J&J Coronavirus Vaccine Interview - Timetable, Testing, Manufacturing - Business Insider

4/7/2020 J&J coronavirus vaccine interview: Timetable, testing, manufacturing - Business Insider
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The top scientist at J&J told us how the $350 billion pharma giant
will have a coronavirus vaccine ready at 'warp speed', then pump
out 1 billion doses
Andrew Dunn Mar 31, 2020, 12:31 PM
H O M E PA G E
https://www.businessinsider.com/jj-coronavirus-vaccine-interview-timetable-testing-manufacturing-2020-3 1/13
Johnson & Johnson is racing to develop a coronavirus vaccine. Heather Hazzan, SELF Magazine
Johnson & Johnson plans to start testing a potential coronavirus vaccine in people
by September. The company is ramping up its manufacturing capacity at the same
time.
The vaccine could win an emergency approval as soon as early 2021, when tens of
millions of doses would be available, Chief Scienti c O cer Paul Sto els told
Business Insider.
The world's largest healthcare company is hoping to produce 1 billion doses of the
vaccine by the end of 2021.
Sto els said the company is working with the US government to build out its
manufacturing, and is having ongoing discussions with contract manufacturers.
J&J is committing more than $500 million to the project, and Sto els expects as
many as 1,000 company employees will soon be working on advancing the vaccine.
Visit Business Insider's homepage for more stories.
H O M E PA G E
In the sprint to develop a coronavirus vaccine that can halt the pandemic, the world's
largest healthcare company is preparing to ramp up its e orts.
This week, Johnson & Johnson selected a lead vaccine candidate, accelerated the
timeline to starting human testing, and laid out the ambitious goal of producing 1
billion doses of it by the end of 2021.
J&J has been researching a coronavirus vaccine since February. The company now
aims to start testing a vaccine in humans no later than September, at least two months
faster than a previous goal of November.
"My people will kill me if I commit to anything earlier than that," said Paul Sto els,
J&J's chief scienti c o cer, when asked if it's possible J&J could start trials before
September.
"We can't commit to that," he said, adding that any further acceleration of the timeline
would be measured in days, not weeks or months. "Early September is like warp
speed."
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Sto els, the chief scientist at J&J, spoke to Business Insider on Monday via a video call
from his home in Belgium. He explained how the pharmaceutical giant plans to tackle
two critical challenges in vaccine development simultaneously: testing to see if the
vaccine works and massively scaling up production to satisfy global demand.
Some biotechnology companies plan to start testing experimental coronavirus

vaccines earlier than J&J. Moderna, an upstart Massachusetts biotech, has already
started dosing patients in a rst trial, while other companies are nearing that point in
the next few weeks.
But those businesses lack the massive resources of J&J, a $350 billion company with
more than 132,000 employees. Facing a pandemic, drug developers are being pressed
not just for a speedy response, but for one that carries sweeping scope. A solution is
only as good as the number of people who can quickly receive a pill or vaccine, and
J&J's manufacturing might sets it apart from rivals on that score.
Read more: There are more than 40 potential coronavirus vaccines in the
works. Here are the top e orts to watch, including the 8 vaccines set to be tested
H O M Ethis
in people PA Gyear.
E
J&J is taking a risk in ramping up manufacturing before getting any clinical

results
J&J's current capacity for producing this coronavirus vaccine is 300 million doses per
year from one plant in the Netherlands. That is if the plant is exclusively focused on
this one vaccine, and not producing the other vaccines it typically does.
Before knowing if the vaccine works in humans, J&J is looking to expand production to
at least three additional plants, Sto els said.
It takes lots of technical work to get additional facilities running. Regulators require
new plants to validate their manufacturing process, testing to show the rst batch is
exactly the same as the 50th or 100th batch.
"That's why we have to do all the investment at risk," Sto els said. "If we don't start
now, we won't have that capacity at the end of the year."
H O M E PA G E
Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels. Johnson & Johnson
By the end of 2020, J&J plans to operate a US-based plant that can add another 300
million doses in annual production capacity, Sto els said.
J&J will also gure out over the next two months how to work with partners to bring on
additional capacity, he added. That includes potentially transferring J&J's technology
process to contract manufacturers, with the goal of bringing them online by the end of
2020.
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J&J could also activate other plants it has around the world, Sto els said.
The US government is nancially supporting J&J's upscaling. The Biomedical

