FDA Direct Ep. 3: Striking a Balance – Framework for Future Covid-19 Vaccine Decisions
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Hey, everybody. Welcome back.
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We're here for our conversation.
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I'm calling it a conversation,
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not a podcast, because this is
sort of our normal business.
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We just talk and people are seeing our,
you know, how we think about things.
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It's just the regular day here at the FDA,
regular day.
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And it's been a really big day, though
the two of you have actually published
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a new vaccine framework, Covid 19
framework, in the New England
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Journal of Medicine.
I was actually just reading it.
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Congratulations,
you two lot going on today.
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Yeah. Big day.
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Let me hang on to that.
My mom's gonna put on the refrigerator.
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Yeah, she has a frame
it for her and send it over.
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I've been.
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I got a haircut.
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I mean, my boss did tell me in
no uncertain terms, Albert Einstein.
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I don't see him anymore.
A little peer pressure.
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But when your boss is, talking about.
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You're a nice guy. Yeah.
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So it's been a big day, and you just
finished kind of a big live stream
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explaining the framework,
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so I thought we could really go dig into
breaking it down and
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and answering some questions
that I've been thinking about.
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And I'm sure others
have been thinking about that today.
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So we're talking
Covid vaccine boosters. Yes.
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And the framework for regulation
and for future approvals.
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Yeah.
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So let's start with basics
for I'm thinking about my grandma
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at home
who doesn't really understand this. Right.
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But she knows what about Covid
19 boosters.
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What is the difference
between a vaccine and a drug?
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I think it's important
just level set on kind of definitions.
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You mentioned this earlier
in your talk, right?
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A vaccine is different from a drug.
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Well, I always say that,
vaccines and drugs should be treated
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similarly in the sense
that when given to the right person
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at the right time,
they both can have benefit.
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But, you know, not every drug is perfect
and not every vaccine is perfect.
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But a vaccine basically is
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a, is something that creates
an immunologic response in the person.
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So you can either fight off a virus,
not acquire a virus, do better.
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If you were to get the virus.
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And there's even a category of vaccines
called cancer therapeutic vaccines,
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where you fight off the cancer,
you've got,
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if you have a cancer
and get one of those vaccines.
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So, you know, sort of a broad category,
but basically means the immune system
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is doing some work in the body,
and we are training the immune system
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based on a product we're administering,
typically an injection.
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Are you hopeful about cancer
vaccines in general?
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Are you hoping
something good comes out in that space?
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Every oncologist
you know, our first mantra is hopeful.
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I mean, we are always hopeful.
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And in the last, you know, 15 years
I've been an oncologist,
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have been so many revolutions
in cancer medicine.
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So I continue to be excited.
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You know, I can't discuss specific
products, but actually, one came to mind.
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There are a number learning, by the way.
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That's a good that's good.
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That's that's a good that yeah. Can't
discuss specific products.
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But there are a number of cancer
therapeutic vaccines in the pipeline,
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that have preliminary data
that's promising.
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And more broadly, immunotherapy has been,
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sort of a major,
boon in the cancer space.
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You know,
I think one of the coolest thing,
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things about this
type of work is the pipeline.
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What you see that is potential.
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That is pretty now looks promising.
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That might provide hope.
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I mean,
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I think there are a number of conditions
we, as doctors treat where we just assume
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these are incurable.
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They are they're terminal.
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There's just nothing we can do.
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And you really get excited
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about coming to work here
and learning about what's in the pipeline.
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But anyway, cancer vaccine.
So that's interesting.
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You get your perspective.
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We've come a long way
from the first vaccine that is the cowpox,
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virus that gave cross immunity protection
smallpox, smallpox in the late 1700s.
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Doctor Jenner brought it to the U.S..
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Doctor,
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try to remember his name.
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A Harvard physician proposed this
to President John Adams.
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At the time, nothing came out of it.
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I don't know what happened.
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Maybe he didn't get the communication.
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Maybe he received it and rejected it.
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I don't want to slander him.
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I'm sure he's nice. Was a nice guy.
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Yeah, but,
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Thomas Jefferson ended up implementing
the national vaccination program.
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And so vaccines have done a lot
of amazing things in the United States.
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Not so much the anthrax vaccine.
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That was a total disaster,
not the swine flu vaccine.
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That was a disaster, not,
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the rotavirus, early
first version of that, that was pulled
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from the market
for intussusception, deception.
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That's right.
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And then there've been some HIV vaccines
that, have actually
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increased the transmission of HIV,
not decreased it.
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And, malaria vaccine has been the holy
grail, you know, a malaria vaccine.
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The number of people have been working
in that space for 20, 30 years.
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And that's been a fraught space.
