August 1, 2025 • 40 mins
Brian Dean Abramson, Adjunct Professor of Vaccine Law, Florida International University College of Law and University of Houston Law Center, speaks with Vanessa Burrows, Partner, Simpson Thacher & Bartlett LLP, and Dr. René Najera, Director of Public Health, College of Physicians of Philadelphia, about the rapidly changing environment of vaccine law and regulation. They discuss current availability, recommendations, and funding of vaccines at the federal level; implications for companies involved in vaccine testing, development, distribution, and administration; the future of employer mandates; changes at the state level; and developments related to the National Vaccine Injury Compensation Program. Brian is the author of AHLA’s Vaccine, Vaccination, and Immunization Law, Third Edition.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
SPEAKER_02 (00:00):
For more information, visit
AmericanHealthLaw.org.
SPEAKER_00 (00:17):
Hello, I am Brian Dean Abramson.
I am the author of the AmericanHealth Law Association's
Treatise Vaccine, Vaccination,and Minimization Law, which has
just come out in its thirdedition earlier this year.
And I also teach vaccine law atthe Florida International
University College of Law andthe University of Houston Law
(00:38):
Center.
And as I came out with thisthird edition, I thought the
state of vaccine law after theevents of the last few years
with the pandemic had somewhatstabilized and we weren't going
to see big changes ordisruptions.
And as it turns out, we are inthe midst of some tremendous
(01:00):
upheaval in the field, which iswhy I am joined here today by
Dr.
Renee Nehera and VanessaBurrows, who are going to join
me in discussing some of theseupheavals in vaccine law, also
matters that we'll be discussingat the forthcoming National
Vaccine Law Conference.
(01:20):
Why don't I go to Vanessa andallow you to introduce yourself
then?
SPEAKER_01 (01:23):
Hi, I'm Vanessa Burrows.
I'm a partner in SimpsonThatcher's Washington, D.C.
office.
I handle health care regulatoryand FDA regulatory matters,
usually in the context ofcapital markets transactions, as
well as for mergers andacquisitions.
And I'll turn it to Rene.
SPEAKER_03 (01:39):
Hi, my name is Rene Nahed.
I am the Director of PublicHealth at the College of
Physicians of Philadelphia.
I'm also the Director of theHistory of Vaccines Project here
at the college, and I'm a fellowof the college as well.
I also teach at Johns HopkinsUniversity and at George Mason
University on public health andepidemiology.
SPEAKER_00 (01:55):
Excellent.
Well, thank you both for beinghere.
And, you know, as I said, we arein a period of upheaval.
And what we are seeing, whatwe've seen throughout the
pandemic is changes to differentareas of vaccine law sort of
progressively increasing.
Or things that have occurredthat brought attention to those
areas in terms of the approvalof the covert vaccine in
(02:17):
particular.
Now, we are seeing somesubstantial changes in the
regulatory structure of vaccinesand really in who's making the
decisions.
in terms of whether vaccines aregoing to be approved.
Would either of you wanna jumpin and talk about what exactly
(02:37):
we're seeing with that and howthat's going to affect
potentially the availability ofvaccines and recommendations for
vaccines?
SPEAKER_01 (02:48):
Sure, so even within the last day, right before we
started this podcast, we'veseen, I think a major change in
terms of which vaccines will berecommended.
which could potentially go toapprovals at a later point in
time.
But the U.S.
Department of Health and HumanServices Secretary Robert F.
(03:09):
Kennedy Jr.
had recommended or formallyrescinded, actually, the federal
recommendation for flu vaccinesthat have thimerosal.
So this is apparently not goingto reduce the vast amount of flu
vaccines that are currently onthe market, but that would
prevent recommendations forthe...
(03:32):
vaccines that do still have athimerosal component, which is,
to my understanding, a smallpercentage of current vaccines.
I don't know, Rene, if you wantto also
SPEAKER_03 (03:41):
comment on that.
Yeah, no, you know, thimerosalhas been a boogeyman in the
anti-vaccine circles for quitesome time now.
It's a solution that containsmercury.
And so when you don't understandchemistry and you don't
understand biology, you know,putting thimerosal into you
through a vaccine seems likesomething very scary, but it's
not.
It's harmless.
It's been around for over 100years We know it's toxicity
(04:03):
levels and the levels in thevaccines are nowhere near toxic.
My worry with this, you know,yeah, thimerosal was removed
from childhood vaccines for themost part at the beginning of
the century, 25 years ago.
And, you know, that's fine.
That's fine for us.
My worry is the rest of theworld.
In the rest of the world, peopledon't enjoy the infrastructure
(04:24):
to keep their vaccines safe interms of storage.
And they rely on thimerosalprimarily to keep the vaccines,
the dead virus vaccines, withoutany kind of bacterial
contamination.
And so all these countries now,they're gonna be looking to the
US and saying, well, the USremoved thimerosal, why do we
still get to have it?
If it's so dangerous, accordingto people like RFK Jr., then why
(04:47):
is it still in our vaccines?
And that's where I think we'regonna see a further erosion
worldwide of vaccine acquisitionby people.
That's my worry when it comes tothese kind of regulatory actions
and their impact on publichealth.
SPEAKER_00 (05:01):
Let me actually step things back a little bit and
give a bit of a primer, becauseI think there are a lot of
people who don't know thestructure by which vaccines are
approved and recommended.
So there is a body in theDepartment of Health and Human
Services called ACIP, theAdvisory Committee on
Immunization Practices.
And there's a very longstandingpractice rule, basically, that
(05:26):
ACIP is composed of experts inthe field, And they make
recommendations.
They say these vaccines shouldbe administered to children or
to pregnant women or to adults.
They make recommendations forall the vaccines.
And those recommendations havelegal consequences.
One of which is currently thatunder the Affordable Care Act,
(05:49):
if ACIP recommends a vaccine,then it has to be covered by
insurance companies.
Another being that if ACIPrecommends a vaccine for women
to children or pregnant women,then that vaccine will fall
under the National VaccineInjury Compensation Program,
which limits the liability bothof manufacturers, and I think
(06:10):
most pertinently to AHLAmembers, to administrators, the
doctors, the hospitals they workfor, their liability has certain
limitations on it due to thatstructure.
And historically, ACIP has been,I think, very well regarded for
the depth of its inquiry intothe safety and effectiveness of
(06:33):
vaccines and their utility forpeople in different age groups
and circumstances.
But for those who are sort ofnot in the know, earlier this
year, and this is something thatwas kind of widely reported in
the news, it's sort of anunusual level of attention for a
vaccine law issue, but SecretaryKennedy fired all 17 members of
(06:54):
ACIP, alleging corruption basedon the fact that some of them
were scientists who had workedon vaccines for vaccine
manufacturers.
Some of them had been involvedin conferences or projects or
things of that sort thatreceived funding from the
manufacturers.
And this was widely derided inthe community of researchers
(07:17):
because these are people whohave real expertise in
vaccinology and immunology andepidemiology.
And he fired those 17 membersand replaced them with eight
people who generally don't havethat expertise.
But many of them have a historyof publicly agreeing with
(07:38):
certain anti-vaccine tropes,some of them kind of myths.
And that body has since beenmuch more reticent to be
full-throated and endorsingvaccines.
And even with therecommendations that body made,
(08:02):
that body made somerecommendations, which Kennedy
then rejected, that$8 persongroup that he appointed made
some recommendations for thevaccination schedule that
Kennedy rejected.
And those have legalconsequences as well in terms of
whether there's going to befunding for those, whether
there's going to be availabilityfor those.
So that's kind of the backgroundand the milieu of what we're
(08:25):
working with.
So what does the horizon sort oflook like for the availability
of vaccines in the United Statesand funding of vaccines in the
United States?
Rene, is there something you canspeak to?
SPEAKER_03 (08:41):
Well, it's yet to be determined, obviously, with
everything still being in flux.
But I can tell you that a lot ofthe local health departments
that provide vaccines,especially for children,
especially coming up in Augustfor the school year so that
these kids meet the requirementsfor their school, they're
preparing for no funding.
They're preparing to beself-funded either through the
(09:03):
local taxes, the local money.
