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