There is a long but well-written article on COVID and breakthroughs
and the like in The New Yorker, published on 22 August 2021.

Dhruv Khullar, the author, is a practicing physician and knows what he
is talking about.

..<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>

Have You Already Had a Breakthrough COVID Infection? The question of
what “infection” means is just one of the riddles posed by the
late-stage pandemic.

Joe Gwinn

On Sunday, August 22, 2021 at 4:10:52 PM UTC-4, Joe Gwinn wrote:
> There is a long but well-written article on COVID and breakthroughs
> and the like in The New Yorker, published on 22 August 2021.
>
> Dhruv Khullar, the author, is a practicing physician and knows what he
> is talking about.
>
> .<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
>
>
> Have You Already Had a Breakthrough COVID Infection? The question of
> what “infection” means is just one of the riddles posed by the
> late-stage pandemic.
>
> Joe Gwinn

The article basically says that breakthrough infections are more hype than a real problem.....and yet why the need for boosters then?

On 8/22/2021 1:10 PM, Joe Gwinn wrote:
> There is a long but well-written article on COVID and breakthroughs
> and the like in The New Yorker, published on 22 August 2021.
>
> Dhruv Khullar, the author, is a practicing physician and knows what he
> is talking about.
>
> Have You Already Had a Breakthrough COVID Infection? The question of
> what “infection” means is just one of the riddles posed by the
> late-stage pandemic.

I've three friends with documented (blood test) break-through infections.
None have serious symptoms -- one is completely asymptomatic.

[I only know ~24 people who've been infected so I'm not sure how
alarming this number is, esp as my sample space is obviously
biased!]

All are "older" so their vaccinations happened relatively early in the
roll-out. All did a fair bit of traveling (vaccination was their
get-out-of-jail-free card) as soon as vaccinated. All tend to
be out-and-about (restaurants, shopping, etc.) quite a bit.

"Life has returned to normal!" (apparently not!)

All have been told to self-quarantine to minimize the potential for
infecting others (obviously, quarantine doesn't do anything for
their own conditions!) -- esp those poor folks who couldn't AFFORD the
vaccine (and had to SETTLE for a $20 counterfeit vaccination card,
instead!)

On Sun, 22 Aug 2021 13:58:50 -0700 (PDT), Brent Locher
<blocher@columbus.rr.com> wrote:

>On Sunday, August 22, 2021 at 4:10:52 PM UTC-4, Joe Gwinn wrote:
>> There is a long but well-written article on COVID and breakthroughs
>> and the like in The New Yorker, published on 22 August 2021.
>>
>> Dhruv Khullar, the author, is a practicing physician and knows what he
>> is talking about.
>>
>> .<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
>>
>>
>> Have You Already Had a Breakthrough COVID Infection? The question of
>> what “infection” means is just one of the riddles posed by the
>> late-stage pandemic.
>>
>> Joe Gwinn
>
>The article basically says that breakthrough infections are more hype than a real problem.....and yet why the need for boosters then?

Because over time the variants will be less and less affected by circa
2021 vaccines, and a booster will restore full effect.

The Flu is the classic extreme. Every year, a new variant, so one can
get it every year. Some variants are worse than others, and while
they don't usually kill healthy people, they may make those people
wish it did.

And because people are frightened by all the media news.

Joe Gwinn

On Sun, 22 Aug 2021 16:10:40 -0400, Joe Gwinn <joegwinn@comcast.net>
wrote:

>There is a long but well-written article on COVID and breakthroughs
>and the like in The New Yorker, published on 22 August 2021.
>
>Dhruv Khullar, the author, is a practicing physician and knows what he
>is talking about.
>
>.<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
>
>
>Have You Already Had a Breakthrough COVID Infection? The question of
>what “infection” means is just one of the riddles posed by the
>late-stage pandemic.
>
>Joe Gwinn

Knows what he is talking about? The article is a mass of uncertainty
and speculation and confusion.

--

Father Brown's figure remained quite dark and still;
but in that instant he had lost his head. His head was
always most valuable when he had lost it.

On Sun, 22 Aug 2021 14:58:23 -0700, jlarkin@highlandsniptechnology.com
wrote:

>On Sun, 22 Aug 2021 16:10:40 -0400, Joe Gwinn <joegwinn@comcast.net>
>wrote:
>
>>There is a long but well-written article on COVID and breakthroughs
>>and the like in The New Yorker, published on 22 August 2021.
>>
>>Dhruv Khullar, the author, is a practicing physician and knows what he
>>is talking about.
>>
>>.<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
>>
>>
>>Have You Already Had a Breakthrough COVID Infection? The question of
>>what “infection” means is just one of the riddles posed by the
>>late-stage pandemic.
>>
>>Joe Gwinn
>
>Knows what he is talking about? The article is a mass of uncertainty
>and speculation and confusion.

He's being honest about the actual state of knowledge.

I'm vaccinated and don't wear a mask, but if I were a doctor, I would
wear a mask as well - time on target matters.

Joe Gwinn

On Sunday, August 22, 2021 at 6:06:56 PM UTC-4, Joe Gwinn wrote:
> On Sun, 22 Aug 2021 14:58:23 -0700, jla...@highlandsniptechnology.com
> wrote:
> >On Sun, 22 Aug 2021 16:10:40 -0400, Joe Gwinn <joeg...@comcast.net>
> >wrote:
> >
> >>There is a long but well-written article on COVID and breakthroughs
> >>and the like in The New Yorker, published on 22 August 2021.
> >>
> >>Dhruv Khullar, the author, is a practicing physician and knows what he
> >>is talking about.
> >>
> >>.<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
> >>
> >>
> >>Have You Already Had a Breakthrough COVID Infection? The question of
> >>what “infection” means is just one of the riddles posed by the
> >>late-stage pandemic.
> >>
> >>Joe Gwinn
> >
> >Knows what he is talking about? The article is a mass of uncertainty
> >and speculation and confusion.
> He's being honest about the actual state of knowledge.
>
> I'm vaccinated and don't wear a mask, but if I were a doctor, I would
> wear a mask as well - time on target matters.

Why do we need to know you don't wear a mask?

>
> Joe Gwinn

On Sunday, August 22, 2021 at 4:10:52 PM UTC-4, Joe Gwinn wrote:
> There is a long but well-written article on COVID and breakthroughs
> and the like in The New Yorker, published on 22 August 2021.
>
> Dhruv Khullar, the author, is a practicing physician and knows what he
> is talking about.
>
> .<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
>
>
> Have You Already Had a Breakthrough COVID Infection? The question of
> what “infection” means is just one of the riddles posed by the
> late-stage pandemic.

Provincetown isn't representative of anything. It was gay party week and the standard salutation is for people to kiss each other on the lips. Then the hygiene in gay bars is beyond atrocious.

Bad article.

>
> Joe Gwinn

On Sunday, August 22, 2021 at 5:58:34 PM UTC-4, jla...@highlandsniptechnology.com wrote:
> On Sun, 22 Aug 2021 16:10:40 -0400, Joe Gwinn <joeg...@comcast.net>
> wrote:
> >There is a long but well-written article on COVID and breakthroughs
> >and the like in The New Yorker, published on 22 August 2021.
> >
> >Dhruv Khullar, the author, is a practicing physician and knows what he
> >is talking about.
> >
> >.<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
> >
> >
> >Have You Already Had a Breakthrough COVID Infection? The question of
> >what “infection” means is just one of the riddles posed by the
> >late-stage pandemic.
> >
> >Joe Gwinn
> Knows what he is talking about? The article is a mass of uncertainty
> and speculation and confusion.

Author uses poppers a lot, obviously. That will do it.

>
>
>
> --
>
> Father Brown's figure remained quite dark and still;
> but in that instant he had lost his head. His head was
> always most valuable when he had lost it.

On Sunday, August 22, 2021 at 5:44:56 PM UTC-4, Joe Gwinn wrote:
> On Sun, 22 Aug 2021 13:58:50 -0700 (PDT), Brent Locher
> <blo...@columbus.rr.com> wrote:
>
> >On Sunday, August 22, 2021 at 4:10:52 PM UTC-4, Joe Gwinn wrote:
> >> There is a long but well-written article on COVID and breakthroughs
> >> and the like in The New Yorker, published on 22 August 2021.
> >>
> >> Dhruv Khullar, the author, is a practicing physician and knows what he
> >> is talking about.
> >>
> >> .<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
> >>
> >>
> >> Have You Already Had a Breakthrough COVID Infection? The question of
> >> what “infection” means is just one of the riddles posed by the
> >> late-stage pandemic.
> >>
> >> Joe Gwinn
> >
> >The article basically says that breakthrough infections are more hype than a real problem.....and yet why the need for boosters then?
> Because over time the variants will be less and less affected by circa
> 2021 vaccines, and a booster will restore full effect.
>
> The Flu is the classic extreme. Every year, a new variant, so one can
> get it every year. Some variants are worse than others, and while
> they don't usually kill healthy people, they may make those people
> wish it did.
>
> And because people are frightened by all the media news.

