The case to infect volunteers with COVID19 to accelerate vaccine testing Nir Eyal

please welcome near a all thank you very

much Chris for the opportunity to

present this and I’m really enjoying the

discussion so far with thousands of

people dying globally every day from

coronavirus and thousands more condemned

to death by its disruptions think about

how much in life we could save by

adopting testing methods for vaccines

that are accelerated suppose we could

shorten time to roll out about one day

or by several months here’s the

conventional way to test the efficacy of

vaccines that the slowest part of

vaccine testing you distribute the

participants to people who get the

vaccine versus people who get a control

and then they go back to their homes and

you wait you wait until there are enough

exposures out there to the virus to

start seeing differences meaningful

differences between these two groups

which might allow you to conclude that

the vaccine is much more helpful for

preventing infections than the control

but my colleagues Marc lips H Peter

Smith and myself have proposed what

would be potentially a faster method and

one is more immune to the worry that

arose recently in a conventional vaccine

trial that the hotspot will move away

before you even reach a statistically

meaningful result here’s what we propose

it’s called a challenge trial and indeed

as Chris said what happens after you

distribute the vaccine to some people

and the control say the placebo to

others is you deliberately infect

everybody or they expose everybody to

the virus soon thereafter you will see

results

and be able to tell whether the vaccine

gives you greater protection then the

control in terms of say infection rates

you’re asking ourselves what’s going on

here this is very risky surely I’m a

bioethicists

aren’t I concerned people wouldn’t die

or get very sick in this trial well how

can we justify such a thing I think that

there is a way to justify it ethically

because there is a way among other

things to make the level of risk one

that we should agree is tolerable there

will be risks but they will remain

tolerable what is tolerable risk why

should there ever be risk in medical

practice medical research well we do

tolerate risks in some context think of

kidney donation everybody agrees that

live kidney donation for the purpose of

sustaining the transplantation system is

a good thing although it gains nothing

medically for the donor and there are

some risks the risks are that there is a

word a death in one in 3,000 cases of

donation let’s talk about the risk in

channel trials for coronavirus vaccines

if they are done in the best possible

way everybody is or most everybody is

likely to get infected but in the

general population

if you select young people say people in

their twenties for the trial we can look

at the number of deaths among people who

are in their 20s in the general

population and that number is lower than

the deaths from live kidney donation it

is 1 in 12 thousand cases so by simply

focusing on that age group alone in the

challenge crowd you’re already getting

to a tolerable risk level if kidney

donation is tolerable which surely it is

furthermore for this trial we should

select people who are not just the

average 20 something-year-old with

competent for rational decision making

and fully informed etc also you should

probably to minimize the risk further

exclude people who have the

preconditions that inclined people to

have severe covent outcomes such as

death once you do that the number should

go we don’t know the number of it should

go

seriously below 1 in 12,000 probability

of death upon that infection and

furthermore I think it would be right to

select the participants not from the

ranks of people who are very unlikely to

get infected at any point but rather

people who are in front-line professions

people who reside in big international

urban hubs were infection in some future

wave and there will be many waves before

we reach hurt immunities in some future

wave is fairly likely so they wouldn’t

move from 0 to 100% of infection or near

hunt percent they would move from

something much closer to a hundred

percent to 100 percent that also further

lowers the net added risk from

participation once you do those things

you get to a level of risk that is far

lower than that of kidney donation in

kidney donation we allow it because it’s

good for one other person and the donor

gives you very fully free and informed

consent and autonomously agree to

undergo a certain risk for somebody

else’s sake the difference is that in

this case we’re talking about not just

one person aided by this but potentially

many thousand saved from death or from

pravesh ment and that is a sort of

balance that from a population level

bioethics seems to me acceptable thank

you fascinating stuff so help me

understand this like let’s first of all

just look at some of the basic math

again I think currently there’s about

four or five thousand people a day dying

from coronavirus that number may plateau

down but it’s just as likely I think to

plateau upwards and so in a month that

means of the order

150,000 people might die and so you know

that’s a huge number of lives at stake

according to when a vaccine becomes

available right that’s the foundation of

the argument in many ways and yet people

behave so strangely in ethics around

numbers in the famous trolley car

experiments people will most people will

agree that they would flick a switch

that would divert a train onto another

track and kill a person if they knew

that that would save five people on the

other line but they wouldn’t for example

push a large person over a bridge onto

the track to stop the train even if they

knew that would also save lives there’s

that we differentiate between

intentional acts that put individuals at

risk and yet so this is like a troy one

of those trolley car experiments but

with on the one hand saving maybe one or

two lives if we’re unlucky if we don’t

do the challenge trials and and

potentially sacrificing hundreds of

thousands of lives through inaction I’m

it is that one crazy way of framing this

the ethics of action versus a mission

and intention versus mere foreseen

effect is very complex in this case I

believe that there is a strong case for

doing it just I’ll throw some pointers

about the general context the trolley

problem wouldn’t be the same if the

person who we are mulling over whether

to sacrifice for the sake of others

would tell us look I’m willing to do it

nor would it be the same if the risk for

them because we selected them in the

right way is very small indeed and we

know that for some individuals out there

populations at risk you know racial

minorities older people people who can’t

easily avoid leaving the work play so it

can’t really easily avoid the workplace

and need to put themselves at risk etc

for them the stakes might be higher than

for this individual

in this particular case I would kind of

cut to the chase and say look look at

the analogy of organ transplantation

look also the analogy of medical trials

that do something very similar they put

healthy people at risk so we can develop

drugs and vaccines for example the

safety trials that these vaccines that

we are talking about now have already

undergone in part which were done in

healthy volunteers who stood nothing to

gain from being given this dose of this

vaccine they only stood to gain a

certain risk it was a first in human

vaccinations nobody objected and said

that’s immoral although they put

themselves at risk to help all of us

