- 'Sup ya beautiful bastards?
Hope you've had a fantastic Friday,
which is a thing I have not said for a very long time,
'cause I hate Fridays.
No, in case you're wondering why you got this video,
because you missed my Monday announcement,
like I said Monday, especially as we're all dealing
with this coronavirus situation, we've got a new schedule.
So you know, an uncertain future, but silver lining,
more of my dumb face and voice.
But today, while I have you, I wanted to cover something
that I've gotten a lot of questions about,
and that is a vaccine for the coronavirus.
So far, the Food and Drug Administration
has not approved any vaccine
for the virus known as SARS-CoV-2.
And so you know you have a lot of people asking,
how far away is a vaccine, why does it take so long?
What does it look like, and of course, who is making it?
Okay, so first thing to know,
there are tons of different vaccines
in the works around the world right now.
And each of these groups is racing
to have their vaccine safe and ready as soon as possible.
And if it was up to President Donald Trump,
we would have one ready by November,
but that appears to be impossible.
Right, and it's not just me saying that.
I haven't been secretly a vaccine expert this entire time,
surprise, it's health officials.
They currently believe that it's going to take
about a year and a half to put any vaccine on the market.
Though there are a handful of optimistic researchers
hoping to have something ready in a year.
- You said recently that you could have some kind of vaccine
within a year or so. - Right, right.
- How do you speed up that timeline,
and how do you fix the problem you said you have,
which is finding a manufacturer?
- Right, well first of all, Margaret,
that one-year timeline would be the world's indoor record
of ever getting a vaccine out,
at least to be able to early-deploy.
You can't do any better than that.
If you go any faster, you'll be cutting dangerous corners.
- And while that may seem like a long time away,
the development of several COVID-19 vaccines
are actually moving at record speed.
All right, but let's talk about one of the vaccines
shooting to be the first on the market.
Back in January, we saw the drug developer Moderna
partner with the National Institutes of Health.
Reportedly, researchers there were working nights
and weekends to develop the first version of this vaccine.
And look, that development happened fast,
because by the end of the month,
Moderna had already received a grant
from the Coalition for Epidemic Preparedness Innovations
to help them manufacture a batch of that drug,
big enough to be used in clinical trial.
And then, late last month,
the Kaiser Permanente Washington Health Research Institute
received approval from the NIH to begin clinical trials
of that vaccine in Seattle.
Trials began this past Monday,
and involved 45 healthy participants
between the ages of 18 and 55.
So this part is known as a phase-one trial.
And according to Kaiser,
this phase will last about 14 months,
because participants will need
to attend 11 in-person visits.
During that time, each person will be randomly split
into one of three different groups,
with each group then receiving a different dosage
of the vaccine.
With those 11 visits, they're getting two vaccinations,
and the other nine visits are initial screening,
as well as follow-up visits.
And in this phase, researchers will specifically be testing,
quote, the safety of various doses
and whether those doses produce an immune response.
Right, and when they say, produce an immune response here,
what they're saying is,
is this potential vaccine going to produce antibodies?
But notably here, in this 14-month phase,
it doesn't actually study the effectiveness of the vaccine
in preventing coronavirus infection.
That work doesn't actually come in 'til phase two,
which we'll talk about in a minute.
But, before we get there,
I wanna talk about what this vaccine looks like,
because it's actually a lot different
than the types of vaccines that we're used to getting.
So, the first thing you gotta know
is this vaccine doesn't include any live form of the virus,
though that is a common form of vaccine.
You see, with vaccines for diseases like measles,
mumps, rubella, and also for chicken pox,
those usually contain a weakened version of the virus.
To keep it really simple, it can infect you and replicate,
but all the harmful parts are removed,
so it can't actually hurt you.
And so the way that this works
is your body's immune system will then clear the virus out,
and know how to get rid of it again
in case you get exposed to the actual virus later.
Now the coronavirus vaccine is also not what's known
as an inactivated or killed vaccine.
Those, along with live vaccines,
are the other most common type of vaccine.
With killed vaccines,
you have the likes of the rabies vaccine,
and also the vaccines for hepatitis A, polio, and cholera.
And so the thing with these vaccines
is that they cannot replicate,
so your antibodies just attack what they're given.
So kind of similar to live vaccines
in that your antibodies are being stimulated
to attack a specific virus,
but killed vaccines are generally considered weaker.
So they're also usually the vaccines
where you're gonna need booster shots, right?
Okay, so at this point, you might be like,
"Phil, okay great, now I know what it's not,"
which I would say, "Shut up, I'm trying to educate you
"and also give you some information that you can repeat
"and sound smarter with later."
Right, so the coronavirus vaccine,
it's not a live vaccine, it's not a killed vaccine,
it's what's known as an mRNA vaccine.
And so, here we're gonna be talking about virology.
Things are gonna be naturally complicated,
though, spoiler alert, I am actually an expert virologist.
