Along with learning the latest recommendations for people affected by Crohn’s or colitis, experts discuss guidelines for vaccines in IBD, including flu shots and …
– [Moderator] Good evening, everyone.
Thank you for joining us
for our COVID-19 and IBD Webinar Series.
Tonight's topic will be
on vaccinations and IBD.
Before we begin,
if you experience any technical
problems during the webinar,
try refreshing the page or browser.
You can also check the handout
provided in this webinar
for troubleshooting tips,
or comment in the question chat box
found in the webinar menu bar.
Please note that this
webinar is being recorded.
A link to the video will
be sent to you via email
and posted to our website
24 hours after the webinar.
French subtitles will be
available the following week.
You can access all our webinar videos
here at
And now I'd like to introduce Mina Mawani,
President and CEO of
Crohn's and Colitis Canada.
– Hi, everyone,
and thank you for joining us tonight.
As we head into the
cooler and shorter days,
we ramped up our online
educational resources
to ensure you get the support you need
in the format that works best for you,
whether that's getting information online,
watching an on-demand webinar
or through our digital app.
There are many times however,
where you may want to connect with someone
going through the same
journey as yourself,
whether you have IBD or are a caregiver.
Our Gutsy Support Program
is a virtual support system
that connects people affected
by Crohn's or colitis.
We've expanded Gutsy Support.
So along with email, you can
now connect by online chat,
audio, and/or video calls.
We also have virtual support groups.
Visit our website to find
out more on how you can join.
There are other times
when you just want to take control
of monitoring your own health.
MyGut is a free, easy to use app
that enables you to track, understand
and manage your journey
with Crohn's or colitis.
MyGut allows you to keep tabs
on how you're feeling
and your daily habits
to see if there's a correlation
to your ongoing wellness.
The app also provides you
with a personalized dashboard and reports
that you can share with
your healthcare provider.
We continue to invest and
enhance this valuable tool.
If you haven't already,
download the MyGut App.
Tonight is our 17th webinar.
We remain committed
to hosting these webinars
as long you need us to.
We'll be holding monthly webinars
and we'll increase the
frequency if needed.
As always, this information
and the webinar recordings
can be accessed on our website
We hope you can join us again
for our next COVID-19 and IBD webinars,
which are scheduled for
November 5th and December 3rd,
please mark your calendars.
And for our upcoming informative
Gutsy learning series,
the next one is on October
27th on our gem project.
You'll hear about the advancements made
in this innovative project
that's looking into the
causes of Crohn's disease.
As you can see, Crohn's and Colitis Canada
believes deeply in our mission
to cure Crohn's and colitis
and to improve the quality of
life of children and adults
affected by these chronic diseases.
We're working hard to
support you with information,
resources and through research.
As you know,
our fundraising has significantly
declined because of COVID.
Our hope is that we're able to support
as many promising research
projects as possible.
You can help us get there
by texting cure, C-U-R-E to 20222,
a $25 donation will be
made towards research
with some of the best
and brightest scientists
right here in Canada
who knows what discoveries
are just around the corner.
Now, guess what's coming up?
November is Crohn's and
colitis awareness month.
It's a month where we work
together to amplify our voices
and raise awareness for
these chronic diseases.
Watch for our emails
and be sure to follow up at getgutsycanada
to find out more about
how you can join in.
This year has been extremely difficult,
but with Thanksgiving upon us,
we are reminded about
all the things we have to be thankful for,
the little things like
going outside for a walk,
the big things like our family,
our friends, our healthcare providers
volunteers, donors, researchers,
and passionate supporters.
We are so thankful for all
the new connections we've made
and for all the things we've learned.
We're grateful for our IBD
family who have come together
to help each other through this crisis
and the opportunity to help.
This Thanksgiving, we
send our very best wishes
to you and your family for good
health and happiness always.
With that, we are so
grateful to our task force
who continues to meet to discuss policies
and recommendations
necessary for our community.
Thank you to today's
panelists, Dr. Mark Loeb
and Dr. Cynthia Seow
in what will be a very interesting
discussion on vaccines.
And of course,
we're so grateful to our
moderators who showed their passion
and dedication to
support our IBD community
on an ongoing basis.
Dr. Gil Kaplan,
who is professor of medicine
at the University of Calgary.
He's an adult gastroenterologist
and epidemiologist.
He's the Chair of our Scientific
Medical Advisory Council,
as well as the Crohn's and
Colitis Canada Board Director,
and Dr. Eric Benchimol,
who has just made a change
and joined us in Toronto
as professor and pediatric
at the hospital for sick children
and University of Toronto.
And NASPGHAN Canadian Councilor,
as well as Chair-Elect
of our Scientific
Medical Advisory Council.
Thank you to everyone tonight
and we hope you enjoy this webinar.
– Thanks, Mina, thanks very much.
Unfortunately, we have a
little technical difficulty
where Dr. Kaplan is not able to connect.
He lost his audio when he was
trying to connect back in.
So it might take him a few
minutes to connect back,
but in the meantime, I'll start us off.
I wanted to introduce today's panelists,
first, Dr. Mark Loeb and Dr. Cynthia Seow.
And we'll give a more formal introduction
before Dr. Loeb's presentation.
And I wanted to kind of update people
on what exactly is happening
with the Crohn's and Colitis
Canada COVID-19 Task Force.
So we met,
again, we're meeting about every two weeks
at the present time,
although that might become more
frequent as we move forward
because of the second wave,
which has hit much of Canada quite hard.
And we've made some updates to the website
and made some updates
to the recommendations,
generally nothing too, too major,
but I wanted to give you an update
as to what you can see on the website.
We're hoping we made it more clear
and answered some of your questions.
You did ask us
to highlight some of the
back to school information,
focus not just on
students, but on teachers
and make some of the
general recommendations
a bit more clear.
So you can see the Crohn's
and Colitis Canada website, has gotten
a little bit of a refresh
and right on the main page,
the second two panels are back to school
and the recommendations about COVID-19.
If you scroll down, you can
click on COVID-19 and IBD.
And as you can see at the top here,
if you wanna get directly there.
The format is really very similar
to what you've seen before,
however, there's some new
areas on the right-hand side
here in terms of back to school.
And if I go to the guidance section,
and as we had before, are you at risk,
that has a new format.
So you remember the period
they started the pyramid
that we had before,
is now a bit simplified on the left here.
So we heard your recommendations
that it was a bit too complicated
and we still have the three sections,
the low-risk or general public health risk
the medium-risk, and then the high-risk.
And then on the left-hand
side, you've got,
who fits into these risk categories.
For the low risk it's people under 65
not taking immunosuppression
who's IBD is in remission
and who are not malnourished
and have no comorbidities.
You've got the recommendation still there.
In the medium-risk section,
you have people who are less than 65
and taking these
immunosuppressive medications.
And the recommendations are shown here.
And in the high-risk category,
you have people who are 65 years or older,
or who are under 65 and on oral
or intravenous systemic corticosteroids
who have moderate to
severe active inflammation,
such as a new diagnosis or a recent flare
and moderate to severe malnutrition
and requirements for parenteral nutrition
or intravenous nutrition are here as well.
And so the recommendations are there.
You can see they haven't
changed all that much.
They're pretty well the
same as they were before,
but a little bit easier to read.
If we go back to the
back to school section,
that's somewhat new here, I've lost it.
Where's the back here, back to school.
We now have guidance for children
and adolescents going back to school.
We have considerations for parents
of children going back to school.
And then we have guidance
for teachers and staff.
In general, the message is always
the same as it is in the other categories
from the guidance document,
that essentially,
it's really age-based recommendation
where children are generally quite safe
going back to school,
even if they're on
immunosuppressive therapies
with the exception of high dose steroids
or children who have
severe active inflammation
or children who have malnourished.
And that's really the
physician has told your family
that your child has moderate
to severe active inflammation
or that your child is malnourished
as a result of active inflammation
that is not yet under control.
The data that's coming out
from the SECURE-IBD Registry,
which is people with IBD who get COVID-19
really reinforce that the
other medications are safe
and that it really is steroids, age,
and probably having severe inflammation
that put you at risk for having
complications from COVID-19,
same with parental considerations.
Some things that we talked about
that parents are raising with us,
the pediatric gastroenterologist
are that you have to consider
not just whether your
child has inflammation
and whether they're on steroids,
but if they need frequent
washer mask access,
you should make sure that they
have free washroom access,
because at the moment,
a lot of schools are
restricting washroom access
to only a couple of people,
and that could be a problem
if your child has urgency.
For example, if they have active colitis
even mild active colitis,
or if they have IBS,
irritable bowel syndrome
on top of their IBD.
The other same thing with school buses.
Because of shortages of bus drivers,
if they're getting sick
and being isolated,
or because they're not able to drive
because of their age or other factors,
some school bus routes
have become much longer.
So consider whether
those long group routes
are possible for your child with IBD
needing washroom access.
And then we really wanna advocate,
and Crohn's and Colitis
Canada is doing an excellent
job trying to advocate to
schools and school boards
to try to be flexible with
moving in and out of e-learning.
And so children who are kind
of in and out or getting sick
may need more flexibility
than the typical child
of going to e-learning
rather than staying in-person
for a full three months or
whatever their recommendation.
Similarly, for guidance for
teachers and staff at schools,
the bottom line is generally,
if you're in remission
and otherwise healthy,
you can follow your local
public health guidelines
in terms of returning to
work and returning to school.
Even people who are
on immunosuppressive
medications or biologics.
