Dr. Gregory Poland: Coming up on Mayo Clinic Q&A,
October is going to be a very exciting month in the U.S. in
regards to COVID vaccines. The FDA is going to look at boosters
for Moderna, boosters for J&J vaccine. They're going to look
at extending that EUA for Pfizer vaccine down to five years of
age. So, five- to 11-year-olds. How soon they'll start
immunizing kids after that EUA approval would probably be
within a couple of weeks.
Along with the prospect of vaccinating children, there are
other signs of progress in the fight against COVID-19.
We have a lot of reason for optimism here. We're going to
see approval of an oral antiviral. We're going to see
extensions, and I hope mix and match allowances, and we're
already seeing the value of people getting immunized in the
downturn in the pandemic.
Dr. Halena Gazelka: Welcome, everyone to Mayo Clinic Q&A. I'm
Dr. Halena Gazelka. We're recording this podcast on
Monday, October the 11th, 2021. Well, the cold weather is
looming, and experts are encouraging people to continue
to get vaccinated as we're beginning to move back indoors
because of the cold weather. Soon those eligible to be
vaccinated may include children ages five to 11. Here with us to
discuss today is our expert, Dr. Greg Poland from the Mayo
Clinic. Welcome, Greg.
Dr. Gregory Poland: Good morning.
Dr. Halena Gazelka: Good morning. Happy Monday.
Dr. Gregory Poland: Thank you. It was an early start to the day
today.
Dr. Halena Gazelka: Well, I'm glad that we just are continuing
your day while you're in keeping going. Greg, can you tell us
what's going on with kids and the EUA, or the emergency use
authorization request by Pfizer to vaccinate them?
Dr. Gregory Poland: October is going to be a very exciting
month in the U.S. in regards to COVID vaccines. On the 14th of
this month, the FDA is going to look at boosters for Moderna,
on the 15th boosters for J&J vaccine, and on the 29th of
October, they're going to look at extending that EUA for Pfizer
vaccine down to five years of age. So, five- to 11-year-olds.
This is coming a little faster than we thought, which is good.
How soon they'll start immunizing kids after that EUA
approval, and I'm guessing they'll get that approval, would
probably be within a couple of weeks. Notably, the the
recommendation is shaping up to look like for five to 11-year
olds, they'll get a 10 microgram dose rather than a 30 microgram
dose. So, they'll get a third of the dose that people 12 and
older get.
Dr. Halena Gazelka: Well, that is exciting news, Greg. I was
thinking about before, how you told us how much paperwork goes
into these meetings, where you review all of this data, and I
thought, well, that's a lot for people to read in a month.
Dr. Gregory Poland: It really is. And you know, and maybe not
too surprising, these younger kids getting a third of the dose
just have superior immune responses.
Dr. Halena Gazelka: Oh, wonderful.
Dr. Gregory Poland: Their young, healthy immune systems really
rev up in response to the vaccine. So, they'll do very
well, I think.
Dr. Halena Gazelka: Oh, that's great. Such good news since we
are more indoors at this time of year.
Dr. Gregory Poland: Indeed. And you know, with school starting,
we've certainly seen surges in different areas. Were
concerned, you know, about this, this rough pattern that has
occurred since the start of the pandemic of every two, three
months a surge, then it lets up a while, everybody relaxes, and
that sparks another surge. And school is one of those
particularly with the Delta variant. So, I'm really, really
happy that we're going to be able to protect kids.
Dr. Halena Gazelka: Greg, what do we know about the demand for
booster shots? Are those who are eligible to get them getting
them?
Dr. Gregory Poland: Yeah, I mean, I think there's been a lot
of movement in that direction. Where we're not seeing movement,
and that's really the concerning part, is unlike other nations,
we've got a really large segment of people who are hesitant or
resistant to getting the vaccine. So, on the one hand,
you've got a large percent of America that's now moving to
their booster dose, kids that will get their primary series,
and then this group of people that will continue to
periodically have infection and drive these surges and these
outbreaks. And it's an almost intractable problem unless you
make mandates.
Dr. Halena Gazelka: Greg, one of the most interesting things that
I think I've heard is going on in research is this thought
about mixing different COVID vaccines. Now currently, if you
had Pfizer, you get another Pfizer, if you can get a
booster, you'd get a Pfizer. What about people getting
different brands of vaccines?
