J&J Starts Testing Single-Dose Covid Vaccine

by birtanpublished on October 2, 2020

so give us a sense of exactly where you
are in this process we heard from alex
gorsky earlier you were going to try to
start these phase three in september
looks like you made it
what's the process from here well we
made it
it's mid-september and we announced
yesterday that we are going to recruit
60 000
people in this study the study will be
run uh mainly in the us but also in
south america
in six countries as well in south africa
to to recruit of diverse
uh people um both young
and old we uh and as well as
diversity in african-americans latino
and the different
people who are at risk what's very
special i think is that this is a single
dose vaccine
we have been able to show to our
research and to our pre-clinical and
clinical testing earlier
that the single dose will be sufficient
to protect people
and so we're going to study this single
dose in this large clinical trial
in the next few months dr you mentioned
the elderly as well as african-americans
hispanics who have been
disproportionately affected by the
coronavirus as you put together your
group of volunteers
do you take that into account do you
over index as it were for some of the
people who are most vulnerable
yes we are doing that and we have been
working over the past months with
epidemiologists and data science to find
where in the us are can we find
regions of very high transmission but
also population groups
which are over indexed on
african-american latino and
uh and and elderly so to make sure that
the risk groups are
are very well-represented and an
efficacy study
now your approach is a bit different
from some others as i understand it and
i'm not a scientist but as i understand
it working with harvard you have
something that is a version of a cold
virus that's
adjusted somehow what advantages does
that give to you for example is it
difficult to store this vaccine in
we have been working on this for 10
years we have done several vaccines our
ebola vaccine is now being deployed in
in we are doing a study we are doing an
evaluation in over 200 000 people
um and that has been approved by emma so
it's a cold factor
which carries a piece of the genetic
material of
of of covet and then the body produces
the protein of the spike protein which
then generate the immunity
it is it is stable at two to eight
celsius for
three months it can be stay kept up for
a long time at minus 20
so it is a way to transport it to the
distribution size of minus 20
then go into the field into the
vaccination sites of two to eight so
it's a single dose simple to transport
and hopefully available on a very large
what's also important is that this is
counted to be effective starting 15 days
after the first injections
and that's very important for the
pandemic because that
that will protect you almost immediately
well if you have a boosted dose then you
need to wake six weeks before it starts
to be effective
and when you have an outbreak somewhere
you want to be able to protect people
fast so
single dose fast protection and easy to
president trump has talked repeatedly
about how fast he wants to have this
do you have any sense of the timeline
about how long it will take to know
whether it is effective as well as safe
or not
or is that itself unpredictable
well it it it's unpredictable but of
course doing 16 000 people and we will
recruit on fast we are very well set up
with more than 200 sites in the world
we will be able to recruit people but we
have our own values also in
what we want to see we want to first
absolutely learn
whether it's effective efficacious but
also whether it's safe and we will not
stop the study until we have enough
safety data
to be sure ourselves uh to then talk
with the regulators to be able to be
using it in emergency use so we predict
that that could be around the year-end
early next year we are now mid-september
uh four or five months would be the
timing for getting to that point where
emergency use could be possible
well talk about emergency use i guess
it's very much in the news these days it
was just yesterday with the president of
the united states referring to it
what does that mean emergency use i'm
told the fda is about to come up with
final regulations on that the president
says he's not sure he's going to abide
by them
what did those regulations look like
in i don't know yet but emergency use is
is a rule where the u.s government can
determine at what point
through fda and cdc can determine
to use a product earlier than approval
we have done that in the past with hiv
we do that sometimes with cancer
and here because of the pandemic and the
emergency the government could
use that that that possibility to do in
emergency use
uh it's again it has to be strict
because um we first want to make sure
that it's safe and effective as this
will deploy it on a very large scale
with very many people so we'll wait for
that outcome of what the fda will come
forward with and further
requirements but we have also our own
requirements which we'll put on the
vaccine before we release it
so that's a very important point there's
a lot of dispute right now about whether
politics may or may not be entering into
the fda approval process
but you're saying johnson johnson will
not go forward if you're not satisfied
no matter what the fda says
that's correct and in the end it's also
our responsibility that when we come
forward with the proposal for emergency
or when the fda or the cdc or or nih
will ask that or the government will ask
that that that we will be ready to uh to
proceed with that so
it's a government but it's also a
company a company decision
this is something all of us are
following very very closely obviously
we're eager to have that vaccine
provided it's effective provided it's
what is the sort of delay period between
on the one hand emergency use approval
actual approval for mass distribution
because most of us want to know when can
we go into our doctor or our local
and get a vaccine what's that delay
what's the time period
well emergency use could expand to to
extensive vaccinations so i think it's
more the comfort that
the fda and the government will have
with the safety but also the
availability of the vaccines i think
the first objective is here to vaccinate
the highest risk people
which are the elderly the healthcare
workers and the people with
comorbidities and then that will curb
the mortality of the disease very
quickly hopefully and then going to the
broader population so
emergency use could be used in the whole
but that's a decision of the government
so so doctor finally
uh when we talked to alex gorski your
ceo a couple of months ago he said that
actually johnson johnson would be
preparing for
mass production of a vaccine even as the
testing's going on obviously you're not
producing the vaccine itself
but are you prepared to go wide when and
if you get the approval
yeah we are at the moment we are
upscaling already the first batches are
in manufacturing
and we will be ready to to deploy early
next year
and we will have at least one billion
vaccines available in the course of next
um we are gearing up more manufacturing
in europe in the
in the us but also in india to make sure
that also we can deploy globally
as it is a global pandemic and so
we will further upscale to reach as many
people as possible because
hopefully a vaccine can put a stop to
the pandemic

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