You saw the title.
Today, we're talking about kids and vaccines.
Should you give your child a vaccine against COVID-19?
What are the potential side effects?
How did we get to vaccines for kids so quickly and yet so
much more slowly than we did for adults?
We're going to talk about all of it,
but I am not an expert in immunology or vaccine creation.
So today, I'm joined by people who are.
So this is Shelby.
She studies early life vaccination,
and I'll let you explain.
Specifically, I'm studying how one
of many factors in our immune system
might affect the response to BCG, the vaccine
against tuberculosis.
Shelby and I are going to be going through the basics
of childhood vaccines.
We're also going to talk with Dr. Paul Offit, a professor
of Pediatrics and an attending physician at the Children's
Hospital of Philadelphia as well as a co-developer
of our current rotavirus vaccine and a member of the Vaccines
and Related Biological Products Advisory Committee.
Right, so I'm one of 12 full-time members on the FDA'S
vaccine advisory committee.
What we typically do is in March of every year,
we pick the flu strains that will
go into the vaccine that will be available to the public
in September.
We're left alone to do the boring, nerdy things
that virologists and immunologists do.
Then COVID hit, and suddenly, our FDA vaccine
advisory committees are live streamed.
They've been on CNN.
We're the constant focus of media attention.
It's been overwhelming.
There's been a lot of talk about whether or not
we even need to be vaccinating kids against COVID.
So at the beginning of the pandemic,
they didn't really seem to be as affected by COVID-19
as adults did.
So while initially, children made up less of our COVID cases
and appeared less at risk for severe disease,
children now make up more than 24%
of all COVID cases in the United States.
For the whole of the pandemic, the overall rate
of COVID in children is 8,498 kids
per 100,000 kids in the population.
And as of the October FDA report,
over 8,300 children ages 5 to 11 have
been admitted to the hospital for COVID
with approximately one third of those requiring the ICU.
Now while most of these recover, as of October 23, 97
children ages 5 to 11 have died from COVID-19.
And additionally, a survey from the UK
has shown that as many as 7% to 8% of children who get COVID
are affected by PASC, or long COVID.
And additionally, even when they avoid hospitalization,
over 5,000 children in the United States
have been reported to experience MIS-C.
But right now, all available evidence
is that we need a vaccine for children.
Right now, we have about 150,000 cases a week.
We have about 2,000 hospitalizations a week.
More than 600 children have died from this virus.
This is a childhood disease.
The version of the Pfizer vaccine
that's been approved so far for kids ages 5 to 11
is a smaller dose of the vaccine than we
are allowed to get as adults.
So why that that?
Is it just because kids are smaller than adults
that they're getting a smaller dose?
No.
Kids' immune systems work differently.
Young kids have immune systems which
are primed for turning on inflammation right away
and getting to work.
These vaccines for children sometimes
don't need to have as much antigen,
the stuff the immune system's responding to.
So you want to find the balance.
And this is kind of the tenant in vaccine science
is finding the balance between what we call reactogenicity,
which is your side effects, and immunogenicity,
which is actually building the immune response.
OK.
You want to balance that.
So the idea is that we're looking for a smaller
dose for kids that will still give them
a high efficacy like we see in adults
but won't give them unnecessary amounts of side effects.
Exactly.
That is exactly the case.
So the endpoint for the 5 to 11-year-old trials
was also different than the endpoint for adult trials.
So for adults, you're looking at, like,
cases in the placebo versus the treated group.
But that's not what they were looking for in the kids trials.
So tell me why that is.
Yeah, so this was an immunobridging study.
So they took patient blood samples,
and they got the serum, which is what the antibodies are in.
And they compared those antibody levels in these 5
to 11-year-old children to that of antibody levels seen
in 16 to 25-year-old vaccinated participants.
Because we saw antibody levels that
were at about the same level as that of those older
participants, we can kind of infer
that there's an equivalent level of protection.
It's great that we really have a way
to look at how potentially effective
this vaccine is going to be without that measure
being sick kids, which none of us want.
No.
Do you feel like there are enough participants
in these trials?
Is it large enough?
Yeah, so that's the critical question.
I mean, because you never know everything.
The question is, when do you think enough to move forward?
So that 12 to 15-year-old trial was 2,360 children.
And there were 18 cases of COVID in that study,
all in the placebo group.
So I got a lot of pretty pointed hate mails
from parents, saying, 2,300 children?
That's it?
So what's the answer to that?
And the answer to that is we could do 23,000 children,
in which case it wouldn't have been
18 cases of children suffering COVID in the placebo group.
It would have been 180.
And at what human price knowledge?
I mean, this is always true.
When do you know enough to say you think
you have enough information?
So what did they do to actually examine
the vaccine dosing for kids?
Well, clinical trials for the Pfizer vaccine in kids
have been underway since March.
They tried a number of doses, including
the adult dose, a 2/3 dose, and a 1/3 dose,
and saw that with just a third the size of the adult dose,
children 5 to 11 created a comparable antibody response
to adults and older adolescents and had less severe side
effects than the larger dose.
So this is really, really awesome,
but I know that some people have been
worried about potential long term effects.