I don't think the boosters they are talking about now are any different from the original vaccine, someone correct me if I am wrong. The boosters they are talking about now are simply to deal with the benefit of the vaccine wearing off over time.

A vaccine that better handles new variants would by definition be a new vaccine and would need to go through the development and approval process again. I'm not sure if it would also protect against the prior strains or not. I guess that depends on the details of the particular vaccine.

--

Rick C.

- Get 1,000 miles of free Supercharging
- Tesla referral code - https://ts.la/richard11209

On Sun, 22 Aug 2021 16:10:40 -0400, Joe Gwinn <joegwinn@comcast.net>
wrote:

>There is a long but well-written article on COVID and breakthroughs
>and the like in The New Yorker, published on 22 August 2021.
>
>Dhruv Khullar, the author, is a practicing physician and knows what he
>is talking about.
>
>.<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
>
>
>Have You Already Had a Breakthrough COVID Infection? The question of
>what “infection” means is just one of the riddles posed by the
>late-stage pandemic.
>
>Joe Gwinn

Well, youcan still get SARS-COV2 even if vaccinated. And 80% of people
will be asymtomatic.

Versus, 18 moonths ago where %20 of people who got SARS-COV2 were
symtomatic.

Cheers ;D

On Monday, August 23, 2021 at 12:22:30 AM UTC-4, Martin Riddle wrote:
> On Sun, 22 Aug 2021 16:10:40 -0400, Joe Gwinn <joeg...@comcast.net>
> wrote:
> >There is a long but well-written article on COVID and breakthroughs
> >and the like in The New Yorker, published on 22 August 2021.
> >
> >Dhruv Khullar, the author, is a practicing physician and knows what he
> >is talking about.
> >
> >.<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
> >
> >
> >Have You Already Had a Breakthrough COVID Infection? The question of
> >what “infection” means is just one of the riddles posed by the
> >late-stage pandemic.
> >
> >Joe Gwinn
> Well, youcan still get SARS-COV2 even if vaccinated. And 80% of people
> will be asymtomatic.
>
> Versus, 18 moonths ago where %20 of people who got SARS-COV2 were
> symtomatic.

Is that a joke?

--

Rick C.

+ Get 1,000 miles of free Supercharging
+ Tesla referral code - https://ts.la/richard11209

On Sun, 22 Aug 2021 16:05:48 -0700 (PDT), Rick C
<gnuarm.deletethisbit@gmail.com> wrote:

>On Sunday, August 22, 2021 at 5:44:56 PM UTC-4, Joe Gwinn wrote:
>> On Sun, 22 Aug 2021 13:58:50 -0700 (PDT), Brent Locher
>> <blo...@columbus.rr.com> wrote:
>>
>> >On Sunday, August 22, 2021 at 4:10:52 PM UTC-4, Joe Gwinn wrote:
>> >> There is a long but well-written article on COVID and breakthroughs
>> >> and the like in The New Yorker, published on 22 August 2021.
>> >>
>> >> Dhruv Khullar, the author, is a practicing physician and knows what he
>> >> is talking about.
>> >>
>> >> .<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
>> >>
>> >>
>> >> Have You Already Had a Breakthrough COVID Infection? The question of
>> >> what “infection” means is just one of the riddles posed by the
>> >> late-stage pandemic.
>> >>
>> >> Joe Gwinn
>> >
>> >The article basically says that breakthrough infections are more hype than a real problem.....and yet why the need for boosters then?
>> Because over time the variants will be less and less affected by circa
>> 2021 vaccines, and a booster will restore full effect.
>>
>> The Flu is the classic extreme. Every year, a new variant, so one can
>> get it every year. Some variants are worse than others, and while
>> they don't usually kill healthy people, they may make those people
>> wish it did.
>>
>> And because people are frightened by all the media news.
>
>I don't think the boosters they are talking about now are any different from the original vaccine, someone correct me if I am wrong. The boosters they are talking about now are simply to deal with the benefit of the vaccine wearing off over time.

Current boosters are the exact same vaccine. Future boosters will
likely not be.

Also likely to be permitted in the future is using an entirely
different vaccine as a booster, for example Pfizer followed by
Moderna, or vice versa. Or J&J followed by Pfizer or Moderna, and so
on.

>A vaccine that better handles new variants would by definition be a new vaccine and would need to go through the development and approval process again. I'm not sure if it would also protect against the prior strains or not. I guess that depends on the details of the particular vaccine.

Getting a existing vaccine approved to cover a new variant is far
easier than starting from scratch, as most of the recipe is unchanged.

Joe Gwinn

On Monday, August 23, 2021 at 9:33:20 AM UTC-4, Joe Gwinn wrote:
> On Sun, 22 Aug 2021 16:05:48 -0700 (PDT), Rick C
> <gnuarm.del...@gmail.com> wrote:
>
> >On Sunday, August 22, 2021 at 5:44:56 PM UTC-4, Joe Gwinn wrote:
> >> On Sun, 22 Aug 2021 13:58:50 -0700 (PDT), Brent Locher
> >> <blo...@columbus.rr.com> wrote:
> >>
> >> >On Sunday, August 22, 2021 at 4:10:52 PM UTC-4, Joe Gwinn wrote:
> >> >> There is a long but well-written article on COVID and breakthroughs
> >> >> and the like in The New Yorker, published on 22 August 2021.
> >> >>
> >> >> Dhruv Khullar, the author, is a practicing physician and knows what he
> >> >> is talking about.
> >> >>
> >> >> .<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
> >> >>
> >> >>
> >> >> Have You Already Had a Breakthrough COVID Infection? The question of
> >> >> what “infection” means is just one of the riddles posed by the
> >> >> late-stage pandemic.
> >> >>
> >> >> Joe Gwinn
> >> >
> >> >The article basically says that breakthrough infections are more hype than a real problem.....and yet why the need for boosters then?
> >> Because over time the variants will be less and less affected by circa
> >> 2021 vaccines, and a booster will restore full effect.
> >>
> >> The Flu is the classic extreme. Every year, a new variant, so one can
> >> get it every year. Some variants are worse than others, and while
> >> they don't usually kill healthy people, they may make those people
> >> wish it did.
> >>
> >> And because people are frightened by all the media news.
> >
> >I don't think the boosters they are talking about now are any different from the original vaccine, someone correct me if I am wrong. The boosters they are talking about now are simply to deal with the benefit of the vaccine wearing off over time.
> Current boosters are the exact same vaccine. Future boosters will
> likely not be.

And what do you base that opinion on? I'm not sure a vaccine against a different variant is actually a "booster" as such. It would be a new vaccine and would receive provisional approval prior to full approval incurring the wrath of Blo.

> Also likely to be permitted in the future is using an entirely
> different vaccine as a booster, for example Pfizer followed by
> Moderna, or vice versa. Or J&J followed by Pfizer or Moderna, and so
> on.

Again, what do you base that statement on? It takes a lot of work to qualify the boosters. The goal is to get a significant improvement over the waning immunity of the vaccine you've had. There is little incentive to explore the many permutations of vaccine combinations. Who would do this research?

> >A vaccine that better handles new variants would by definition be a new vaccine and would need to go through the development and approval process again. I'm not sure if it would also protect against the prior strains or not. I guess that depends on the details of the particular vaccine.
> Getting a existing vaccine approved to cover a new variant is far
> easier than starting from scratch, as most of the recipe is unchanged.

The vaccines are approved for use against COVID in the USA. Some will shortly be approved without the EUA label. In no case is further approval required to use the vaccines for new variants. If the vaccine is modified for a new variant I have seen nothing to suggest the vaccine does not need to run the gauntlet of approval again.

--

Rick C.

-- Get 1,000 miles of free Supercharging
-- Tesla referral code - https://ts.la/richard11209

On 8/23/2021 6:33 AM, Joe Gwinn wrote:
> Current boosters are the exact same vaccine. Future boosters will likely
> not be.