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But your point's well taken.
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Vaccines can be miraculous when done well.
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And also there have been missteps
in the history of medicine.
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Two vaccines prevent illness.
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Yeah.
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So I would say that many of the vaccines
the public thinks about are vaccines
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that when given to people,
they don't acquire the illness
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or when given to enough people
that don't require the illness.
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For instance, if you get a hep B vaccine,
you're not going to get it.
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B if enough people in a population
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get the measles vaccine,
you're not going to see spread of measles.
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The Covid 19 vaccine was always,
hoped for, you know,
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that it would stop the spread of Covid 19,
but unfortunately it didn't.
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You know, everyone who's received
a Covid 19 vaccine and everyone who didn't
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has eventually been exposed to SARS-CoV-2,
the virus, and gotten Covid.
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So Covid 19 vaccines
don't prevent you from getting the virus.
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But what they did do
very clearly in the first quarter of 2021
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and the trials in 2020
was that if you were to get it,
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you're much less likely
to get severe disease, hospitalization.
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And those end points were,
you know, more important.
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But there's a broader question, which is
you get a huge benefit from the first dose
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and you may get some additional benefit
from the second dose.
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But how many doses do you need
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before you sort of hit
the plateau of the benefit you're in?
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T cells being sort of optimized
to prevent severe illness.
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Because that's really
what everyone's concerned about, right?
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Severe
severe illness with the, HPV vaccine,
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it's recommended to get two before age
15 and three after age 15.
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And it's interesting
because the number of doses
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thought to be required
to get that sort of optimized
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B and T cell protection
against severe illness
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or against severe infection,
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changes with age, which kind of is in line
with the new vaccine
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framework for the Covid
19 boosters that you've laid out.
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So that's a really good segue
to the Covid 19, booster framework.
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But before we get into that,
did I say that right now?
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That's right. This is the big moment.
We've been waiting for it. Yeah.
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So before we get into what
what you're proposing with the framework,
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I think it's important to understand,
like what is the current state
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when it comes to the booster
or the Covid 19 vaccine boosters?
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I think the current state is that
we have entered,
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you know, almost unwittingly, a paradigm
where every individual about six months
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and older is recommended every year
to get an annual Covid 19 shot life.
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So if they live to age 80, that's 80
shots, maybe 84 shots of the first few.
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Yeah, it's like 83 shots. Yeah.
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I mean, it's it seems to many people,
a big open question,
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you know, should a seven year old
get seven shots, an eight year old get,
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you know, what is the right
number of shots to get the maximum benefit
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for severe disease,
but also not to overdo something.
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And so our regulatory framework
that we have outlined
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in the new in the journal paper,
really that strikes a balance, you know,
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for folks who are at high risk of severe
outcomes, those over the age of 65
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and those with at least one risk factor
for severe disease,
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we are going to expedite the approval
of products based on immunogenicity,
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which basically means prove to me
that you get antibodies against the virus,
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and we're going to make those products
available to those high risk groups.
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But for people at low risk, healthy
people, we're going to ask the companies
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to do what we often ask, which is generate
evidence in a clinical trial
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that these additional doses
have a benefit for people.
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And the specific age
group we've suggested and agreed upon with
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some of these companies
is 50 to 60 for a place where
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if you look across the globe,
there's a lot of differences of opinion.
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Some countries go down to 45
and some go to 65, 65 and up.
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There tends to be consensus for 50 to 64.
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Yeah, there's differences of opinion.
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So we're going to go into that difference
of opinion space kind of place.
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We called equipoise where we genuinely
are uncertain and generate
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some relevant data for the American people
and the doctors who quite frankly,
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don't know what to do.
They're hungry for data.
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I mean, somebody comes to you 52 years old
and perfectly healthy.
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Yeah.
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And they're asking you, should
I get my fifth or sixth Covid booster?
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I mean, I have not
I don't have any evidence
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to inform an educated,
strong recommendation.
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It's been a guessing game.
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It's been again.
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And to clarify to what you said
earlier, right.
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That fifth or sixth, seventh, eighth,
you know, 80 shots.
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That is different than what we have for
other vaccines like HPV where it's 2 or 3.
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Right?
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We kind of believe
we've optimized the T-cell cellular.
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So we're an outlier in
how we're currently doing.
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We're an international outlier.
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Now, I'm sure based on your announcement
today in the lecture that you gave in live
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streamed, the media is going to call you
a contrarian.
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You predict it.
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I'm going to predict the contrary.
Their favorite word.
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Yeah.
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But as you point out,
the United States is the contrarian. Yes.
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I mean, Norway and Sweden and United
Kingdom and Austria and Germany.
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They, don't have this one size
fits all policy.
