Getting the Covid Vaccine

[tbyers11]

They haven't had studies in kids under 16 read out yet, so I think it'll still be a while yet before the kids can be vaccinated. Moderna has a study in ages 12-16 that they hope will read out in the Spring. So presumably not long after that maybe 12+ can get vaccinated, assuming the results are positive (it's harder to find efficacy differences in children as they don't appear to contract the disease as readily). Someone was surmising that middle- and high-school aged kids could be vaccinated in the Fall. Moderna has just started a study in under 12s, where they will work their way downward in age after they find it safe in older kids.

Pfizer has only just started a study of 12+ kids, so they will lag behind Moderna by a fair amount. And they haven't reported about a trial in under 12s.

Pfizer is actually ahead of Moderna for 12+ kids. They finished their enrollment in January while Moderna finished theirs in February. If both those studies go well, kids 12 and up could be vaccinated by ~August.

Moderna, as CDu noted, did start enrollment in a 6 month-11 year old study last week but they are rolling out sites slowly and performing dose ranging studies before placebo comparisons. It could take months to enroll the ~7000 kids they are looking for. Probably Q1 2022 before vaccines are authorized for kids under 12

Here is a recent article addressing some of the issues with kids. Younger adults tend to have greater reactogenicity to the vaccine than older adults, if this trend continues into kids it could be tricky finding the right dose that stimulates immunity but limits reactogenicity. Also, since kids are less likely to have symptomatic infection and transmission of the virus will (hopefully) be less widespread in the coming months it will be difficulty to determine efficacy. Moderna suggests they will look at neutralizing Ab levels in kids and compare to adults which should work but is less likely to be a definitive, quick yes than comparing cases between vaccine and placebo in the adult efficacy trials

[Bluedog]

Pfizer is actually ahead of Moderna for 12+ kids. They finished their enrollment in January while Moderna finished theirs in February. If both those studies go well, kids 12 and up could be vaccinated by ~August.

Moderna, as CDu noted, did start enrollment in a 6 month-11 year old study last week but they are rolling out sites slowly and performing dose ranging studies before placebo comparisons. It could take months to enroll the ~7000 kids they are looking for. Probably Q1 2022 before vaccines are authorized for kids under 12

Here is a recent article addressing some of the issues with kids. Younger adults tend to have greater reactogenicity to the vaccine than older adults, if this trend continues into kids it could be tricky finding the right dose that stimulates immunity but limits reactogenicity. Also, since kids are less likely to have symptomatic infection and transmission of the virus will (hopefully) be less widespread in the coming months it will be difficulty to determine efficacy. Moderna suggests they will look at neutralizing Ab levels in kids and compare to adults which should work but is less likely to be a definitive, quick yes than comparing cases between vaccine and placebo in the adult efficacy trials

If we reach "herd immunity" by the summer (like some predict although that's certainly not a sure thing) or just very low community spread, won't it basically be impossible to test the efficacy of the vaccine for children? I guess you go to other countries that have had a slower vaccine rollout. Of course, you'd still be able to test the safety side of it. Or it just becomes a multi-year study like most, such as influenza I assume. One of the "positives" of high community spread in the US was the fact that vaccine trials got their results much faster. I'm certainly not an expert like you are though.

I do have some fear that because the fear of COVID has been so great (mostly justifiably, but sometimes misplaced) that it is going to be VERY hard to have a shift in mindsets to allow our young children to do things once again that we used to take for granted (e.g. hug a classmate) which will stunt their social-emotional growth if they go through three years of being told to stay away from everyone and always wear a mask. Older kids this is less of a concern certainly.

[tbyers11]

If we reach "herd immunity" by the summer (like some predict although that's certainly not a sure thing) or just very low community spread, won't it basically be impossible to test the efficacy of the vaccine for children? I guess you go to other countries that have had a slower vaccine rollout. Of course, you'd still be able to test the safety side of it. Or it just becomes a multi-year study like most, such as influenza I assume. One of the "positives" of high community spread in the US was the fact that vaccine trials got their results much faster. I'm certainly not an expert like you are though.