Possibly. Though one has to wonder the incentive for investing in
a NEW vaccine if folks are still resisting the old one.

And, the likely need to qualify the NEW vaccine in pts with either
of the previous vaccines *plus* those who opted to "exercise their
personal freedoms" (but have since become chickenshits in the face
of whatever NEW threat emerges)

> Also likely to be permitted in the future is using an entirely different
> vaccine as a booster, for example Pfizer followed by Moderna, or vice versa.
> Or J&J followed by Pfizer or Moderna, and so on.

I'd be less confident of that as official policy. It may be
authorized as an expedient if certain vaccine-boosters are less
available (something is better than nothing).

But, I think that would make the already lagging science just even more
burdened -- tracking the efficacy of various combinations, various
timings, various populations, etc.

And, would likely INCREASE the unease in the public: "I want a XXXX
booster, not a YYYY!" You can already imagine the "influencers"
weighing in on that...

"Join Club XXXX! With every membership you get a free set of
final documents -- just in case!"

>> A vaccine that better handles new variants would by definition be a new
>> vaccine and would need to go through the development and approval process
>> again. I'm not sure if it would also protect against the prior strains or
>> not. I guess that depends on the details of the particular vaccine.
>
> Getting a existing vaccine approved to cover a new variant is far easier
> than starting from scratch, as most of the recipe is unchanged.

*If* the variant is closely related to the previous strains.
But, do we even know how to characterize new strains (beyond
sequencing)?

E.g., annual flu shots don't incur *years* of testing before
*authorization* (as would a vaccine for hepatitis, pneumonia, etc.)

On Mon, 23 Aug 2021 06:45:48 -0700 (PDT), Rick C
<gnuarm.deletethisbit@gmail.com> wrote:

>On Monday, August 23, 2021 at 9:33:20 AM UTC-4, Joe Gwinn wrote:
>> On Sun, 22 Aug 2021 16:05:48 -0700 (PDT), Rick C
>> <gnuarm.del...@gmail.com> wrote:
>>
>> >On Sunday, August 22, 2021 at 5:44:56 PM UTC-4, Joe Gwinn wrote:
>> >> On Sun, 22 Aug 2021 13:58:50 -0700 (PDT), Brent Locher
>> >> <blo...@columbus.rr.com> wrote:
>> >>
>> >> >On Sunday, August 22, 2021 at 4:10:52 PM UTC-4, Joe Gwinn wrote:
>> >> >> There is a long but well-written article on COVID and breakthroughs
>> >> >> and the like in The New Yorker, published on 22 August 2021.
>> >> >>
>> >> >> Dhruv Khullar, the author, is a practicing physician and knows what he
>> >> >> is talking about.
>> >> >>
>> >> >> .<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
>> >> >>
>> >> >>
>> >> >> Have You Already Had a Breakthrough COVID Infection? The question of
>> >> >> what “infection” means is just one of the riddles posed by the
>> >> >> late-stage pandemic.
>> >> >>
>> >> >> Joe Gwinn
>> >> >
>> >> >The article basically says that breakthrough infections are more hype than a real problem.....and yet why the need for boosters then?
>> >> Because over time the variants will be less and less affected by circa
>> >> 2021 vaccines, and a booster will restore full effect.
>> >>
>> >> The Flu is the classic extreme. Every year, a new variant, so one can
>> >> get it every year. Some variants are worse than others, and while
>> >> they don't usually kill healthy people, they may make those people
>> >> wish it did.
>> >>
>> >> And because people are frightened by all the media news.
>> >
>> >I don't think the boosters they are talking about now are any different from the original vaccine, someone correct me if I am wrong. The boosters they are talking about now are simply to deal with the benefit of the vaccine wearing off over time.
>> Current boosters are the exact same vaccine. Future boosters will
>> likely not be.
>
>And what do you base that opinion on? I'm not sure a vaccine against a different variant is actually a "booster" as such. It would be a new vaccine and would receive provisional approval prior to full approval incurring the wrath of Blo.

Based on following the literature. The current booster shots are
identical to whatever vaccine is being boosted. It is not new, and
does not require a new full-approval dance. The standard term for
this is "booster", without hair-splitting.

"Blo"?

>> Also likely to be permitted in the future is using an entirely
>> different vaccine as a booster, for example Pfizer followed by
>> Moderna, or vice versa. Or J&J followed by Pfizer or Moderna, and so
>> on.
>
>Again, what do you base that statement on? It takes a lot of work to qualify the boosters. The goal is to get a significant improvement over the waning immunity of the vaccine you've had. There is little incentive to explore the many permutations of vaccine combinations. Who would do this research?

Again, by following the literature. There are very good reasons to
want to mix-and-match. First, it greatly simplified the logistics of
treating an entire population. Second, from the theory, a mis-matched
booster probably increases protection over a matched booster, and in
any case is no worse. So, unless mixing causes side effects, it will
likely be done.

>> >A vaccine that better handles new variants would by definition be a new vaccine and would need to go through the development and approval process again. I'm not sure if it would also protect against the prior strains or not. I guess that depends on the details of the particular vaccine.
>> Getting a existing vaccine approved to cover a new variant is far
>> easier than starting from scratch, as most of the recipe is unchanged.
>
>The vaccines are approved for use against COVID in the USA. Some will shortly be approved without the EUA label. In no case is further approval required to use the vaccines for new variants. If the vaccine is modified for a new variant I have seen nothing to suggest the vaccine does not need to run the gauntlet of approval again.

Any doctor can prescribe a fully-approved vaccine for use as a
booster, matched or mixed.

It's incomplete to say that vaccines are approved. What is actually
approved is the entire production process, the detailed recipe if you
will, that yields the stuff in the bottle, and the bottles for that
matter, for millions of doses. This is because minor-looking changes
in recipe have caused big problems in the past.

Once one has developed a recipe and gotten it approved, one needs
re-approval to change that recipe. But if most of the recipe is
unchanged, the approval process is far faster.

To handle COVID variants, all that changes is the specific DNA or
equivalent RNA sequence that is loaded into the carrier, a virus shell
or liposome respectively. The vast majority of the recipe is
unchanged.

FYI, for some small-molecule drugs (not including "biologicals" like
vaccines), there is talk of granting full approval for the original
drug molecule, regardless of manufacturer, because in such cases only
the molecule matters, not how it was made. The reason this is
important is that this kind of approval greatly eases the burden to
clone a drug whose patents have expired, and competition reduces
prices.

Joe Gwinn

On Monday, August 23, 2021 at 11:13:11 AM UTC-4, Joe Gwinn wrote:
> On Mon, 23 Aug 2021 06:45:48 -0700 (PDT), Rick C
> <gnuarm.del...@gmail.com> wrote:
>
> >On Monday, August 23, 2021 at 9:33:20 AM UTC-4, Joe Gwinn wrote:
> >> On Sun, 22 Aug 2021 16:05:48 -0700 (PDT), Rick C
> >> <gnuarm.del...@gmail.com> wrote:
> >>
> >> >On Sunday, August 22, 2021 at 5:44:56 PM UTC-4, Joe Gwinn wrote:
> >> >> On Sun, 22 Aug 2021 13:58:50 -0700 (PDT), Brent Locher
> >> >> <blo...@columbus.rr.com> wrote:
> >> >>
> >> >> >On Sunday, August 22, 2021 at 4:10:52 PM UTC-4, Joe Gwinn wrote:
> >> >> >> There is a long but well-written article on COVID and breakthroughs
> >> >> >> and the like in The New Yorker, published on 22 August 2021.
> >> >> >>
> >> >> >> Dhruv Khullar, the author, is a practicing physician and knows what he
> >> >> >> is talking about.
> >> >> >>
> >> >> >> .<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
> >> >> >>
> >> >> >>
> >> >> >> Have You Already Had a Breakthrough COVID Infection? The question of
> >> >> >> what “infection” means is just one of the riddles posed by the
> >> >> >> late-stage pandemic.
> >> >> >>
> >> >> >> Joe Gwinn
> >> >> >
> >> >> >The article basically says that breakthrough infections are more hype than a real problem.....and yet why the need for boosters then?
> >> >> Because over time the variants will be less and less affected by circa
> >> >> 2021 vaccines, and a booster will restore full effect.
> >> >>
> >> >> The Flu is the classic extreme. Every year, a new variant, so one can
> >> >> get it every year. Some variants are worse than others, and while
> >> >> they don't usually kill healthy people, they may make those people
> >> >> wish it did.
> >> >>
> >> >> And because people are frightened by all the media news.
> >> >
> >> >I don't think the boosters they are talking about now are any different from the original vaccine, someone correct me if I am wrong. The boosters they are talking about now are simply to deal with the benefit of the vaccine wearing off over time.
> >> Current boosters are the exact same vaccine. Future boosters will
> >> likely not be.
> >
> >And what do you base that opinion on? I'm not sure a vaccine against a different variant is actually a "booster" as such. It would be a new vaccine and would receive provisional approval prior to full approval incurring the wrath of Blo.
> Based on following the literature. The current booster shots are
> identical to whatever vaccine is being boosted. It is not new, and
> does not require a new full-approval dance. The standard term for
> this is "booster", without hair-splitting.