The exception to that again, is steroids,
high dose steroids, 20 milligrams or more,
having severe active inflammation
and being malnourished.
In those cases, you're at risk
for severe complications to COVID-19.
And we would recommend thinking about
whether or not you can
modify your job duties
in order to work from home
or stay physically
distance from other people.
So all of these recommendations are here.
You can see updated last week
or updated a few days
ago, yesterday actually,
sorry about that.
And please read them over.
If you have any questions,
please feed them back to the
Crohn's and Colitis staff.
We're always looking for your feedback
and for your suggestions.
And if you have any questions
that we haven't addressed
in the guidance document,
please feel free to let us know,
and we'll try to meet as a task force
and try to address them
and provide you with some information.
So with that, I will pass
it on, I hope to Dr. Kaplan.
Is Dr. Kaplan on?
He thinks his internet
is down in his office.
So we'll hold off on Dr. Kaplan for now.
Why don't we jump to
the first poll question?
So Nico or Sarah, are you…
Yeah, there we go.
So we're hoping to poll the
audience a couple of times
and see what your feelings are.
Okay, so the first poll question is
if Health Canada and the FDA
approve a COVID-19 vaccine,
what is the likelihood
that you will take the COVID-19 vaccine?
We're not gonna get into politics today,
just if it's approved by
Health Canada and the FDA
and all the regulatory authorities,
what is the likelihood
that you would take?
We need jeopardy music for this, I think.
All right, so should we show the answer?
So 72% say yes.
That's a quite good,
especially considering
the public poll questions
that we've heard from the
United States and Canada,
you're more likely to take the vaccine
than the typical Canadian,
which I think it was around 50%
last time I heard it in
terms of poll numbers.
But let's see if we can
hear from Dr. Mark Loeb
and we'll see what you feel afterwards.
So I'd like to introduce Dr. Loeb.
And we'll put up the introduction slide.
If we can get the next slide, Nico.
So I we've mixed up the slides.
So let me pull up Dr. Loeb's
introductory information.
Dr. Loeb is an infectious disease expert
at McMaster University,
and an expert really in
vaccinology and vaccines.
He does a lot of research in
the development of vaccines
and also the clinical care of patients
asking about vaccines.
He's to speak to us about
the vaccine landscape
and what the likelihood of
a COVID-19 vaccine will be
and what that will look
like as we move forward.
So I'll let Dr. Loeb
provide a little bit more of
an introduction for himself.
But Dr. Loeb, take it away.
Thank you very much
Dr. Loeb, are you there?
– Yes, I am.
Can you hear me?
– [Eric] Yeah, we can
hear you, absolutely.
– Great.
Thank you so much.
Well, I'd like to begin by
just thanking the organizers.
Thank you for the kind
invitation to present tonight.
I'm not sure who's controlling the slides,
but maybe if I could have the next slide
unless I have control of it.
There's a huge burden, as
you all know, of COVID-19.
I just looked on the WHO dashboard
in terms of the most recent figures,
36 million cases worldwide
with a little over a million deaths.
It's just really an
enormous burden of illness.
And what I'd start off with
is just showing you a photo
or a diagram of the SARS-CoV-2,
so the agent that causes COVID-19.
So as you can see,
this is a figure of a virus,
and this is an RNA virus.
And what's really important
is the spike of glycoprotein.
So that's essentially
the part of the virus
that attaches to the receptor cell,
and that begins the whole infection.
So very early on, someone
will cough in your face,
or you'll be in close contact,
the virus will hit one of your cells
through this spike glycoprotein.
And it's really important
because this is the antigen
that all of the vaccines are directed to.
So they're either
directed to the full-length
spike glycoprotein
or this little blue part
which is the receptor binding domain.
Next slide, please.
So I put in this slide just to show you
how viruses infect cells.
So this is an example of COVID-19.
So what happens is that we're saying
is that the virus will
interact with the receptor
and it'll get into the cell.
And essentially it's a lot of
complicated things going on,
but essentially,
the virus hijacks the
protein-making machinery of the cell
to replicate itself,
and then mature viruses
just leave the cell
and then go on to infect other cells.
So this is an early part of the infection
and this is where antivirals would act,
they could interact anywhere
depending on the agent,
along anywhere in this pathway
to stop the infection from getting worse.
Next slide, please.
If let's say you don't have any treatment
and you just continue and
the infection goes on,
ultimately what happens,
or what could happen
is you end up with a severe
infection in the lungs.
And this is exactly what
this slide is showing.
It's showing basically
a lot of inflammatory
cells in the alveoli,
which is really the tips of the lungs.
And this is the most
distal part of the lungs.
So this is where drugs like steroids
will have an anti-inflammatory effect.
So like dexamethazone, and
that's about so far really,
the only therapeutic that's
been shown to reduce mortality.
So it's really our best agent right now
for treating COVID-19.
So it's important about the timing
because you don't want people
to be treated with steroids early on,
because early on,
that might interfere
with the host's ability
to basically stop the virus
through its own immune system.
So essentially steroids are used
when there's a lot of inflammation
and that's later on in the infection.
Next slide, please
So I showed this slide
because it really summarizes what we know.
There are different groups
that have looked at this,
but this is one of the better studies
where they measure the immune response
to actual COVID-19 infection.
They weren't patients that
were very severely ill,
they were moderately ill.
But what's really important to know
is that there was a
robust immune response.
In other words,
100% of the people who
got infected with COVID-19
mounted a CD4, which is like
a T-helper cell response.
And the level of that response
correlated to the antibody production.
You see this IgG and IgA,
about 70% of people had
a CD8 cell response.
So that really says that
when under natural infection,
there is a rigorous immune response,
at least to healthy people.
And what's also very interesting
is they didn't only look at
people who got infected with COVID-19,
but they looked at the response
in people never got infected.
And they found there was
some cross-reactivity.
In other words, people who
likely would have been infected
many years earlier
through exposure to the
seasonal coronavirus,
those four strains, about 50%
of them had a CD4 response
and 20% of them had a CD8 response.
So that might mean
that just being exposed
to seasonal coronavirus
might protect you to at least some degree.
Next slide, please.
So this slide is sort of complicated,
but this is when we're talking
about vaccines for COVID-19
safety is paramount of course.
So it's safety and efficacy.
That's the whole story about vaccines.
And one concern has been the possibility
for what's called Th2 response.
So what happens there without
going into all of the details,
what happens is that there's
a sort of an inflammation
that occurs that's due to
the vaccine that causes a,
it's almost like
an allergic type of
reaction of eosinophils.
And now that's been seen in
animal models mainly in SARS-1.
Fortunately, the candidate vaccines
that are being tested
now have a Th1 response.
So that's actually good news,
because that would suggest that
it might be less likely that
we'll see this Th2 response.
So we don't wanna be seeing that.
Next slide, please.
So the other thing is this term called
correlates of protection.
So I showed you that slide of what happens
when people get naturally infected.
So there's antibodies, there's
neutralizing antibodies
and then there's these T cell
and B cell sort of reactions.
And no one knows right now,
whether it's really a T cell response
that will be protective against COVID-19,
or will it be neutralizing antibodies
or maybe both of those.
So that's important to know,
because when we know that,
you could measure that and have an idea
of what's actually protecting people.
I just show this
because this is a correlate
of protection for influenza.
We've been studying
influenza for many years,
and even now,
we don't really have a really
good correlative protection
for that virus.
We have things called HAI
titers and NHA titer 1:40,
just gives us about a 50%
likelihood of protection.
So that's almost like flipping the coin,
it's not very good.
It's a little bit better in children.
We know that a titer
of 1:360 is protective,
but we still debate
about the role of T cells
and protection for influenza.
So there is a body of literature
that suggests that T cells
might be important in older adults,
but it's not a slam dunk,
so it's still controversial.
So I'm just saying that
because it might be awhile
before we really understand
what's really the correlative
protection for COVID-19.
Next slide, please.
So I want to get into
now how vaccines work
before going into the COVID-19 vaccine.
So if you look at the first figure,
figure one, basically what vaccines do,
they introduce either a whole
virus that's been inactivated
or sometimes a live virus
that's been attenuated
or bits and pieces of the virus.
So those are introduced into the body.
And then your immune system
has these dendritic cells that
are antigen-presenting cells.
They take those components that
have been injected into them
and they will show them,
they'll present them to T cells,
and they'll stimulate this
number of T cells and B cells
that'll recognize the virus
which is like the vaccine,
and they'll rapidly expand
in number, they'll increase.
Some of the T cells, like in figure four,
will directly kill cells that are infected
those are CDAT cells, others
like the T-helper cells,
CD4 cells will secrete signals
to create a bigger immune reaction.
And they'll basically get the B cells
to produce these antibodies.
So you can see the antibodies
or these little Y shaped molecules,
that just really block the virus
from attaching to the receptor
on the cell they usually infect.
And not only that, a small proportion
of both the T cells and the B cells
become long loop memory cells.
Well, the next time when you
see the real virus happening,
all this sort of reaction will occur,
but it will occur faster
and it will protect you.
And essentially, that's how vaccines work.
Next slide, please
So in terms of the types of vaccines,
again, just generally and for COVID-19,
there are inactivated vaccine
and those are generally
chemically-treated vaccine.
So they're not live.
The live vaccines often
they're attenuated vaccine.
So they're live,
they create a really
rigorous immune response.
So sometimes you only need one dose there.
They're subunit vaccines.
So that's bits and pieces of the virus.
Sometimes it's just a protein.
Then there are recombinant vectors.