I do have some fear that because the fear of COVID has been so great (mostly justifiably, but sometimes misplaced) that it is going to be VERY hard to have a shift in mindsets to allow our young children to do things once again that we used to take for granted (e.g. hug a classmate) which will stunt their social-emotional growth if they go through three years of being told to stay away from everyone and always wear a mask. Older kids this is less of a concern certainly.

Yes, it might be difficult-to-impossible to have an efficacy based placebo for under 12s if it doesn’t start now. That is why the article suggests that measuring neutralizing Ab titers in kids and determine that they are non-inferior to adult levels could be a mechanism for approval. But that will likely be a tougher bar to cross than simple efficacy. If community spread is low and stays low the regulatory agencies will also likely be more cautious in making sure that there is as little reactogenicity as possible in kids before approval.

To your second point, if community spread is low, like really low, there should be a discussion if young kids would need to wear masks even if they are not yet vaccinated. If transmission stays low and we do periodic testing to check and have plans in place should an cluster occur I think we have to consider it. Australia, New Zealand, Vietnam, Thailand, Taiwan and other countries got transmission down and didn’t wear masks even though they weren’t vaccinated.

[rsvman]

If the companies know from their earlier trials what level of antibodies equates with protection, they could substitute immunogenicity for efficacy in their trials in children, as tbyers is saying.
In other words, assume that if the vaccine engenders a robust antibody response, producing similar antibody tigers in tykes as it did in adults, then the FDA would likely accept that as a surrogate for protection, and give it the ok (providing the companies can also prove safety).

[Bluedog]

Thank you both!

[aimo]

NC State started vaccinating students yesterday.

[dudog84]

If the companies know from their earlier trials what level of antibodies equates with protection, they could substitute immunogenicity for efficacy in their trials in children, as tbyers is saying.
In other words, assume that if the vaccine engenders a robust antibody response, producing similar antibody tigers in tykes as it did in adults, then the FDA would likely accept that as a surrogate for protection, and give it the ok (providing the companies can also prove safety).

I want some antibody tigers!!! Where do I get them?

[OldPhiKap]

I want some antibody tigers!!! Where do I get them?

Charlie Sheen?

[YmoBeThere]

I want some antibody tigers!!! Where do I get them?

Check with Carole?

[aimo]

NC State started vaccinating students yesterday.

Correction. Students at higher risk and staff. All students on 4/5.

[LegoBatman]

Didn't hear from any of them but managed to get signed up at a local pharmacy - trying multiple times to see if they had any shots. Get my first Pfizer in the morning.

Someone must have said something to the scheduling gods. Local twitter vaccine source would tweet that a place had appointments and they would be gone in 20 minutes or less. I, somehow, managed to catch one and got scheduled. Much dancing and rejoicing around here.

Congrats! That is how I got my first shot at then end of Feb - happened to be sitting at my desk when the City's alert went out and clicked quickly enough to get a spot. We weren't fast enough to get a spot for my wife then, as they ran out of spots while she was filling out the forms. She got a spot the next week when I happened to check the CVS website at the right time.

[LegoBatman]

Moderna #2 is scheduled for tomorrow. Looking forward to being fully vaccinated as restrictions are being lifted. My wife gets Moderna #2 on Easter Monday and the in-laws get Pfizer #2 next week, so in about a month my wife and I might be able to have our first "date night" in over a year!

[DukieInKansas]

In the 15 minute holding period.

Never felt the needle but did feel the vaccine going in.

[rsvman]

I want some antibody tigers!!! Where do I get them?

LOL! My phone doesn't understand the word "titers" at all, so it autocorrects to "tigers." It amuses me.


Oh, and my wife is teed up for her first vaccine dose at 1 PM today!!!!! Finally! She has been trying to get an appointment for weeks and weeks. She has to drive all the way to Portsmouth (about 20-25 miles and through a tunnel) to get it, but that is well worth it.