Hmmm... you seem to be mixing your ideas. If it is against a new variant, it clearly would not be the same vaccine. Or are you suggesting the new variant can be addresses simply by giving more of the same vaccine? I've not heard that put forward before. If two shots of the vaccine are not effective against a variant, why would three shots be expected to work better?

> "Blo"?

I don't always remember people's names and that is all that Google Groups will show me. It seems to think it is vital to disguise people's email addrersses no matter what. Even if I click the address and then click the captcha it continues to obscure them.

> >> Also likely to be permitted in the future is using an entirely
> >> different vaccine as a booster, for example Pfizer followed by
> >> Moderna, or vice versa. Or J&J followed by Pfizer or Moderna, and so
> >> on.
> >
> >Again, what do you base that statement on? It takes a lot of work to qualify the boosters. The goal is to get a significant improvement over the waning immunity of the vaccine you've had. There is little incentive to explore the many permutations of vaccine combinations. Who would do this research?
> Again, by following the literature. There are very good reasons to
> want to mix-and-match. First, it greatly simplified the logistics of
> treating an entire population.

I think you have that backwards. If they are administering vaccine A in a region it is MORE complex to provide vaccine B as a booster.

> Second, from the theory, a mis-matched
> booster probably increases protection over a matched booster, and in
> any case is no worse. So, unless mixing causes side effects, it will
> likely be done.

There is zero evidence a different vaccine provides better protection. More importantly it is not inexpensive to study this. Most importantly no one involved has an incentive to study it (meaning the vaccine companies) so it won't be studied and won't be approved. This is what you just replied to.. Did you not read that?

> >> >A vaccine that better handles new variants would by definition be a new vaccine and would need to go through the development and approval process again. I'm not sure if it would also protect against the prior strains or not. I guess that depends on the details of the particular vaccine.
> >> Getting a existing vaccine approved to cover a new variant is far
> >> easier than starting from scratch, as most of the recipe is unchanged.
> >
> >The vaccines are approved for use against COVID in the USA. Some will shortly be approved without the EUA label. In no case is further approval required to use the vaccines for new variants. If the vaccine is modified for a new variant I have seen nothing to suggest the vaccine does not need to run the gauntlet of approval again.
> Any doctor can prescribe a fully-approved vaccine for use as a
> booster, matched or mixed.

Yes, they can, but they have no reason to do so as there is no evidence it gives any advantage. If the mixed vaccination turns out to have issues, even if only remotely connected, the doctors would be in deep do-do for what is essentially off label use. But you didn't respond to my statement about new variants. Bottom line is you seem to be confused about variants. No new approval is required to use previously approved vaccines against a new variant. You do understand that, right?

> It's incomplete to say that vaccines are approved. What is actually
> approved is the entire production process, the detailed recipe if you
> will, that yields the stuff in the bottle, and the bottles for that
> matter, for millions of doses. This is because minor-looking changes
> in recipe have caused big problems in the past.
>
> Once one has developed a recipe and gotten it approved, one needs
> re-approval to change that recipe. But if most of the recipe is
> unchanged, the approval process is far faster.
>
> To handle COVID variants, all that changes is the specific DNA or
> equivalent RNA sequence that is loaded into the carrier, a virus shell
> or liposome respectively. The vast majority of the recipe is
> unchanged.

Not particularly relevant. The vaccine has to be tested and approved. Even if they don't need to get approval for the manufacturing process, it is not much of a simplification. There is a lot of work involved in testing a new vaccine for safety and efficacy. Don't downplay that.

> FYI, for some small-molecule drugs (not including "biologicals" like
> vaccines), there is talk of granting full approval for the original
> drug molecule, regardless of manufacturer, because in such cases only
> the molecule matters, not how it was made. The reason this is
> important is that this kind of approval greatly eases the burden to
> clone a drug whose patents have expired, and competition reduces
> prices.

Ok, tea, china.

--

Rick C.

-+ Get 1,000 miles of free Supercharging
-+ Tesla referral code - https://ts.la/richard11209

On 8/23/2021 8:12 AM, Joe Gwinn wrote:
> Based on following the literature. The current booster shots are
> identical to whatever vaccine is being boosted. It is not new, and
> does not require a new full-approval dance. The standard term for
> this is "booster", without hair-splitting.

That is conditional on the original vaccine being "approved".
Otherwise, you have to rely on an EUA for the booster, as well.

> Again, by following the literature. There are very good reasons to
> want to mix-and-match. First, it greatly simplified the logistics of
> treating an entire population. Second, from the theory, a mis-matched
> booster probably increases protection over a matched booster, and in
> any case is no worse. So, unless mixing causes side effects, it will
> likely be done.

The "probably increases protection" has no foundation in the data.

You're also assuming that people are rational beings (clearly evidence to
the contrary) and that "any port in a storm" will not further hamper
distribution (as folks get "opinions" as to which shot they *want*
instead of which is AVAILABLE.

We already saw that in the initial rollout where folks "prefered"
one vaccine over another -- for WHATEVER reason. How many
vaccinations were delayed because someone was more interested in getting
the vaccine they wanted instead of the one that was available?

(I have no idea of the actual number but know many people who had
deliberate preferences for the Pfizer over Moderna. The fact that
the Moderna was more accessible may have contributed to this
perception: "Pfizer is harder to come by so it must be *better*!")

> Any doctor can prescribe a fully-approved vaccine for use as a
> booster, matched or mixed.

Assume the approval allows this. "Guidance" can say otherwise
(and a doctor who violates that guidance exposes himself to
litigation).

Note that approval also typ allows (enables) *advertising*. Will we
see a war of vaccines roll out in the media?? Instead of PSAs from
"third parties", will the manufacturers start trying to influence
"selection decisions" among their potential customers?

> It's incomplete to say that vaccines are approved. What is actually
> approved is the entire production process, the detailed recipe if you
> will, that yields the stuff in the bottle, and the bottles for that
> matter, for millions of doses. This is because minor-looking changes
> in recipe have caused big problems in the past.
>
> Once one has developed a recipe and gotten it approved, one needs
> re-approval to change that recipe. But if most of the recipe is
> unchanged, the approval process is far faster.

The FDA is all about *process*. They try to respond with a modicum
of intelligence to the authorization process. But, largely rely
on the petitioner to do the real leg work.

So, doing something The Same Way (that was previously approved)
goes a long way to garnering subsequent approvals -- your previous
actions act as "precedent".

> To handle COVID variants, all that changes is the specific DNA or
> equivalent RNA sequence that is loaded into the carrier, a virus shell
> or liposome respectively. The vast majority of the recipe is
> unchanged.

But you still have to test to see that the mRNA results in the synthesis
of that look-alike. And, still have to test that it has no obvious
side effects.

The problem with a genuine approval (vs. an EUA) is the FDA has a harder
time shutting down "problems"; with an EUA, it can be revoked on a moment's
notice and the decision is *final*.