And a number of the COVID-19 vaccines
are these recombinant vectors.
Basically what you take is a Nano-Virus
or something like that as a vehicle,
and you put a piece of nucleic acid
from, for example, spike into it,
and then that infects somebody,
and that's the vaccine that
creates the immune response.
There are also nucleic
acid vaccines, RNA and DNA.
They can create an immune response.
Often you'll need more
than one dose for those.
And then there a virus like
particles that simulate a virus
but it's particles put together
and they simulate your immune
system to protect you as well.
Next slide, please.
So in terms of COVID-19 vaccines,
they're using platforms
that are pathogen agnostic,
and that means that there are platforms
where you can insert a piece of a spike,
the spike antigen to protect
you against COVID-19,
but it could be other viruses as well.
The platforms work for different viruses.
So it's good in terms of that,
because if it's successful
it could be used for other viruses.
So these platforms express an antigen
and make a vaccine to multiple pathogens
on the same platform.
And again, it could be the
ones we were talking about,
nucleic acid vaccines, protein subunits,
non-replicating vector vaccine.
So it's very exciting.
However, they don't have the track record
in the sense that they've
never been scaled up before.
So this is a sort of a test in a way.
Next slide, please.
So this is just a diagram
showing these pathogenic
agnostic platforms.
I showed you the spike protein before.
So essentially, if you take
a COVID-19 or the SARS-CoV-2,
you take the gene that
codes for the spike protein
and you put it, let's say in an adenovirus
and that infects somebody,
usually those are injection
types of vaccines.
And that'll create the antibody response
that we just went over a few minutes ago.
Another way to do this is
to create a subunit vaccine.
So the spike will just code for a protein
and you'll get a lot of these
free-floating spike protein
causing immune response.
And for the nucleic acid vaccines,
it's just those bits of RNA or DNA
that are just taken up into the cell
and create an immune response.
Next slide, please.
So in terms of clinical trials,
it's important to understand
that there's a sequence.
So when you look at COVID-19,
there's preclinical data.
So there has to be data that suggests that
there's a promise to the antigens.
And then once the preclinical data
that might or might not
include animal models,
once it's felt that there's enough data
for this to work in people,
then there'll be a phase one study.
So usually that's a pretty small trial
involving 50 or 60 people.
They're called first in human studies.
And it's really all about safety,
just to make sure that
you don't try the vaccine in 10 people,
you try it one or two people,
you watch really carefully
and then you just continue to
expand to make sure it's safe.
And you also measure the immune response.
So there's sort of stop and go rules.
And if everything looks good,
then you go to phase two.
So phase two is usually,
they're trials that
involve 500 or 600 people,
and those are randomized controlled trial.
So vaccine versus placebo.
And you're looking at immune response.
So you're looking at what we
were talking about before,
the T cell response,
neutralizing antibodies,
and then it's the same sort of thing.
If that looks good, then you
go to the definitive trial,
which is the phase three study.
Here, you're taking
10,000 to 40,000 people,
and you're randomizing them
either to the vaccine or to the placebo,
but it's sort of in real life,
because they're getting
exposed to COVID vaccine.
And the hypothesis of course,
is that those people who
were exposed to the vaccine
will be less likely to develop COVID-19
versus those that got the placebo.
By and large, the primary
outcome of the trial
is COVID-19 tested by PCR.
And most of the regulatory bodies
want an efficacy of 50% risk reduction.
So they want that vaccine
to be at least 50% reduction
with a 30% efficacy of the
lower confidence interval.
Next slide, please.
So the traditional approach
to vaccine development
is very long and expensive.
You select a target,
you do animal studies,
you do a phase one study
and if it's safe, then you progress.
It's not overlapped,
it's very sequential.
There are multiple stops along the way.
Once the vaccine has been
shown to be effective,
then it moves to manufacture and scale.
Generally, it takes a 10-year
period of time to do this.
Next slide, please.
The pandemic approach is very different
because there'll be animal studies
and first in human studies
sometimes done in parallel,
the safety and the dose selection
are done at the same time,
manufacturing has to occur
before you even have any idea
whether the vaccine is going to work.
If you're a vaccine company,
you're going out on a limb.
And so the companies are
taking a large amount of risk
making millions of doses
with the hope that the vaccine will work.
Next slide, please.
And this slide just summarizes
what I've been saying.
There's accelerated timelines.
So basically, it's not 10
years of academic research,
skip that, go into preclinical phase one,
phase two, phase three trials,
it's all sort of overlapped.
And as the phase three are going on,
the manufacturing process is going on,
then if everything is good,
the vaccine is approved
and then you get into a distribution mode.
Next slide, please.
So this is a landscape
of COVID-19 candidates
in phase three trials.
So if you look at the overall
and you could go to WHO website,
and they keep it relatively up-to-date.
There are over 200 candidates,
but there's only a select few
that I'm showing you here that are
oh, go back, back up one side, please.
So there's only a few select
that are in phase three.
So this is the 10,000 to 40,000 range.
So you could see here
that a lot of them are,
those new platforms I was mentioning,
the non-replicating viral vectors,
basically these genetically
engineered viruses.
Here's the Oxford
AstraZeneca one for example,
there's one from CanSino Biologics,
there's an RNA vaccine from Moderna,
non-replicating from Janssen
protein subunit and RNA.
So you get a whole bunch of types.
I've highlighted the ones
that the Canadian government
has made procurement arrangements with.
So these are of course,
companies that are not based in Canada,
but as you might have
heard of in the news,
the Canadian government has said
"Well, we're gonna
procure these vaccines."
So one of the major
limitations we have in Canada
is that we do not have
biomanufacturing capability for vaccines.
So we have scientists
who can develop vaccines,
but to actually make millions
of doses, package them,
do all that sort of stuff,
that has to be done right now
unfortunately, outside of the country.
Next slide, please.
And this is just to show you,
these are just very early
stage candidate vaccines
that are being looked at in Canada.
So virus like particles,
DNA, protein, subunit
replicating vectors, DNA.
So all of the types of
vaccines I was talking about.
And that was my last slide.
Thank you.
– [Gil] Thank you, Mark, it's Gil Kaplan.
And I hope everyone can hear me.
Mark, actually if you could nod
if you could hear me as well
just so I know.
Thank you.
– I can hear you, welcome.
– [Dr. Gil] Okay, perfect.
I just wanna apologize to you
and to the audience for disappearing.
I mean, my office and my internet
completely just crashed on me
just a moment before the webinar started.
And that's why you and
all the other panelists
lost me this evening
as we were going live.
But I'm now actually on my phone,
which is the first time in the
17 webinars that we've done
that I've been off my iPhone.
So I hope that this projects okay.
And I just wanted to start
by just thanking you for your presentation
and for the work that you've done
shepherding vaccine research
over the past several decades,
including the battle that you're taking
amongst a number of
scientists around the world
in meeting research for
a vaccine for COVID.
I guess one of my first kind of
follow-up questions to
your presentation is,
we see so many different countries
working on vaccine trials
and there are different stages.
And for example, the Russian government
just recently approved regulatory
approval of their vaccine
after just less than two
months of limited human testing
and admittedly have Canada and the FDA,
we're keeping a much
more guarded approach.
And that's leading to a little bit of
concern and angst amongst many people
of the safety of a vaccine for COVID.
And I just wanted to get your perspective
on what is the approach that Health Canada
is gonna take to approve a vaccine?
What does it have to prove
in terms of being effective and safe
so that people can feel
confident in the vaccine
that that we'll ultimately get?
– Gil, that's a really,
really important question.
I think people have to
know that Health Canada,
both in terms of their ability
in terms of the approvals for vaccines
and also biomanufacturing,
they are just top notch.
Like they will never approve a vaccine
that hasn't gone through all the stages,
and particularly, they
would never approve vaccine
that hasn't gone through
a phase three randomized controlled trial.
So they're being obviously
very, very careful,
but it's great because at the same time,
they're putting huge resources
into quick turnaround.
So if you have a candidate
vaccine and you want to bring it
to Health Canada for approval for testing,
they're basically saying
that they're gonna turn it
around in about two weeks,
which is amazing.
They really do an awesome job
in terms of regulating both
the approval of the vaccine
and also the biomanufacturing process.
– [Dr. Gil] Excellent.
And then just giving us
a little bit more information around,
in these clinical trials,
how are patients being studied
and participating in study
for the safety of the vaccine?
And are they looking at different
populations beyond just,
initially healthy volunteers
are looked at initially
and as you go through
phases there's more people.
If you could talk a little
bit about the safety.
– Yeah, no, absolutely.
So basically, the bottom
line with any vaccine,
but particularly with COVID-19 vaccine
is that pharmacovigilance,
it's a word safety,
has to go throughout.
So it has to start at phase
one, phase two and phase three.
There has to be a very,
very careful assessment
of safety throughout.
Now, it's important to know
that even though you have a 10,000, 20,000
or even a 30,000 person trial,
and there's no safety signal
that's really good,
but sometimes you need much higher numbers
to detect the safety signals.
So just because a phase three trial
has proved successful
and is safe, that's good,
and it's good to be…
If all of those boxes are checked,
it's shown efficacy and safety,
it could go on to having
people vaccinated,
but you never wanna stop
their pharmacovigilance.
You wanna continue because
you wanna make sure
that if there's a very rare safety signal,
30,000 won't be enough,
you might need 3 million doses to see it.
So you really have to always
be very, very careful.
Now, in terms of your other question,
in terms of participants
who are getting the vaccine,
that depends on the trial.
