How COVID-19 human challenge trials work -- and why I volunteered | Sophie Rose

Prevodilac: Zoran Brajovic Lektor: Ivana Korom

[Recorded on October 26, 2020.

[Ovaj govor je snimljen 26. Oktobra 2020.

COVID-19 vaccine development

Razvoj vakcine za COVID-19

and ethical considerations around human challenge trials

i etička razmatranja kontrolisane ljudske infekcije

are constantly evolving.]

se neprestano razvijaju.]

In April 2020,

Aprila 2020,

I made what many perceive as a risky decision.

donela sam, kako su mnogi mislili, rizičnu odluku.

I volunteered to be deliberately infected with COVID-19.

Javila sam se da budem namerno zaražena COVIDom-19.

This infection would be part of what is called a human challenge trial,

Ova infekcija bi bila deo studije kontrolisane ljudske infekcije

where young, healthy people are given a vaccine

gde su mladim, zdravim ljudima date vakcine

and are deliberately exposed to the virus that causes COVID-19.

i namerno su izloženi virusu koji izaziva COVID-19.

These trials help researchers figure out more quickly

Ova ispitivanja pomažu istraživačima da brže shvate

if a vaccine is working.

da li vakcina deluje.

I think this research is crucial,

Mislim da je ovo istraživanje ključno,

because today, I'm going to speak to you for six minutes.

zato što ću vam danas govoriti 6 minuta.

In that time,

Tokom tog vremena,

roughly 1,250 people will be confirmed infected with COVID-19.

otprilike 1.250 ljudi će biti zaraženo COVIDom-19.

Twenty-one people will die.

Dvadeset jedna osoba će preminuti.

And then this pattern will repeat hour after hour and day by day,

A onda će se ovaj obrazac ponoviti iz sata u sat i iz dana u dan,

until we're able to vaccinate most of the eight billion people

dok ne budemo u stanju da vakcinišemo većinu od osam milijardi ljudi

affected by this global crisis.

pogođenih ovom globalnom krizom.

Scientists have been working around the clock

Naučnici su radili danonoćno

to make those vaccines a reality.

da te vakcine postanu stvarnost.

But what should we do when the human cost of waiting for those vaccines

Ali šta bi mi trebalo da radimo kada cena čekanja tih vakcina

is rising by the day?

raste dnevno?

This is where human challenge trials come in.

Ovde nastupaju studije kontrolisane ljudske infekcije.

They're different from the traditional phase three vaccine trials

One su drugačije od tradicionalnih ispitivanja treće faze vakcine

taking place now,

koja se odvijaju sada,

where people are given a vaccine or placebo

gde se ljudima da vakcina ili placebo

and asked to go about their everyday lives.

i zatraži se da se vrate svojim svakodnevnim životima.

Here, researchers have to wait to see how many people in each group

Ovde, istraživači moraju da čekaju da vide koliko ljudi u svakoj grupi

become infected.

bude inficirano.

Until enough of them get sick,

Dok se dovoljno njih ne zarazi,

we don't have enough data to know whether a vaccine is working.

nemamo dovoljno podataka da znamo da li vakcina deluje.

Finding an effective vaccine with this method

Nalaženje efikasne vakcine ovom metodom

can take months or sometimes years,

može trajati mesecima ili nekad godinama,

and it requires thousands of volunteers.

i potrebno je hiljade volontera.

A challenge trial works faster

Studije kontrolisane ljudske infekcije deluju brže

because researchers control exposure,

jer istraživači nadziru izloženost,

instead of waiting for people to get sick.

umesto čekanja da se ljudi razbole.

So instead of a year,

Zato umesto jedne godine,

we could know in as little as a month

možemo znati za manje od mesec dana

whether a vaccine seems effective.

da li je vakcina efikasna.

Instead of thousands of volunteers,

Umesto hiljade volontera,

a challenge trial relies on just 50 to 100.

studija kontrolisane ljudske infekcije zavisi od samo 50 do 100.

Because we know for certain

Zato što znamo zasigurno

when people are exposed and develop disease,

kada su ljudi izloženi i razviju bolest,

these trials also allow us to gather data

ova ispitivanja nam takođe dozvoljavaju da skupimo podatke

about the early stages of infection and our immune response.

o ranim fazama infekcije i našem imunom odgovoru.