On Mon, 23 Aug 2021 08:48:54 -0700 (PDT), Rick C
<gnuarm.deletethisbit@gmail.com> wrote:

>On Monday, August 23, 2021 at 11:13:11 AM UTC-4, Joe Gwinn wrote:
>> On Mon, 23 Aug 2021 06:45:48 -0700 (PDT), Rick C
>> <gnuarm.del...@gmail.com> wrote:
>>
>> >On Monday, August 23, 2021 at 9:33:20 AM UTC-4, Joe Gwinn wrote:
>> >> On Sun, 22 Aug 2021 16:05:48 -0700 (PDT), Rick C
>> >> <gnuarm.del...@gmail.com> wrote:
>> >>
>> >> >On Sunday, August 22, 2021 at 5:44:56 PM UTC-4, Joe Gwinn wrote:
>> >> >> On Sun, 22 Aug 2021 13:58:50 -0700 (PDT), Brent Locher
>> >> >> <blo...@columbus.rr.com> wrote:
>> >> >>
>> >> >> >On Sunday, August 22, 2021 at 4:10:52 PM UTC-4, Joe Gwinn wrote:
>> >> >> >> There is a long but well-written article on COVID and breakthroughs
>> >> >> >> and the like in The New Yorker, published on 22 August 2021.
>> >> >> >>
>> >> >> >> Dhruv Khullar, the author, is a practicing physician and knows what he
>> >> >> >> is talking about.
>> >> >> >>
>> >> >> >> .<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
>> >> >> >>
>> >> >> >>
>> >> >> >> Have You Already Had a Breakthrough COVID Infection? The question of
>> >> >> >> what “infection” means is just one of the riddles posed by the
>> >> >> >> late-stage pandemic.
>> >> >> >>
>> >> >> >> Joe Gwinn
>> >> >> >
>> >> >> >The article basically says that breakthrough infections are more hype than a real problem.....and yet why the need for boosters then?
>> >> >> Because over time the variants will be less and less affected by circa
>> >> >> 2021 vaccines, and a booster will restore full effect.
>> >> >>
>> >> >> The Flu is the classic extreme. Every year, a new variant, so one can
>> >> >> get it every year. Some variants are worse than others, and while
>> >> >> they don't usually kill healthy people, they may make those people
>> >> >> wish it did.
>> >> >>
>> >> >> And because people are frightened by all the media news.
>> >> >
>> >> >I don't think the boosters they are talking about now are any different from the original vaccine, someone correct me if I am wrong. The boosters they are talking about now are simply to deal with the benefit of the vaccine wearing off over time.
>> >> Current boosters are the exact same vaccine. Future boosters will
>> >> likely not be.
>> >
>> >And what do you base that opinion on? I'm not sure a vaccine against a different variant is actually a "booster" as such. It would be a new vaccine and would receive provisional approval prior to full approval incurring the wrath of Blo.
>> Based on following the literature. The current booster shots are
>> identical to whatever vaccine is being boosted. It is not new, and
>> does not require a new full-approval dance. The standard term for
>> this is "booster", without hair-splitting.
>
>Hmmm... you seem to be mixing your ideas. If it is against a new variant, it clearly would not be the same vaccine. Or are you suggesting the new variant can be addresses simply by giving more of the same vaccine? I've not heard that put forward before. If two shots of the vaccine are not effective against a variant, why would three shots be expected to work better?

Read my answer again. If little changes, then there is little to
prove.

>> "Blo"?
>
>I don't always remember people's names and that is all that Google Groups will show me. It seems to think it is vital to disguise people's email addrersses no matter what. Even if I click the address and then click the captcha it continues to obscure them.
>
>
>> >> Also likely to be permitted in the future is using an entirely
>> >> different vaccine as a booster, for example Pfizer followed by
>> >> Moderna, or vice versa. Or J&J followed by Pfizer or Moderna, and so
>> >> on.
>> >
>> >Again, what do you base that statement on? It takes a lot of work to qualify the boosters. The goal is to get a significant improvement over the waning immunity of the vaccine you've had. There is little incentive to explore the many permutations of vaccine combinations. Who would do this research?
>> Again, by following the literature. There are very good reasons to
>> want to mix-and-match. First, it greatly simplified the logistics of
>> treating an entire population.
>
>I think you have that backwards. If they are administering vaccine A in a region it is MORE complex to provide vaccine B as a booster.

Huh? Next available is always easier than multiple-choice
it's-gotta-match.

>> Second, from the theory, a mis-matched
>> booster probably increases protection over a matched booster, and in
>> any case is no worse. So, unless mixing causes side effects, it will
>> likely be done.
>
>There is zero evidence a different vaccine provides better protection. More importantly it is not inexpensive to study this. Most importantly no one involved has an incentive to study it (meaning the vaccine companies) so it won't be studied and won't be approved. This is what you just replied to. Did you not read that?

Evidence not claimed. Reread, this time noticing the word theory in
context. Given the theory, the tests will be made.

>> >> >A vaccine that better handles new variants would by definition be a new vaccine and would need to go through the development and approval process again. I'm not sure if it would also protect against the prior strains or not. I guess that depends on the details of the particular vaccine.
>> >> Getting a existing vaccine approved to cover a new variant is far
>> >> easier than starting from scratch, as most of the recipe is unchanged.
>> >
>> >The vaccines are approved for use against COVID in the USA. Some will shortly be approved without the EUA label. In no case is further approval required to use the vaccines for new variants. If the vaccine is modified for a new variant I have seen nothing to suggest the vaccine does not need to run the gauntlet of approval again.
>> Any doctor can prescribe a fully-approved vaccine for use as a
>> booster, matched or mixed.
>
>Yes, they can, but they have no reason to do so as there is no evidence it gives any advantage. If the mixed vaccination turns out to have issues, even if only remotely connected, the doctors would be in deep do-do for what is essentially off label use. But you didn't respond to my statement about new variants. Bottom line is you seem to be confused about variants. No new approval is required to use previously approved vaccines against a new variant. You do understand that, right?

Which is exactly the kind of medical decision doctors make every day.

>> It's incomplete to say that vaccines are approved. What is actually
>> approved is the entire production process, the detailed recipe if you
>> will, that yields the stuff in the bottle, and the bottles for that
>> matter, for millions of doses. This is because minor-looking changes
>> in recipe have caused big problems in the past.
>>
>> Once one has developed a recipe and gotten it approved, one needs
>> re-approval to change that recipe. But if most of the recipe is
>> unchanged, the approval process is far faster.
>>
>> To handle COVID variants, all that changes is the specific DNA or
>> equivalent RNA sequence that is loaded into the carrier, a virus shell
>> or liposome respectively. The vast majority of the recipe is
>> unchanged.
>
>Not particularly relevant. The vaccine has to be tested and approved. Even if they don't need to get approval for the manufacturing process, it is not much of a simplification. There is a lot of work involved in testing a new vaccine for safety and efficacy. Don't downplay that.

I'm telling you how it works in practice, and I said less work, not no
work. If you don't like this process, I suggest that you take it up
with the FDA.

Joe Gwinn

On Mon, 23 Aug 2021 10:16:17 -0700, Don Y
<blockedofcourse@foo.invalid> wrote:

>On 8/23/2021 8:12 AM, Joe Gwinn wrote:
>> Based on following the literature. The current booster shots are
>> identical to whatever vaccine is being boosted. It is not new, and
>> does not require a new full-approval dance. The standard term for
>> this is "booster", without hair-splitting.
>
>That is conditional on the original vaccine being "approved".
>Otherwise, you have to rely on an EUA for the booster, as well.
>
>> Again, by following the literature. There are very good reasons to
>> want to mix-and-match. First, it greatly simplified the logistics of
>> treating an entire population. Second, from the theory, a mis-matched
>> booster probably increases protection over a matched booster, and in
>> any case is no worse. So, unless mixing causes side effects, it will
>> likely be done.
>
>The "probably increases protection" has no foundation in the data.

Not claimed. Please reread, this time studying the word theory in
context.

>You're also assuming that people are rational beings (clearly evidence to
>the contrary) and that "any port in a storm" will not further hamper
>distribution (as folks get "opinions" as to which shot they *want*
>instead of which is AVAILABLE.
>
>We already saw that in the initial rollout where folks "prefered"
>one vaccine over another -- for WHATEVER reason. How many
>vaccinations were delayed because someone was more interested in getting
>the vaccine they wanted instead of the one that was available?
>
>(I have no idea of the actual number but know many people who had
>deliberate preferences for the Pfizer over Moderna. The fact that
>the Moderna was more accessible may have contributed to this
>perception: "Pfizer is harder to come by so it must be *better*!")

All true; relevance unclear.

>> Any doctor can prescribe a fully-approved vaccine for use as a
>> booster, matched or mixed.
>
>Assume the approval allows this. "Guidance" can say otherwise
>(and a doctor who violates that guidance exposes himself to
>litigation).

It's possible, but not at all common. I think that the FDA did that
with Quinine, to prevent its being over-used for nocturnal leg cramps.
I recall my primary-care doctor complaining about that.

>Note that approval also typ allows (enables) *advertising*. Will we
>see a war of vaccines roll out in the media?? Instead of PSAs from
>"third parties", will the manufacturers start trying to influence
>"selection decisions" among their potential customers?

All true; relevance unclear.