A lot of clinics have closed aswell, something that we saw even
before this decision with thefiring of ACIP and the
replacement, the federal moneywas withheld for clinics out in
Texas where there's a massivemeasles epidemic going on.
So a lot of the local healthdepartments that actually do the
(09:24):
work, they're preparing for nothaving the money available for
vaccination.
The vaccines are there.
They're still being produced bythe manufacturers.
It's all the money to pay forthose vaccines, which You know,
at a small scale, they're notvery expensive, but when then
you start talking about hundredsand thousands of kids, then yes,
it starts getting expensive,especially for low income health
(09:48):
departments in low incomecounties in the United States
that are going to be affected.
So it's just a cascading effectthat has now reached the local
public health workers.
The average person in the U.S.
will probably still get toaccess vaccines.
They'll probably still get to goto their physician and get it
prescribed and then go get itbecause the vaccines have not
been outlawed per se.
(10:10):
But as far as the poor,low-income countries in the
U.S., that's where there's goingto be trouble.
because the money is beingrescinded or just withheld from
them to be used for theseprograms.
Number one, catch kids up, whichwe saw during the pandemic that
a lot of kids didn't get theirvaccinations.
So now they're being caught up.
And number two, get kids forentering the school system,
(10:32):
which tens of thousands ofchildren enter the school system
every year.
They also need their vaccines tobe up to date as a requirement
for education.
And they're not going to be ableto have them at a reduced or
free rate.
SPEAKER_00 (10:45):
That is going to be a troubling development because
that'll be a vector throughwhich these diseases spread.
I think we're seeing that withthe current measles outbreak.
That's sort of an illustrationof what happens when you have
reductions both in support forthose programs and increases in
hesitance driven by a lot of therhetoric we're seeing.
(11:09):
Vanessa, can you speak to howthis is going to affect the
public companies that areinvolved in vaccine testing,
development, distribution, andadministration?
SPEAKER_01 (11:19):
Sure.
So we do advise public companieson risk factors and how to
explain to the public throughSEC filings, Securities and
Exchange Commission filings,what the potential risks to
their companies are.
One thing, and also this happensin kind of the private context
as well, just advising,acquirers on risks associated
(11:43):
with particular products thatmight be either in development
or already commercially marketedand what these changes could
mean for them.
I think generally speaking, itseems to have been a very stable
area in the past.
Since the Affordable Care Actwas passed, there were
recommendations for coverage forvaccines so that health plans
(12:05):
would have to provide coveragefor preventative services and
people would know that theirvaccines would be covered on an
annual basis if it's a fluvaccine or otherwise.
And then we also saw during theCOVID-19 pandemic that Congress
passed additional laws such asthe CARES Act that provided
coverage for COVID-19 vaccinesspecifically.
(12:25):
So kind of the risk factorsassociated with development of
new vaccines, those I think arestill there, but the risk
factors that companies are mayneed to consider adjusting are
the ones that are associatedwith recent events in the
Department of Health and HumanServices and at ACIP.
(12:47):
What the recommendations are,could the recommendations be
revoked?
With the decision recently, thisis not to say that there's
indications that other drugapprovals or vaccine approvals
will be revoked, but to theextent that there's going to be
future actions to decreaserecommendations for particular
(13:09):
products or decrease the numberof individuals who are eligible.
Let's say no longer makerecommendations for children or
no longer make recommendationsfor pregnant women or limit the
recommendations for the COVIDvaccine to individuals of a
certain age who are on the olderside.
All of that might lead to adecrease in vaccine uptake,
(13:31):
maybe a decrease inmanufacturing.
There could be new safety oradverse event report
requirements.
I mean, currently vaccinemanufacturers have to provide
adverse event data and reportthat to FDA, as do healthcare
providers who are administeringthe vaccines.
But to the extent that therecould be other requirements
(13:53):
imposed, then that would be anadditional obligation on a
provider or a vaccinemanufacturer that they might
have to follow and address thoserecommendations as well.
So just generally speaking,companies in this space, I
think, are taking a new look atwhat their current risks are and
what their future risks couldbe.
(14:13):
And if this would have amaterial impact on any of their
products or their revenue.
SPEAKER_00 (14:19):
So we are looking at something of a chilling effect
on the development of newvaccines, just because there's
sort of a fear that HHS with itscurrent constituency or current
leadership might impose somecostly new, for example, as they
(14:40):
did, I think they have done withsome vaccines already.
They've said, you know, we'renot going to allow this for
certain groups unless youconduct an entirely new clinical
trial.
And those are tremendouslyexpensive.
So I wanted to ask, and I thinkI'll direct this at Renee, if
you have any thoughts on this.
(15:02):
How is this going to affect theability of employers to mandate
vaccines or encourage orincentivize or otherwise
increase vaccination rates fortheir employees, particularly in
the healthcare sector wherevaccination may be ubiquitous?
SPEAKER_03 (15:18):
Yeah, I was thinking of the healthcare sector right
off the bat, right?
But what you have to understandis that in the healthcare
sector, for the most part, youhave people that are not vaccine
adverse, you know, they'reThey're pro-vaccination.
They understand the science.
They understand the need to,even if the vaccine increases
your risk of whatever, they'rewilling to take that risk
because they're that kind ofpeople.
You know, we're talkingphysicians, physician assistant
(15:39):
nurses, et cetera.
That said, you know, what is ahospital going to do for
infection prevention purposes?
For example, with the fluvaccine, when somebody like HHS
says, you know, the flu vaccinein a certain age group is not as
effective or the COVID vaccineor hepatitis B is also a big
(16:01):
deal in healthcare settings.
And it's very infectious and youneed to be protected against it
because you come into contactwith it almost daily if you're
in direct patient contact in theUnited States.
And so it's going to be toughfor them to, on the one hand
say, here's the science, here'sthe evidence, here's why you
need to be vaccinated and alsoto protect us from liability of
you getting hurt on the job bygetting this infection and this
(16:22):
disease.
But on the other hand, thehonchos at HHS, you know, in the
most powerful nation in theworld are saying, don't do it.
So how do we marry the two?
Hopefully for the most part,people will understand that the
people in charge at HHS rightnow are, if not anti-vaccine,
they're vaccine hesitant.
And so, you know, they'll justkind of work with that.
(16:45):
A lot of the medicalorganizations, societies, et
cetera, are giving their ownpoint of view on these things
and they're stepping up to fillin the gaps that HHS, CDC, FDA
might not be filling in.
But it's going to be tough tokind of put together, marry
those two situations.
(17:06):
On the one hand, the science,and on the other one, the
policy.
And it's something that, it's atension that has not been seen
in a long time when it comes tovaccination.
You see it more in discussionforums online, but now we're
seeing it in the real world.
And it's gonna be interesting tosee how you know, it, it plays
out with, with healthcareinstitutions.
And of course, you know, thenthere are others that are other,
(17:27):
um, other employers who mightrequire certain vaccines based
on the work that their employeesdo.
I'm thinking of restaurants andI'm thinking of food handlers
and some companies require thehepatitis A vaccine because you
have hepatitis A and you'reprocessing food, you might
affect a lot of people andthat's a big liability, right?
How do you mandate that if forsome reason down the line, HHS
(17:49):
decides that the hepatitis Avaccine is not recommended or
not to be used?
and so on and so forth.
So it's going to be a delicatebalance between the science and
the policy.
And I do not wanna be in theposition of the people that have
to make that decision right now.
That's how I see it affectingcompanies at this point.
SPEAKER_00 (18:10):
Well, so far we've only been talking really about
HHS and the changes in thefederal government.
What are we seeing from thestates in terms of their action
towards vaccination mandates andemployer mandates?
SPEAKER_03 (18:24):
Yeah, so some states are reverting.
Mississippi and West Virginia,for example, were some of the
handful of states, I think likethree or four, that had no
exceptions for vaccines otherthan medical exceptions.
And now they're changing theirtune.
Now they're adding exceptionsbased on philosophical,
religious points of view.
(18:44):
And so that is opening the doorfor people to just say, I don't
want my kid vaccinated.
You know, I'll sign the form andthat's it.
where it used to be that you hadto go to a physician and get a
proper diagnosis, and thenthat's the only way you could
get around getting vaccinated.