One of the things that we know about vaccines
is that side effects typically appear pretty quickly
after vaccination, not years or decades later.
Right, because vaccines aren't like drugs.
They're made to be destroyed by the body.
So all of their components are gone within a couple of weeks,
and you're just left with the immune cells trained
against some part of the virus.
Any possible side effects would show up in this time
while the body is building this immunity, which
is why the two months of safety data
was enough to start using these vaccines.
Our op for safety was the same, usually
two months after the last dose, because all the safety issues,
including serious safety issues that
have occurred with vaccines usually occur
within six weeks of a dose.
One of the things, too, that I think
when you move from the clinical trial
out into giving this to millions of people,
that's when you're going to start picking up
these really rare adverse events that happen only one
in a million times.
You have to give the vaccine to a million people to see it.
And I think the other thing that's
important to keep in mind is that everybody
doesn't get the vaccine on the same exact day.
So even though it might seem like these events are happening
three or four months out, it's still usually
only less than two weeks after that specific person
got the vaccine.
It's just that we're rolling out to all these people over time.
Absolutely.
That's such an important concept to keep in mind.
So we've been at vaccines really since the smallpox vaccine
in the late 1700s.
We have a lot of experience with vaccines.
And vaccines certainly can cause serious and occasionally
the kind of side effects that cause permanent harm or death.
True.
The oral polio vaccine could cause polio.
It was rare-- roughly 1 per 2.4 million doses but real.
The yellow fever vaccine can cause something
called viscerotropic disease, which
is a nice way of saying yellow fever.
Natural viruses also generally do all these things as well.
The important thing to note here is
that in all cases, all cases, those side effects occur
within six weeks of a dose.
So the notion of this sort of long term effect, the thing
that you realize 10 years later, 20 years later,
has never existed.
So any adverse side effects from these vaccines we're
going to see them very quickly.
Examples that we've seen so far in older adolescents and adults
have been things like anaphylaxis and myocarditis.
It's important to note that all of these
are not only extremely rare but also treatable.
The group that had the highest risk of myocarditis
was the 16 to 17-year-old male, where the risk was as high as 1
in 5,000, which is still rare but not
as rare as for the general population.
I mean, the good news about myocarditis,
if there's any good news to be had with something that
causes inflammation of your heart muscle,
it's that it was really short lived
self-resolving, and transient.
I mean, we saw a few children in our hospital,
and they just did well on their own.
I mean, some got anti-inflammatory, some didn't.
They all got better.
And also, you should realize that SARS-COV-2 virus also
causes myocarditis.
I mean, COVID is associated with myocarditis at a rate much
greater than this.
I mean, there was a study in-- it was reported
in JAMA Cardiology of athletes in the Big Ten conference who
had COVID, all of whom got cardiac MRIs, and roughly 2.5%
had evidence of myocarditis.
You know, so that's like 1 in 45,
which is a lot more common than one in 5,000.
So I think there are no risk-free choices, just
choices to take different risks and the trick is
to always take the lesser risk.
The whole reason why the FDA and the CDC and so many people
have done work into looking at this data
is to weigh the risks between the potential side effects
from getting the vaccine and the potential side effects
and long term repercussions of getting COVID.
And in all of these cases so far for all of the age groups
that they have looked at, it is so much better
to get the vaccine with these incredibly rare side effects
than it is to get COVID.
Absolutely, because I mean, you can't live in a bubble.
Nobody is living in isolation able to avoid
potential exposure.
We can limit our exposures, but there's always a chance.
And so your question is, do you want
to be exposed with some protection,
or do you want to be exposed without it
and risk all of these long term events that we know happen
and that go beyond just myocarditis?
They extend into very serious complications.
And then additionally, it's like,
you don't know when you're exposed to COVID.
You might not for a week or two weeks.
But you know exactly when you got that vaccine,
and knowing what the things you need to watch out for
gives you just a lot of agency in your own health
and in those decisions.
I love that.
I love the idea that getting the vaccine
is a way of having agency over your own health.
Absolutely.
I think that's so important because that's
what we all want, right?
That's what we want.
We want to have some control over our health.
And I feel like, gosh, over the past year,
it's been very scary.
We felt out of control in a lot of ways.
So I think getting this vaccine for yourself and for your kids,
if you have kids, is a way of getting back
that agency for your health and your family's health.
We do see our children as particularly vulnerable.
And so it just feels wrong to sort of pin them down
and inoculate them with a biological
that you don't understand.
And so I understand the pushback.
But I work in a hospital, and you
see a lot of parents crying in that hospital.
And they all wish they had vaccinated their children that
was over 12.
If you still have questions or concerns about the vaccines,
your regular care provider or pediatrician
can talk with you more about your or your child's
specific situation and help you make the best
choice for you and your family.
So we hope that this was helpful.
We'll put updated information in the description below,
and I want to say thank you to everybody
who helped me make this video.
So thank you to you for coming up to Los Angeles to join me
and for helping put all of this information
together and a big thank you to Dr. Paul
Offit for talking with us and sharing his expertise.
As always, thank you to you for watching.
And remember to go forth and do science and get vaccinated.