So there are some studies
that are using participants
who are like healthy between
the ages of 18 and 65,
some are going beyond 65,
some are enrolling people
who have medical
conditions that are stable.
So it really depends on the study.
– [Dr. Gil] Thank you.
And then once the vaccines are approved,
like how long do vaccines last for?
Is this something,
like the influenza vaccine,
we get the shot every year
other vaccines, you just need it once.
Do you have a sense of how
long the vaccine will last
and what do you think that
will be for corona vaccine?
– Yeah, so that's a good question.
And it's hard to say,
because first of all,
our knowledge right now of the
natural infection of COVID-19
is relatively poor.
We don't know if someone
and there's been…
As I showed before,
there'd been millions
and millions of people
who've been infected with COVID-19.
So we don't really know well
how long are those people protected.
There aren't any good studies.
So it's really difficult to say
how long someone will be protected for
with a particular vaccine,
because that has to be tested.
That's point number one.
Point number two is it'll depend
to a certain extent on
the type of vaccine.
So if you have a live attenuated vaccine
based on previous experience,
it's fair to say that
there might be more of a
prolonged period of protection.
If you have a DNA or RNA vaccine,
it's likely that you'll
need multiple doses
just to prolong the the
level of protection.
And even if you look at
those vector vaccines
that are using adenoviruses,
they're not all the same,
some might lead to longer
protection than others.
The bottom line is we have
to continue to study that,
we have to continue to do
randomized control trials.
And even once they're done,
we need to do long-term
studies in those people
who've been vaccinated
to answer those really important questions
that you're asking.
– [Dr. Gil] The one comment you made about
the fact that Canada doesn't have
a biological manufacturing
facility to produce vaccines.
So I'm just curious, when
a vaccine is approved,
what happens next?
How do you go from approval of a vaccine
to vaccinating 37 million Canadians?
– When a vaccine is approved for Canada,
there's also biomanufacturing approval.
It's really, really carefully regulated.
So let's say Canada,
let's say there's a successful vaccine.
Let's say Canadian developed vaccine,
and let's say it's being
manufacturing outside of the country,
and then it's sent back.
What about distribution?
That's one thing, I do think that for us
biomanufacturing is a weakness,
distribution is a strength though.
If you look at during H1N1,
Canada did a really good job
distributing the vaccine
to high-risk groups.
So I don't think we're gonna
fall there, to be honest.
I think we'll do a good job
once we have a secure vaccine.
– [Dr. Gil] That's excellent.
There are a lot of people
who are hesitant about
vaccines in general.
And I just wanted you
to give us some comments
about what happens if people
refuse to get vaccinated.
If we don't get kind of
a large turnout of people
taking a COVID vaccine,
what is the impact gonna
be to protecting people,
like patients with
inflammatory bowel disease
who are a bit more
vulnerable to this disease?
– That question is for
issue of herd effect
or sometimes called herd immunity.
And the concept there is that
the more people get vaccinated,
the less likely that the
COVID-19 will circulate.
So that's been the focus of my research
for the last 15 years or so,
has been vaccinating children
to stop the spread in entire communities
and to see that indirect protection.
So the idea basically is if
you vaccinate healthy people,
they develop a very
rigorous immune response.
And if there's enough people,
the thresholds might vary
depending on the vaccine
and the pathogen that
you're talking about,
but if they're high enough levels,
because everybody is immune,
the virus just won't circulate.
So the answer then is that if
there's low levels of uptake,
that is a risk for other people,
particularly for those
who might not be able to mount
rigorous, robust immune
response to vaccine themselves.
– [Dr. Gil] And so just my last question
is just kind of a final
reflection on things.
Do you think a vaccine
can get us back to normal?
– Well, that's a hard question,
because I do think it'll go a long way
and I think it'll probably
be more complicated,
because it'll probably not be one vaccine,
it might be different vaccines.
But I think we will be in
the physical distancing
and mask scenario for quite a while,
but I think the vaccines
will help enormously.
And I think it'll be a
really important step for,
but we have to do it as we've
been just very carefully
making sure that the vaccine
is effective is, safe
and is also effective in the populations
that need it the most.
– [Dr. Gil] Thank you.
And Mark, we're gonna have you come back
a little bit later on
when we talking about some
of the vaccine guidelines
for inflammatory bowel disease patient,
but really appreciate for your
presentation and your time
to be able to answer these
complicated questions
about COVID vaccines.
– Okay, thank, Gil.
– [Dr. Gil] This is going to be
a little bit different for me
because I usually control the screen
and I'm not on my iPhone,
but I just wanted to still give
everyone kind of an update.
So if we go to the next slide.
Thank you.
So again, for people who've
watched these webinars before,
this is a very familiar
slide that shows us
that there's been over 36 million people
who have tested positive for
COVID throughout the world
in over 188 countries throughout the world
that are battling with COVID right now
with over a million people
who have unfortunately
succumb to the disease.
And if we can go to the next slide,
it will show us what's
happening in Canada.
And we see that
there are over 170,000 cases
of COVID across Canada.
And one of the interesting slides,
if you look at the
bottom left-hand corner,
you'll see this orange graph
where it actually goes from
April, July to October,
and you can see in Canada,
we had a spike of cases
in April and in May.
And you can actually see that
there has been a lull across July,
and it looks like
we're now entering that
second wave of COVID-19
that we've all been kind of predicting
and we're seeing on the news.
And if we go to the next slide.
What we can see here is
how those 173,000 cases
are distributed across the country,
with the provinces with
the highest populations
having most cases.
But if you go to the next slide,
you'll see the cases
standardized to the populations.
The number of people who have COVID
relative to the number of
people living in the province.
If you go to the next slide,
you'll see these are the incidents rates,
the rates of cases per a
hundred thousand people.
And continue to see that Quebec
has the highest burden
of COVID in the country.
But unfortunately, if
you look here at Alberta,
it now is the second highest
province in the country
surpassing Ontario in terms
of cases per population.
And part of that reason as being
outbreaks that we've seen
throughout the province
including in hospitals,
and in particular, I work
at the Foothills Hospital,
where we've been dealing firsthand
with a really bad outbreak
that's affected a number of the wards,
the patients in the hospital
and the healthcare providers.
Reminding us of the
importance of this disease
and how we're going into the
second wave over the fall.
And if you go to the next slide.
And actually, if you
can just advance across,
this is an animated slide
that shows the outcomes in BC,
and then the next click
will show us in the Prairies
and then next in Ontario, Quebec,
and then followed by the Maritimes.
And you can just see across,
these look very similar
to the data that we reported in the past,
where we're seeing the
highest burden of disease
in terms of case fatality rates
still in Quebec and Ontario,
with the Western part
of Canada, Maritimes,
tend to still have had
pretty good outcomes
in terms of the people who
have contracted the disease.
And so if we go to the next slide,
this is the SECURE-IBD database.
It's a database showing
with every webinar.
And it reflects the number
of cases of individuals
with inflammatory bowel disease
who have contracted COVID.
And you can see that there
are now over 2,500 cases
in countries all throughout the world
that have reported the cases.
There's actually two publications
have come out of the database,
one published in Gastroenterology
and one recently in Gut.
Again, highlighting the
most important risk factor
really is age as being a risk factor
for the most severe
complications of COVID.
And so if we go to the next slide,
I just wanna spend a moment
just to answer this
really important question
and kind of a lead up
to Eric's and Cynthia
coming aboard to talk
about vaccines and IBD.
And the really the question is,
why should everyone get a flu shot
during the COVID-19 pandemic?
And then the short answer
to this question is,
yes, everyone should.
And I'm gonna show you some
reasons why that's the case
as we go to the next slide.
And I think the very first webinar
actually showed this slide.
This was back on March 19th.
And it shows how COVID is
different from influenza, the flu.
And this first point is (indistinct),
which is how infected is
the flu versus COVID-19.
And we can see the flu infects about,
for every one person gets infected
that person tends to infect
one in a third people,
which is double the rate in COVID-19.
Now this is based on the
properties of the virus.
If you do things like physical
distancing, mask wearing,
you can actually bring down
the infections of the virus.
And then if you go to the next point,
we can see the case fatality rate.
So what is the proportion
of people who get infected?
And the flu is actually low,
less than 0.1% of the
population with the flu,
where in Canada,
the case fatality rate
for COVID-19 is 1.6%.
And this was based on a
study that came out of the
Canadian Medical Association
Journal a few months ago
that standardized the death rate
against not only reported cases,
but also adjusted for
unrecorded cases of COVID-19
that tend to be more mild.
So if we go to the next slide,
we can see some really interesting data
from the United Kingdom
that's just been recently published.
Looking in this blue slide
is the number of people
who have died in the UK
from January to the end
of August from COVID,
approximating nearly 50,000 people,
which is considerably higher
than people dying from
influenza and even pneumonia.
And in fact, if you go to the next slide,
which is a little bit
of a complicated graph,
but what it shows you
is the number of people
who have died from influenza
and pneumonia together
in these yellow bars,
dating back from 2000 all the way to 2020.
And in the background
is the number of people
who have died from COVID
in the first nine to 10
months of the pandemic.
And you can see here, year
after year after year,
COVID has been much more virulent
much more deadly than influenza
and pneumonia combined.
So if you go to the next slide,
and this is just information
looking at what's
happened to the flu season
in the Southern hemisphere.
So everyone has to remember,
in the Southern hemisphere,
winter happens in our summer,
and that's when they get the flu.