with their full consent there are adults

complaining the risks and there are ways

to ensure that and we accept those

things it’s not ideal but there is no

other way to generate vaccines and I

would apply the same to Jones grouse

much of the medical establishment is

passionately wedded to the to this sort

of principle Hippocratic oath of first

do no harm how would you describe the

the ethics of that oath at a time of

global emergency again a complex complex

issue I want to stress two things first

that the number of people the dramatic

number of people who could be aided by a

faster method of testing vaccines

matters and second that it’s not the

only argument we mobilize it’s not

simply an argument of to bread to make

an omelet you need to break eggs the

argument is very much respectful of the

consent of these individuals of the

ability to after minimizing the risk by

focusing on the lower risk populations

and by providing excellent care in the

trials bringing down the risk to an

acceptable level so it’s not the case

that we are violating the rights of

individuals to maximize utility or

things of that sort

we’re both maximizing utility and

respecting rights and this marriage is

very very compelling in defending the

use of these accelerator designs so

we’ll take a couple of questions from

our community can you pop those on

screen so here’s one how would you get

people who’ve been marginalised by

medical science and vulnerable groups to

participate how do you cope with in

factoring privileged and process this is

an excellent question it brings up some

complexities because there are things to

gain and things to lose from involving

more marginalized populations from

focusing on on populations which are

more franchised and here are some of the

complexities I’ll to throw around and

some issues you wanna you wanna have

study participants who are very likely

to comprehend the risks very fully that

goes nicely with highly educated

participants um you don’t want to

exploit people who are participating

only because they think that they would

get money out of it my own preference

would be not to pay in this trial but

there are other people think that we

should be who don’t have any

alternatives for their care however on

the other hand you also want to ensure

that

constituencies of marginalized

populations of global marginalized

populations can have this claim and say

we participate in this trial now give us

these vaccines or that we will have

tested biologically that this works in

different types of human bodies

including not always the bodies of the

people who are most enfranchised so it’s

a complex balance sometimes there is

correlation I mentioned earlier I think

it will better to test the vaccine in

people who otherwise are likely to get

infected unfortunately in our very

unjust world that often correlates with

prior disadvantage so it’s not

exploitative not exploitative the far

the exact balance might be something

like try to focus on people who

otherwise

would probably get infected but are not

the most marginalized while guarding and

ensuring the quality of informed consent

it’s complex but these are exactly the

kinds of thoughts that we should be

having right now and one more question

how do you prevent or mitigate

unnecessary deaths with challenge trials

especially in a fast-track setting like

this so first it’s about the selection

criteria you want to focus on people who

are young and otherwise free from risk

factors hypertension obesity etc the

tend to correlate with bad outcomes from

the disease there is no guarantee that

nobody will develop severe kovat that

nobody will die but you can really

decrease dramatically the chances that

this will happen when you do that second

you want in the trial to provide the

best medical care available for this

disease by the time this happens there

might be novel therapeutics they might

be scarce first access to this I think

you no decency should be in the trials

so that we know that in return for this

person volunteering to get the trolly

earth it’s actually much less dramatic

than that get the risk of being hit of a

trolley and it’s a small risk I argued

we ensure that we treat them the best

way we can and that’s not just I would

propose knighting them decorating them

but also given the best possible care

and engaging them in discussions they

are agents they’re not guinea pigs

engaging them in the planning of what

will happen in these trials the

nonprofit one day sooner has I think

already recruited

I mean tens of thousands of volunteers

willing to participate is that how

should society regard this I mean at the

moment the the conversation seems over

weighed by fear of a death isn’t there

another scenario where we basically

recognize people willing to do this as

as heroes and celebrate them the same

way you know we might celebrate someone

who was going off to fight a noble war

or you know do something heroic for

like an astronaut who’s willing to risk

their life to go into space

you know we celebrate those people I

just wonder whether there’s any way of

actually changing the narrative and

whether that would make a difference to

accelerating the possibility of these

things actually happening I couldn’t

agree more I’m imagining that with these

people and they’re I mean I’m floored by

their courage by the intelligence the

leadership knows much more about many

technical aspects of these trials than I

do they’ve explored it seriously

academically many of them are graduates

of the best universities in the world or

teachers and the best universities in

the world and an amazing combination of

of courage intelligence good intentions

and if the volunteers come from these

ranks high chance of really

comprehending consent they know what

they’re getting into and I think every

every ground for the highest honors that

our societies have we’ll take one more

question and then I’m gonna bring back

dr. Kim and David and we’ll have a

four-way conversation so let’s have the

next conversation from our community

it’s coming I tell you what let’s not do

that let’s bring back talk to Kim and

David and just continue the conversation

because I I I have a question for dr.

Kim on this as to how how he views the

status oh you know what the question

popped up with organ donations which

have we have a long history of knowing

the rest based on actual data how do you

figure this out in this novel case

before you really know those risks great

question there was a time by the way

that for organ donation we allowed it

and we didn’t know the risks quite yet

this is the nature of science um there

are many unknowns for an emerging

infection I think in this case we

already have the bottom line number the

bottom line number is the biggest risk

in these trials is comes from the

infection and we know that if you focus

on the

of an age group we know what in the

general population in a developed

country with access to critical care etc

that number is roughly and it’s roughly

one in 12,000 which I argued is already

a tolerable risk level and the number

should be below that there are further

unknowns sometimes even that group

people die young people sometimes die of

this you healthy young people do it’s

very rare but when they do we don’t know

what was exactly responsible was it a

you know special gene or whatnot the

bottom line risk level for that group is

the number that is most pertinent for

the decisions about the risk for a group

where you do not know what genes people

have we don’t know what genes they have

to put them at risks here