>> It's incomplete to say that vaccines are approved. What is actually
>> approved is the entire production process, the detailed recipe if you
>> will, that yields the stuff in the bottle, and the bottles for that
>> matter, for millions of doses. This is because minor-looking changes
>> in recipe have caused big problems in the past.
>>
>> Once one has developed a recipe and gotten it approved, one needs
>> re-approval to change that recipe. But if most of the recipe is
>> unchanged, the approval process is far faster.
>
>The FDA is all about *process*. They try to respond with a modicum
>of intelligence to the authorization process. But, largely rely
>on the petitioner to do the real leg work.
>
>So, doing something The Same Way (that was previously approved)
>goes a long way to garnering subsequent approvals -- your previous
>actions act as "precedent".

All true; relevance unclear.

>> To handle COVID variants, all that changes is the specific DNA or
>> equivalent RNA sequence that is loaded into the carrier, a virus shell
>> or liposome respectively. The vast majority of the recipe is
>> unchanged.
>
>But you still have to test to see that the mRNA results in the synthesis
>of that look-alike. And, still have to test that it has no obvious
>side effects.

True.

>The problem with a genuine approval (vs. an EUA) is the FDA has a harder
>time shutting down "problems"; with an EUA, it can be revoked on a moment's
>notice and the decision is *final*.

Well, while rare, approval can be withdrawn. And given the number of
credible vaccine alternatives available, it would not be all that
difficult to de-approve one of them if a lot of problems are found.

Joe Gwinn

On Monday, August 23, 2021 at 2:16:23 PM UTC-4, Joe Gwinn wrote:
> On Mon, 23 Aug 2021 08:48:54 -0700 (PDT), Rick C
> <gnuarm.del...@gmail.com> wrote:
>
> >On Monday, August 23, 2021 at 11:13:11 AM UTC-4, Joe Gwinn wrote:
> >> On Mon, 23 Aug 2021 06:45:48 -0700 (PDT), Rick C
> >> <gnuarm.del...@gmail.com> wrote:
> >>
> >> >On Monday, August 23, 2021 at 9:33:20 AM UTC-4, Joe Gwinn wrote:
> >> >> On Sun, 22 Aug 2021 16:05:48 -0700 (PDT), Rick C
> >> >> <gnuarm.del...@gmail.com> wrote:
> >> >>
> >> >> >On Sunday, August 22, 2021 at 5:44:56 PM UTC-4, Joe Gwinn wrote:
> >> >> >> On Sun, 22 Aug 2021 13:58:50 -0700 (PDT), Brent Locher
> >> >> >> <blo...@columbus.rr.com> wrote:
> >> >> >>
> >> >> >> >On Sunday, August 22, 2021 at 4:10:52 PM UTC-4, Joe Gwinn wrote:
> >> >> >> >> There is a long but well-written article on COVID and breakthroughs
> >> >> >> >> and the like in The New Yorker, published on 22 August 2021.
> >> >> >> >>
> >> >> >> >> Dhruv Khullar, the author, is a practicing physician and knows what he
> >> >> >> >> is talking about.
> >> >> >> >>
> >> >> >> >> .<https://www.newyorker.com/science/medical-dispatch/have-you-already-had-a-breakthrough-covid-infection>
> >> >> >> >>
> >> >> >> >>
> >> >> >> >> Have You Already Had a Breakthrough COVID Infection? The question of
> >> >> >> >> what “infection” means is just one of the riddles posed by the
> >> >> >> >> late-stage pandemic.
> >> >> >> >>
> >> >> >> >> Joe Gwinn
> >> >> >> >
> >> >> >> >The article basically says that breakthrough infections are more hype than a real problem.....and yet why the need for boosters then?
> >> >> >> Because over time the variants will be less and less affected by circa
> >> >> >> 2021 vaccines, and a booster will restore full effect.
> >> >> >>
> >> >> >> The Flu is the classic extreme. Every year, a new variant, so one can
> >> >> >> get it every year. Some variants are worse than others, and while
> >> >> >> they don't usually kill healthy people, they may make those people
> >> >> >> wish it did.
> >> >> >>
> >> >> >> And because people are frightened by all the media news.
> >> >> >
> >> >> >I don't think the boosters they are talking about now are any different from the original vaccine, someone correct me if I am wrong. The boosters they are talking about now are simply to deal with the benefit of the vaccine wearing off over time.
> >> >> Current boosters are the exact same vaccine. Future boosters will
> >> >> likely not be.
> >> >
> >> >And what do you base that opinion on? I'm not sure a vaccine against a different variant is actually a "booster" as such. It would be a new vaccine and would receive provisional approval prior to full approval incurring the wrath of Blo.
> >> Based on following the literature. The current booster shots are
> >> identical to whatever vaccine is being boosted. It is not new, and
> >> does not require a new full-approval dance. The standard term for
> >> this is "booster", without hair-splitting.
> >
> >Hmmm... you seem to be mixing your ideas. If it is against a new variant, it clearly would not be the same vaccine. Or are you suggesting the new variant can be addresses simply by giving more of the same vaccine? I've not heard that put forward before. If two shots of the vaccine are not effective against a variant, why would three shots be expected to work better?
> Read my answer again. If little changes, then there is little to
> prove.

Ok, if you don't want to discuss it, I understand. I think the issue is pretty clear.

> >> "Blo"?
> >
> >I don't always remember people's names and that is all that Google Groups will show me. It seems to think it is vital to disguise people's email addrersses no matter what. Even if I click the address and then click the captcha it continues to obscure them.
> >
> >
> >> >> Also likely to be permitted in the future is using an entirely
> >> >> different vaccine as a booster, for example Pfizer followed by
> >> >> Moderna, or vice versa. Or J&J followed by Pfizer or Moderna, and so
> >> >> on.
> >> >
> >> >Again, what do you base that statement on? It takes a lot of work to qualify the boosters. The goal is to get a significant improvement over the waning immunity of the vaccine you've had. There is little incentive to explore the many permutations of vaccine combinations. Who would do this research?
> >> Again, by following the literature. There are very good reasons to
> >> want to mix-and-match. First, it greatly simplified the logistics of
> >> treating an entire population.
> >
> >I think you have that backwards. If they are administering vaccine A in a region it is MORE complex to provide vaccine B as a booster.
> Huh? Next available is always easier than multiple-choice
> it's-gotta-match.

Multiple choice??? Most locations provide one or two vaccines. They've already managed to match shot 1 with shot 2. I don't see any problems with matching shot three to 1 and 2. What you are talking about is potentially giving other versions of vaccine instead possibly while the first two are still being given as the initial shot. That means they need to set up distribution for two additional vaccines. How is that more simple?

> >> Second, from the theory, a mis-matched
> >> booster probably increases protection over a matched booster, and in
> >> any case is no worse. So, unless mixing causes side effects, it will
> >> likely be done.
> >
> >There is zero evidence a different vaccine provides better protection. More importantly it is not inexpensive to study this. Most importantly no one involved has an incentive to study it (meaning the vaccine companies) so it won't be studied and won't be approved. This is what you just replied to.. Did you not read that?
> Evidence not claimed. Reread, this time noticing the word theory in
> context. Given the theory, the tests will be made.

Exactly my point! From YOUR theory. There is no theory of vaccinations that says mismatching the vaccine booster will improve anything. This will only be done once the concept is TESTED. The drug companies have been testing matched boosters and no one is going to test mismatched booster shots.

> >> >> >A vaccine that better handles new variants would by definition be a new vaccine and would need to go through the development and approval process again. I'm not sure if it would also protect against the prior strains or not. I guess that depends on the details of the particular vaccine.
> >> >> Getting a existing vaccine approved to cover a new variant is far
> >> >> easier than starting from scratch, as most of the recipe is unchanged.
> >> >
> >> >The vaccines are approved for use against COVID in the USA. Some will shortly be approved without the EUA label. In no case is further approval required to use the vaccines for new variants. If the vaccine is modified for a new variant I have seen nothing to suggest the vaccine does not need to run the gauntlet of approval again.
> >> Any doctor can prescribe a fully-approved vaccine for use as a
> >> booster, matched or mixed.
> >
> >Yes, they can, but they have no reason to do so as there is no evidence it gives any advantage. If the mixed vaccination turns out to have issues, even if only remotely connected, the doctors would be in deep do-do for what is essentially off label use. But you didn't respond to my statement about new variants. Bottom line is you seem to be confused about variants. No new approval is required to use previously approved vaccines against a new variant. You do understand that, right?
> Which is exactly the kind of medical decision doctors make every day.