And what you can see here
in the bottom of this graph
is the number of weeks into 2019,
with this week 52 being the end of 2019
and week one being the first week of 2020.
And then if you click on the next point,
you can see that this week 11 of 2020
is when WHO declares a lockdown.
And the things that happened to lockdown
in terms of us being at home,
and then subsequently the
hygiene, the physical distance,
and the later on the mask,
what you can see here
is the number of reported
influenza cases drop dramatically
through the course of the rest of 2020.
And if you go to the next slide,
it's actually even more graphic
is what this was showing.
And I think if you could
just hit the next slide,
this is the number of,
or proportion of people
who tested positive for
influenza in Australia in 2019.
And then if you click on the next one,
you can see in that same
period between April and August
is significantly less
number of people tested
positive for influenza
during that same time period,
and that's in Australia.
And if you click on the next two,
you'll see data from South Africa.
And also the next point would be in 2019
and also into 2020, we see a
lot less cases of influenza
in the Southern hemisphere.
If we go to the next slide,
this brings us to this notion
that the things that we're doing today,
these past few months to protect us COVID.
In this other hemisphere,
it looks like that's actually
reduced the amount of flu that's happened.
And that's really important.
Now, of course, we don't know
exactly what's gonna happen
in the Northern hemisphere
in Canada, for example,
because the second wave of flu season
is approaching us right now.
But we do know that
if we do things like
hygiene, physical distancing,
wearing masks, screening for symptoms,
testing and contract tracing
and subsequent isolation,
those are effective in
protecting us from COVID-19.
And it may also reduce
the rates of influenza.
And if you click the next slide.
Let me click on to the next image here.
What you'll see is just a graphic
of the Swiss cheese model,
which tells us that
any one of these events
is not sufficient to control the virus.
And in fact, if you relied on just one,
so for example, just rapid testing,
you could get an outbreak.
And we saw this, for example
at the White House currently,
when they relied on testing
and then didn't do the other
pieces, the physical distance
and the wearing masks to protect themself.
And now we're dealing with a huge outbreak
in the upper echelons
of the leadership of the United States.
And so if we go to the next point.
The big difference between
what we have to treat influenza
and what we have (indistinct)
So we do have a vaccine for influenza,
and that's an additional
tool in our toolbox
to be able to reduce
the burden of influenza
during the second wave of COVID.
If we go to the next slide.
And it's my last slide.
And it's just a point
that I wanted to make,
that why is it so important
to get your flu shot?
It comes down to five key points.
And the first thing is,
all of us were worried about a twindemic
where you'd have a rapid rise
and there'd be a second wave
in winter of COVID-19 followed
by cases of influenza.
And if we get lots of cases,
for every case of influence
that ends up in hospital,
that's one less bed, that's
one less intensive care room,
one less physician, a nurse
to be able to care for
somebody with COVID.
And so if we have something
that is affordable
that is preventable through a vaccine,
we're going to better
treat our healthcare system
if you get a flu shot.
Secondly, we know that a
lot of the symptoms of flu
overlap with that of COVID-19,
and that's gonna make it
really difficult, challenging
to make a diagnosis of
flu or of a COVID-19,
something that we didn't
really have to deal with
during the first wave.
And so if we can prevent flu,
that's gonna help us a
lot in the second wave.
The other thing, and this is
a really important point is,
because COVID is a brand new disease,
we don't know what the impact
of getting fluids on
COVID-19 or vice versa.
If you get COVID-19,
what would be the impact if
you get substance about flu.
And the best way to protect
yourself from this unknown
is to vaccinate and prevent the disease.
And then the fourth point is,
that even though the death
rate of influenza is 0.1%,
it's still not zero,
and people can be
hospitalized and they can die.
And we know that that if
you have a flu vaccine,
it is not 100% perfect.
There are some people
who would still get flu,
but there's a lot of data to show
that risk of severity
of illness is reduced
if you get your flu shot.
And so my very last point.
Exactly one thing we can do is
if everyone gets the flu shot
if we know that less people get the flu,
we can now focus on COVID-19.
So I'll stop there,
and I'll bring Eric back to
the polls here (indistinct)
learn about some of the important vaccines
that we have for the IBD population.
And Eric, thank you so much for managing
during my chaotic loss.
And the first time in 17 episodes,
where one of the two of us
just disappeared during a webinar.
– Yeah, no, it is the first time,
which is pretty good
considering all the technical difficulties
people have learned to live
with over the past six months.
But no, thanks, Gil.
I mean, I think it worked
well to have you present
and and thank you to Nico and Sarah
for advancing the slides for him.
So can we put up the next poll question
before I start speaking?
So the poll question
will be directly related
to what Gil was speaking about just now,
if we can get it up.
The poll question really is,
are you planning on getting
the flu vaccine this year?
So if you can fill that poll question.
Give it about 10 seconds.
All right, can we see the results?
93% say yes, that is impressive.
I probably should have
asked that poll question
before Gil spoke instead of after.
I'm sure Gil was persuasive to get it,
but hopefully I'll be even more persuasive
to that 6% who is not sure.
So I'm going to share my slides now.
Can somebody give me a
slide sharing permission?
Oh, I've got it now.
There we go.
So everybody should be
able to see my slides,
although I don't think it's…
Yeah, there we go.
Okay, perfect.
So I'm gonna present a little bit
about the new clinical practice
guidelines that are coming,
not yet published
by the Canadian Association
of Gastroenterology.
Sort of from the context
of what it means for you as patients.
Canadian Association of Gastroenterology
is the national group
of gastroenterologists,
the professional society
of gastroenterologists
and pediatric gastroenterologists
in the country.
And they produce regular
clinical practice guidelines
very rigorously developed for
clinical practice guidelines
for doctors, nurses, nurse practitioners,
to help guide them
on how to treat patients with
IBD and other conditions.
And of course, the light
in my office just went off
just as I started speaking.
So hopefully you can't see me,
I'll turn on the light after I'm done.
So these clinical practice guidelines
were co-chaired by myself
and Dr. Jennifer Jones
from Dalhousie University,
who unfortunately was not
able to join us tonight.
And can somebody tell me,
do they see me on the webcam or?
Yeah, I guess other people
can see that my light was out.
Okay, give me a second
and I'm gonna turn on the light.
But I just wanted to introduce
who the co-authors of the guidelines were.
The co-authors are listed here.
It really is a national
group of co-authors,
gastroenterologists and
infectious disease specialists
from across the country,
adult and pediatric providers
who really aided in
creating these guidelines.
And we have Dr. Cynthia Seow
here from the University of Calgary,
who is going to be one of the
co-presenters and panelists
to explain the guidelines as they go.
As well, we had patient representatives,
and this was actually
the first time I believe,
that patient representatives
took such an active role
in creation of a clinical
practice guideline for CAG.
So we really appreciate the
IBD patient and family members
who participated in giving
feedback on these guidelines.
And I should say that
sort of a disclaimer here
is this is a trailer,
it's an appetizer like a movie trailer.
They have not yet been
peer reviewed or published
and they're under peer review
at a scientific journal now.
And so they may change slightly
from the final version.
It's also important to note that
I can't present them in full
because they haven't been
peer reviewed and published.
So it's really just to give you
an idea of what we will be talking about.
And I can't present it
publicly for two reason,
number one is that
there's confidentiality
agreements with the journal.
So at the time the publication happens
they ask before that we don't
talk about the publication.
And some of these aspects of
the clinical practice guideline
may change as a result of
the peer review process.
Although it's highly unlikely
that there's gonna be any major changes.
However, given the importance
of the Crohn's and Colitis
Canada Webinar Series
and speaking to all of you,
CAG formerly gave me permission
to be able to talk to you
about these guidelines ahead of time.
So you're getting an appetizer right now.
It's also important to note that
there's strict conflict
of interest policies
whenever we talk about
vaccine research and
vaccine recommendations.
There's always a question
of what are conflicts of interests are.
The two chairs, myself and Dr. Jones
could have no high-risk
conflicts of interest at all.
So we could not have conflicts of interest
related to companies
that produce vaccines.
More than 50% of the committee
had to have no high-risk
conflicts of interest as well.
And members who were in
direct conflict of interest,
meaning that they had worked
with vaccine manufacturing companies,
they could participate in the discussion,
but they could not vote on the statements.
And the guidelines
were supported by an
unrestricted grant to CAG
from the Canadian Institutes
of Health Research
and from CANImmunize.
So no vaccine company, no vaccine producer
was involved with the creation
of these guidelines at all.
So let's talk a little
bit about the process
that we take in producing
these guidelines.
So first the idea is approved
by the CAG Clinical Affairs Committee.
We then developed what's
called PICO questions,
of what's the population we wanna study,
what's the intervention we wanna study,
what's the comparative
and what's the outcome.
And these were really
related to all vaccines
that we wanted to study.
So each of these had to be evaluated,
and outcomes were primarily
the effectiveness of the vaccine.
So how well it works
specifically in IBD patients,
but if there wasn't
evidence in IBD patients,
it could be in other immunosuppressed
patients for example.
It was also safety,
so we wanted to make sure that
there was safety of the vaccine
if we were gonna recommend it.
And then there was also
a cost effectiveness,
cost benefit ratio.
So we wanted to make sure that
it wasn't gonna bankrupt
the healthcare system
if we recommended this vaccine for use,
and that it was cost-effective.
The questions were then reviewed
by the patient representatives.
There was then a systematic
review of the literature.
We evaluated the
literature for the quality.
So how well-designed the
studies were in the literature
and we use something
called the GRADE Process.