Advanced
H O M E Research
PA G E and Development Authority (BARDA) committed this week $421
million to building out the vaccine capacity for J&J, according to Reuters.
But J&J is also putting serious resources on the table, as Sto els said the company is
committing more than $500 million to the project.
Sto els estimated J&J will soon have as many as 1,000 employees working on this
project, spanning all the elements of drug development: research, manufacturing,
statistical analysis, regulatory matters, and so on.
Overall, J&J has more than 15,000 employees in research and development, with an
annual research budget of about $11 billion.
How the vaccine works and will be tested
J&J's vaccine will target the surface spike protein of the coronavirus, a popular target
among vaccine programs.
There are still critical unknowns about how e ective a vaccine can be against this
virus. Sto els said a critical question that human testing will answer is if J&J's vaccine
prevents infection entirely, or if it primes the immune system, helping prevent people
with
HOthe
Mcoronavirus
E PA G E from experiencing the most serious form of the disease.
"If it doesn't prevent for infection, and it still prevents for serious disease, it's still very
valuable," Sto els said.
SVB Leerink analyst Geo rey Porges wrote in a recent note that the spike protein is a
logical target for a vaccine, but its viability isn't proven. Porges wrote in a March 23
note to investors that "vaccine developers are simply taking punts in the dark" by
selecting a speci c protein, an appropriate but still risky approach given the urgency.
Sto els and J&J CEO Alex Gorsky have both expressed con dence in the chances of
success with the lead candidate.
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"Why we say we are quite con dent is that we've done this four times for HIV, RSV,
Ebola, and Zika," Sto els said.
While the company has crafted vaccines for each of these four diseases, none of them
have yet to reach market or gain US regulatory approval for various reasons. In the case
of Zika, the outbreak died down before researchers could perform a large-scale test of
the vaccine, while clinical trials are ongoing for the HIV and RSV vaccines.
H O M E PA G E
With COVID-19, J&J has found an antigen that produces antibodies that neutralize the
virus, according to the company's research. The company is collaborating with BARDA
and the Beth Israel Deaconess Medical Center to develop the vaccine.
Sto els said past experience with the technology has shown neutralizing antibodies
are "typically predictive" of inducing a response in animals and humans.
The rst trial is now expected to start no later than September. It will enroll somewhere
between 200 and 500 people, Sto els estimated. He anticipated it will fully enroll in
just one day and produce results in a month.
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rest
Sto els said J&J and its collaborators will then pore over that data for about a week,
studying the immune responses of multiple dose strengths that were tested. These
results will quickly build the next study which Sto els said would recruit 10,000,
20,000 or even 50,000 people.
Another key unknown is what the disease will look like when that trial begins.
"The one challenge we will have is we need to go where the disease is," Sto els said.
"We will have to shift over the world: Where is the infection going?"
Health
H O Mauthorities
E PA G E will have to decide who gets the vaccine rst, Sto els says
A nal unknown on Sto els' mind is who will get the vaccine rst, given the incredible
global demand. Sto els expects J&J will have tens of millions of doses available in early
2021 and reach hundreds of millions of doses later in the year.
"What's needed is an agreement by authorities on who are the highest risk people who
need to be vaccinated," he said.
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the solution starts with community.
For Sto els, healthcare workers are on the top of his list of risk. These frontline workers
are dealing with the disease on a daily basis, he said, at great risk to themselves.
That is followed by the elderly and people with certain diseases, Sto els said, but the
decision will ultimately need to be made by health authorities as production capacity
is built up.
"You can't have a spike from zero to 100 million vaccines overnight," he said. "It doesn't
work like that."
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4/7/2020 J&J coronavirus vaccine interview: Timetable, testing, manufacturing - Business Insider

DOW S&P 500 NASDAQ 100

Multiphysics and Design

Visit Business Insider's homepage for more stories.

We all WFH: How companies & managers can

Some biotechnology companies plan to start testing experimental coronavirus

J&J is taking a risk in ramping up manufacturing before getting any clinical

59% of Americans say managing

The US government is nancially supporting J&J's upscaling. The Biomedical

How the vaccine works and will be tested

Seniors Love Posture Corrector

3 ways to put your money worries to

Americans are lonely. Experts say

CORONAVIRUS LIVE UPDATES 3 hours ago

As China lifts its coronavirus lockdowns, authorities are using a color-coded

Workers at essential businesses say they're insulted by 'pathetic' rewards of

The UK health system is so overwhelmed that a hospital is converting all its

Featured Health Articles:

How valuable was this story for you?

Don’t miss industry news. Get our daily newsletter today.

NOW WATCH: Drugmakers are developing coronavirus vaccines in record

More: Health Dispensed Johnson & Johnson coronavirus

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