Will it be safe Vaccine safety science from Cowpox to COVID19
[Music]
the cow pock
or the wonderful effects of the new
inoculation
this is a cartoon by 18th century
satirical artist
james gilray and it depicts the rumors
being spread
by by people who are opposed to the
practice of this inoculation
and here you can see these bovine-like
appendages springing out of people
which was um which was the idea that
they’d been given this preparation of
cow pox which was a much milder disease
than the dreaded smallpox and since the
first attempts to vaccinate
against smallpox the 18th century people
have held
concerns about the safety of vaccines
what injecting people
with cow pox caused strange things to
happen
and today we face similar challenges
where ideas almost as wild as this
cartoon are actually exploding
did bill gates invent the coronavirus
pandemic so he could put microchips
into the vaccines and then could these
be activated by 5g
the covert pandemic is not only a
pandemic of a virus but it is also
a fantastic myth epidemic with
extraordinary
ideas spreading faster and further than
the truth
and while no other public health
intervention have saved more lives than
clean water antibiotics and vaccines
vaccines have always come with some
level of social disruption
so this talk is about how the explosion
and distortion of truth
and particularly around vaccine safety
is challenging
us in our efforts to control diseases
and can
throt potentially our efforts to deploy
our emerging covet 19 vaccines
now no vaccine is 100 safe or 100
effective but some come pretty close
the safety of inoculation and
vaccination are relative
on the left is a drawing that shows a
typical reaction to the ancient practice
of smallpox varialation
nasty fatal in about one percent
and but very much preferable to actually
acquiring the
disease naturally and on the right is a
drawing of a typical reaction to
vaccination against smallpox
still pretty big by the end of the 20th
century smallpox vaccination carried a
death rate of around one percent
um or about one million people died who
received the vaccine but serious events
were actually quite common
and it may seem strange that people
would take a procedure
that carried such a high risk of death
or a nasty reaction
but when faced with the the disease that
killed around 30 percent of its victims
it was a perfectly rational decision
when the threat of smallpox became a
distant memory
the risk was the risks associated with
vaccination became a greater focus for
people
and so began the vaccine confidence life
cycle
this is a diagram that many of us in the
business call the famous chen diagram
it’s based on a drawing published in
1994 by american doctor
dr bob and what it shows is that before
a vaccine is available when a disease is
present and really scary
there’s a high acceptance of the vaccine
when it arrives it’s embraced
and the disease starts to go away as the
disease becomes less visible
people shift their focus to the
potential safety of the vaccine
maybe about focusing on real or even
just perceived
safety effects and the disease
inevitably resurges
reminded that the disease is actually
really terrible confidence in the
program resumes
and the disease becomes controlled but
let’s think about these possible side
effects
what is real and what is rumor and how
can we tell
vaccine safety is assessed throughout
the life of the product and sometimes
beyond
it begins in the lab after review and
approval by the appropriate regulatory
authorities tasked with protecting our
health
the vaccine can progress to perhaps 30
or so
human volunteers in what we call a phase
one trial
this is to test the dosing and the
safety and to examine the immune
response
all going well from here a larger study
called a phase two
might progress and here there’ll be a
few hundred volunteers
the safety will be monitored closely and
those early volunteers can be followed
up for perhaps a year or more
and if all has gone well then phase
three
studies might progress and these can
include tens of thousands of people
and some will get the vaccine and others
will get a placebo
or a dummy injection which has no
benefit and by the end of these trials
we can compare the outcomes between the
vaccinated
and those who did not receive a vaccine
and providing the vaccine has been shown
to be effective
and there are no risks you know
increased risks for serious safety
events
it might become the vaccine might get
approval
by the regulatory authorities to be used
but the assessment of the vaccine is not
in there
we can’t yet rule out the potential for
very rare events that may be caused by
the vaccine
and this is where the next stage of
assessment steps in
or what we call phase four
and that has thousands of millions to
participants here is where we get into
really big data we need vast numbers of
people
if a vaccine causes a serious adversary
and say one per hundred thousand people
we need some pretty big data to show it
if the event occurs
in say one per million people then we
need even bigger data to show it
so obviously we can’t run clinical
trials with millions of people in
so fortunately there’s a much more
pragmatic way to do this
and let me give you an example of the
power of big data
one common myth associated with vaccines
is that they cause autism
particularly the mmr vaccine the measles
mumps rubella vaccine
and this has been proven wrong over and
over again during the past 20 years
by big data and a very nice example
of the power of big data in assessing
vaccine safety comes from denmark
investigators here tracked over 650 000
children who were born between 1999
and 2010. most of them got vaccinated
and around 32 000 did not they found
that around six and a half thousand were
diagnosed with autism
and then the researchers found that
there was no increased risk in autism
among the kids who received the mmr
vaccine
and those who did not also the study
didn’t find any increased risk for
autism
even in subgroups of kids who who had
high risks for example that who
had a sibling who had autism or scored
high on an autism risk assessment
test there are many other studies just
like this one
addressing even just this one question
so big data can help us answer very big
questions
about vaccines
but today we’re facing a new challenge
and i’m sure that most of you didn’t
have this one in their diary for 2020.
