Vaccine Trials

[Chuckanut]

+1 That’ll be my choice as well, as I doubt we consumers will have much choice.

From what I have heard, any vaccine available in 2021 will be improved on over the next 2-5 years. Some labs are already working on version 2.0 that will be more effective and/or last longer. Figure on at least one more shot at some point in this decade.

 

[CaptTom]

From what I have heard, any vaccine available in 2021 will be improved on over the next 2-5 years. Some labs are already working on version 2.0 that will be more effective and/or last longer. Figure on at least one more shot at some point in this decade.

Agreed. I'll be getting one as soon as I'm allowed/eligible and they're available. If a better one comes out (like they did with the shingles vaccines) I'll get that one when it's available, too. I'm not really concerned about the cost. Probably my insurance will cover it, but if not, I'd pay for it. In the overall picture, the cost, time and inconvenience are trivial compared to the benefit.

I'm not saying anyone else should feel this way. Just my perspective. The great thing is, I don't need to rely on anyone else getting the vaccine if it's as effective as the trials so far have suggested. So those who choose not to won't effect me. This is a win-win, no matter how you feel about vaccines.

 

[explanade]

Maybe with pandemic fatigue, there might be a greater number of people willing to get the vaccine early than was the case back in early summer.

 

[audreyh1]

Do you know the typical age when insurance (BCBS) starts covering the Shingrix shot?

I was able to get it at 100% covered at 59. BCBSTX.

 

[ransil]

Do you know the typical age when insurance (BCBS) starts covering the Shingrix shot?

I check this yesterday BCBS Mass, website says its covered, but I don't trust it and will call when I go get it.
When in CVS a few weeks ago for the flu shot pharmacist said she checked it and said not covered.

Wife is on UHC and the website there says its covered, way better website than BCBS.

when getting the cost quote avg around $250 is that per shot or for the 2 shots?

 

[Dtail]

I was able to get it at 100% covered at 59. BCBSTX.

Same here at 59 with BCBSFL.

 

[Dtail]

I check this yesterday BCBS Mass, website says its covered, but I don't trust it and will call when I go get it.
When in CVS a few weeks ago for the flu shot pharmacist said she checked it and said not covered.

Wife is on UHC and the website there says its covered, way better website than BCBS.

when getting the cost quote avg around $250 is that per shot or for the 2 shots?

When the cost of 250 is quoted, I am fairly sure it is just for one shot.

 

[Amethyst]

I asked the hygienist who cleaned my teeth last week, if he was excited about the COVID vaccine. (I was assuming that dental workers would be first in line).

He said didn't want to get it until it had been out for a year.

Somehow, I doubt his employer will want him to wait that long.

 

[RetireBy90]

Pfizer so submit for EUA 20 Nov

This morning (20 Nov) I see reporting that Pfizer will submit for EUA to FDA today. Also reports that FDA has asked the expert panel to set aside 8-10 Dec for a review of the vaccine.

 

[gerntz]

From what I have heard, any vaccine available in 2021 will be improved on over the next 2-5 years. Some labs are already working on version 2.0 that will be more effective and/or last longer. Figure on at least one more shot at some point in this decade.

I don't doubt there will be 3.0 & 4.0 by 2025. I mean 1.0 took less than a year.

 

[Go-NoGo]

I don't doubt there will be 3.0 & 4.0 by 2025. I mean 1.0 took less than a year.

I have my doubts that there will be a version 2.0 or 3.0 of the approved vaccines.

If the existing Pfizer or Moderna vaccines are safe and effective, there is very little incentive for them to find a new molecule/RNA fragment. Pharma companies will have to perform new clinical trials to prove safety and efficacy - trials which have 30-40k people are not cheap to run.

Not to mention that once you have mass inoculations, incidence of COVID-19 will decline, finding patients to enroll in these trials will be extremely difficult, and then proving effectiveness will be even harder as patients in the placebo and treatment arms are less likely to be infected. They will have to undergo a challenge trial to prove efficacy, which borders on unethical as you have proven meds that are already available.

If there are new versions, my expectations is it will be a v1.1 where the lipid nanoparticles that are currently being used to encapsulate the mRNA will be reformulated so that it will not require super cold storage. Even this will have to undergo FDA regulatory review for safety/efficacy.

 

[ivinsfan]

I asked the hygienist who cleaned my teeth last week, if he was excited about the COVID vaccine. (I was assuming that dental workers would be first in line).

He said didn't want to get it until it had been out for a year.

Somehow, I doubt his employer will want him to wait that long.

I don't think waiting a year will be needed. These vaccines are a one off. The large amount of people being vaccinated at once will quickly bring any potential problems in the open.

 

[sengsational]

An update on the Oxford / Astra Zeneca vaccine is also positive. BBC reports “ The Oxford coronavirus vaccine shows a strong immune response in adults in their 60s and 70s, raising hopes that it can protect age groups most at risk from the virus.” https://www.bbc.com/news/health-54993652

Refreshingly, the vaccine developers reported in The Lancet, a medical journal, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32466-1/fulltext

They appear to be positioning this one as "the fogey vaccine", since there are many references to the older population in this paper.

If these responses correlate with protection in humans, these findings are encouraging because older individuals are at disproportionate risk of severe COVID-19 and so any vaccine adopted for use against SARS-CoV-2 must be effective in older adults.

This result is behind the two mRNA vaccines since they used a marker for disease prevention instead of actual disease prevention. Given the smaller study population and the fact that it's adenovirus based, I'm feeling less comfortable with this one, but it will catch-up.

 

[SecondCor521]

They appear to be positioning this one as "the fogey vaccine", since there are many references to the older population in this paper.