LOL! Medical doctors are not much different from mechanics except they are trained better and make fewer off the cuff decisions. They go by the book least they be sued for screwing up. This is just the sort of highly inflammatory situation where very, very few doctors are going to stick their necks out. Doctors aren't going to mismatch boosters because YOU think it is a good idea.

On 8/23/2021 11:27 AM, Joe Gwinn wrote:
> On Mon, 23 Aug 2021 10:16:17 -0700, Don Y
> <blockedofcourse@foo.invalid> wrote:
>
>> On 8/23/2021 8:12 AM, Joe Gwinn wrote:
>>> Based on following the literature. The current booster shots are
>>> identical to whatever vaccine is being boosted. It is not new, and
>>> does not require a new full-approval dance. The standard term for
>>> this is "booster", without hair-splitting.
>>
>> That is conditional on the original vaccine being "approved".
>> Otherwise, you have to rely on an EUA for the booster, as well.
>>
>>> Again, by following the literature. There are very good reasons to
>>> want to mix-and-match. First, it greatly simplified the logistics of
>>> treating an entire population. Second, from the theory, a mis-matched
>>> booster probably increases protection over a matched booster, and in
>>> any case is no worse. So, unless mixing causes side effects, it will
>>> likely be done.
>>
>> The "probably increases protection" has no foundation in the data.
>
> Not claimed. Please reread, this time studying the word theory in
> context.

Nor did I claim that YOU made that claim! :> Please reread, this
time studying the word "no foundation in the data".

>> You're also assuming that people are rational beings (clearly evidence to
>> the contrary) and that "any port in a storm" will not further hamper
>> distribution (as folks get "opinions" as to which shot they *want*
>> instead of which is AVAILABLE.
>>
>> We already saw that in the initial rollout where folks "prefered"
>> one vaccine over another -- for WHATEVER reason. How many
>> vaccinations were delayed because someone was more interested in getting
>> the vaccine they wanted instead of the one that was available?
>>
>> (I have no idea of the actual number but know many people who had
>> deliberate preferences for the Pfizer over Moderna. The fact that
>> the Moderna was more accessible may have contributed to this
>> perception: "Pfizer is harder to come by so it must be *better*!")
>
> All true; relevance unclear.

If people think they have a choice and (rightly or otherwise)
think that some choices are BETTER than others, then this can hinder
uptake of the new treatment.

E.g., when my other half was vaccinated, Pfizer was the most
available vaccine. When I was vaccinated, Moderna took that
spot.

Yet, in each case, both were technically available and,
had we been so inclined, we could have "shopped around"
for our "vaccine of choice". As there was little available
data to indicate one as better than the other (esp in light
of the inevitable future developments), we opted to "settle"
for whatever was administered on the days of our respective
vaccinations.

Other friends made very deliberate efforts to get specific
vaccines. "Why?" Silence.

>> Note that approval also typ allows (enables) *advertising*. Will we
>> see a war of vaccines roll out in the media?? Instead of PSAs from
>> "third parties", will the manufacturers start trying to influence
>> "selection decisions" among their potential customers?
>
> All true; relevance unclear.

Again, we already have a problem with "spin" on the vaccines, masks,
etc. Will having folks with vested financial interests ALSO
adding to that dialog in very public ways (e.g., advertisements)
further complicating this?

There's little attention brought to the annual flu vaccine. You
basically get what the pharmacist gives you. Folks are accepting
of this. Even if they technically *may* have "a choice", they
neither exercise it nor are consciously aware of it.

Flu doesn't have the social imperative that covid carries. It's
easy to imagine thinly disguised adverts -- appearing as PSAs -- that
try to influence consumers to adopt vaccine A vs. B. Where do they
turn for guidance?

>>> It's incomplete to say that vaccines are approved. What is actually
>>> approved is the entire production process, the detailed recipe if you
>>> will, that yields the stuff in the bottle, and the bottles for that
>>> matter, for millions of doses. This is because minor-looking changes
>>> in recipe have caused big problems in the past.
>>>
>>> Once one has developed a recipe and gotten it approved, one needs
>>> re-approval to change that recipe. But if most of the recipe is
>>> unchanged, the approval process is far faster.
>>
>> The FDA is all about *process*. They try to respond with a modicum
>> of intelligence to the authorization process. But, largely rely
>> on the petitioner to do the real leg work.
>>
>> So, doing something The Same Way (that was previously approved)
>> goes a long way to garnering subsequent approvals -- your previous
>> actions act as "precedent".
>
> All true; relevance unclear.

It's more than just "once one has developed a Rx and gotten it approved".
The reason being that the FDA isn't an "Underwriter's Laboratory" that
actually *does* anything -- besides reviewing what *you* have done.
It's not like THEY are going to run additional trials to verify your
claims. (UL, OTOH, *will*)

>> The problem with a genuine approval (vs. an EUA) is the FDA has a harder
>> time shutting down "problems"; with an EUA, it can be revoked on a moment's
>> notice and the decision is *final*.
>
> Well, while rare, approval can be withdrawn.

Yes, but then the manufacturers have standing to require the gummit
to prove their claims.

The FDA usually tries to coerce manufacturers into taking things
off the market willingly ("Let's not get the lawyers involved").

By contrast, an EUA can be revoked (almost) on a whim -- if some
politician gets nervous about claims of blood clots, then the
manufacturer has little say in the outcome.

> And given the number of
> credible vaccine alternatives available, it would not be all that
> difficult to de-approve one of them if a lot of problems are found.

Again, lawyers. Do you think Pfizer (et al.) would willingly surrender
a chunk of their market without a litigated fight?

OTOH, revoke their EUA and all they can do is engage in a propaganda
campaign (public sentiment).

On Tuesday, August 24, 2021 at 12:35:25 AM UTC+10, Don Y wrote:
> On 8/23/2021 6:33 AM, Joe Gwinn wrote:
> > Current boosters are the exact same vaccine. Future boosters will likely not be.
>
> Possibly. Though one has to wonder the incentive for investing in a NEW vaccine if folks are still resisting the old one.

The vaccine hesitant are a minority. There are plenty of people who would pay for better protection, and many of them would pay for the mere promise of better protection.
> And, the likely need to qualify the NEW vaccine in pts with either
> of the previous vaccines *plus* those who opted to "exercise their
> personal freedoms" (but have since become chickenshits in the face
> of whatever NEW threat emerges).
>
> > Also likely to be permitted in the future is using an entirely different
> > vaccine as a booster, for example Pfizer followed by Moderna, or vice versa.
> > Or J&J followed by Pfizer or Moderna, and so on.

A complete waste of time. They are all designed to get your cells to synthesise exactly the same version of the Covid-19 spike protein

> I'd be less confident of that as official policy. It may be authorized as an expedient if certain vaccine-boosters are less available (something is better than nothing).
>
> But, I think that would make the already lagging science just even more burdened -- tracking the efficacy of various combinations, various timings, various populations, etc.

Since there is almost certainly going to be no difference at all it would be a waste of time and effort.
,
> And, would likely INCREASE the unease in the public: "I want a XXXX booster, not a YYYY!" You can already imagine the "influencers" weighing in on that...
>
> "Join Club XXXX! With every membership you get a free set of final documents -- just in case!"
>
> >> A vaccine that better handles new variants would by definition be a new
> >> vaccine and would need to go through the development and approval process
> >> again. I'm not sure if it would also protect against the prior strains or
> >> not. I guess that depends on the details of the particular vaccine.

More on the details of the individual immune systems each generating their own individual antibodies to the antigen being used to provoke them.

> > Getting a existing vaccine approved to cover a new variant is far easier
> > than starting from scratch, as most of the recipe is unchanged.
>
> *If* the variant is closely related to the previous strains.
> But, do we even know how to characterize new strains (beyond
> sequencing)?

Sequencing does characterise them exactly. The genome is a complete description of a strain of the virus. What it does in the body depends on the body - and every human genome is different (though identical twins, triplets and so forth don't differ much).

> E.g., annual flu shots don't incur *years* of testing before *authorization* (as would a vaccine for hepatitis, pneumonia, etc.).

Good point.

--
Bill Sloman, Sydney

On 23/08/2021 14:45, Rick C wrote:
> On Monday, August 23, 2021 at 9:33:20 AM UTC-4, Joe Gwinn wrote:

>> Also likely to be permitted in the future is using an entirely
>> different vaccine as a booster, for example Pfizer followed by
>> Moderna, or vice versa. Or J&J followed by Pfizer or Moderna, and
>> so on.
>
> Again, what do you base that statement on? It takes a lot of work to
> qualify the boosters. The goal is to get a significant improvement
> over the waning immunity of the vaccine you've had. There is little
> incentive to explore the many permutations of vaccine combinations.
> Who would do this research?