The statements were written.
We then had the consensus meeting
to review each of the
statements and recommendation.
There was discussion,
revision and then voting.
And if we couldn't agree,
we may revise again and vote again.
And there were some statements
that we just could agree on
and you'll see one a little bit later.
The manuscript was then written,
reviewed again by the
patient representatives
and then reviewed by
all of CAGs memberships.
So all the gastroenterologists
in the country
and pediatric gastroenterologist
in the country reviewed it
and provided comments.
And then we had to address their comments
before we submitted it to
the journal for peer review,
and then eventually
official release from CAG.
So that's where we are
in the process right now.
So some recommendations.
Not all of them, again,
some important ones
for, I think particularly
the world in COVID-19.
So the first general
recommendation we made was that
gastroenterologists or nurses
should do a complete review
of the patient's immunization
history at diagnosis with IBD
and at regular intervals afterwards
by the gastroenterologist.
So we don't leave it up
to the family physician
or a pediatrician.
The gastroenterologists
needs to be responsible
and review what the
immunization history is.
Practically, this can
be very, very difficult,
particularly for adult
So it's worth mentioning
that if the adult
gastroenterologist seems rushed
and isn't able to have time
to ask you these questions
about immunization history,
it's worthwhile for you
to advocate for yourself
and give your immunization history.
So go to your gastroenterologists
with that card
that tells you the immunization history
or the app, CANImmunize
if you use the app.
And that may trigger the doctor
to do a full review of your immunity
and see what vaccines you might need
or what other measures you might need.
Recommendation two is
all appropriate vaccine
should be given optimally
as soon as possible,
ideally, before starting
immunosuppressive therapy,
because we know that
immunosuppressive therapy
may reduce your response to the vaccine.
And we'll talk about that in a little bit,
but also you won't be
able to get live vaccines
if you're on immunosuppressive therapy.
Again, we'll mention that in a second.
But if you require urgent therapy,
you should not delay the urgent therapy
for your IBD in order to get a vaccine.
It's more important that you
get the treatment for IBD
rather than the vaccine at the moment.
We can deal with the vaccine issue later.
So we split the recommendations
into two groups,
live vaccines and what we call inactive
or not live vaccines, as
Mark had mentioned earlier.
Examples of live vaccines
are the MMR vaccine,
which really is only given
in toddlers or one-year-old,
18-months-old, and sometimes
four to six year olds.
Chicken pox vaccine, varicella,
the rotavirus vaccine,
which is really only given in infancy,
so below the age of one.
And then the nasal
spray influenza vaccine,
not the injection influenza
vaccine, the nasal spray
or flu mist is the brand
name is a live vaccine.
It's now very much fallen out of favor.
There was a time a few years ago in Quebec
that was all you could get.
But we all know that
the nasal spray flu mist
is not as effective as the
inactive injectable vaccine.
So that's not an issue.
There was also a shingles live vaccine.
We'll talk about that in a second.
That's also no longer recommended.
But in general, live
vaccine should be given
unless you're on
immunosuppressive therapy.
So immunosuppressive therapy
includes medicines like
(indistinct) and 6-MP, methotrexate
and also all the biologic medicines
infliximab, Remicade, Humira all of those,
as well as tofacitinib Xeljanz.
So don't give live vaccines
if you're on those.
It is also worth mentioning
that there are travel
vaccines that are live.
None of us are doing a lot
of traveling right now,
but you shouldn't get a live vaccine
if you're on these medicines.
We also looked at pregnant women with IBD,
knowing that rotavirus is given
in the first year of life.
And we couldn't make a
recommendation for or against
giving live vaccines to the children,
the infants of women who are on biologics
in the first six months of life.
And that's a new recommendation.
Prior to this, we were saying
absolutely, don't give live vaccines
like rotavirus in the
first six months of life
because the baby may still
have the biologic onboard,
the infliximab or Remicade or Humira,
may still have that in their blood system.
But there's some evidence, weak evidence
that maybe it's safe to
give the live vaccine.
In general, we just couldn't
come to a conclusion
for or against giving live vaccine.
So if you're pregnant
and you're on a biologic,
speak to your gastroenterologist,
speak to your obstetrician
and speak to the baby's pediatrician
before deciding what to do going forward.
Now there's a whole list
of inactive or non-life
vaccines in the guidelines.
Some of them are listed here.
I'm gonna focus on a few
of them, shingles, the flu
and some of the other vaccines
that are given particularly in schools.
And we'll talk about that in a second.
So firstly, I should say that in general,
all of these vaccines are
recommended for people with IBD
even if they're immunosuppressed,
even if they're on biologics.
Being on biologics or
being immunosuppressed
does not seem to increase your
chance of having a bad event,
a bad reaction to these vaccines.
And you cannot get the
virus from these vaccines
'cause there's no live virus
particles in these vaccines
as opposed to in live vaccines
if you're immunosuppressed,
you may theoretically develop the virus
from the vaccine itself
because your immune system
can't react against the vaccine.
In the case of these vaccines,
there's no live virus,
so it's safe to give.
Now there is question
as to whether they mount a full response,
and we'll talk about what
that means in a second,
whether you can actually
become fully immune
when you're on biologics
or immunosuppressives and
you get these vaccines.
So let's talk about shingles.
So there were nine cohort
studies in the literature,
nine studies that show that IBD patients
are about 1.2 to 1.8 times increased risk
of developing shingles,
and probably they're at
increased risk even more
if they're on biologics.
And then we know that one
small molecule, Xeljanz,
definitely increases your
risk of developing shingles.
And the risk increases with age as well.
It's important to note
that the new shingles vaccine
is a recombinant vaccine,
it's not a live vaccine,
and it's in fact,
one of those rare cases
where it's more effective
than the live vaccine was the
first version that we had.
So as a result of this new
vaccine becoming available
and knowing that a lot of
patients are on biologics,
we are recommending that shingles
be given to all adults who have IBD
and whether you're over 50 or under 50.
And that's a new recommendation,
before that it was for
people who were over 50
and it's paid for by most
ministries of health,
probably all ministries of
health that we know of in Canada,
if you're over 50.
however, if you're under 50
coverage is still limited.
So you may have to pay
for the shingles vaccine.
Sometimes your insurance may cover it,
but you may have to pay out-of-pocket
and then you ask for coverage
from your insurance company.
Hopefully you'll be able
to defend your choice
to get the vaccine by showing them
this clinical practice guideline
when it becomes available.
But because of that risk of
shingles in people with IBD,
especially who are immunosuppressed,
we do recommend it.
So flu.
So Gil dealt with the flu
and how important it is
in people with IBD, particularly
in time of COVID-19.
There were two studies
that examined the risk of
influenza in IBD patients.
And it looks like there is an
increased risk of influenza
and hospitalization from
influenza if you have IBD.
And the second study
only showed an increased
risk of hospitalization
in ulcerative colitis
patients, not Crohn's,
but in general, there seems
to be an increased risk.
However, despite this,
there's lots of evidence in IBD patients
that people just aren't getting
the influence of vaccine.
28% of Americans in one study,
50% of Alberta children in another study,
28% of adults in Germany in a third study.
So unfortunately, the message
is not getting across,
and we're really trying to work on that.
And we did a study in children under 18
with IBD in Ontario and
found similar things.
The good news here is that IBD patients
were more likely to get the
vaccine than non-IBD patients.
However, we're still only
reaching like 20, 25% at the most.
So we're still not there yet.
But in this study,
we compared children with
IBD to non-IBD patients
and then we also compared
children with IBD to themselves.
So comparing the years
that they got the flu shot
compared to the years that
they didn't get the flu shot.
And what we found was the
original purpose of the study
was to look at whether the flu
might cause a flare-up of IBD.
And we found that there
was really no evidence
that it caused a flare-up of IBD
as defined by increased
need to see a doctor
or be hospitalized for your IBD
in the time period after your flu shot.
What we found in fact is that
in the years that children
got their flu shot,
they saw their doctors 20%
less for IBD-related reasons
than in years they didn't
get their flu shot.
We know from lots of other viruses,
that getting a virus can flare-up IBD.
And therefore, it seems like perhaps
getting the flu shot prevents
you from getting the flu,
and therefore prevents the flu
from causing a flare-up of your IBD.
We think that viruses
alter the immune system
or alter the gut microbiome
and that's how they cause
a flare-up of the IBD,
but we're not sure 100%.
But the reality is it seems like patients
are better off in years that
they get their flu shot,
at least in this study
of children with IBD.
So the recommendations really were,
we looked at the evidence for children,
adults under 65 years old and
adults are over 65 years old.
And in all cases, we
recommended strongly in favor
of getting your flu shot
every year in all age groups.
So really, really important
to get your flu shot
if you have IBD both to prevent the flu
and potentially to
prevent flare-ups of IBD.
One additional considerations
in a COVID world are there,
well, symptoms overlap.
So you might think you have COVID,
but it's actually the flu.
But you're still missing school and work.
Because of it, you got COVID test,
you gotta wait for your
COVID test results.
If you can avoid getting any
sort of flu-like symptoms,
you should.
So the flu shot will prevent the flu,
which means you're less likely
to mix it up with COVID.
COVID-19 and influenza
co-infection might happen.
And we don't really know how
they will affect each other.
We don't know if that
will make you more likely
to develop pneumonia
if you get co-infected
with both at the same time.
And I'd rather not take
the chance, frankly.
So I'm getting to get
my flu shot this year.
And as Gil mentioned,
we're worried about health
system overload with COVID-19.
