Vaccine Trials

[Alan]

Quote:

Originally Posted by SecondCor521 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/ng...ccine-be-ready

[gerntz]

Quote:

Originally Posted by Go-NoGo 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]

Quote:

Originally Posted by 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.

Thanks for your effort.

[bmcgonig]

Quote:

Originally Posted by 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.

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]

Quote:

Originally Posted by bmcgonig 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]

Quote:

Originally Posted by 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.

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?

[gerntz]

Now AstraZeneca vaccine showing good efficacy. Not as high so far as first two. Uses different mechanism to deliver also. And can be stored with just refrigeration. Still a two shots system.

[Chuckanut]

Quote:

Originally Posted by 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?

Emphasis added.

I would say if I was that person, I would wear a mask, but I would also feel much better in the event I found myself in a group of unmasked folks without my own mask. Even a 1 in 20 chance of infection is not that great for highest risk people. Just my 2¢ based upon the very little I know.

[explanade]

Quote:

Originally Posted by 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?

Quote:

Originally Posted by Chuckanut Emphasis added. I would say if I was that person, I would wear a mask, but I would also feel much better in the event I found myself in a group of unmasked folks without my own mask. Even a 1 in 20 chance of infection is not that great for highest risk people. Just my 2¢ based upon the very little I know.

Not only that, there's a belief that vaccines, at least the early ones, will prevent disease but not necessarily infections.

The assumption is that the vaccines won't raise an immune response effectively in the parts of the body where you get infected, which are the nasal passages, mouth and possibly the eyes.

What they would do is prevent infection from spreading and taking hold in your lungs and other organs like the heart.

For the upper respiratory tract, there are vaccines and drugs being developed which would be delivered as inhalers, to attack the virus in those areas.

That also means while you are less likely to get sick, you can get infected and be infectious to other people.

[audreyh1]

Quote:

Originally Posted by 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.

Yes, thanks for your contribution! And I hope you have access to a vaccine soon!

[Montecfo]

Quote:

Originally Posted by gerntz Now AstraZeneca vaccine showing good efficacy. Not as high so far as first two. Uses different mechanism to deliver also. And can be stored with just refrigeration. Still a two shots system.

Looks like there may be quite a few paths to beating Covid, and coming to market pretty quickly.

[CaptTom]

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Originally Posted by explanade That also means while you are less likely to get sick, you can get infected and be infectious to other people.

Oooo. I hadn't thought of that. That's a bit of a bummer. I was thinking about the vaccine as a sort of "super power" that would allow me to relax a bit.

OTOH, at some point everyone who wants one will have the vaccine, and only those who would rather get sick than take the vaccine will be at risk. I'm going to have a hard time working up a lot of sympathy for those folks.

[sengsational]

Quote:

Originally Posted by explanade That also means while you are less likely to get sick, you can get infected and be infectious to other people.

The term I've heard for a vaccine that makes it so you can't infect someone else after the vaccine has trained your body to recognize it is a "sterilizing vaccine". No current Sars-CoV-2 vaccine claims to fall into this category. But in my thinking (warning, he's doing it again!), if your body recognizes some virus that enters your body and starts eliminating it right away, there won't be nearly as many virus particles created, and fewer particles to share on your exhales or within your shared 'bodily fluids'.

[Chuckanut]

If the vaccine helps with herd immunity, it has to be doing something that keeps the virus from spreading at its normal rate.

[Teacher Terry]

We will definitely be getting the vaccine so we can get our lives back. We will probably be in the second group being older with health issues. We are glad we got out some this summer. In light of the cases rising everywhere I am surprised people are traveling for the holiday. We sat outside today with a high of 48 degrees to visit with my son and his wife. Masks were worn and we sat far apart. We lasted 90 minutes until we were frozen).

[Alan]

Quote:

Originally Posted by Chuckanut If the vaccine helps with herd immunity, it has to be doing something that keeps the virus from spreading at its normal rate.

My thoughts as well. A spokesman from AstraZeneca yesterday said that they are geared up to produce 3.5 billion doses worldwide next year. That has got to help towards herd immunity.