It has already been reported as successful and safe in European trials
intended mainly to deal with fluctuating supplies of matched vaccine.

https://www.nature.com/articles/d41586-021-01359-3

Otherwise you get into a bind of can't have the first jab because there
will be no availability of the second matched vaccine in 12 weeks time.
That was a problem for some UK medics early on when the vaccines were
scarce (much less of a problem now).

It is known that repeated doses of virus based vaccines become less
effective with each successive repetition. RNA ones are too new to
really be sure. Mix and match is certainly on the cards in future.

>>> A vaccine that better handles new variants would by definition be
>>> a new vaccine and would need to go through the development and
>>> approval process again. I'm not sure if it would also protect
>>> against the prior strains or not. I guess that depends on the
>>> details of the particular vaccine.
>> Getting a existing vaccine approved to cover a new variant is far
>> easier than starting from scratch, as most of the recipe is
>> unchanged.
>
> The vaccines are approved for use against COVID in the USA. Some
> will shortly be approved without the EUA label. In no case is
> further approval required to use the vaccines for new variants. If
> the vaccine is modified for a new variant I have seen nothing to
> suggest the vaccine does not need to run the gauntlet of approval
> again.

I think they will be able to do it on the substantially the same as an
existing vaccine basis but with a tweak in the genetic code. That is how
they do annual flu vaccines without a complete rehash of type approval.

What is less clear though is whether or not boosters are actually needed
in double vaccinated people with normal immune function. The vaccine
can't stop Delta Covid infections happening but it blunts their
severity. That is probably how the endgame will ultimately play out.

Pfizer would obviously love to sell you a new booster jab annually but
that is an entirely different question.

If it became more dangerous still then a booster for more older people
would be needed. We have to watch Israel to see what the future holds.

--
Regards,
Martin Brown

On 23/08/2021 16:48, Rick C wrote:
> On Monday, August 23, 2021 at 11:13:11 AM UTC-4, Joe Gwinn wrote:
>> On Mon, 23 Aug 2021 06:45:48 -0700 (PDT), Rick C
>> <gnuarm.del...@gmail.com> wrote:
>>

>>> And what do you base that opinion on? I'm not sure a vaccine
>>> against a different variant is actually a "booster" as such. It
>>> would be a new vaccine and would receive provisional approval
>>> prior to full approval incurring the wrath of Blo.

>> Based on following the literature. The current booster shots are
>> identical to whatever vaccine is being boosted. It is not new, and
>> does not require a new full-approval dance. The standard term for
>> this is "booster", without hair-splitting.
>
> Hmmm... you seem to be mixing your ideas. If it is against a new
> variant, it clearly would not be the same vaccine. Or are you
> suggesting the new variant can be addresses simply by giving more of
> the same vaccine? I've not heard that put forward before. If two
> shots of the vaccine are not effective against a variant, why would
> three shots be expected to work better?

The problem being observed worldwide is that no matter which vaccine you
choose at around the 6 months mark the protection from infection by
Covid wanes to a measurable extent. Latest figures from the UK ZOE study
suggest Pfizer wanes the fastest from 88% to 74% and AZ more slowly from
77% to 67% (and based on Israeli data it looks like Pfizer keeps on
falling after that - they are seeing worst case efficacy of ~40% now).

https://www.bbc.co.uk/news/health-58322882

They still protect from serious illness and death but they allow people
to become infected and so transmit the disease onwards. UK is now seeing
a big surge in Scotland where the schools have already gone back. They
saw their highest *ever* daily infection number yesterday!

https://www.scotsman.com/health/coronavirus/covid-scotland-highest-ever-daily-cases-of-coronavirus-reported-half-of-cases-are-under-25-3357664

The booster shot is to whack the immune system back into having large
numbers of antibodies in circulation to block initial infection. There
is some evidence in Europe that deliberately using an mRNA vaccine after
an AZ course may confer some additional benefits.

Viral based vaccines apparently don't elicit such a good response the
third time around (according to the Nature article).

>>>> Also likely to be permitted in the future is using an entirely
>>>> different vaccine as a booster, for example Pfizer followed by
>>>> Moderna, or vice versa. Or J&J followed by Pfizer or Moderna,
>>>> and so on.
>>>
>>> Again, what do you base that statement on? It takes a lot of work
>>> to qualify the boosters. The goal is to get a significant
>>> improvement over the waning immunity of the vaccine you've had.
>>> There is little incentive to explore the many permutations of
>>> vaccine combinations. Who would do this research?

>> Again, by following the literature. There are very good reasons to
>> want to mix-and-match. First, it greatly simplified the logistics
>> of treating an entire population.
>
> I think you have that backwards. If they are administering vaccine
> A in a region it is MORE complex to provide vaccine B as a booster.

Most regions of the UK were running at least two vaccines on each site.
An mRNA one for the youngsters and AZ for the middle aged and elderly.

There were supply issues in the early stages so a lot of work was done
to see if mix and match based on immediate availability of vaccine on
the day would be safe and effective. The scheme was intended to
vaccinate people to a double dose as quickly as possible.

>> Second, from the theory, a mis-matched booster probably increases
>> protection over a matched booster, and in any case is no worse. So,
>> unless mixing causes side effects, it will likely be done.
>
> There is zero evidence a different vaccine provides better
> protection. More importantly it is not inexpensive to study this.

That is untrue on both counts. I have already cited a publication in
Nature on the results of one of the preliminary studies of the mix and
match strategy. It seems to work best for AZ followed by Pfizer/Moderna.

https://www.nature.com/articles/d41586-021-01359-3

FTAOD That article is dated and titled:

19 May 2021
Mix-and-match COVID vaccines trigger potent immune response

> Most importantly no one involved has an incentive to study it
> (meaning the vaccine companies) so it won't be studied and won't be
> approved. This is what you just replied to. Did you not read that?

It already has been studied and it works!

>>>>> A vaccine that better handles new variants would by
>>>>> definition be a new vaccine and would need to go through the
>>>>> development and approval process again. I'm not sure if it
>>>>> would also protect against the prior strains or not. I guess
>>>>> that depends on the details of the particular vaccine.
>>>> Getting a existing vaccine approved to cover a new variant is
>>>> far easier than starting from scratch, as most of the recipe is
>>>> unchanged.
>>>
>>> The vaccines are approved for use against COVID in the USA. Some
>>> will shortly be approved without the EUA label. In no case is
>>> further approval required to use the vaccines for new variants.
>>> If the vaccine is modified for a new variant I have seen nothing
>>> to suggest the vaccine does not need to run the gauntlet of
>>> approval again.
>> Any doctor can prescribe a fully-approved vaccine for use as a
>> booster, matched or mixed.
>
> Yes, they can, but they have no reason to do so as there is no
> evidence it gives any advantage. If the mixed vaccination turns out
> to have issues, even if only remotely connected, the doctors would be
> in deep do-do for what is essentially off label use. But you didn't
> respond to my statement about new variants. Bottom line is you seem
> to be confused about variants. No new approval is required to use
> previously approved vaccines against a new variant. You do
> understand that, right?

Equally there is no reason why they cannot slightly change the genetic
payload of the vaccine to target the worst nuisance strains going
forwards. That is exactly what they do for flu vaccines every year.

>> It's incomplete to say that vaccines are approved. What is
>> actually approved is the entire production process, the detailed
>> recipe if you will, that yields the stuff in the bottle, and the
>> bottles for that matter, for millions of doses. This is because
>> minor-looking changes in recipe have caused big problems in the
>> past.
>>
>> Once one has developed a recipe and gotten it approved, one needs
>> re-approval to change that recipe. But if most of the recipe is
>> unchanged, the approval process is far faster.
>>
>> To handle COVID variants, all that changes is the specific DNA or
>> equivalent RNA sequence that is loaded into the carrier, a virus
>> shell or liposome respectively. The vast majority of the recipe is
>> unchanged.
>
> Not particularly relevant. The vaccine has to be tested and
> approved. Even if they don't need to get approval for the
> manufacturing process, it is not much of a simplification. There is
> a lot of work involved in testing a new vaccine for safety and
> efficacy. Don't downplay that.

They have to do some testing sure, but they are starting from an already
approved formulation and making very small well controlled changes.

--
Regards,
Martin Brown