5 year old daughter recently went to the doctor for her kindergarten physical and needed 4 shots, including her flu shot. She was determined not to show any discomfort, and succeeded. She really wants to get the Covid shot(s). My son only needed the flu vaccine, which he got last weekend. He told the Both kids got to pick some toys as a reward for their bravery.

Archinerd wrote: ↑Tue Oct 05, 2021 2:09 pm I got J&J because it's the first one I could get when I could get one. The only other person I know who got J&J had a break thru case 2 weeks ago and now has long covid... so I think I'll probably get a booster when I can. I'd much prefer the rest of the world to get shots first, but that's not going to happen.

I do think the J&J people should likely be getting a second shot before most of the Pfizer and Moderna people get a 3rd, fwiw.

In other news:

FDA expects to authorize Pfizer vaccine for 5-11 year olds shortly after 10/26 public hearing

“How many days it will take I can't tell you exactly… we're not going to be wasting any time”

FDA’s Dr. Peter Marks tells ABC’s @cheyennehaslett

Sorry it's so late; I was at work.

Smoove_B wrote: ↑Tue Oct 05, 2021 12:02 pm

El Guapo wrote: ↑Tue Oct 05, 2021 11:53 am As a non-expert who is nonetheless on the internet, it seems like J&J would have the strongest case for a general booster, right? I've seen a variety of stuff that suggests that J&J seems to give less protection than Pfizer / Moderna, but becomes comparable with two doses.

Yes, I think this is a good take. However, I'll be curious to see what the booster update rate is for J&J as I'm confident many (majority?) of the people opting for J&J (intentionally chose, not offered because of mobility/access issues) picked it because it was a single shot.

Regardless, this all goes back to the core argument over booster shots and if/how they should be used. My Twitter is filled with various infectious disease doctors and researchers saying they aren't going to get one, despite being technically eligible. It's not over fear but instead a belief that for the overwhelming majority of people they're just not necessary. It's also coming from a place that believes we're collectively better off making sure everyone has at least one shot vs a spectrum across the population that includes 0-3 shots.

I chose J&J for speed. I needed a vax to go to DragonCon and I needed it to be fully effective in 16 days. Lots probably did do it for a single shot option though. There are studies saying the J&J shot shows remarkable effectiveness even after 8 months though.

Smoove_B wrote: ↑Tue Oct 05, 2021 10:42 pm

Archinerd wrote: ↑Tue Oct 05, 2021 2:09 pm I got J&J because it's the first one I could get when I could get one. The only other person I know who got J&J had a break thru case 2 weeks ago and now has long covid... so I think I'll probably get a booster when I can. I'd much prefer the rest of the world to get shots first, but that's not going to happen.

I do think the J&J people should likely be getting a second shot before most of the Pfizer and Moderna people get a 3rd, fwiw.

In other news:

FDA expects to authorize Pfizer vaccine for 5-11 year olds shortly after 10/26 public hearing

“How many days it will take I can't tell you exactly… we're not going to be wasting any time”

FDA’s Dr. Peter Marks tells ABC’s @cheyennehaslett

Sorry it's so late; I was at work.

What exactly are they doing at the hearing? What I don't get is the "we expect to authorize it after the hearing" part, in that if there's little that's reasonably in doubt or that shouldn't change...why not just authorize it now?

El Guapo wrote: ↑Wed Oct 06, 2021 12:30 am What exactly are they doing at the hearing? What I don't get is the "we expect to authorize it after the hearing" part, in that if there's little that's reasonably in doubt or that shouldn't change...why not just authorize it now?

As I understand it, the time between now and the hearing is when they review the data submitted by Pfizer and confirm the results of the trials.

Archinerd wrote: ↑Tue Oct 05, 2021 2:09 pm

Smoove_B wrote: ↑Tue Oct 05, 2021 12:02 pm Yes, I think this is a good take. However, I'll be curious to see what the booster update rate is for J&J as I'm confident many (majority?) of the people opting for J&J (intentionally chose, not offered because of mobility/access issues) picked it because it was a single shot.

I got J&J because it's the first one I could get when I could get one. The only other person I know who got J&J had a break thru case 2 weeks ago and now has long covid... so I think I'll probably get a booster when I can.
I'd much prefer the rest of the world to get shots first, but that's not going to happen.