We're usually almost every
year, health system overload
because of the flu, especially
in pediatric hospitals.
And so if you can prevent that,
if you can help prevent
health system overload
by preventing yourself
from getting the flu
please, please do, so get your flu shot.
The last couple of slides
I wanted to just mention
special considerations
with school-based vaccines.
So grade six to nine,
is typically depending on the province
when schools administer vaccines.
And you can check for your
province's information
at this website
in terms of what vaccines
are given to children
in grade six to nine in your province.
But most commonly, it's HPV,
the human papillomavirus
hepatitis B, and meningococcus.
All three of those vaccines
are recommended for people
with IBD in general.
And so it's important
that children get vaccinated
for these viruses.
However, at least Ontario,
decided that they will not administer
the grade seven vaccines this
year in the 2021 school year.
So that's a big concern for pediatricians,
because that means
if parents want their
kids to be vaccinated,
they're gonna have
to go to the primary
care provider to get it.
And primary care providers
are overloaded right now,
family, doctors, and pediatricians,
and many of them are doing virtual care
and things like that.
So that's a concern,
but we can't change
that decision right now.
My suggestion is that
if you want your child to be vaccinated,
and I would suggest
that you get vaccinated,
go see your primary care provider,
make an appointment for these vaccines.
You can theoretically
wait til grade eight,
but we don't know whether Ontario
is gonna catch up on all the vaccines
they missed in grade seven.
So my suggestion is get your child covered
and go make an appointment
with the family doctor.
So with that, I'll stop sharing my screen
and we'll move on to the panel discussion.
So I wanted to introduce our panelists.
So we were introduced already to…
Just make sure that I'm not
sharing my screen anymore.
So we were introduced
already to Dr. Mark Loeb,
who's an infectious disease
expert at McMaster University
and professor of microbiology
at McMaster University.
I also wanted to introduce
Dr. Cynthia Seow,
who's a longtime friend of mine,
and we trained together
at University of Toronto
many, many years ago,
too many years ago.
Dr. Seow is a pregnancy
and IBD specialists
at University of Calgary
and an associate professor of medicine
in the division of
gastroenterology and hepatology
and the department of medicine
and community health sciences
at University of Calgary
Dr. Seow's specialties include
maternal fetal medicine in IBD
and optimization of biologic
therapies in IBD as well.
She established University of
Calgary's IBD pregnancy clinic
and research registry in 2013
for pregnant women living
with Crohn's and colitis.
And Dr. Seow also sat, as I mentioned,
on the CAG Clinical Practice Guidelines
Consensus Committee for the Vaccines.
So if we can have a Dr. Seow
and Dr. Loeb's webcams up.
There you are.
Hi, Cynthia.
– Hi, thank you very much for inviting me.
– You're very welcome.
And thank you Mark for
rejoining, I appreciate it.
So let's start with a
question for Cynthia.
Cynthia, how safe is a flu
vaccine for pregnant women
and is it effective?
– Yeah, I wanna reassure everyone
that the flu vaccine is absolutely safe
as well as very effective
for pregnant women.
So we really, really strongly
recommend that you get it,
particularly in light
of the COVID pandemic.
It's really important
because as you've heard,
the symptoms of influenza
can also that mimic the
symptoms of COVID or vice versa.
So you wanna protect
yourself as best as you can.
And further, you're not
just protecting yourself,
you're protecting the health of your baby.
Patients who are pregnant
who do develop the influenza illness
are at risk of adverse outcomes,
including having a baby born prematurely.
And we all know that unfortunately
premature, preterm babies
are at increased risk
of long-term complications,
such as other infections in life,
not just influenza, but other infections,
are also at risk of neurological problems.
So by getting the influenza vaccine,
you can protect yourself.
You can protect yourself
from having the baby born too early.
And then the third benefit
is that there's also passive immunity,
which means that you can
provide protection for your baby
from developing influenza
in the early stages.
And that's particularly important
because the influenza vaccine
is only given for kids
after the age of six months.
So on all those accounts,
absolutely do recommend
the influenza vaccine
in terms of safety and
efficacy for pregnant women.
– Perfect, thanks.
So what other vaccines are important
to consider during pregnancy?
– Yeah, the diptheria,
tetanus and pertussis
the DPT vaccine is also really important.
This is something that has been,
I guess relatively new
in the Canadian sphere for pregnant women.
So in the past,
there would just be boosters
for example every 10 years.
But now because of the advantage
of having passive immunity,
again, the ability
to pass those protective
antibodies to your baby,
they do recommend that you have
the DPT for every pregnancy.
So if you have three babies
three years in a row,
yes, you do require
and you should receive the DPT
for every one of those three years
to help those three babies.
That's a very common question asked.
You do not need to wait 10
years between the vaccines
or 10 years between the babies.
– I think some of us
probably feel like
pincushions all the time,
and if you're getting pregnant every year,
you're probably getting lots of folks,
but I think we all want healthy
babies when we have kids.
So it is important to make sure
that we protect the children as well.
And what about rubella serology?
That's done for every
pregnant woman, right?
– Yeah.
So there is a standardized
prenatal testing
for all pregnant women,
and it does test against common viruses
that a pregnant woman should be immune to,
and they include viruses
that would have potentially
bad effects on the baby.
The big concern about the rubella
is that at the moment the
vaccine is a live vaccine
and we do not recommend
that pregnant women,
regardless of whether
they're immune suppressed
and otherwise from other medications,
all pregnant women should
not receive a live vaccine.
So this is another call out,
that if you are considering a pregnancy,
you should discuss this
with your IBD specialist ahead of time,
because there's lots of things,
as you've heard on previous webinars
that you can do to optimize that pregnancy
from an IBD standpoint, from
a preventative care standpoint
and should get everything
done before you get pregnant.
That's a perfect opportunity.
– Absolutely.
And then I think that's a
good segue to talk about,
that I think patients should
be speaking to their IBD doctor
if they're on a biologic for their IBD
about what that means for the infant.
And do you wanna speak a little
bit about what that means,
is the biologics transmitted
to the infant in the pregnancy?
How does that work?
– Yeah, so it's really important
for women who are on chronic
medications for the IBD
to continue their medications
throughout the pregnancy.
Many women are concerned
that the medication
will have bad effects for the baby.
But by and large,
with the exception only of
tofacitinib and methotrexate,
all medications are safe during pregnancy,
specifically for the biologics,
which include infliximab,
adalimumab, vedolizumab and ustekinumab,
we recommend that you
continue that medication
so that you stay well for the pregnancy,
'cause again, if you get sick,
you're more likely to have a preterm birth
and that has bad outcomes for baby.
These biologics do not cross
the placenta in the first trimester,
so are not responsible for birth defects,
but they do cross the placenta
in the second and third trimesters
and so the baby does get exposed.
And depending on which
drug it is, on average,
the drug is present in the baby's system
for about six months of their life.
So for that reason, as Dr.
Benchimol mentioned before,
we have in the past said
that moms should not provide
the live rotavirus vaccine
to biologic-exposed infant.
It's only for the biologics.
The other ones like (indistinct),
no, no, that you don't
need to worry about.
But for biologic-exposed kids,
don't get the live rotavirus vaccine.
But the good news is that
there's a lot of research
about that at the moment.
And perhaps in the coming years,
we can demonstrate that in fact is safe
because it's a different vaccine
to, for example, the BCG.
– So in general, I think most doctors
will right now recommend
that the infant does not get the vaccine,
also because rotavirus
is not a huge cause of death in Canada.
Typically we can treat,
although it can be very
very severe in infants.
We have good hospitals,
we have a good healthcare system
and so we can treat it.
Right now we're erring
on the side of caution
and not giving rotavirus to most infants
whose mothers are on a biologic,
but that may change in the future.
So let's get away from pregnancy for a bit
and let's talk about pneumococcus.
So what is pneumococcus
and what sort of symptoms does it cause?
– So a pneumococcus is a bacteria,
and it can cause a number of illnesses,
anything from having plugged
ears, to having gunky eyes,
to having a pneumonia.
And the big concern
and why we're worried
about it for IBD patients
is that it appears that IBD patients
may be about one and a half times
the risk of the general population
for developing pneumococcal infections.
And that may occur even regardless
of what kind of medications
that person is on.
So we talked about
a number of different types of
respiratory infections early.
We talked about COVID, we've
talked about influenza.
They're both viruses.
The difference with pneumococcal pneumonia
is it's a bacterial infection,
but it can also cause a pneumonia.
So it can either cause
a pneumonia by itself
or it can complicate a viral pneumonia.
So it's really important for IBD patients,
particularly those who
are immune suppressed,
that means that they're on
(indistinct) or methotrexate or a biologic
to receive the pneumococcal vaccinations
prior to starting on the medications.
You get the best response
if you do it beforehand.
But having said that,
if you've already started
on the medications,
you can still receive the vaccines.
I'm sorry.
– There's four, right?
So there's two different
types of pneumococcal vaccine
in different frequencies.
– So children under the age of five
do receive it as part of
the pediatric guidelines,
but for older children or adults with IBD
who are on biologics
or immune suppressants,
there are two vaccines
usually we give the Prevnar 13 first
and then you wait some months
before you receive the
pneumococcal vaccine,
the Pneumovax 23.
So there are two vaccines.
You have to give them best in the order
with a few months apart.
And then for those who
continue on immunosuppressants,
there is a booster dose
at the five year mark,
and that provides excellent coverage
against bacterial pneumonia
caused by the pneumococcal bacteria.