I'm not, I lied to you just now.
But, to kinda break it down on a basic level,
this coronavirus is wrapped up in a capsule.
On the surface of that capsule
is what's known as a spike protein,
and that spike protein is really important here
because the coronaviruses use it to latch onto human cells.
But because it's on the surface,
it's also the first thing antibodies are going to recognize
and latch onto.
Now the other important thing to realize here
is that mRNA makes proteins, including that spike protein.
And now what they've made is a vaccine
that includes the mRNA coding for that spike protein.
Right, so essentially, the idea here
is that if you inject this mRNA vaccine
into your deltoid muscles, the mRNA will then use machinery
inside your cells to make spike proteins.
Right, and so what happens next is similar
to how I described those live
and killed vaccines a minute ago.
In theory, your antibodies will then attack
and remember that spike protein.
And so the idea would be you get this vaccine
and if you're exposed to COVID-19,
your immune system should already be able
to recognize those spike proteins
on its surface and attack it.
And something that was really interesting
is the entire reason the development of this vaccine
was able to move so quickly is because these researchers
were able to use genetic sequences
that Chinese doctors uploaded to a database,
really just days after the virus was discovered.
So instead of having to rely
on physical samples of the virus,
Moderna was able to study the virus
and the spike protein's coding,
which is also why you saw Moderna getting this grant,
and why we're not talking about a traditional live
or killed vaccine.
Right, and so according to the NIH
National Library of Medicine,
researchers expect this phase of the trial
to be completed by June 1st of next year.
Okay, so that is phase one, which brings us to?
- [Child] Do you know what phase is next, think hard.
(toy whistle blowing)
- That's right, phase two.
(children cheering)
And in phase two, as long as everything has been successful,
this vaccine will then be tested
in even bigger pools of participants.
Remember that first phase was only 45 people.
So now we're talking about somewhere in the hundreds.
Though it's still way too early
to know exactly how many people
they're going to try to test.
Also during phase two, scientists will continue
to further look at the safety of this drug,
but the main goal here is to see if the vaccine
is going to be effective against the coronavirus.
Basically, does it stimulate an accurate immune response?
Now reportedly, Moderna is already actively preparing
for a potential phase two,
with the company possibly starting to manufacture material
for that phase in as little as a few months.
And if this phase is successful,
that vaccine will then move into phase three
of the clinical trial.
There it'll be tested with even more people.
Researchers will also look at things like side effects.
They'll also compare it to some of the current treatments
that we have right now, with the big question being,
is this better than what's already available?
Which, of course right now we're talking about a situation
where there is no other vaccine.
But, of course they're not the only one in this race.
In fact, there are no lack of vaccines being developed.
I mean, actually, CEPI,
the organization that gave Moderna its grant,
also gave out two others.
One of those to a lab
at the University of Queensland in Australia,
and there, that lab included a stabilized
and isolated synthetic form of the spike protein
directly in its vaccine.
And the idea there is that using the actual protein
will provoke a strong and accurate immune response.
And they are actually planning
to begin clinical trials by this summer.
There's also another vaccine being developed
by a company called Inovio,
which has also gotten a grant from CEPI.
Additionally, you have companies
like Johnson and Johnson's Janssen,
Sanofi, Pfizer, the biotech CureVac,
also, other vaccines in development in China,
Canada, England, and other countries.
But, the key here is the development in the United States
is currently the first to enter trials.
Which actually, on the note of record speed,
I wanted to dive a little deeper into that.
Right, for example, you look back to the SARS outbreak
that started in 2002.
It took 20 months to get the vaccine to phase-one trials.
And then, with Zika,
which is the fastest we've ever seen a virus
go from outbreak to phase-one clinical trials,
that still took seven months
to get a vaccine ready for testing.
But then you compare that to here
where researchers finished working
on this potential Moderna vaccine on January 13th.
So just two days after those Chinese scientists
uploaded the coronavirus sequence,
and it's already being tested on people.
That is unprecedented.
All right so, 1 1/2 years,
while it may sound like an incredibly long time,
it is wild that this is even possible.
But, there's a lot of 'em and they're always big.
Even if everything goes according to the best
of Moderna's plans or anyone else's plans,
1 1/2 years is still a long, long time
for people living in the now.
The world feels like it's changing,
the weight of concern increasing.
I mean, going back to that Zika example,
that epidemic had pretty much already died down
by the time that the vaccine
was approved for clinical trials.
Or SARS, that died down after four months,
and whole companies just abandoned their vaccines afterward.
Which actually brings me to my next point, money.
Money, money, money, sweet, sweet money, money,
and here's the thing, you have these outbreaks,
but usually they don't last all that long.
Which yes, is definitely, definitely a good thing.
Do not get me wrong there,
but that also means that no one's really gonna be
buying your vaccine after it's over.