California went the oppositeway.
California used to havephilosophical and medical and
non-medical extensions, and theywent to just medical, increased
(19:07):
the rate of vaccination,increased the acceptance of
vaccines in the state.
And so that really worked out.
But now we have these two statesAnd then you have other states
that are looking again, youknow, after this debate in the
early 2000s with things like theHPV vaccine.
We're taking another look at theHPV vaccine, and I'm thinking of
Texas and other states in theSouth, you know, places where
(19:28):
HPV disproportionately affectspeople of color.
So they're looking at thesevaccines as dangerous.
You have states like, I forgetif it's South Dakota or North
Dakota, they were wanting toclassify people.
the mRNA vaccines as genetictherapy or as agents of
biological warfare.
And so this just shows amisunderstanding of what the
(19:49):
mRNA vaccines are.
So you're seeing these littlebills that we try to keep on top
of by tracking them online, butyou see them, and sometimes they
don't get past committees, andsometimes they do.
And so when they do, it's amobilization of pro-science
people, particularly parents, totry to talk to their legislators
and get them to not do whatthey're thinking of doing.
(20:10):
But it all centers around theability to be exempt from
certain vaccines, which kind of,you know, it's kind of scary
because where does it stop?
Do you just then instead ofexempting people, do you just
make it an opt-in instead of anopt-out?
And then what does that lead to?
And we see some of that withmeasles.
(20:32):
Pertussis is another one,another disease that is
exploding in the U.S.
You know, and with measles comesrubella.
People should go and see whathappened with rubella in the
1960s before the vaccine wasavailable.
It brought us Roe versus Wadebecause of everything that was
going on to pregnant women atthe time with rubella.
So yeah.
(20:53):
You know, that's what'spercolating out there.
It'll all depend on the tonethat the politics takes.
And right now we're superpolarized.
So, you know, we'll pay closeattention to what happens, but
that's what keeps me open bythis.
A big state with a bigpopulation all of a sudden
saying, okay, vaccines areopted.
(21:14):
It's up to the parents to optinto vaccines and we don't need
to worry about them having them,you know?
And so we're off to the raceswith big epidemics.
SPEAKER_00 (21:23):
One thing that keeps me up is something that's gone
on in a big state with a smallpopulation, which is Montana,
where the state banned employervaccination mandates.
So it's the law of the statenow, and I think it only applies
to COVID vaccination, but thereare other states that have sort
of legislators with similarmindsets and views on
(21:46):
vaccination.
And that was actually challengedin court and initially the
United States District Court inMontana throughout that
prohibition on various groundsand the grounds that you may
have employees who are unable tobe vaccinated and for their
protection they need to bearound employees who are
vaccinated.
And the United States Court ofAppeals for the Ninth Circuit
(22:09):
overturned that.
So now it is the law of the landthat a state can actually ban
employer vaccination mandates orbut sort of draconian limits on
it.
You know, Texas has putrequirements in place that if an
employee basically says theyhave a religious or
philosophical or conscientiousobjection to vaccination, the
(22:32):
employer has to grant them anexemption.
So it's an exception that eatsthe rule.
So that's something that we'reseeing.
And I think the states are beingvery divergent and it's a very
different way path than we'vehad historically.
At the outset of the COVIDpandemic, we saw that there were
a lot of states that didn't wantto take measures to prevent the
(22:55):
spread of COVID, didn't want tobe kind of pro-vaccination when
the vaccine was developed.
And the federal government tryto step up and fill in that gap
with an OSHA requirement, whichwas ultimately struck down by
the Supreme Court.
So there are certainly limitsthat have been imposed on what
(23:19):
employers can do, even in thehealthcare field, even where
it's most stringently requiredthat people be vaccinated.
And on top of that, We're seeingan increase in courts around the
country and in the Supreme Courtof a willingness to expand
(23:42):
religious exemptions and saythat even where you're allowed
to have vaccinationrequirements, We're going to
take federal laws that requirethat you not discriminate on the
basis of religion and extendthem into broader and broader
abilities of people to object tovaccination or avoid
vaccination.
So that's certainly an area ofconcern where we're going to
(24:06):
have people in those positionsin America.
positions where there aremedical professionals who are
dealing directly with patientsand should be vaccinated and
maybe in some sense beingdissuaded from being vaccinated.
I want to shift a little bit tothe distinction between COVID
(24:27):
vaccine and other vaccines andthe vaccine entry compensation.
Vanessa, is that something thatyou wanted to speak to?
I
SPEAKER_01 (24:34):
think In general, there's the National Vaccine
Injury Compensation Program,which provides compensation for
certain types of vaccines.
It's gotten a little bit ofattention over the years and
kind of in waves, but morerecent attention from the Senate
Homeland Security andGovernmental Affairs Committee
(24:57):
because they have been focusingon children who've been injured
or individuals who've beeninjured by vaccines.
But the program does cover ifthere's a vaccine that is
mandated.
Any individuals who are injuredthat have certain types of
injuries, when the injuriesappeared within a certain
timeframe of the vaccinationbeing administered to the
(25:20):
individual and protectsmanufacturers and provides
certain liability protectionsfor manufacturers of those
vaccines.
But it does provide a way forindividuals who are injured to
receive compensation.
Of course, to the extent thatthere would be a severe adverse
event associated with theadministration of a vaccine,
(25:42):
arguably there's no compensationthat could equate for that.
you know, in general, thisprovides a congressionally
mandated mechanism forindividuals to seek recourse
through the federal court systemand through this program.
So recently, as I mentioned, theSenate Homeland Security and
Governmental Affairs Committeehas had a few hearings about the
(26:05):
individuals and this programgenerally.
I don't think that they're is anappetite to push major
legislation to make seriouschanges to the program at this
point in time.
But of course, having thesehearings draws attention to the
program and what it does.
It has been amended over time toinclude additional types of
(26:28):
vaccines.
So for example, I think it wasamended during the COVID-19
pandemic to provide additionaltypes of to cover additional
types of vaccines that werebeing administered during that
time.
But correct me if I'm wrong,Brian or Renee, on that.
SPEAKER_00 (26:42):
Well, I think there's been a very interesting
history in the past decade or soof the VICP just because
Shoulder injuries were added toit, and they were added at the
tail end of the Obamaadministration, and they were
removed by the Trumpadministration.
They were put back by the Bidenadministration.
And at the moment, it doesn'tseem like there's any intent on
(27:06):
the part of the second Trumpadministration to remove them
again.
But shoulder injuries from...
basically from an incorrectadministration technique where
the needle doesn't go in quiteright, aren't necessarily caused
by anything to do with thevaccine themselves.
They're entirely aboutadministration.
And since those were added tothe program, they very quickly
(27:31):
came to account for half of allvaccine injury claims with the
VICP and a substantial increase.
So that and vagabagal syncope,which is basically fainting, or
vasobagal syncope, those wereadded, and those have added some
strain to the program.
There haven't been new vaccinesadded in some time.
(27:56):
And I think the last vaccine wasadded, I want to say it was
rotavirus, which was a whileago, maybe influenza in 2005.
But one of the big bones ofcontention is that the COVID
(28:17):
vaccine is itself not covered bythe Vaccine Injury Compensation
Program.
And that's sort of aninteresting topic of, you know,
Kennedy thinks it should be.
It's currently covered by athing called the Countermeasures
Injury Compensation Program,which is a separate program set
up under the PREP Act.
And that program is sort ofnotoriously stingy compared to
(28:40):
the VICP.
There have been far fewerdeterminations that an injury
was caused by the vaccine, farsmaller awards, with one kind of
a substantial outlier wheresomeone was awarded about$2.5
million for an asserted COVIDvaccine injury.
But outside of that, they'vebeen in the tens of thousands,
(29:02):
which is much lower than theVICP usually awards.
But the thing is, a vaccine, asthe law is currently structured,
cannot be added to the vaccineinjury compensation program
unless it's recommended by ACIPfor administration to children
or pregnant women.
And ACIP is not going to makethat recommendation for the
(29:22):
COVID-19 vaccine as ACIP iscurrently constituted.