This data is impossible to gather in any other way,

Ove podatke je nemoguće skupiti na bilo koji drugi način,

especially for people who become infected but never show symptoms.

pogotovo inficirane ljude koji nikad ne pokazuju simptome.

This knowledge is important for designing policies

Ovo znanje je važno za određivanje pravila

that limit COVID-19 transmission.

koja ograničavaju prenos COVIDa-19.

The time saved translates into precious months' head start

Sačuvano vreme se prevodi u dragocene mesece prednosti

on manufacturing,

na proizvodnju,

getting us more working COVID-19 vaccines faster.

tera nas da brže pravimo efikasne COVID-19 vakcine.

These trials are useful --

Ova ispitivanja su korisna

even though recent phase three results sound encouraging.

iako skorašnji rezultati treće faze zvuče obećavajuće.

The arrival of the first vaccine is going to be a monumental breakthrough.

Dolazak prve vakcine će biti važno otkriće.

It just isn't quite the fairytale ending we're all hoping for.

Nije baš bajkoviti završetak kojem se svi nadamo.

We're going to need multiple vaccines,

Trebaće nam brojne vakcine,

because we just don't have the infrastructure needed

zato što nemamo potrebnu infrastrukturu

to immunize all eight billion people on the planet with just one kind.

da imunizujemo svih osam milijardi ljudi na planeti sa samo jednom vrstom.

Each type of vaccine requires its own special process and equipment

Svaki tip vakcine zahteva svoj specijalni proces i opremu

to make, store and deliver it.

da se napravi, skladišti i isporuči.

If we had multiple working COVID-19 vaccines,

Kad bismo imali više osposobljenih COVID-19 vakcina,

we could make use of all of our equipment at the same time.

mogli bismo upotrebiti svu našu opremu u isto vreme.

Some of the leading candidates need to be kept extremely cold

Neki od vodećih kandidata moraju biti čuvani ekstremno hladni

before they are delivered to people.

pre nego što se isporuče ljudima.

This can be really hard,

Ovo može biti vrlo teško

especially in countries where there isn't reliable electricity

pogotovo u zemljama gde ne postoji pouzdana struja

or a secure method to store them.

ili sigurna metoda da se skladište.

Scientists have been using human challenge trials

Naučnici koriste studije kontrolisane ljudske infekcije

for hundreds of years.

stotinama godina.

They've sped up the development of vaccines against typhoid and cholera,

Ubrzali su razvoj vakcina protiv tifoida i kolere,

and they've helped us better understand how immunity develops

i pomogli su nam da bolje razumemo kako se razvija imunitet

to things like the flu, malaria and dengue.

na stvari kao što su grip, malarija i denge.

We've even used them for other types of coronavirus before.

Takođe smo ih koristili za druge tipove korona virusa u prošlosti.

There's been a lot of debate

Bilo je dosta razgovora

about whether challenge trials are too risky.

o tome da li su "izazov ispitivanja" previše rizična.

I happen to think that those risks are worth taking.

Slučajno mislim da su ti rizici vredni pokušaja.

A challenge trial would only recruit young and healthy participants --

Studije kontrolisane ljudske infekcije bi bile samo za mlade i zdrave učesnike -

think between the ages of 20 and 29.

između 20 i 29 godina.

Fewer than one percent of people in that age-group

Manje od jednog procenta ljudi u toj ciljnoj grupi

need to be taken to hospital after becoming infected with COVID-19.

mora biti odvedeno u bolnicu nakon infekcije COVIDom-19.

So it would likely be even lower in a challenge trial,

Znači da bi čak bilo niže u studiji kontrolisane ljudske infekcije

because researchers check to make sure

zato što istrazivači proveravaju

that participants have no preexisting conditions.

da učesnici nemaju već postojeće bolesti.

The risk of a young healthy person dying of COVID-19

Rizik da mlada zdrava osoba umre od COVIDa-19

is around five thousandths of a percent.

je oko 5 hiljaditih delova procenta.

