Physician Explains How Quick a Covid-19 Vaccine May Be Created | Trigger + Management | WIRED

published on July 2, 2020

– To end the COVID-19
pandemic and to return

to some kind of normal,
we're gonna need a vaccine

But how long will it take to develop one?

[upbeat keyboard music]

12 to 18 months is the timeline
that we keep hearing about

for a potential COVID-19 vaccine

– When do we have a vaccine?

12 to 18 months

– We're 12 to 18 months
away from this going away

– But here's a comparison

The fastest vaccine we've
previously developed

was for mumps and that
took four years to develop

And typically it takes 10 to
15 years to develop a vaccine

So 12 to 18 months would
be record breaking

So let's look at how vaccines for viruses

are typically developed

[upbeat keyboard music]

Stage one, the exploratory stage

The exploratory stage is
also known as the research

or discovery stage for a vaccine

Here researchers are trying to come up

with the best possible way to
immunize us against a virus

This first stage can take
between two to four years

But right now scientists are
speeding through stage one,

partly because of new technologies,

and also because this SARS coronavirus

has some similarities
to the first SARS virus

Researchers are developing
nucleotide-based vaccines

that use the virus's genetic code

to potentially protect us from infection

This is a new way of developing a vaccine,

where the virus's RNA or
DNA prompts our bodies

to make a part of the virus

and that's how we develop immunity to it

In January 2020, Chinese scientists shared

the genetic sequence
of the new coronavirus

This allowed researchers around the world

to understand what the virus looked like

and how it worked, and
it gave them a headstart

to developing a vaccine

So if nucleotide-based vaccines work,

that could mean that we're done

with this first exploratory stage

and that cuts up to four
years off our timeline

But, and this is a big but,
nucleotide-based vaccines

have never made it through
clinical trials and FDA approval

So the exploratory stage
can take up to four years

But thanks to existing
research and new technologies

for vaccine development,
some COVID-19 vaccines

may already be through this stage

Stage two, preclinical stage
[upbeat keyboard music]

This is where scientists
start testing the vaccine

in cell cultures and in animals to see

if it triggers an immune response

If there's no immune
response or the vaccine

is causing harm to cells,
then it's back to square one,

the exploratory stage

So how quickly can we move
through the pre-clinical stage

for a COVID-19 vaccine?

Well, the reality is there's
no way to speed up this stage

And it'll probably take at least a year

But one way to make this more efficient

is to start doing different stages

of vaccine development simultaneously

This is exactly what some
COVID-19 vaccine scientists

are doing right now

They're testing the vaccine in animals

at the same time that they're
testing the vaccine in humans

Doing the testing in animals and humans

at the same time is unusual

But the FDA does have a fast-track process

in cases of public health emergencies

Most vaccines don't make it
past the preclinical stage

But the American biotech company Moderna

is working on a COVID-19
vaccine and was able

to get from the first exploratory stage

to human trials in 63 days

Stage three: clinical trials
[upbeat keyboard music]