Dr. Gregory Poland: You know that so-called mix and match
ideas also going to be reviewed by the FDA I think again on that
on the 29th of October. I've been privy to those preliminary
data, all I can say or am allowed to say, is that looking
at those data, it works. You see really nice immunogenicity.
You do not see any significant increase in reactogenicity, or
safety issues. So, I suspect it will be approved. That will be
very helpful for travelers, for clinicians. As you know, you and
I are faced all the time by patients and often because of
where we work, patients that have come from other countries
using vaccines that for example, maybe AstraZeneca vaccine that
we don't have here in the U.S. And I think it will be very,
it's a very practical thing to be able to say you can mix and
match these vaccines.
Dr. Halena Gazelka: Yeah, that's really exciting news.
Convenient, I would think.
Dr. Gregory Poland: Indeed.
Dr. Halena Gazelka: Another study I wanted to ask you about
Greg, was in the New England Journal of Medicine, and they
talked about how immunity in men may wane faster than it does in
women after Pfizer vaccine. Tell me about that.
Dr. Gregory Poland: I knew you were gonna bring this up.
Dr. Halena Gazelka: I couldn't pass up an opportunity, Greg.
Dr. Gregory Poland: I think you're referring to the Israeli
healthcare worker study. It was just published in the New
England Journal, as you mentioned, and it is
interesting. You're exactly right. What they showed is that
in men, antibody decayed or waned faster, significantly
faster than in women. It also waned faster in people over the
age of 65 and in people who were immunocompromised. None of that
is a surprise. I have to admit to you Halena, I've studied
vaccines for 40 years, and in every vaccine that I have
studied, women have superior immune responses to men, they
just do. We don't know precisely why that is. I know you and my
wife have offered an explanation, but it's not a
scientific one.
Dr. Halena Gazelka: Sometimes no explanation is required, Greg.
Dr. Gregory Poland: But you know, I think that the point is
that, as I have written about for almost two decades now, in
time we're going to move toward a more personalized or
individualized vaccinology approach. It may well mean, for
example, that men need a booster sooner than women, or maybe it's
at least older men need a booster before older women do.
Those are the kinds of things that having data like this would
enable. It also fits with the clinical picture that we see.
Men have suffered more in this pandemic than women in terms of
hospitalization, deaths, etc. So, you know, it does fit with
the clinical data, and then it's incumbent on us to design policy
around that.
Dr. Halena Gazelka: What's the status of the Merck antiviral
pill?
Dr. Gregory Poland: Well, this is another area that's exciting.
I mean, it's going to turn out that the fall here is good news
in terms of this pandemic. So, Molnupiravir is the name, it's a
mouthful, of the antiviral, the dose is going to be two pills
taken twice a day for I can't remember now, is it four or five
days, I think four days. We don't know yet how low of an age
you'll be able to use it in. So, I don't have that
information yet. But the exciting thing is that it cuts
the risk of hospitalization and death by 55 or 50%. So, you
know, like all antivirals, it's not a miracle cure, but the
earlier you get to that infection and treat it makes a
significant difference. Now, why are we so excited about this
over the antiviral we have or monoclonal antibodies? This is
oral, all the rest have to be administered by injection or IV
infusion.
Dr. Halena Gazelka: So, you can take this is at home perhaps?
Dr. Gregory Poland: You can take this at home, and then the nice
part about this, is this kind of fits with the same paradigm that
we already have in clinical medicine with treatment of
influenza, with an antiviral. With influenza, in fact, we now
have an option where you take one pill, one time We're not
there yet with COVID-19. But who knows, as more research occurs.
So, this is very exciting news to be able to treat people who
develop COVID regardless of whether they got vaccine or not
as an outpatient and decrease that, you know, surge demand
that we have seen on the medical system.
Dr. Halena Gazelka: Greg, is it known yet if that antiviral
would be used in conjunction with monoclonal antibody, for
instance?
Dr. Gregory Poland: There probably wouldn't be a need to
simultaneously do that. Now, potentially, you know, you could
envision maybe some clinical scenarios where you're sort of
throwing everything at the fire to see what would help, but the
antivirals tend to work best, the earlier that they're used.
So, you really don't want to wait until somebody is, you
know, is on a ventilator in the ICU. And again, that's the value
of this as an oral outpatient treatment.
Dr. Halena Gazelka: So, the earlier, you know, the better?