That means for every 100,000 20-year-olds who become infected with COVID-19,

To znači na svakih 100.000 20-godišnjaka koji se inficiraju COVIDom-19,

about five die.

oko petoro njih umre.

If I were to give birth in the United States,

Da se porađam u Americi,

my risk of dying would be higher than that.

moj rizik od umiranja bi bio viši od toga.

Or you could choose to think about it this way.

Ili možete izabrati da razmišljate ovako.

If my little sister needed a kidney,

Da je mojoj mlađoj sestri potreban bubreg,

I wouldn't hesitate for a moment before I offered her mine.

ne bih oklevala ni trenutka da joj ponudim svoj.

And if I can take on that risk to benefit a loved one,

I ako mogu da rizikujem na taj način da pomognem voljenom,

it makes sense to allow people to take on a similar risk

ima smisla dozvoliti ljudima da rizikuju na sličan način

to speed up the development of a vaccine

da bi se ubrzao razvoj vakcine

that would benefit not just their loved ones,

koja bi doprinela ne samo njihovim voljenima,

but everyone around them as well.

već svima oko njih takođe.

There's a lot we still don't know,

Ima puno toga što i dalje ne znamo,

especially about the long-term effects of COVID-19 infection.

pogotovo o dugoročnim efektima infekcije COVIDom-19.

I volunteered despite that uncertainty

Javila sam se uprkos toj neizvesnosti

because like many of you, I feel frustrated

zato što se kao mnogi, osećam frustrirano

knowing that hundreds of thousands of people are dying.

znajući da stotine hiljada ljudi umire.

And that's without mentioning the millions more who are struggling

I to ne računajući milione koji se muče

as measures to stop the spread take a toll on their physical,

jer su mere za suzbijanje širenja uticale na njihovo psihičko,

emotional and mental well-being.

emocionalno i mentalno zdravlje.

It turns out I'm not alone in feeling this way.

Izgleda da nisam jedina koja se oseća tako.

Since May, over 39,000 people from across the world

Od maja, preko 39.000 ljudi iz celog sveta

have volunteered to participate in potential COVID-19 challenge trials

se javilo da učestvuje u potencijalnim ispitivanjima COVIDa-19

through a nonprofit I helped found called 1Day Sooner.

preko neprofitne organizacije "Dan ranije" čije osnivanje sam pomogla.

We advocate for challenge trial participants

Zalažemo se za učesnike u studijama kontrolisane ljudske infekcije

and have been encouraging stakeholders to begin preparing for these trials.

i ohrabrujemo zainteresovane strane da započnu pripreme ispitivanja.

As early as May,

Još u maju,

when challenge trials were still being considered

kada su studije kontrolisane ljudske infekcije i dalje bile razmatrane

for their role in the fight against COVID-19,

zbog njihove uloge u borbi protiv COVIDa-19,

the World Health Organization cited 1Day Sooner

Svetska zdravstvena organizacija navela je "Dan ranije"

as an example of the kind of public engagement needed

kao primer vrste javnog angažovanja

to run a challenge trial.

koji je potreban da bi se počela studija kontrolisane ljudske infekcije.

In mid-October,

the UK government formally announced their intention

Sredinom oktobra,

britanska vlada formalno je najavila svoje namere

to conduct a challenge trial at the beginning of 2021.

da sprovede studiju kontrolisane ljudske infekcije početkom 2021. godine.

It is clear that the COVID-19 pandemic is a global crisis.

Jasno je da je pandemija COVIDa-19 globalna kriza.

It has inspired record-shattering innovation,

Inspirisala je rekordne inovacije,

and it has highlighted the heroic acts of many frontline workers,

i naglasila je herojska dela mnogih ključnih radnika,

but is has also taken a catastrophic toll.

ali isto uzela i kastrofalne žrtve.

The arrival of each new vaccine brings us one step closer to rebuilding.

Dolazak svake nove vakcine nas dovodi korak bliže ponovnoj izgradnji.

But the true global solution

Ali pravo globalno rešenje

lies in those vaccines being in the hands of people all over the world.

leži u tim vakcinama koje su u rukama ljudi širom sveta.

Challenge trials could be a part of that solution.

Studije kontrolisane ljudske infekcije bi mogle biti deo rešenja.

Thank you.

Hvala vam.