This third stage is clinical trials

or testing the vaccine in people

Most vaccines don't ever
reach clinical trials

But if they do, then this stage
can take 19 months or more

and it consists of three phases

In the first phase, the
experimental vaccine

is given to a small group of people

This phase can take about three months

If an experimental vaccine is safe,

then it moves on to phase two

Phase two typically takes at
least six to eight months

During phase two, the vaccine is given

to several hundred people,
including a control group

who get a placebo, not the actual vaccine

The control group helps
researchers compare

how the vaccine works and
control for different variables

In phase three, thousands of people,

usually folks in the outbreak area,

will receive the experimental vaccine

This phase can also last at least

six to eight months if not longer

And at this point, researchers
are looking to make sure

the vaccine is effective and
to monitor any side effects

These are best-case scenarios in terms of

the timeline for each
phase of human testing

Right now, there are at
least three COVID-19 vaccines

in phase-one clinical trials in the US

One way to speed up
phase-three clinical trials

is to do something called
a human challenge trial

That's where people are given the vaccine

but then the scientists
intentionally infect them

with the virus to see more quickly

if the vaccine really works

It might sound like an extreme way

to speed up vaccine development,

but it's been done many times before,

including with cholera, dengue, and flu

Human challenge trials raise
many ethical red flags

In 2017, there was a proposed
human challenge trial

to speed up a Zika
vaccine and Zika of course

can cause severe birth defects

And that human challenge
trial was criticized

by ethicists as being too risky

So, doing the math, the quickest way

that a COVID-19 vaccine
could make its way through

human testing without doing
human challenge trials

is around 15 months

But there could be delays at
any point along this timeline

Stage four, regulatory review
[upbeat keyboard music]

At this stage, the vaccine
manufacturer submits

an application to receive a license

so that they can manufacture the vaccine

Typically, it takes the
FDA 10 months to conduct

a standard review, or six
months for a priority review

But the FDA can move faster

in case of a public health emergency

And some FDA programs
allow for a rolling review

That's where the vaccine
maker is submitting

information as they go
along instead of waiting

'til they've finished and then
submitting the application

The FDA is responsible
for overseeing the safety

of any drug or vaccine
available in the US

So, its review of this information

is absolutely critical before the vaccine

can make its way to a large population

No COVID-19 vaccines in the
US are near this stage

Over in the UK, scientists
at the University of Oxford

are hopeful that emergency
approval of their vaccine

by UK regulators could mean
it's available in September

The best case would be a rolling review

of a potential COVID-19
vaccine taking less than

the usual timeline of six to 10 months

Stage five: manufacturing
[upbeat keyboard music]

This is the stage where
drug companies start making

and distributing their vaccines

It takes an incredible amount of resources

and investment in
infrastructure, raw materials,

and scientific expertise

Manufacturing a vaccine
can take a long time

According to one estimate,
it can take between

seven to 36 months to produce
and deliver a vaccine

It can also take a really
long time for companies

to scale-up their
manufacturing capabilities

The drug company Pfizer
told The New York Times

that it took them $600
million and five years

just to produce a manufacturing plant

for one of their pneumococcal vaccines

And currently, we are not
at the manufacturing stage

for a COVID-19 vaccine

But if we were, how quickly would we move?

To be honest, this is an unknown

and depends very much on the capacity

of the drug company involved

Stage six: quality control
[upbeat keyboard music]

So, we're not done yet

Once the vaccine is
distributed to the public,

there's the ongoing
stage of quality control

And this is done in the US by the CDC,

the FDA, and the vaccine maker

[upbeat keyboard music]
So how long will it take

before a vaccine is
available for the public?

Well, we can go through each stage

and add up the time taken

But often these are time ranges

and we're seeing right now that sometimes

one stage is done at the
same time as another stage

When experts optimistically say that they

expect a COVID-19 vaccine
by the end of 2020,

they're talking about an
emergency use-authorized vaccine,

not a fully approved one and
very limited supplies of one

Seeing a vaccine in 12 to 18 months

would mean producing millions of doses

by January or June of 2021

If things continue to move
as quickly as they are now,

there's a possibility that there could be

a COVID-19 vaccine in two
years, likely in early 2022

The major delays in
potentially seeing a vaccine

by the new year would be the time it takes

to safely move through clinical trials

and the manufacturing stage

Clinical trials usually
take a minimum of 15 months

And that's if everything goes perfectly

with the vaccine working
exactly the way it was designed

and not causing major side effects

The manufacturing stage
is another unknown

Producing a safe and effective vaccine

for millions or billions
of people could take,

at minimum, seven months

I know we're excited and
desperate for a vaccine

to be available within 12 to 18 months

But what's even more
important than rushing

is that we have a vaccine that's safe

and a vaccine that works

And until then, we're
going to have to stick with

the things that we know work,

including those containment measures

such as physical distancing

[upbeat keyboard music]

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