HHS under Kennedy hasspecifically contravened such a
recommendation for those groupsthat would bring in under the
VICP.
So it's going to take an act ofCongress to put COVID-19 vaccine
(29:44):
under the VICP if they want tomove it out from the CICP.
So that's kind of an interestingdirection where things are going
with that.
And there are competing kind ofbills that have been brought in
the House of Representativesgoing in very different
directions.
One bill that has garnered somesupport would, in fact, move...
(30:09):
COVID to the CICB and increasethe number of special masters
who deal with these cases.
There's a statutory limit ofeight special masters to deal
with all these vaccine injurycases, which made sense 40 years
ago when there were a handful ofthem.
Now, when there are thousands ofthem and the docket is bloated
with the shoulder injury casestaking up half of it, if we add
(30:30):
COVID cases to that, it'llbasically double again.
So that's structural change thatwould need to be made in order
for these cases to be heard inany sort of reasonable amount of
time.
But there's also a bill pendingin Congress that would just
eliminate all of these casesmanufacturer limitations and
liability, administratorlimitations and liability, and
(30:52):
get rid of all of theseprovisions of the VICP.
And that has some support aswell.
And I saw an analysis of thatstudy.
These sort of two competingdirections are each garnering
enough support to ensure thatneither one of them is going to
pass.
So something is going to have togive at some point because the
(31:13):
current situation is notsustainable forever.
I
SPEAKER_03 (31:18):
want to make an important distinction here that
just that something getsreported to the vaccine adverse
events reporting system or thatsomething reaches the vaccine
court, as it's called, doesn'tmean that it was an actual
injury from the vaccine.
As you mentioned, the shoulderinjuries are because of the
(31:40):
administration.
So that's human error.
which is fine to try to get somecompensation, especially if the
injury was severe enough.
You also have some cases fromthe storage of the vaccines.
And we go back to the issue ofthimerosal.
Thimerosal-free vaccines canspoil.
And there have been instanceswhere those vaccines have been
administered to people and theyhave some sort of bacterial
(32:00):
contamination and they causesome sort of injury.
Again, you know, not the vaccineper se, but the administration,
the handling of the vaccine.
So I think it's important forthose who are listening to this
that just because the cases havejumped or the cases are
happening doesn't mean that thevaccines are less safe.
If anything, they've beengetting safer with time.
It's just that, you know,there's this thing that we use
(32:21):
in epidemiology calledsurveillance bias.
If you look for something longenough, you're going to find it.
And so when you have millionsupon millions upon millions of
people getting the COVIDvaccine, even if it causes a one
in a million chance, you'regoing to have several hundreds
of people who are going to beflaming or having legitimate
claims of injury.
And then you're going to haveall the, you know, temporarily
(32:42):
associated.
So it happened after thevaccine, so I'm blaming it on
the vaccine.
vaccine, which we see all thetime with the HPV vaccine.
The HPV vaccine, you go into theVaccine Adverse Events Reporting
System, and many of the claims,many of the claims are for blood
clots.
And if you look at the caseswith details, they are blood
clots in women who had othercomorbidities that increased
(33:05):
their risk of blood clotsaltogether, smoking, overweight,
obesity, and use ofcontraceptives.
And so was it the vaccine or wasit any of those things?
Well, it's hard to tease apartwithout actually, you know,
having a study with each one ofthese people.
But it is what it is.
And I think, you know, as yousaid, if we increase the number
(33:25):
of vaccines and make it into thesystem, then it's going to
increase the number of reports.
And in the public space, pointof view, it's going to increase
the danger of the vaccine.
Then they turn to theirlegislators or to the current
administration.
And it's like a self-fulfillingprophecy of a circle.
(33:48):
Now we think vaccines are moredangerous, so we need to get rid
of them, or you need tocompensate me more if I take on
the risk.
And it's just one of thosethings that in public health, we
kind of throw our hands in theair because it's one of those
things that we cannot control.
We just have to deal with it andcontinue to educate the public.
SPEAKER_00 (34:05):
Right, and then I think it's worth adding to that
couple points, one being thatthe vaccine injury compensation
program itself is a no faultcompensation program.
You don't actually have to showthat there was any fault on the
part of anyone involved in themanufacturer or administration
of the vaccine.
And for certain kinds ofinjuries, you don't actually
(34:25):
have to show the vaccine causedthe injury.
You just have to show aproximity in time between
vaccination condition and.
for compensation purposes,everything else is assumed.
And also, I think it's importantto note that in this entire
framework of things, there aresome people who are either
(34:48):
outright bad actors and tryingto stir the pot and score
political points, or people whojust genuinely believe bad
things about vaccine that aren'tsupported by the science and the
research.
And we see...
claims that are being filed,VAERS reports that are being
filed that are kind ofblatantly, no, that's not really
(35:14):
connected, but filed by peoplewho want to make that
connection.
We see that a lot with theautism cases.
There was a study in about 25years ago where someone claimed
to have found the connectionbetween vaccination and autism.
That study was later found to befraudulent.
(35:34):
But that connection was made insort of the public mind.
Very good studies have been donesince then showing that there is
no correlation betweenvaccination and autism.
And in fact, the signs of autismchanges to the brain structure
can now be found in children inthe womb before any vaccines are
(35:56):
administered.
So that's sort of beendisqualified as a component of
the development of autism.
And I've recently posted aboutthe fact that exposure to fossil
fuel fumes is stronglycorrelated with the development
of autism in children.
But we have this committee nowon HHS that has been formed to,
(36:21):
quote unquote, determine thecauses of autism.
And that is a group of peoplewho have this sort of long-term
history of asserting thatthere's a connection between
vaccines and autism.
So there may be, again, comingfrom our federal government,
something of a foregoneconclusion that they're sort of
(36:41):
looking to cherry-pick evidenceto support which again would be
used to affect recommendationsfor vaccination, recommendations
for compensation for vaccineinjuries, what's going to end up
on that table, what people aregoing to end up, what's going to
(37:01):
end up coming out of thegovernment's pocket for that.
Vanessa, did you have anyadditional thoughts that you
wanted to
SPEAKER_01 (37:10):
add?
I mean, I think that's, yeah,there's going to be probably
continuing developments over thecourse of the next, you know,
three and a half years or so inthis space and people should be
prepared.
I think people had a certainperspective as to what might
happen based on, you know,initial confirmation hearings
for Secretary Kennedy and thathas, you know, continued to
(37:35):
change.
I think we'll continue to seeadditional changes and companies
should just, and healthcareproviders should just take the
steps that they can to, addressconcerns from their patients,
address concerns from otherhealthcare providers, address
concerns from people in researchand development to the best that
they can.
And then to the extent that thepolicies are to reduce
(37:59):
recommendations for vaccines,answer questions about off-label
usage potentially.
I'm not encouraging off-labelusage by any means, but let's
say that certain vaccines arelimited for certain patient
populations.
the federal government can makethe recommendations as to what
patient populations areappropriate for a drug that's
(38:21):
FDA approved.
But generally speaking, the USFood and Drug Administration
does not regulate how physiciansdecide to administer the drug
and for the individuals theydecide to administer a drug for.
So even if the recommendationschange, if a physician
determines it's appropriate forthe particular patient, let's
(38:43):
say the recommendation is for 62and above, and the patient is
61, but has a bunch of comorbidconditions, and the physician
determines that it's appropriateto administer the drug to
someone who is age 61, thephysician determines in most
states has that ability withinthe scope of their practice of
(39:03):
medicine to make thatdetermination.
You know, if let's say somethingdid happen to that individual
who's 61 and not 62, you know,the physician could be sued.
You know, that's why they havemalpractice insurance, but, but
there is even, even if therecommendations change, you
know, physicians still have theability to make determinations
as to what's appropriate fortheir own patients.
SPEAKER_00 (39:25):
Excellent.
And I think that's, that's a, Avery good summation.
And I want to thank you bothvery much, Renee and Vanessa,
for joining me for this podcast.
And it's been very informative,I think, to me and to hopefully
everybody who's watching.
And thank you so much.
(39:45):
And let's hope that everyonestays safe and healthy out
there.