As a writer for Wired put it,
"No one wants to make a product
"that's not going to be used."
Though, with COVID-19, it does appear that this situation
could end up being different than those previous outbreaks.
I mean, you have some health officials
worrying that this could be seasonal.
And the federal government is also working
under the assumption this pandemic
could last 18 months or longer.
Making vaccines is cost-intensive.
In fact, so much so that the vaccine business
is dominated by just four companies,
Pfizer, Merck, GSK, and Sanofi.
And yes, earlier I did mention
that both Pfizer and Sanofi are making vaccines.
And reportedly, GSK has also started development
on one as well.
The Washington Post also reporting
that Merck is pursuing either a vaccine or medication.
Actually, I wanna take a second
to focus on Merck for a second.
So back with the Ebola epidemic,
Merck started developing a vaccine.
That vaccine was approved and put on the market last year,
but, by then, the crisis was already over.
All right, so, Zika, SARS, Ebola,
stuff like this keeps happening.
Companies are calling
to disrupt their profit-seeking operations
to develop a vaccine for an outbreak,
that vaccine then fades,
and many times these companies are left in the red.
And that is where this big circle comes back around to CEPI.
In a 2018 interview, CEPI's CEO, Richard Hatchett,
said that the drug makers, quote,
"have very clearly articulated
"that the current way of approaching this
"to call them during an emergency
"and demand that they do this
"and that they reallocate resources,
"disrupt their daily operations
"in order to respond to these events,
"is completely unsustainable."
But that's also a pretty glaring catch-22
because you need these types of companies
to develop emergency response vaccines.
Right, so in 2017, in response to the way
that the Ebola epidemic was handled,
CEPI was formed as a private-public partnership.
The idea being that it could award grants
for swift vaccine development targeting emerging threats
that the pharmaceutical industry might otherwise ignore.
Notably, it was actually co-founded
by the Bill and Melinda Gates Foundation
and the Wellcome Trust,
with the Gateses pumping in $100 million.
Also we had countries like Japan, Norway, Germany,
India, Australia, Belgium, Canada, the UK,
though, notably not the United States.
However, back in 2006, the United States did found BARDA,
the Biomedical Advanced Research and Development Authority,
and it, reportedly, has also been streamlining the process
for many drug manufacturers.
I should also note that vaccines
are not the only solutions being explored now.
There are also other drugs that might treat the virus
that are currently in phase three of clinical trials.
And the biggest name that comes to mind here is remdesivir.
It's made by Gilead Sciences who make antiviral drugs
for things like HIV and the flu.
And the reason it's already in phase three,
which, if you don't remember,
we said normally it doesn't happen until years
into a drug's trials,
it's because it was originally developed for Ebola,
but it's also shown success in animals
against other coronaviruses like MERS and SARS.
And so now it's being tested on COVID-19 as well.
They are set to report their findings next month,
and the doctors in the United States and Italy
have been approved to test the drug
on a small number of patients with severe COVID-19.
And here, one patient in Washington even reported recovering
after being treated, but one person,
that's hardly enough for approval.
Yesterday, we also saw Trump say that he's pushing
for the FDA to approve hydroxychloroquine against COVID-19.
Now, hydroxychloroquine is antiviral,
but notably, it was developed to treat malaria.
However, it has shown some success
in patients with COVID-19,
and it already has market approval.
Okay, now Trump said that it would be made available.
- Almost immediately.
- But, we later saw the FDA
kind of scale back Donald Trump's comments,
saying to use hydroxychloroquine for COVID-19 patients,
you'd need another clinical trial.
Saying over the next couple of weeks,
we'll have more information that we're really pushing hard
to try to accelerate,
and that will be a bridge to other therapies
that will take us three to six months to develop.
And this is a continuous process.
There is no beginning and end.
And to reiterate, these are not vaccines.
So while solutions like remdesivir and hydroxychloroquine
may help out those who already have COVID-19,
it will not stop others from getting it.
But, and once again, they are big, and they are many,
even remdesivir brings us back to a central issue.
It was developed for an Ebola crisis that has since shifted,
and they were looking for other ways to use the drug.
Otherwise, like manufacturers of vaccines,
their work and their money might go down the drain
once the crisis ends.
Right, which once again, isn't to say
that they should not put in this work,
but it does appear like it's a greater reason
why groups like CEPI have been set up and need to be set up.
Right, its funding is one of the reasons
we've seen such a fast response
from some of these smaller startup biotech companies.
And it's a model that can prove to be very, very effective
in these moments of crisis.
But yeah, ultimately, that brings us
to the end of the video.
I know this is definitely a different kind of video.
If you liked it, let me know, hit that like button.
Hopefully with this one, you learned something,
you feel more informed, more understanding
of the situation that we're dealing with.
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But, with all that said, of course as always,
my name is Philip DeFranco, you've just been filled in.
I love your faces, and I'll see you next time.
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