Same reason for getting J&J. My wife and I will be glad to get the boosters. She's been mad at me for signing us up for "the dumb one" but it was the only one I could find when it opened up for our age group (50+). If the efficacy gets brought up to comparative levels we'll both be a bit relieved. I was actually considering looking around to see if we could get a Moderna shot somewhere since they're available everywhere around me.

Will be getting my booster on Friday under orders suggestion from the medical director. Chose Friday because dose 2 knocked me on my ass.

Smoove_B wrote: ↑Tue Oct 05, 2021 12:02 pm

El Guapo wrote: ↑Tue Oct 05, 2021 11:53 am As a non-expert who is nonetheless on the internet, it seems like J&J would have the strongest case for a general booster, right? I've seen a variety of stuff that suggests that J&J seems to give less protection than Pfizer / Moderna, but becomes comparable with two doses.

Yes, I think this is a good take. However, I'll be curious to see what the booster update rate is for J&J as I'm confident many (majority?) of the people opting for J&J (intentionally chose, not offered because of mobility/access issues) picked it because it was a single shot.

Regardless, this all goes back to the core argument over booster shots and if/how they should be used. My Twitter is filled with various infectious disease doctors and researchers saying they aren't going to get one, despite being technically eligible. It's not over fear but instead a belief that for the overwhelming majority of people they're just not necessary. It's also coming from a place that believes we're collectively better off making sure everyone has at least one shot vs a spectrum across the population that includes 0-3 shots.

I got the J&J shot since it was the first offering available to me at the time (April 2021). I'll get a booster shot if recommended by CDC. As to the other point - getting more people initially vaccinated - I agree, but the most I can do is support efforts to send vaccines to other parts of the world.

LawBeefaroni wrote: ↑Wed Oct 06, 2021 9:30 am Will be getting my booster on Friday under orders suggestion from the medical director. Chose Friday because dose 2 knocked me on my ass.

Good luck! My booster dose hit me about 50% harder than my 2nd shot. I had a worse headache and a higher and more persistent fever. Still, like the 2nd shot, I was fine after two days.

Unagi wrote: ↑Wed Sep 29, 2021 1:18 pm

Unagi wrote: ↑Tue Sep 14, 2021 4:49 pm So, my 11 yr old daughter had a small headache this morning and went into the nurses office.
I guess 'just a headache' is indeed how a majority of kids experience COVID, so the nurse was alarmed (I didn't even know she had one).

She's pulled from school now, I got her tested, and she's now home until the results of a lab test come back negative... (none of that fancy rapid-test crap).
We should know in 48 hours.

Her headache is basically gone now... but, it's indeed rare that she even has a headache, so I'm only 50/50 I guess on what to expect.

So, my (vaccinated) 14 yr old reports to have lost most of their sense of taste this morning and went into the nurses office... So, we are now home together - waiting to get the results of their test.

Results came back Monday (took forever, results were ready Friday, but their communication to me failed somewhere).

Negative. Hooray!

So, loss of taste for non-Covid reasons....
Their taste has come back ever so slightly but not by a lot.

Ralph-Wiggum wrote: ↑Wed Oct 06, 2021 9:46 am

LawBeefaroni wrote: ↑Wed Oct 06, 2021 9:30 am Will be getting my booster on Friday under orders suggestion from the medical director. Chose Friday because dose 2 knocked me on my ass.

Good luck! My booster dose hit me about 50% harder than my 2nd shot. I had a worse headache and a higher and more persistent fever. Still, like the 2nd shot, I was fine after two days.

Ditto on Pfizer, only my arm was red and I could feel the heat coming off it for a bit more than two days. Still, glad I did.

Unagi wrote: ↑Wed Oct 06, 2021 10:06 am
Results came back Monday (took forever, results were ready Friday, but their communication to me failed somewhere).

Negative. Hooray!

So, loss of taste for non-Covid reasons....
Their taste has come back ever so slightly but not by a lot.

Woot!

We'll both get our Pfizer boosters as soon as we reach the 6-month mark (December). Wife will be 65; I'll be a few months shy of that magic age, but I see that "overweight" (BMI >25) is considered an underlying condition, and I'm at 28.7.

Smoove_B wrote: ↑Tue Oct 05, 2021 10:42 pmIn other news:

FDA expects to authorize Pfizer vaccine for 5-11 year olds shortly after 10/26 public hearing

“How many days it will take I can't tell you exactly… we're not going to be wasting any time”

FDA’s Dr. Peter Marks tells ABC’s @cheyennehaslett

Sorry it's so late; I was at work.

