to end the covert 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 12 to 18 months
is the timeline that we keep hearing
about for a potential kovat 19 vaccine
where do we have a vaccine 12 to 18
months were 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 a
record-breaking so let's look at how
vaccines for viruses are typically
developed stage 1 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 1 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
corona virus this allowed researchers
around the world to understand what the
virus looked like and how it worked and
it gave them a head start to developing
a vaccine so if a 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 Coe bid 19 vaccines may
already be through this stage stage 2
preclinical stage 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 preclinical stage for a co bid 19
vaccine well the reality is there's a no
way to speed up this stage and it will
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 covert 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 coded 19 vaccine and was
able to get from the first exploratory
stage to human trials in 63 days stage 3
clinical trials 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 2 phase 2 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 covin 19 vaccines in Phase one
clinical trials in the u.s. one way to
speed up phase 3 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
raised many ethical red flags in 2017
there was a proposed human challenge
child to speed up a Zika vaccine and
Zika of course can cause severe birth
defects and that human challenge tall
was criticized by ethicists as being too
risky so doing the math the quickest way
that a coded 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 4
regulatory review 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 for
they 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
it's absolutely critical before the
vaccine can make its way to a large
population Naoko bid 19 vaccines in the
US and near this stage over in the UK
scientists in 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 code 19 vaccine taking less
than the usual timeline of 6 to 10
months
stage 5 manufacturing this is a stage
where drug companies stop 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 7 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 six hundred
million dollars 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 covert 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 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 so how long will it take for 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 to
covered 19 vaccine by the end of 2020
they're talking about an emergency use
authorized vaccine not 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 Kovach
19 vaccine in two years likely in early
2022 the major delays and 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
their 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