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They don't go after young people,
healthy young people, year after year,
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extoll them to get a shot without evidence
that that shot has benefit.
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They target elderly, high risk.
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And now we're falling in line
and not just recommended.
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I mean mandates and colleges.
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I mean,
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so that's one piece that you pulled
for this New England
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Journal paper out today that I just love
the vaccine recommendation
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for the Covid booster by country and other
countries, by country in Australia.
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You have to be over 65 and high risk.
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And can we can we clarify
how we're defining high risk?
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Well, we're going to go by a fairly
well accepted standard,
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which is the centers for Disease Control
have a list of high risk conditions.
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It's detailed in our article.
It is a living document.
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They do update that list.
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And, it's a broad document.
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I mean, it's a broad set of conditions,
including obesity, physical inactivity,
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depression, and pretty much any condition
that makes someone immunocompromised
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is included in that list.
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About Albert Einstein. Hair.
Is that a risk?
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That risk factor has been
has been mitigated in the United Kingdom,
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you have to be 75 years of age
and higher risk to have a Covid booster.
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Recommended to you
France, 80 years old and high risk.
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I mean, the United States is the country
and we are the international outliers.
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And that's a really good point.
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And I think when you know, those of us
who have I ran
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a laboratory,
we had an international group of people.
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I've got people from Switzerland,
from France and from the UK in my lab
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working with me.
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They look at our Covid policy
and they think,
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okay, what's wrong with the Americans?
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Why are you so far outside the accepted
mainstream consensus?
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I call it my medical dogma.
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But, okay, we have to back up.
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I don't understand so this agency, what,
you know, reviewed evidence
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to put out this recommendation
and approved things in the past.
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What how did they get it wrong?
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If every other country is following
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one set of evidence,
what are what were we looking at?
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I guess I'd say one thing is, you know,
the circumstances have changed over time.
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I mean, you know,
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I don't want to, play Monday
morning quarterback and say, who got runs
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right or wrong. But the circumstances
have substantively changed.
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And most Americans have had Covid not just
once or twice, perhaps many times.
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Sometimes they may not even know
how many they've had it.
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Our hospitals are no longer overflowing
with patients with severe disease.
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The rates of severe disease are down.
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And just as the population
severity of the virus has changed,
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so too should our regulatory framework
change to accommodate that.
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Now, of course, there have always been
philosophical differences
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between Americans and Europeans,
and those will continue.
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And there are small differences
around the edges.
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But broadly, we're basically
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bringing our policy up to speed
with what we're dealing with right now.
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So in that group, the high risk group,
where you're saying that,
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you're envisioning a framework
for approval
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without a preexisting randomized control
trial
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on that particular new vaccine.
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You are, suggesting
that you still want to see data,
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but it can be done in the post-marketing
commitment.
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Absolutely.
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And that's the kind of flexibility
we often have at the FDA.
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We make things available early,
particularly for life
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threatening conditions.
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But we also fact check on the back end,
make sure we're getting what we thought.
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And so our framework is both
you over 65 high risk.
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You're going to get early access
through immunologic endpoints.
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And then hopefully the companies
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complete the agreed upon.
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And I fully expect that they will complete
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the agreed
upon post-marketing commitments.
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And they generate that randomized evidence
and that evidence will be informative
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into the future.
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The other thing people may ask
is they say, well,
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you know,
by the time you get the evidence,
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it'll already be out of date
because the virus keeps changing.
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But the simple fact is the virus
is not changing like influenza changes.
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It's changing internal.
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Some of our data
suggest 24 fold slower than influenza.
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And the
Who is still endorsing in this season J
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and one or vaccines that target and one
which they also endorsed a year ago.
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So this is not influenza.
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This is a vaccine.
This is a virus that spreads
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in the summertime
in air conditioned environments.
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This is a virus
where you can generate data
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and we have an obligation at FDA
to only approve products
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where we believe with confidence
that the benefits outweigh the harms.
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And I think we can say that for high
risk people, for older people, but for low
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risk people, we need additional evidence
to be able to say that with confidence,
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because it's been 4 or 5 years
since we've had a randomized trial,
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there's much more population
immunity now, much more.
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And so, you don't
it sounds like you don't envision,
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a needs for a randomized
control trial each year. But
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if I understand it correctly,
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I think, you know,
this may not even be, a shot.
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That's a yearly shot.
Maybe it should be. It should.
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It should be a shot offered
when the virus changes,
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when the antigen of the virus
substantively changes, a shift, a shift.
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And that's different from the flu vaccine.
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The flu.
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You know, flu is a
is a virus with lots of differences.
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It's it's true. It's a shifting virus.
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It's it's it's shifting all the time.