SPEAKER_01 (39:50):
Thanks, Brian.
SPEAKER_00 (39:50):
Thank you for having us.
SPEAKER_02 (39:56):
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For more information about AHLAand the educational resources
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And stay updated on breakinghealthcare industry news from
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(40:17):
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SPEAKER_00 (00:17):
Hello, I am Brian Dean Abramson.
I am the author of the AmericanHealth Law Association's
Treatise Vaccine, Vaccination,and Minimization Law, which has
just come out in its thirdedition earlier this year.
And I also teach vaccine law atthe Florida International
University College of Law andthe University of Houston Law
(00:38):
Center.
And as I came out with thisthird edition, I thought the
state of vaccine law after theevents of the last few years
with the pandemic had somewhatstabilized and we weren't going
to see big changes ordisruptions.
And as it turns out, we are inthe midst of some tremendous
(01:00):
upheaval in the field, which iswhy I am joined here today by
Dr.
Renee Nehera and VanessaBurrows, who are going to join
me in discussing some of theseupheavals in vaccine law, also
matters that we'll be discussingat the forthcoming National
Vaccine Law Conference.
(01:20):
Why don't I go to Vanessa andallow you to introduce yourself
then?
SPEAKER_01 (01:23):
Hi, I'm Vanessa Burrows.
I'm a partner in SimpsonThatcher's Washington, D.C.
office.
I handle health care regulatoryand FDA regulatory matters,
usually in the context ofcapital markets transactions, as
well as for mergers andacquisitions.
And I'll turn it to Rene.
SPEAKER_03 (01:39):
Hi, my name is Rene Nahed.
I am the Director of PublicHealth at the College of
Physicians of Philadelphia.
I'm also the Director of theHistory of Vaccines Project here
at the college, and I'm a fellowof the college as well.
I also teach at Johns HopkinsUniversity and at George Mason
University on public health andepidemiology.
SPEAKER_00 (01:55):
Excellent.
Well, thank you both for beinghere.
And, you know, as I said, we arein a period of upheaval.
And what we are seeing, whatwe've seen throughout the
pandemic is changes to differentareas of vaccine law sort of
progressively increasing.
Or things that have occurredthat brought attention to those
areas in terms of the approvalof the covert vaccine in
(02:17):
particular.
Now, we are seeing somesubstantial changes in the
regulatory structure of vaccinesand really in who's making the
decisions.
in terms of whether vaccines aregoing to be approved.
Would either of you wanna jumpin and talk about what exactly
(02:37):
we're seeing with that and howthat's going to affect
potentially the availability ofvaccines and recommendations for
vaccines?
SPEAKER_01 (02:48):
Sure, so even within the last day, right before we
started this podcast, we'veseen, I think a major change in
terms of which vaccines will berecommended.
which could potentially go toapprovals at a later point in
time.
But the U.S.
Department of Health and HumanServices Secretary Robert F.
(03:09):
Kennedy Jr.
had recommended or formallyrescinded, actually, the federal
recommendation for flu vaccinesthat have thimerosal.
So this is apparently not goingto reduce the vast amount of flu
vaccines that are currently onthe market, but that would
prevent recommendations forthe...
(03:32):
vaccines that do still have athimerosal component, which is,
to my understanding, a smallpercentage of current vaccines.
I don't know, Rene, if you wantto also
SPEAKER_03 (03:41):
comment on that.
Yeah, no, you know, thimerosalhas been a boogeyman in the
anti-vaccine circles for quitesome time now.
It's a solution that containsmercury.
And so when you don't understandchemistry and you don't
understand biology, you know,putting thimerosal into you
through a vaccine seems likesomething very scary, but it's
not.
It's harmless.
It's been around for over 100years We know it's toxicity
(04:03):
levels and the levels in thevaccines are nowhere near toxic.
My worry with this, you know,yeah, thimerosal was removed
from childhood vaccines for themost part at the beginning of
the century, 25 years ago.
And, you know, that's fine.
That's fine for us.
My worry is the rest of theworld.
In the rest of the world, peopledon't enjoy the infrastructure
(04:24):
to keep their vaccines safe interms of storage.
And they rely on thimerosalprimarily to keep the vaccines,
the dead virus vaccines, withoutany kind of bacterial
contamination.
And so all these countries now,they're gonna be looking to the
US and saying, well, the USremoved thimerosal, why do we
still get to have it?
If it's so dangerous, accordingto people like RFK Jr., then why
(04:47):
is it still in our vaccines?
And that's where I think we'regonna see a further erosion
worldwide of vaccine acquisitionby people.
That's my worry when it comes tothese kind of regulatory actions
and their impact on publichealth.
SPEAKER_00 (05:01):
Let me actually step things back a little bit and
give a bit of a primer, becauseI think there are a lot of
people who don't know thestructure by which vaccines are
approved and recommended.
So there is a body in theDepartment of Health and Human
Services called ACIP, theAdvisory Committee on
Immunization Practices.
And there's a very longstandingpractice rule, basically, that
(05:26):
ACIP is composed of experts inthe field, And they make
recommendations.
They say these vaccines shouldbe administered to children or
to pregnant women or to adults.
They make recommendations forall the vaccines.
And those recommendations havelegal consequences.
One of which is currently thatunder the Affordable Care Act,
(05:49):
if ACIP recommends a vaccine,then it has to be covered by
insurance companies.
Another being that if ACIPrecommends a vaccine for women
to children or pregnant women,then that vaccine will fall
under the National VaccineInjury Compensation Program,
which limits the liability bothof manufacturers, and I think
(06:10):
most pertinently to AHLAmembers, to administrators, the
doctors, the hospitals they workfor, their liability has certain
limitations on it due to thatstructure.
And historically, ACIP has been,I think, very well regarded for
the depth of its inquiry intothe safety and effectiveness of
(06:33):
vaccines and their utility forpeople in different age groups
and circumstances.
But for those who are sort ofnot in the know, earlier this
year, and this is something thatwas kind of widely reported in
the news, it's sort of anunusual level of attention for a
vaccine law issue, but SecretaryKennedy fired all 17 members of
(06:54):
ACIP, alleging corruption basedon the fact that some of them
were scientists who had workedon vaccines for vaccine
manufacturers.
Some of them had been involvedin conferences or projects or
things of that sort thatreceived funding from the
manufacturers.
And this was widely derided inthe community of researchers
(07:17):
because these are people whohave real expertise in
vaccinology and immunology andepidemiology.
And he fired those 17 membersand replaced them with eight
people who generally don't havethat expertise.
But many of them have a historyof publicly agreeing with
(07:38):
certain anti-vaccine tropes,some of them kind of myths.
And that body has since beenmuch more reticent to be
full-throated and endorsingvaccines.
And even with therecommendations that body made,
(08:02):
that body made somerecommendations, which Kennedy
then rejected, that$8 persongroup that he appointed made
some recommendations for thevaccination schedule that
Kennedy rejected.
And those have legalconsequences as well in terms of
whether there's going to befunding for those, whether
there's going to be availabilityfor those.
So that's kind of the backgroundand the milieu of what we're
(08:25):
working with.
So what does the horizon sort oflook like for the availability
of vaccines in the United Statesand funding of vaccines in the
United States?
Rene, is there something you canspeak to?
SPEAKER_03 (08:41):
Well, it's yet to be determined, obviously, with
everything still being in flux.
But I can tell you that a lot ofthe local health departments
that provide vaccines,especially for children,
especially coming up in Augustfor the school year so that
these kids meet the requirementsfor their school, they're
preparing for no funding.
They're preparing to beself-funded either through the
(09:03):
local taxes, the local money.
A lot of clinics have closed aswell, something that we saw even
before this decision with thefiring of ACIP and the
replacement, the federal moneywas withheld for clinics out in
Texas where there's a massivemeasles epidemic going on.
So a lot of the local healthdepartments that actually do the
(09:24):
work, they're preparing for nothaving the money available for
vaccination.
The vaccines are there.
They're still being produced bythe manufacturers.
It's all the money to pay forthose vaccines, which You know,
at a small scale, they're notvery expensive, but when then
you start talking about hundredsand thousands of kids, then yes,
it starts getting expensive,especially for low income health
(09:48):
departments in low incomecounties in the United States
that are going to be affected.