in december 2019 a strange pneumonia
was noticed in wuhan china and soon
after the cause of this was identified
as a new coronavirus
and sadly the world were not prepared to
prevent the spread of the virus
and while china managed to get it under
control other countries
have not and today there have been over
32 million cases and almost 1 million
deaths
and deaths in some places have
outstripped the ability of the health
system
and the ability of the undertakers and
the cemeteries to cope
the covert world illustrates what the
world looks like without just one
vaccine major epidemics and pandemics
are as old as civilization itself and
you can find
mass graves everywhere so to help get us
out of this 21st century pickle we need
safe and effective vaccines urgently
how can we do this when normally it
takes 10 to 15 years
and up until now the fastest vaccine
ever developed was the mumps vaccine
that was in 1967 and it took four years
so what can we do to meet this need
well this is not 1967. in fact this is
2020 and it’s an international emergency
over the past few decades we’ve
developed technologies for vaccine
development
whereby you don’t even need the
disease-causing organism you only need
its genetic code
and with the genetic code in hand
scientists can make a range of vaccine
types
they can do this very very fast and the
reason they can do this very fast is
because they’ve now got some practice
recent experience with ebola vaccines
previous coronaviruses
and other emerging diseases means that
there’s some templates that are actually
ready to go you just plug in the
instructions for the new virus and press
play
the hardest part is actually testing
them in people to make sure
that they not only work but are also
very safe
and without missing out any steps
science and technology gave us the first
covert
vaccine in humans into a human in less
than 45 days
but these are just candidates at the
moment we don’t know for sure
if they work or how safe they are how
can we assess them super fast without
skipping out any vital steps and how can
we squash a decade
into a year
there are two things that make the
seemingly impossible possible
and first is lots and lots of money
vaccine development is very expensive
and risky business
most candidates will fail before they
before they get very far
and the more further down the track they
get the more money they cost
upwards of a billion dollars and then
add to that
the cost of actually making the facility
building the
facility to make millions and millions
of doses that’s another billion dollars
so investors need to be very cautious
and often a single company is going this
alone
however for covert this risk has been
spread
among many many into entities across the
globe so in a nutshell
money is no object the other thing is
running the steps in parallel to each
other
instead of completing each step or phase
before moving to the next one
activities are being overlapped with
each other in concert as though millions
of lives depended on it
and this has been done before in the
recent effort to bring a vaccine
uh ebola vaccine to africa
but once these trials have gathered
enough data to show a vaccine works
or doesn’t and and and they know that
you know they know the safety profile or
for a certain number of people we still
can’t rule out
possible rare safety events so enter the
next phase
into big data
today i have on my wrist more computing
power
than nasa had to send astronauts to the
moon and bring them back safely
we have massive administrative data
collections we have artificial
intelligence
we have smartphone apps and we have
social media and we have statistical
methods
that most people couldn’t even imagine
30 years ago
imagine a study that can utilize the
entire team of 5 million
where you can look at all the emergency
room visits you can look at all the
admissions to hospital
and you can link these events to the
vaccination exposure
and then you know which cases were
vaccinated and which were not and you
can make comparisons about risk
just like they did in denmark and we can
do this in almost real time
today we have the technology and the
expertise to detect harm from a vaccine
that occurs so rarely
perhaps only one in a million people
experience the harm or even fewer
but despite the science of vaccine
safety the thing that worries people
most about vaccines
is safety and hesitancy towards vaccines
is growing
so what is vaccine hesitancy
vaccine hesitancy refers to the delay in
acceptance or the refusal of vaccines
