Welcome back to Chester's news wrap on this friday fighter
and the FDA made headlines for delaying review of Pfizer's
Covid 19 vaccine for kids under the age of five
. This in order to better assess its effectiveness against
the omicron variant sources telling the Wall Street Journal early
testing data showed effectiveness against Delta while Delta was still
the dominant strain. But some vaccinated Children in the
study later developed Covid after the arrival of omicron joining
me now to help all of us, including myself
better understand what exactly is going on here is Professor
Peter Pitts. He's founder of the Center for Medicine
in the Public Interest. Former FDA Associate Commissioner welcome
to the show. So what exactly is at the
heart here? What is the main issue going on
here with this delay? What's happening? Well,
the issue is data, the two shot data was
not strong enough to protect these Children advisers. Now
looking at a three shot regimen dataset which is going
to be presented to the FDA once it's ready and
I'm sure that once that data is presented, the
FDA will look at it quickly and completely. Probably
send it to an advisory committee. And if the
data is good. Uh move on to issue an
emergency use authorization, not an approval But an authorization
to use for Children ages six months and up.
So can you help me better understand this? It
appears as if the Wall Street Journal report concluded that
because COVID-19 cases were low for for as long as
they were. It appeared as if the effectiveness of
the vaccine was not as strong as maybe it was
. Help me better understand what exactly they were looking
at. Sure. Well obviously it's kind of a
very inter variant situation. The overwhelming majority of people
in the US right now getting infected with Covid 19
are getting the omicron variant. It seems that the
fighter data was against the delta variant which is fine
. But we we want want to make sure that
the the vaccine works against the predominant variant right now
which obviously is no Macron. So going forward,
the FDA wants to look at data specifically against Macron
and it looks like that's going to be a three
shot regimen versus two which was uh efficient against delta
but not Macron because obviously omicron is more infectious peter
. What does the timing look like for next steps
to to go through this data that they very much
want to look at. I mean I can't imagine
this is to some degree of time consuming process.
Well you can't rush it. I mean obviously collecting
the data is a time consuming process, reviewing the
data is a time consuming process. So what both
sides, Advisor biontech and the FDA have to do
is have an all hands on deck proposition. Once
the data is ready to get down to it,
make sure all the experts can look at it.
Make sure the advisory committee can look at it swiftly
afterwards and then have the FDA make a decision.
So I would say, you know, it all
depends. Yeah. So kind of from from day
one, once after he gets a final dataset,
I mean let's say it could be, you know
, as little as a week. So what does
this do with regards to parents? What do you
tell parents that are sitting there? They're seeing all
these headlines. Maybe they feel as if there's been
inconsistent guidance and maddeningly. So they say we said
this and then we said that the data said this
and now it says that what do you do if
you're a parent there with regards to finding information that
makes yourself confident that you're doing what's best for your
child or your best in your family. Because I
think even the best, the best intentioned person out
there at some point has been confused about a lot
of the information that's been shared. I think that's
fair. It's totally fair. And unfortunately the government
doesn't seem to be able to communicate its way out
of a paper bag. I think, you know
, the single simple messages follow the science and science
is hard but we're doing the best that we can
, we're working as quickly as we can to reach
a good decision based on science. Now the real
problem is this is going to further confuse parents for
Children ages 16 and down as to what to do
because that cohort teenagers down to Age five, I
think you only have about a 15% vaccination rate,
which is dismal, we've got to do a better
job. And my my fear here is that the
confusion about young Children six months to five is going
to further confuse parents of older kids and have them
wait. Which is a dangerous proposition. What are
we seeing right now with regards to Children contracting COVID-19
? What are the numbers? And what are some
of the stories indicate to us about where we are
in this fight? Well, the first thing is
that you're for Children. The vaccine works as it
does for adults and it works this way. It
doesn't make anybody immune forever. That's not what vaccines
do. That's been a communications mistake by the government
from the beginning. What it does say that if
your child does get ill, uh, their symptoms
will be mild and they will Be less infectious to
others. So it reinforces the value of vaccines to
protect your child and to have everybody else protected from
your child. So it's a community effort, not
just what my child is going to do. I
think the message to parents is if you have questions
about the COVID-19 vaccine, go talk to your pediatrician
. In fact, the government needs to have a
communications effort and outreach efforts to pediatricians to make sure
that they're part of this effort to, that hasn't
happened. That's got to be. I think the
top of the president's agenda, reach out to pediatricians
get them onboard convince parents to get their Children vaccinated
. And I think that the more older Children get
vaccinated, the more likely it is for younger Children
for their parents to want their kids get vaccinated as
well. You know, we're finally in a long
overdue sense. Perhaps you're peter having this conversation about
so called long covid and the effects and adults.
Um, I think for many people like myself who
previously have gotten Covid 19 to get sick for a
couple of days and luckily hopefully you're you're back on
your feet pretty soon as I have been both times
, that's not the case for every adult who gets
it. There are lingering symptoms, very severe ones
at times that can linger on for many days,
many weeks months down the line. What do we
know with regards to long Covid's impact on young Children
? I really feel that this is a part of
the conversation we're not having enough of. Is there
any data to suggest what that looks like there?
There's very little data. A lot of it is
anecdotal and of course the plural of anecdote isn't data
. So we can't rush to conclusions. But the
truth is that for the first variant of Covid 19
for certainly probably for the Delta variant people with long
Covid will have different types of long lasting symptoms.
We don't know if it's a perpetual, we don't
know if it's going to end after six months after
a year. We've got to do a lot of
serious science and collected a lot of data and that's
gonna take cooperation between government and academia and physicians and
patients. We've all got to be in this together
and make sure we can get the data. So
we understand what the problem is naturally the first step
to solving the problem. You know, I've covered
national politics for many years. Peter the phrase,
the plural of anecdote isn't data is the thing that
I wish every single american voter understood as it pertains
to better understanding stories of national political importance. So
thank you for that. Um, I I am
at a time here, but but real quick.
What's your sense on the United States moving into a
more endemic phase of this pandemic? Maybe even this
year. I think we're actually gonna get there probably
in the spring. People need to, I need
to quit the chicken little ism and recognize this is
here to stay, we can deal with just like
we did with the flu relax. Do the right
thing. We can all get back to the next
normal, do the right thing. Professor Peter Pitts
is founder of Center for Medicine in the Public Interest
. Also, former FDA Associate commissioner. Happy friday
. Thanks for taking the time for a really important 00:07:04.420 --> conversation