So it's just a cascading effectthat has now reached the local
public health workers.
The average person in the U.S.
will probably still get toaccess vaccines.
They'll probably still get to goto their physician and get it
prescribed and then go get itbecause the vaccines have not
been outlawed per se.
(10:10):
But as far as the poor,low-income countries in the
U.S., that's where there's goingto be trouble.
because the money is beingrescinded or just withheld from
them to be used for theseprograms.
Number one, catch kids up, whichwe saw during the pandemic that
a lot of kids didn't get theirvaccinations.
So now they're being caught up.
And number two, get kids forentering the school system,
(10:32):
which tens of thousands ofchildren enter the school system
every year.
They also need their vaccines tobe up to date as a requirement
for education.
And they're not going to be ableto have them at a reduced or
free rate.
SPEAKER_00 (10:45):
That is going to be a troubling development because
that'll be a vector throughwhich these diseases spread.
I think we're seeing that withthe current measles outbreak.
That's sort of an illustrationof what happens when you have
reductions both in support forthose programs and increases in
hesitance driven by a lot of therhetoric we're seeing.
(11:09):
Vanessa, can you speak to howthis is going to affect the
public companies that areinvolved in vaccine testing,
development, distribution, andadministration?
SPEAKER_01 (11:19):
Sure.
So we do advise public companieson risk factors and how to
explain to the public throughSEC filings, Securities and
Exchange Commission filings,what the potential risks to
their companies are.
One thing, and also this happensin kind of the private context
as well, just advising,acquirers on risks associated
(11:43):
with particular products thatmight be either in development
or already commercially marketedand what these changes could
mean for them.
I think generally speaking, itseems to have been a very stable
area in the past.
Since the Affordable Care Actwas passed, there were
recommendations for coverage forvaccines so that health plans
(12:05):
would have to provide coveragefor preventative services and
people would know that theirvaccines would be covered on an
annual basis if it's a fluvaccine or otherwise.
And then we also saw during theCOVID-19 pandemic that Congress
passed additional laws such asthe CARES Act that provided
coverage for COVID-19 vaccinesspecifically.
(12:25):
So kind of the risk factorsassociated with development of
new vaccines, those I think arestill there, but the risk
factors that companies are mayneed to consider adjusting are
the ones that are associatedwith recent events in the
Department of Health and HumanServices and at ACIP.
(12:47):
What the recommendations are,could the recommendations be
revoked?
With the decision recently, thisis not to say that there's
indications that other drugapprovals or vaccine approvals
will be revoked, but to theextent that there's going to be
future actions to decreaserecommendations for particular
(13:09):
products or decrease the numberof individuals who are eligible.
Let's say no longer makerecommendations for children or
no longer make recommendationsfor pregnant women or limit the
recommendations for the COVIDvaccine to individuals of a
certain age who are on the olderside.
All of that might lead to adecrease in vaccine uptake,
(13:31):
maybe a decrease inmanufacturing.
There could be new safety oradverse event report
requirements.
I mean, currently vaccinemanufacturers have to provide
adverse event data and reportthat to FDA, as do healthcare
providers who are administeringthe vaccines.
But to the extent that therecould be other requirements
(13:53):
imposed, then that would be anadditional obligation on a
provider or a vaccinemanufacturer that they might
have to follow and address thoserecommendations as well.
So just generally speaking,companies in this space, I
think, are taking a new look atwhat their current risks are and
what their future risks couldbe.
(14:13):
And if this would have amaterial impact on any of their
products or their revenue.
SPEAKER_00 (14:19):
So we are looking at something of a chilling effect
on the development of newvaccines, just because there's
sort of a fear that HHS with itscurrent constituency or current
leadership might impose somecostly new, for example, as they
(14:40):
did, I think they have done withsome vaccines already.
They've said, you know, we'renot going to allow this for
certain groups unless youconduct an entirely new clinical
trial.
And those are tremendouslyexpensive.
So I wanted to ask, and I thinkI'll direct this at Renee, if
you have any thoughts on this.
(15:02):
How is this going to affect theability of employers to mandate
vaccines or encourage orincentivize or otherwise
increase vaccination rates fortheir employees, particularly in
the healthcare sector wherevaccination may be ubiquitous?
SPEAKER_03 (15:18):
Yeah, I was thinking of the healthcare sector right
off the bat, right?
But what you have to understandis that in the healthcare
sector, for the most part, youhave people that are not vaccine
adverse, you know, they'reThey're pro-vaccination.
They understand the science.
They understand the need to,even if the vaccine increases
your risk of whatever, they'rewilling to take that risk
because they're that kind ofpeople.
You know, we're talkingphysicians, physician assistant
(15:39):
nurses, et cetera.
That said, you know, what is ahospital going to do for
infection prevention purposes?
For example, with the fluvaccine, when somebody like HHS
says, you know, the flu vaccinein a certain age group is not as
effective or the COVID vaccineor hepatitis B is also a big
(16:01):
deal in healthcare settings.
And it's very infectious and youneed to be protected against it
because you come into contactwith it almost daily if you're
in direct patient contact in theUnited States.
And so it's going to be toughfor them to, on the one hand
say, here's the science, here'sthe evidence, here's why you
need to be vaccinated and alsoto protect us from liability of
you getting hurt on the job bygetting this infection and this
(16:22):
disease.
But on the other hand, thehonchos at HHS, you know, in the
most powerful nation in theworld are saying, don't do it.
So how do we marry the two?
Hopefully for the most part,people will understand that the
people in charge at HHS rightnow are, if not anti-vaccine,
they're vaccine hesitant.
And so, you know, they'll justkind of work with that.
(16:45):
A lot of the medicalorganizations, societies, et
cetera, are giving their ownpoint of view on these things
and they're stepping up to fillin the gaps that HHS, CDC, FDA
might not be filling in.
But it's going to be tough tokind of put together, marry
those two situations.
(17:06):
On the one hand, the science,and on the other one, the
policy.
And it's something that, it's atension that has not been seen
in a long time when it comes tovaccination.
You see it more in discussionforums online, but now we're
seeing it in the real world.
And it's gonna be interesting tosee how you know, it, it plays
out with, with healthcareinstitutions.
And of course, you know, thenthere are others that are other,
(17:27):
um, other employers who mightrequire certain vaccines based
on the work that their employeesdo.
I'm thinking of restaurants andI'm thinking of food handlers
and some companies require thehepatitis A vaccine because you
have hepatitis A and you'reprocessing food, you might
affect a lot of people andthat's a big liability, right?
How do you mandate that if forsome reason down the line, HHS
(17:49):
decides that the hepatitis Avaccine is not recommended or
not to be used?
and so on and so forth.
So it's going to be a delicatebalance between the science and
the policy.
And I do not wanna be in theposition of the people that have
to make that decision right now.
That's how I see it affectingcompanies at this point.
SPEAKER_00 (18:10):
Well, so far we've only been talking really about
HHS and the changes in thefederal government.
What are we seeing from thestates in terms of their action
towards vaccination mandates andemployer mandates?
SPEAKER_03 (18:24):
Yeah, so some states are reverting.
Mississippi and West Virginia,for example, were some of the
handful of states, I think likethree or four, that had no
exceptions for vaccines otherthan medical exceptions.
And now they're changing theirtune.
Now they're adding exceptionsbased on philosophical,
religious points of view.
(18:44):
And so that is opening the doorfor people to just say, I don't
want my kid vaccinated.
You know, I'll sign the form andthat's it.
where it used to be that you hadto go to a physician and get a
proper diagnosis, and thenthat's the only way you could
get around getting vaccinated.
California went the oppositeway.
California used to havephilosophical and medical and
non-medical extensions, and theywent to just medical, increased
(19:07):
the rate of vaccination,increased the acceptance of
vaccines in the state.
And so that really worked out.
But now we have these two statesAnd then you have other states
that are looking again, youknow, after this debate in the
early 2000s with things like theHPV vaccine.
We're taking another look at theHPV vaccine, and I'm thinking of
Texas and other states in theSouth, you know, places where
(19:28):
HPV disproportionately affectspeople of color.