This result is behind the two mRNA vaccines since they used a marker for disease prevention instead of actual disease prevention. Given the smaller study population and the fact that it's adenovirus based, I'm feeling less comfortable with this one, but it will catch-up.

The Lancet article linked about this seemed to be talking about a phase 2 trial. I don't know if phase 3 for this vaccine will be a challenge trial - apparently they do those in England, and I think the "Oxford" in this vaccine means it's partially developed across the pond - or one like Moderna and Pfizer did where it's just a bunch of people going about their daily business. So I think this vaccine is just chronologically behind in terms of development.

 

[RetireBy90]

Oxford identifies protective genes

Interesting read,



https://www.cnbc.com/2020/11/20/cri...ntified-genes-that-protect-against-covid.html

• A team of CRISPR scientists at the New York Genome Center, New York University and Icahn School of Medicine at Mount Sinai say they have identified the genes that can protect human cells against Covid-19.
• Leading virologist at Mount Sinai, Dr. Benjamin tenOever, developed a series of human lung cell models for coronavirus screening to better understand immune responses to the disease and co-authored the study.
• The goal was two-fold: to identify the genes that make human cells more resistant to SARS-CoV-2 virus; and test existing drugs on the market that may help stop the spread of the disease.

 

[Alan]

The Lancet article linked about this seemed to be talking about a phase 2 trial. I don't know if phase 3 for this vaccine will be a challenge trial - apparently they do those in England, and I think the "Oxford" in this vaccine means it's partially developed across the pond - or one like Moderna and Pfizer did where it's just a bunch of people going about their daily business. So I think this vaccine is just chronologically behind in terms of development.

It is Oxford University in England, and the phase 3 trial has been underway with 10’s of thousands of volunteers in multiple countries around the world. They are very close to getting the sort of number of infected people they want before unblinding the trial to see how many of the infected were the placebo group.

When pressed by an interviewer on the radio yesterday the spokesperson would not commit to when, just that they were very close. Until the unblinding happens they won’t know for sure how effective it is.

https://www.theguardian.com/world/n...cker-when-will-a-coronavirus-vaccine-be-ready

 

[gerntz]

I have my doubts that there will be a version 2.0 or 3.0 of the approved vaccines.

If the existing Pfizer or Moderna vaccines are safe and effective, there is very little incentive for them to find a new molecule/RNA fragment. Pharma companies will have to perform new clinical trials to prove safety and efficacy - trials which have 30-40k people are not cheap to run.

Not to mention that once you have mass inoculations, incidence of COVID-19 will decline, finding patients to enroll in these trials will be extremely difficult, and then proving effectiveness will be even harder as patients in the placebo and treatment arms are less likely to be infected. They will have to undergo a challenge trial to prove efficacy, which borders on unethical as you have proven meds that are already available.

If there are new versions, my expectations is it will be a v1.1 where the lipid nanoparticles that are currently being used to encapsulate the mRNA will be reformulated so that it will not require super cold storage. Even this will have to undergo FDA regulatory review for safety/efficacy.

I suppose we can go into what makes a change 1.1 vs. 2.0, but I won't.

But not needing super cold or even cold storage for poor geographies would be a great advance. So would needing just one shot vs. two or even taking it orally. Making their effectiveness period longer than what it turns out to be would help too. While 95% effective is great, 99.9% would be better.

 

[kyzymurgist]

DW and I functionally unblinded our phase 2 Novavax trial today. We apparently beat the odds and are both in the control group based on negative results from the Assure rapid antibody test which has 99% specificity.

So no gym or indoor pickleball this winter. Looking forward to availability of the Pfizer or Moderns version.

 

[gerntz]

DW and I functionally unblinded our phase 2 Novavax trial today. We apparently beat the odds and are both in the control group based on negative results from the Assure rapid antibody test which has 99% specificity.

So no gym or indoor pickleball this winter. Looking forward to availability of the Pfizer or Moderns version.

Thanks for your effort.

 

[bmcgonig]

DW and I functionally unblinded our phase 2 Novavax trial today. We apparently beat the odds and are both in the control group based on negative results from the Assure rapid antibody test which has 99% specificity.

So no gym or indoor pickleball this winter. Looking forward to availability of the Pfizer or Moderns version.

Not that it matters too much I'm sure, but for your case you might instead be interested in sensitivity which gives you the number of false negatives.

 

[bmcgonig]

One of the WWIV members in their latest podcast said that his only worry about the pfeizer vaccine was the last chain in the delivery link. The temperature requirements are complex at the CVS or local pharmacy etc. It's more likely that errors occur there than anywhere else in the delivery and distribution chain, and errors can decrease the efficacy.

 

[kyzymurgist]

Not that it matters too much I'm sure, but for your case you might instead be interested in sensitivity which gives you the number of false negatives.

Sensitivity is 100%

 

[Brat]

According to this morning's local news broadcast, an Oregon long-term care facility has put themselves on the high need list and has arranged with Walgreens to administer the shots.

I will be covered by Kaiser as of Jan 1. Their research group in Seattle was involved in the development of the Moderna vaccine.

 

[gerntz]

One of the WWIV members in their latest podcast said that his only worry about the pfeizer vaccine was the last chain in the delivery link. The temperature requirements are complex at the CVS or local pharmacy etc. It's more likely that errors occur there than anywhere else in the delivery and distribution chain, and errors can decrease the efficacy.

Good point I think. Reason to think bigger distribution locations would be a better source. Might be a good reason for say CVS with 5 stores in an area only store & distribute from one of those.

 

[kcowan]

If you can get a 95% effective vaccine and you are in the highest risk group, what are the chances tht you will go without a mask among Covid-ineffected people?