– That's great.
That is what the Clinical
Practice Guideline does recommend,
is that that IBD patients
should be getting that vaccine.
And I'll turn it over to Mark.
Mark, do you agree about
the pneumococcus risk
in immunosuppressed patients?
– Yeah, no, absolutely.
I think 100%.
– Good.
So on a different topic, Mark,
are you anticipating
that the COVID vaccine
will be live or inactive,
and obviously that will have implications
for whether IBD patients
can receive that vaccine
if it's live or inactive?
– Yeah.
So I'd rather not use the term inactivate
'cause that's a particular
type of vaccine.
So if we talk about as live
or non-live first of all,
so if we look at the data, if
we look at the WHO dashboard
that lists all the vaccines,
over 200 plus candidate vaccines.
If you look at all of those,
there's just a handful, just a
couple that are live vaccine.
So I'd say on a probability basis,
it's more likely that
the successful vaccines
will be the "non-live vaccines"
but we don't know which.
So it can be a live vaccine.
But I'm just saying from
a probability standpoint
and it could be an RNA
or DNA or a subunit,
all of those types are possible.
We've heard earlier that we
want to avoid live vaccines
in patients who are immune suppressed.
So if it's a non-live vaccine,
that takes that out of the equation.
So that would be a good thing
if it eventually happens that way.
– That's great.
Once the vaccine comes out,
what are the chances is a
question from the audience,
what are the chances that IBD patients
are gonna mount an immune
response to the COVID vaccine,
especially those IBD patients
who are immunosuppressed
like on a biologic?
Can you explain what
mounting an immune response
means to the audience first
and then explain why it's important?
– The answer to that
has a lot of components,
Because first of all right now,
we don't actually really know
what part of the immune response will be.
Remember, I talked a little bit
about the correlates of protection.
So we don't know whether it
will be neutralizing antibodies
or T cells or whatever.
So we don't know what the real signal is
first of all, for what
will protect anybody
against COVID from the vaccine.
So that's one point.
So we need to know that for number one,
number two, when you look at studies,
it's usually never binary
unless you're using a placebo.
When you subject someone to an antigen,
there's usually some
sort of immune response.
Then the question becomes,
what is the type of immune
response that you need
and how much of it do
you need to be protected?
And those are the key questions.
So I do think it's really important
that as the phase three trials roll out,
and a phase three vaccine
seems to be effective,
that's when we want to be
doing immunogenicity studies
in people who have IBD, who
are on immunosuppressives.
Rapid trials, I don't think
they need to be that large,
maybe 500 or so.
And that'll inform things going forward,
because we want to be
doing things based on data.
And that's the way I think to do it.
– This is another audience
question, very good question.
Have there been IBD patients
included in the COVID trials
or the phase three
trials that are out now?
– I unfortunately don't have
a running list of all the…
I'm familiar with the
eligibility criteria.
I know that a number of
trials have at this point
excluded people who are immunosuppressed.
And the rationale for that is,
they wanna see for the first
vaccine, they wanna say,
"Well, does it work?"
If they're gonna look at who it works for,
that will look
generally for either a
more healthy population
or some trials have said
they're including people
who have medical conditions
but are stable.
So if someone's very,
very immune suppressed,
likely they would not be in
at least many of these trials.
I can't speak definitively though,
because I haven't seen all
the eligibility criteria.
But as I say, I think it
will be very important
that once there is a
vaccine or vaccines, plural,
that appear to work
then that's a point
where we really want to
roll out immunogenicity studies.
Because the other thing is that
even within a subgroup of a
randomized controlled trial,
you might not even have
the power to say that.
So often in a subgroup analysis,
it's hypothesis generating it,
it doesn't give you a definitive answer.
– That's great, thanks.
And we will run a couple of minutes over
just to answer a couple more
questions from the audience,
if that's okay.
Cynthia, a non-COVID
vaccine-related question for you.
Is it safe for IBD patients
to get a non-live vaccine
during an IBD flare?
– Yeah, it is safe to
receive a non-live vaccine
during an IBD flare,
but I think I'll make
several comments about that.
If you're already sick,
probably talking about preventative care
is one of the things that is
not really top on your list,
you're probably trying to get
over your flare at that time.
So again, it really shout out
to the need for being preventive,
being proactive and
getting that vaccine early.
The second thing is that if a
patient is having an IBD flare
they may be treated with
immune suppressing medications,
including steroids.
As you well know,
steroids can make a
patient feel better quicker
and are used as induction agent
to get them feeling well quickly.
They're not a long-term medication.
That's why we didn't discuss it before.
But when a patient is acutely sick,
they get high doses of steroids
and that can really impact on
how well a vaccine can work.
And then the other thing
that always concerns me
is that we know that in this world,
there is hesitancy for
patients to receive vaccine.
So if you receive a vaccine
when you're already feeling sick,
you may falsely attribute
some of the sick feelings
and the unwellness to the vaccine
and that might make you more hesitant
about receiving other vaccines
when actually those symptoms
were just related to the disease flare.
So yeah, in summary,
an IBD flare does not prevent you
from receiving a non-live vaccine,
but there's probably better time to do it
and that's before the flare.
– Agreed.
And it's important to note that
the non-live vaccines, no vaccine at all
has been associated with a
flare-up or with new onset IBD.
So if you get the vaccine
and your IBD flares up,
in all the studies anyway
that we've been able to see
in large numbers of patients,
the vaccines don't seem
to be the cause of that,
it just may have been bad luck.
That being said,
we don't obviously know
everything about vaccines
and how it changes the
immune system, but for now,
it seems like all the vaccines,
non-live vaccines are safe.
If you're in remission, then
you should be getting them.
And that you should speak
to your doctor about that.
Another question for Mark
came from the audience.
If I've had a bad reaction to
getting a vaccine in the past,
should I avoid getting
vaccinated in the future?
– That's a good question.
Because for many vaccines
for example, we'll take flu vaccine.
The real reason not to get vaccinated
would be a very serious
anaphylactic reaction.
But by and large, as Cynthia was saying,
there are a lot of people, for example,
I'll just use the example
of the flu vaccine.
They get the flu vaccine
and they get for example
infection with another circulating
virus at the same time,
they put it together,
they say, "Oh, I got this flu vaccine
and it's made me sick."
First of all
it's unlikely the flu vaccine
they would have received
it's not a live vaccine,
so they're not getting a live infection,
but there're confounding relationship
between the receipt of the
vaccine and these adverse events.
So it's really important
that for the most part,
you really have to look at
what is this bad reaction.
And by and large, it's really anaphylaxis
the most serious type of allergic reaction
that you're worried about.
And most of the others
generally tend to be minor
or tend to be ones that people are just,
they're putting things together
that really shouldn't be put together.
– That's great.
All right, I think we will end it there.
We've sort of run through
most of the questions
that people have asked.
So with that, please
let us know how we did
and what you'd like covered
for future webinars.
I think we have a plan
for the next webinar
and that's to update people
on the new publication
from the SECURE-IBD Registry
and the evidence behind what we know about
how COVID-19 acts in IBD patients.
So we think that it's gonna
be the November webinar.
But please, please provide feedback
as to how you felt about this webinar
and about the topics you
wanna cover in the future,
and that prompt will appear on your screen
directly after this webinar
to complete the survey.
Thank you very much.
And if we can get the next slide.
As usual, we wanna thank
all the frontline healthcare workers
and frontline workers in general,
including grocery, store workers,
people delivering our
food, restaurant workers,
and everybody who is putting
their lives on the line,
both to treat people with
COVID and people with IBD,
and also to keep our economy running
as best as it possibly
can at point in time.
So thank you very much.
I also wanted to put another plug in
as usual for Crohn's and Colitis Canada.
We've had a lot of difficulties
with raising funds in a virtual world.
It's not the same as raising
funds person-to-person,
being able to go out and ask for money,
as well fundraising events.
We know that in Canada health charities
have suffered tremendously
through the shutdown,
through COVID-19.
And Crohn's and Colitis Canada,
unfortunately is no different.
Because CCC is the number one
non-government funder of IBD research,
that really does mean that finding a cure
unfortunately is suffering
at the same time.
And providing all of these
programs that we do for patients,
most people are working
on a volunteer basis,
but it does require
staff behind the scenes.
Sarah and Nico, really
help out tremendously.
And we really want to be able
to continue to support
these types of programs
and support educational
events for patients,
as well as advocacy events
on behalf of patients to government.
So with that, I put in another plea
as I always do on these webinars,
so please if you have extra funds,
consider donating to
Crohn's and Colitis Canada.
I believe the Gutsy Walk
Donation is closed at this point,
but you can still go
and you can go to donate
now button at the top right.
So please, please, if you don't mind,
please donate to Crohn's
and Colitis Canada
if you have any extra funds.
And with that, Gil…
Gil, still online?
Anything else to say, Gil?
– [Dr. Gil] Yeah, I just
wanted to thank the panelists.
And Eric, again I wanted
to thank you personally
for jumping in there
when I had some technical challenges.
I think there might've been
a Halloween ghost on this webinar
between my internet crashing
just as the webinar started
and your lights mysteriously turning off.
– My lights switch everyday at 8:00 p.m,
I've got to figure out
a way to turn that off.
– [Dr. Gil] I think it was a great panel.
And I think the last message
I wanna to leave everyone
is I hope that you heard the message that,
we're really, really keen
that everyone gets their
flu shot this season,
and the sooner you do it, the better.
Stay safe, everyone.
– Take care, everybody.

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