So they're looking at thesevaccines as dangerous.
You have states like, I forgetif it's South Dakota or North
Dakota, they were wanting toclassify people.
the mRNA vaccines as genetictherapy or as agents of
biological warfare.
And so this just shows amisunderstanding of what the
(19:49):
mRNA vaccines are.
So you're seeing these littlebills that we try to keep on top
of by tracking them online, butyou see them, and sometimes they
don't get past committees, andsometimes they do.
And so when they do, it's amobilization of pro-science
people, particularly parents, totry to talk to their legislators
and get them to not do whatthey're thinking of doing.
(20:10):
But it all centers around theability to be exempt from
certain vaccines, which kind of,you know, it's kind of scary
because where does it stop?
Do you just then instead ofexempting people, do you just
make it an opt-in instead of anopt-out?
And then what does that lead to?
And we see some of that withmeasles.
(20:32):
Pertussis is another one,another disease that is
exploding in the U.S.
You know, and with measles comesrubella.
People should go and see whathappened with rubella in the
1960s before the vaccine wasavailable.
It brought us Roe versus Wadebecause of everything that was
going on to pregnant women atthe time with rubella.
So yeah.
(20:53):
You know, that's what'spercolating out there.
It'll all depend on the tonethat the politics takes.
And right now we're superpolarized.
So, you know, we'll pay closeattention to what happens, but
that's what keeps me open bythis.
A big state with a bigpopulation all of a sudden
saying, okay, vaccines areopted.
(21:14):
It's up to the parents to optinto vaccines and we don't need
to worry about them having them,you know?
And so we're off to the raceswith big epidemics.
SPEAKER_00 (21:23):
One thing that keeps me up is something that's gone
on in a big state with a smallpopulation, which is Montana,
where the state banned employervaccination mandates.
So it's the law of the statenow, and I think it only applies
to COVID vaccination, but thereare other states that have sort
of legislators with similarmindsets and views on
(21:46):
vaccination.
And that was actually challengedin court and initially the
United States District Court inMontana throughout that
prohibition on various groundsand the grounds that you may
have employees who are unable tobe vaccinated and for their
protection they need to bearound employees who are
vaccinated.
And the United States Court ofAppeals for the Ninth Circuit
(22:09):
overturned that.
So now it is the law of the landthat a state can actually ban
employer vaccination mandates orbut sort of draconian limits on
it.
You know, Texas has putrequirements in place that if an
employee basically says theyhave a religious or
philosophical or conscientiousobjection to vaccination, the
(22:32):
employer has to grant them anexemption.
So it's an exception that eatsthe rule.
So that's something that we'reseeing.
And I think the states are beingvery divergent and it's a very
different way path than we'vehad historically.
At the outset of the COVIDpandemic, we saw that there were
a lot of states that didn't wantto take measures to prevent the
(22:55):
spread of COVID, didn't want tobe kind of pro-vaccination when
the vaccine was developed.
And the federal government tryto step up and fill in that gap
with an OSHA requirement, whichwas ultimately struck down by
the Supreme Court.
So there are certainly limitsthat have been imposed on what
(23:19):
employers can do, even in thehealthcare field, even where
it's most stringently requiredthat people be vaccinated.
And on top of that, We're seeingan increase in courts around the
country and in the Supreme Courtof a willingness to expand
(23:42):
religious exemptions and saythat even where you're allowed
to have vaccinationrequirements, We're going to
take federal laws that requirethat you not discriminate on the
basis of religion and extendthem into broader and broader
abilities of people to object tovaccination or avoid
vaccination.
So that's certainly an area ofconcern where we're going to
(24:06):
have people in those positionsin America.
positions where there aremedical professionals who are
dealing directly with patientsand should be vaccinated and
maybe in some sense beingdissuaded from being vaccinated.
I want to shift a little bit tothe distinction between COVID
(24:27):
vaccine and other vaccines andthe vaccine entry compensation.
Vanessa, is that something thatyou wanted to speak to?
I
SPEAKER_01 (24:34):
think In general, there's the National Vaccine
Injury Compensation Program,which provides compensation for
certain types of vaccines.
It's gotten a little bit ofattention over the years and
kind of in waves, but morerecent attention from the Senate
Homeland Security andGovernmental Affairs Committee
(24:57):
because they have been focusingon children who've been injured
or individuals who've beeninjured by vaccines.
But the program does cover ifthere's a vaccine that is
mandated.
Any individuals who are injuredthat have certain types of
injuries, when the injuriesappeared within a certain
timeframe of the vaccinationbeing administered to the
(25:20):
individual and protectsmanufacturers and provides
certain liability protectionsfor manufacturers of those
vaccines.
But it does provide a way forindividuals who are injured to
receive compensation.
Of course, to the extent thatthere would be a severe adverse
event associated with theadministration of a vaccine,
(25:42):
arguably there's no compensationthat could equate for that.
you know, in general, thisprovides a congressionally
mandated mechanism forindividuals to seek recourse
through the federal court systemand through this program.
So recently, as I mentioned, theSenate Homeland Security and
Governmental Affairs Committeehas had a few hearings about the
(26:05):
individuals and this programgenerally.
I don't think that they're is anappetite to push major
legislation to make seriouschanges to the program at this
point in time.
But of course, having thesehearings draws attention to the
program and what it does.
It has been amended over time toinclude additional types of
(26:28):
vaccines.
So for example, I think it wasamended during the COVID-19
pandemic to provide additionaltypes of to cover additional
types of vaccines that werebeing administered during that
time.
But correct me if I'm wrong,Brian or Renee, on that.
SPEAKER_00 (26:42):
Well, I think there's been a very interesting
history in the past decade or soof the VICP just because
Shoulder injuries were added toit, and they were added at the
tail end of the Obamaadministration, and they were
removed by the Trumpadministration.
They were put back by the Bidenadministration.
And at the moment, it doesn'tseem like there's any intent on
(27:06):
the part of the second Trumpadministration to remove them
again.
But shoulder injuries from...
basically from an incorrectadministration technique where
the needle doesn't go in quiteright, aren't necessarily caused
by anything to do with thevaccine themselves.
They're entirely aboutadministration.
And since those were added tothe program, they very quickly
(27:31):
came to account for half of allvaccine injury claims with the
VICP and a substantial increase.
So that and vagabagal syncope,which is basically fainting, or
vasobagal syncope, those wereadded, and those have added some
strain to the program.
There haven't been new vaccinesadded in some time.
(27:56):
And I think the last vaccine wasadded, I want to say it was
rotavirus, which was a whileago, maybe influenza in 2005.
But one of the big bones ofcontention is that the COVID
(28:17):
vaccine is itself not covered bythe Vaccine Injury Compensation
Program.
And that's sort of aninteresting topic of, you know,
Kennedy thinks it should be.
It's currently covered by athing called the Countermeasures
Injury Compensation Program,which is a separate program set
up under the PREP Act.
And that program is sort ofnotoriously stingy compared to
(28:40):
the VICP.
There have been far fewerdeterminations that an injury
was caused by the vaccine, farsmaller awards, with one kind of
a substantial outlier wheresomeone was awarded about$2.5
million for an asserted COVIDvaccine injury.
But outside of that, they'vebeen in the tens of thousands,
(29:02):
which is much lower than theVICP usually awards.
But the thing is, a vaccine, asthe law is currently structured,
cannot be added to the vaccineinjury compensation program
unless it's recommended by ACIPfor administration to children
or pregnant women.
And ACIP is not going to makethat recommendation for the
(29:22):
COVID-19 vaccine as ACIP iscurrently constituted.
HHS under Kennedy hasspecifically contravened such a
recommendation for those groupsthat would bring in under the
VICP.
So it's going to take an act ofCongress to put COVID-19 vaccine
(29:44):
under the VICP if they want tomove it out from the CICP.
So that's kind of an interestingdirection where things are going
with that.
And there are competing kind ofbills that have been brought in
the House of Representativesgoing in very different
directions.
One bill that has garnered somesupport would, in fact, move...
(30:09):
COVID to the CICB and increasethe number of special masters
who deal with these cases.