Max Peck wrote: ↑Wed Oct 06, 2021 1:18 am

El Guapo wrote: ↑Wed Oct 06, 2021 12:30 am What exactly are they doing at the hearing? What I don't get is the "we expect to authorize it after the hearing" part, in that if there's little that's reasonably in doubt or that shouldn't change...why not just authorize it now?

As I understand it, the time between now and the hearing is when they review the data submitted by Pfizer and confirm the results of the trials.

The part that's weirding me out is with the past EUA expansions, Pfizer submitted data and an EUA request, then the FDA committee meeting was scheduled and carried out, then it was approved. For the 5-11 cohort, the FDA first asked for an expansion of the trial, then Pfizer's CEO came out saying to expect an EUA request by 9/30, then Pfizer submitted some data but no EUA request, then the FDA scheduled their meeting, and here we are on 10/6 with still no (to my knowledge) official EUA request from Pfizer.

So if they are using the time from now to the 10/26 meeting to review the data already submitted by Pfizer, why hasn't Pfizer officially requested the EUA yet? Are they going to submit more data first? What changed to push the EUA request date from the publicly-stated 9/30 by nearly a week and counting, when the 9/30 goal was given not that far before 9/30? Is that delay going to push the committee's date, or the subsequent approvals to follow?

It's just a messaging mess, as expected at this point, I guess.

I can only assume somehow there is data that is still being reviewed. Because setting up the meetings and giving formal recommendations is the easy part. I don't believe there's a production/supply issue that could be screwing things up - the idea that they'd approve it and no shots would be available. I just don't know.

Smoove_B wrote: ↑Wed Oct 06, 2021 2:56 pm I can only assume somehow there is data that is still being reviewed. Because setting up the meetings and giving formal recommendations is the easy part. I don't believe there's a production/supply issue that could be screwing things up - the idea that they'd approve it and no shots would be available. I just don't know.

Is it possible Pfizer requested that date so that in the anticipation of a yea verdict, they have enough product on hand to meet the immediate demand?

I really don't think so. I don't believe there are supply issues at all for vaccinations. And I know there will be a surge of 5-11 year olds being vaccinated, but I fear it's going to top out around 30% of the total number that can be (nationally). If you look at the data for 12-17 year olds:

As of July 31, 2021, coverage with ≥1 dose of COVID-19 vaccine among adolescents aged 12–17 years was 42%, and 32% had completed the series. Series completion rates varied widely by state, ranging from 11% to 60%, and was 25% for adolescents aged 12–13 years, 30% for those aged 14–15 years, and 40% for those aged 16–17 years.

Until each state mandates it for school, it's going to continue to be a problem.

Final-fuckin-ly...

https://www.nytimes.com/2021/10/07/us/p ... -5-11.html

Zaxxon wrote: ↑Wed Oct 06, 2021 2:44 pm It's just a messaging mess, as expected at this point, I guess.

I work in health PR (not with Pfizer), so I'm very sympathetic to the messaging mess. The speed at which things are moving throws everything out of whack.

Normally, you would submit data and file for approval at the same time. I'm guessing that in this case, FDA agreed to take the initial data ASAP so that they could begin preparing for the Advisory Committee meeting. FDA staff need that time to do a deep, rigorous analysis of the data and prepare briefing materials for the Committee members, who are outside experts. The briefing materials include both FDA's assessment of the submitted data and the key questions they are asking the Committee to address.

Filing for the EUA likely took longer because there were additional hoops to jump through - legal/regulatory boxes to be checked or additional sub-analyses of the data to be conducted.

I would expect the FDA to act very quickly after the Advisory Committee recommendation. Normally it takes weeks or months for an FDA decision after an Advisory Committee meeting, but for COVID vaccines it's been a matter of days.

I appreciate the explanation.

My company has delayed return to the office (previously scheduled for 11/2). They are not giving us a new target date, just that they will give us 30 days advance notice. I remember when the return to office date was labor day 2020. those were simpler times.

I'm in the office 5 days a week. Most of my counterparts at the mothership are WFH 5 days a week.

Had a chat with my boss wherein he said we may all be moving to 2-3 days a week WFH and co-officing or whatever you call it. Space is at a premium and this would definitely help.

I'd be OK with going to a split schedule. I was the easy call. I think he's going.to have more difficult calls getting the 100% WFHers back into the office a few days a week.