despite their availability or the
services being available to people
surveys from all over the world
continually highlight that the main
concerns people have
center around vaccine safety or the
perceived risks of vaccines
the vaccine confidence project attracts
people’s opinions about vaccines all
over the world
and here we can see in 2015
there were some populations that had at
least 40 percent
of people disagreeing that vaccines were
safe
are these fears based on science
no they’re based on something much more
complicated
vaccine hesitancy is complex and context
specific
and it varies across time and place and
a right across vaccines
it’s influenced by factors such as
complacency
convenience and confidence
yet you’re actually more likely to be
struck by lightning that experience a
serious adverse event
to to a vaccine the odds of being struck
by lightning in the us are around 1 in
280
000 but addressing this problem is not
easy and the covert 19 pandemic and the
explosion of information
or the emphademic is making it even
harder
part of the problem is that we’re
hardwired to take shortcuts when it
comes to processing information
the tendency to accept information that
confirms your beliefs
is explained by confirmation by us while
the idea that bill gates invented the
covert pandemic
or that covert vaccines will be a form
of mind control
are likely to feel true for people who
have conspirational beliefs
the idea that vaccines are full of
dangerous chemicals is likely to feel
true
to people who have a fear of chemicals
or chemophobia
messages that make such claims can be
amplified
and this can be very very fast and very
effective at shifting people’s opinions
when the messages resonate
with their underlying beliefs it is much
easier to believe something you read
if you already want to believe it
there are many facts around the
development of covert vaccines that are
becoming distorted
or are misunderstood and falsehood flies
rumors are contributing to to what is
being now called an
epidemic an over abundance of
information
from true some not and the facts have
become lost or distorted
and sadly lies travel faster and further
a study published in science in 2018
followed 126 000 rumors that were spread
by around 3 million people
and the false news reached people faster
than the truth and it diffused have
diffused further
using twitter data from 2006 to 2017 the
investigators classified news as true
or false using information from six
independent fact checkers
and the false falsehoods diffused faster
farther deeper and more broadly than the
truth
all categories of information the
authors suggested
that it was the novelty of false
information such as fear and disgust and
surprise
that made it more shareable and finally
bots
shared truth uh equally truth and lies
equally it was the people that actually
amplified the lies
so what does this mean for covert
vaccines
when kiwis were asked if they’d get a
covert vaccine
74 percent said yes which is about the
the global
average when people were asked why they
would not take a vaccine
concerns about safety were the most
cited and this is consistent globally
so why are so many people concerned
about the safety of a future
covert 19 vaccine perhaps
we’re just not doing a very good job of
helping people to understand how vaccine
safety might be assessed
but we also need to address something
far more complex than simply providing
better and more information
we need to foster trust and we need to
inoculate against misinformation as well
vaccine science has come a long way
since the days of the smallpox
inoculation
in just a few weeks uh from posting the
genetic code for this new pandemic
pathogen
vaccines were ready for the human
volunteers
in just nine months from the time china
and the who
raised the alarm several vaccines are
now in advanced clinical trials that
will soon yield data about their
efficacy
and about their safety but the vaccine
journey doesn’t stop
there and with preparation and
collaboration we can actually perform
the largest vaccine safety studies ever
undertaken
the covert pandemic has brought with it
an epidemic an
overabundance of information that has
resulted in an unprecedented distortion
of facts
no matter how safe a covert 19 vaccine
proves to be
we may face a challenge in convincing
people about the data
and in all this we all have a role to
play from global agencies
scientific journals mass media social
media platforms
and the one thing that everybody can do
is to check
before they share thank you