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And in fact, in some ways so quickly
that sometimes our flu vaccines,
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don't exactly
match the strains that end up circulating.
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It's it's always a bit of a guessing game,
but Covid 19,
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we'll let the virus tell us how often
we need to reassess our strategy,
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see its mutation rate,
see where we are in 18 months,
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and maybe this is
at a every 12 month shot,
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but maybe an every 18 months
or every three years or every
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I don't know the answer.
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I let biology dictate that.
Not my opinion.
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Bigfoot has seen very leaky
polymerase is in the influenza.
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Oh, there he is.
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People are asking me if he's a real guy.
Look at this guy.
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Oh, it's good to see a Bigfoot.
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And, then I and and Angela here
have been excited to see you.
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So thanks for the update.
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He's our AV tech. Yeah.
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So I know, we don't have too much time
left, but, Well,
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that's because the boss wants me to go
do some things.
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The boss told me a big today.
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He gave me a big To-Do list today.
And so I got to do.
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I got to do these things.
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First thing on the To-Do
list is get a haircut tech,
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develop a new vaccine for him. Work check.
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And now I got to pick up his dry cleaning.
So I got to get out of his.
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But I think, you know one thing
when we talk about vaccines, you know,
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there's this kind of question about what
does the FDA do versus what is CDC do.
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And I think it's important just to kind of
clarify what our role in this is.
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Yeah.
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So, we look at the evidence and,
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issue, licenses
or what's generally known as an approval
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based on claims
that match existing evidence.
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And so that's generally
the role of the FDA as a regulator.
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And then the CDC has a recommendation
schedule that's independent of the FDA.
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So that's a little bit how,
you know, we're different from the CDC
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in the sense that we're not recommending
or not recommending.
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We're looking at evidence
and applications.
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And so I think, you know, this is
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a bit of a turning point in the sense
that we are not going to be rubber
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stamping every single vaccine booster
that comes here to the FDA,
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without a clinical trial
or clinical, evidence,
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or citing evidence from 4 or 5 years ago.
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And so, I think people want to know
what the data shows.
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85% of health care workers said no
to the last Covid booster.
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That says something
that's that says either they're hungry
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for some updated evidence
it's been too long or they have concerns.
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Yeah.
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And I think that most doctors I know
will be responsive to the evidence
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if it shows overwhelming
benefit of these products and 50 to 64,
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they're going to go out there
and endorse it with passion
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because they'll have evidence
to guide those conversations.
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If those studies are
in fact null or negative.
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And they don't,
it doesn't have much benefit,
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then I think it'll make us rethink
what we're doing here, and we'll have to
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perhaps think about other ways
to generate evidence.
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So I think so
just to make sure I'm tracking that.
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So to date,
there really has not been strong evidence
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of studies
conducted on those healthy populations to
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to show that there is a benefit
besides the initial studies,
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I mean, I don't want to take away
for the initial studies in my mind, where
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well-done studies randomized
controlled trials launched in 2020
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that showed reduction
in symptomatic SARS-CoV-2,
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as well as trends toward improved
severe disease for both Pfizer
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and Moderna and, those are that
and Johnson and Johnson at the time,
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and and we had evidence early on
that was robust.
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But then we slipped into this,
this paradigm where booster
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after booster dose three and four
and five and six, and the evidence
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for the subsequent doses was always more
and more ambiguous and uncertain.
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Some people point out what they call
observational studies,
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where they say, well, look, let's go
look in the population,
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look at people got six verse five doses,
see who did better.
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But we all know that people who choose
to get six and the people who don't,
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the different groups of people.
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And so we have this bias there,
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which is the type of person
who seeks that extra dose.
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And only the studies
that we propose get around that bias.
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Well, then
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I thank you for, bringing us closer
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to the international community
on how they approach vaccines.
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So that's great.
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And, Angela, any other.
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No, I mean, I,
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I think this is a great step
in the march and common sense and gold
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standard science together. So
I'm really excited to see where this goes.
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And we would talk for another hour.
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I know, but you gotta know
how to give a lecture right now.
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I do,
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I do,
385
00:18:18,197 --> 00:18:19,565
but the public should certainly check out
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this, this paper
because I think it's really helpful
387
00:18:21,700 --> 00:18:23,435
and understanding the framework. Yeah.
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And thanks for the opportunity,
Commissioner,
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and thank you
for putting this conversation together.
390
00:18:26,705 --> 00:18:28,640
Great hair, great to see. Great job.
391
00:18:28,640 --> 00:18:29,975
Keep up the good work. Thank you sir.
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Okay good.
393
00:18:34,246 --> 00:18:37,316
Yeah. Good. Good job.