[DukieInKansas]

LOL! My phone doesn't understand the word "titers" at all, so it autocorrects to "tigers." It amuses me.


Oh, and my wife is teed up for her first vaccine dose at 1 PM today!!!!! Finally! She has been trying to get an appointment for weeks and weeks. She has to drive all the way to Portsmouth (about 20-25 miles and through a tunnel) to get it, but that is well worth it.

I briefly considered grabbing an appt in Atchison - slightly more than an hour drive. Since it was the first day of trying, I passed on it to try for one closer and sooner. Fortunately, I was successful.

I'm glad her persistence finally paid off.

[dudog84]

LOL! My phone doesn't understand the word "titers" at all, so it autocorrects to "tigers." It amuses me.


Oh, and my wife is teed up for her first vaccine dose at 1 PM today!!!!! Finally! She has been trying to get an appointment for weeks and weeks. She has to drive all the way to Portsmouth (about 20-25 miles and through a tunnel) to get it, but that is well worth it.

It amused me too.

Arm is a bit sore from yesterday's 1st Moderna shot but not bad, not as sore as Shingrix. Two close friends have had miserable reactions to the 1st shot but they had COVID last year. Both dreading the 2nd shot.

I got to walk to my appointment. Got a call from my backup on Tuesday that would have required a 25-mile drive, so I'm happy.

[YmoBeThere]

Since it was the first day of trying, I passed on it to try for one closer and sooner. Fortunately, I was successful.

That is great news.

I'll be honest, the wait between shots is starting to drag.

[Stray Gator]

Governor DeSantis announced today that Florida will open eligibility for COVID-19 vaccinations to all people over age 40 starting next Monday, March 29, and then to all people over age 18 the following Monday, April 5.

https://www.wesh.com/article/florida...dults/35936042

Here in Orlando/Orange County, the eligible age for vaccinations was already lowered to 40 on Monday of this week.

[cato]

Pfizer is actually ahead of Moderna for 12+ kids. They finished their enrollment in January while Moderna finished theirs in February. If both those studies go well, kids 12 and up could be vaccinated by ~August.

Moderna, as CDu noted, did start enrollment in a 6 month-11 year old study last week but they are rolling out sites slowly and performing dose ranging studies before placebo comparisons. It could take months to enroll the ~7000 kids they are looking for. Probably Q1 2022 before vaccines are authorized for kids under 12

Here is a recent article addressing some of the issues with kids. Younger adults tend to have greater reactogenicity to the vaccine than older adults, if this trend continues into kids it could be tricky finding the right dose that stimulates immunity but limits reactogenicity. Also, since kids are less likely to have symptomatic infection and transmission of the virus will (hopefully) be less widespread in the coming months it will be difficulty to determine efficacy. Moderna suggests they will look at neutralizing Ab levels in kids and compare to adults which should work but is less likely to be a definitive, quick yes than comparing cases between vaccine and placebo in the adult efficacy trials

I’m anticipating a future where we decide to more fully open up without vaccinating kids under 12. We will have a TON of evidence of how significant this crows is as an infection vector AND the best mitigation measures. Based on the results of our local elementary school district (zero outbreaks in the schools that have been open since September), I think that people already probably have a pretty good idea of how to open safely. Unfortunately, I suspect that a lot of what has worked to date has worked because roughly 40% of the kids have been remote, allowing the school to create pods of fewer kids than would be the case if everyone were coming to school in person.

At any rate, given what we know now about susceptibility and what we suspect about transmissibility among the under 12 set, I think most authorities are going to have to make decisions about how to reopen (not if) once there are safe and effective vaccines widely available to everyone age 12 and up.

[rasputin]

Mrs. rasputin and I drove to Spittle County to get our first Pfizer shot yesterday. Both of us felt mostly OK; a little tired and achy last night, and sore at the place of injection, but not a big deal.