There's a statutory limit ofeight special masters to deal
with all these vaccine injurycases, which made sense 40 years
ago when there were a handful ofthem.
Now, when there are thousands ofthem and the docket is bloated
with the shoulder injury casestaking up half of it, if we add
(30:30):
COVID cases to that, it'llbasically double again.
So that's structural change thatwould need to be made in order
for these cases to be heard inany sort of reasonable amount of
time.
But there's also a bill pendingin Congress that would just
eliminate all of these casesmanufacturer limitations and
liability, administratorlimitations and liability, and
(30:52):
get rid of all of theseprovisions of the VICP.
And that has some support aswell.
And I saw an analysis of thatstudy.
These sort of two competingdirections are each garnering
enough support to ensure thatneither one of them is going to
pass.
So something is going to have togive at some point because the
(31:13):
current situation is notsustainable forever.
I
SPEAKER_03 (31:18):
want to make an important distinction here that
just that something getsreported to the vaccine adverse
events reporting system or thatsomething reaches the vaccine
court, as it's called, doesn'tmean that it was an actual
injury from the vaccine.
As you mentioned, the shoulderinjuries are because of the
(31:40):
administration.
So that's human error.
which is fine to try to get somecompensation, especially if the
injury was severe enough.
You also have some cases fromthe storage of the vaccines.
And we go back to the issue ofthimerosal.
Thimerosal-free vaccines canspoil.
And there have been instanceswhere those vaccines have been
administered to people and theyhave some sort of bacterial
(32:00):
contamination and they causesome sort of injury.
Again, you know, not the vaccineper se, but the administration,
the handling of the vaccine.
So I think it's important forthose who are listening to this
that just because the cases havejumped or the cases are
happening doesn't mean that thevaccines are less safe.
If anything, they've beengetting safer with time.
It's just that, you know,there's this thing that we use
(32:21):
in epidemiology calledsurveillance bias.
If you look for something longenough, you're going to find it.
And so when you have millionsupon millions upon millions of
people getting the COVIDvaccine, even if it causes a one
in a million chance, you'regoing to have several hundreds
of people who are going to beflaming or having legitimate
claims of injury.
And then you're going to haveall the, you know, temporarily
(32:42):
associated.
So it happened after thevaccine, so I'm blaming it on
the vaccine.
vaccine, which we see all thetime with the HPV vaccine.
The HPV vaccine, you go into theVaccine Adverse Events Reporting
System, and many of the claims,many of the claims are for blood
clots.
And if you look at the caseswith details, they are blood
clots in women who had othercomorbidities that increased
(33:05):
their risk of blood clotsaltogether, smoking, overweight,
obesity, and use ofcontraceptives.
And so was it the vaccine or wasit any of those things?
Well, it's hard to tease apartwithout actually, you know,
having a study with each one ofthese people.
But it is what it is.
And I think, you know, as yousaid, if we increase the number
(33:25):
of vaccines and make it into thesystem, then it's going to
increase the number of reports.
And in the public space, pointof view, it's going to increase
the danger of the vaccine.
Then they turn to theirlegislators or to the current
administration.
And it's like a self-fulfillingprophecy of a circle.
(33:48):
Now we think vaccines are moredangerous, so we need to get rid
of them, or you need tocompensate me more if I take on
the risk.
And it's just one of thosethings that in public health, we
kind of throw our hands in theair because it's one of those
things that we cannot control.
We just have to deal with it andcontinue to educate the public.
SPEAKER_00 (34:05):
Right, and then I think it's worth adding to that
couple points, one being thatthe vaccine injury compensation
program itself is a no faultcompensation program.
You don't actually have to showthat there was any fault on the
part of anyone involved in themanufacturer or administration
of the vaccine.
And for certain kinds ofinjuries, you don't actually
(34:25):
have to show the vaccine causedthe injury.
You just have to show aproximity in time between
vaccination condition and.
for compensation purposes,everything else is assumed.
And also, I think it's importantto note that in this entire
framework of things, there aresome people who are either
(34:48):
outright bad actors and tryingto stir the pot and score
political points, or people whojust genuinely believe bad
things about vaccine that aren'tsupported by the science and the
research.
And we see...
claims that are being filed,VAERS reports that are being
filed that are kind ofblatantly, no, that's not really
(35:14):
connected, but filed by peoplewho want to make that
connection.
We see that a lot with theautism cases.
There was a study in about 25years ago where someone claimed
to have found the connectionbetween vaccination and autism.
That study was later found to befraudulent.
(35:34):
But that connection was made insort of the public mind.
Very good studies have been donesince then showing that there is
no correlation betweenvaccination and autism.
And in fact, the signs of autismchanges to the brain structure
can now be found in children inthe womb before any vaccines are
(35:56):
administered.
So that's sort of beendisqualified as a component of
the development of autism.
And I've recently posted aboutthe fact that exposure to fossil
fuel fumes is stronglycorrelated with the development
of autism in children.
But we have this committee nowon HHS that has been formed to,
(36:21):
quote unquote, determine thecauses of autism.
And that is a group of peoplewho have this sort of long-term
history of asserting thatthere's a connection between
vaccines and autism.
So there may be, again, comingfrom our federal government,
something of a foregoneconclusion that they're sort of
(36:41):
looking to cherry-pick evidenceto support which again would be
used to affect recommendationsfor vaccination, recommendations
for compensation for vaccineinjuries, what's going to end up
on that table, what people aregoing to end up, what's going to
(37:01):
end up coming out of thegovernment's pocket for that.
Vanessa, did you have anyadditional thoughts that you
wanted to
SPEAKER_01 (37:10):
add?
I mean, I think that's, yeah,there's going to be probably
continuing developments over thecourse of the next, you know,
three and a half years or so inthis space and people should be
prepared.
I think people had a certainperspective as to what might
happen based on, you know,initial confirmation hearings
for Secretary Kennedy and thathas, you know, continued to
(37:35):
change.
I think we'll continue to seeadditional changes and companies
should just, and healthcareproviders should just take the
steps that they can to, addressconcerns from their patients,
address concerns from otherhealthcare providers, address
concerns from people in researchand development to the best that
they can.
And then to the extent that thepolicies are to reduce
(37:59):
recommendations for vaccines,answer questions about off-label
usage potentially.
I'm not encouraging off-labelusage by any means, but let's
say that certain vaccines arelimited for certain patient
populations.
the federal government can makethe recommendations as to what
patient populations areappropriate for a drug that's
(38:21):
FDA approved.
But generally speaking, the USFood and Drug Administration
does not regulate how physiciansdecide to administer the drug
and for the individuals theydecide to administer a drug for.
So even if the recommendationschange, if a physician
determines it's appropriate forthe particular patient, let's
(38:43):
say the recommendation is for 62and above, and the patient is
61, but has a bunch of comorbidconditions, and the physician
determines that it's appropriateto administer the drug to
someone who is age 61, thephysician determines in most
states has that ability withinthe scope of their practice of
(39:03):
medicine to make thatdetermination.
You know, if let's say somethingdid happen to that individual
who's 61 and not 62, you know,the physician could be sued.
You know, that's why they havemalpractice insurance, but, but
there is even, even if therecommendations change, you
know, physicians still have theability to make determinations
as to what's appropriate fortheir own patients.
SPEAKER_00 (39:25):
Excellent.
And I think that's, that's a, Avery good summation.
And I want to thank you bothvery much, Renee and Vanessa,
for joining me for this podcast.
And it's been very informative,I think, to me and to hopefully
everybody who's watching.
And thank you so much.
(39:45):
And let's hope that everyonestays safe and healthy out
there.
SPEAKER_01 (39:50):
Thanks, Brian.
SPEAKER_00 (39:50):
Thank you for having us.
SPEAKER_02 (39:56):
If you enjoyed this episode, be sure to subscribe to
AHLA's Speaking of Health Lawwherever you get your podcasts.
For more information about AHLAand the educational resources
available to the health lawcommunity, visit
AmericanHealthLaw.org.
And stay updated on breakinghealthcare industry news from
the major media outlets withAHLA's Health Law Daily Podcast,
(40:17):
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To subscribe and add thisprivate podcast feed to your
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