Dr. Gregory Poland: Right. So, we don't know quite yet when
this drug will come up before the FDA for review, I imagine
pretty quickly since we already have the high-level efficacy and
safety data. And almost certainly, unless there are any
surprises, it would end up getting approved.
Dr. Halena Gazelka: Say, Greg, this is a little off topic from
COVID. But I wanted to get your take on the first ever malaria
vaccine that the World Health Organization is endorsing. Tell
us about that. That sounds like amazing,
Dr. Gregory Poland: We will finally be able to eliminate
malaria in Minnesota. We have a cure for that in Minnesota. It's
called winter.
Dr. Halena Gazelka: Right and it's coming soon.
Dr. Gregory Poland: We don't have mosquitoes then. But you're
exactly right. There's a vaccine called the RTS,S Mosquirix is
what it's going to be called, made by GSK. And this is very
interesting. Looks like it's going to be a four-dose series,
again, significantly decreases the risk of severe disease. We
don't know about death, but presumably it will cut the risk
of death. You know, let's take Africa, you have Sub-Saharan
Africa, you have 400-500,000 kids a year who die of malaria.
Now, this vaccine is probably only about 50% effective. So,
it's a start. One study showed 30% efficacy, so it's a start.
And it probably only lasts about four years. So, it's not a
panacea. But a very exciting new paradigm for a vaccine against a
parasite. Parasites are very complex organisms. So, this will
be a vaccine against a parasite, a pathogen that has ravaged the
human population for centuries and centuries. So, this is very
exciting news in the field of vaccines.
Dr. Halena Gazelka: Great. Any other thoughts you'd like to
share with our listeners today?
Dr. Gregory Poland: You know, I want to push a little bit
Halena, just because we have seen some very, very sad cases
nationally. And that is the importance of immunizing women
who want to get pregnant or who are pregnant with COVID vaccine.
And again, this has a double benefit. It protects the mom,
and it protects the child both unborn and immediately after
birth. In fact, I know this is going to sound almost
unbelievable. The risk of death in a pregnant woman with COVID
is 70% higher than in a non-pregnant woman of the same
age. And, you know, by the way, we see similar kinds of
statistics for pregnant women who develop influenza. So,
particularly that second to third trimester, it's really
important that a woman be updated with pertussis vaccine,
COVID vaccine, and influenza vaccine. So, it's also a
reminder that in the midst of all the COVID information, there
are important things you can do to protect your well-being, your
health, and your life above and beyond COVID, and that's
pertussis, shingles, pneumonia, influenza vaccines.
Dr. Halena Gazelka: Wow. I had no idea, Greg, that the risk of
flu was so high in pregnant women.
Dr. Gregory Poland: And you know, we talked about a
twin-demic last year, and I think I've mentioned before now
the concern is over a tri or even quad-demic. What has
happened is last year we saw almost no influenza, right? I
personally did not see a single flu case. That has never
happened in my career, never. But we were wearing masks. We
were distanced at that time. By pretending that the pandemic is
over, we've already seen more cases of influenza than we did
all of last year. And we've seen surges in RSV, respiratory
syncytial virus, which, you know, makes people sick, but it
can kill young kids and elderly adults when we don't have a
vaccine against it. So, we really do want to urge people be
careful here, you're going to hear news. And I think it's true
that the COVID-19 pandemic is going to wane, and it has waned
quite a bit already in the last few weeks, it will wane further.
But many predictive models concern. It's speculation. But
based on what we had, the pattern we have seen over the
last 19-20 months, concern that as we get deeper into winter,
with travel, the holidays, etc., that we'll see another surge,
both because of the large number of unvaccinated people and
waning immunity where you see breakthrough cases.
Dr. Halena Gazelka: So, in summary, Greg, what are you
thinking and feeling this month about the trajectory of
COVID-19?
Dr. Gregory Poland: Well, I'm really pleased as you can tell,
I mean, there's some serious things to attend to. But we have
a lot of reason for optimism here. I think we're gonna see
approval of a vaccine for kids down to age five. We're going
to see approval of an oral antiviral. We're going to see
extensions, and I hope mix and match allowances for vaccines,
and we're already seeing the value of people getting
immunized and the downturn in the pandemic. I still have
concerns about the people who are not immunized. But I think
we can be very positive here, particularly as we get to the
holidays if people will remember what we said all along hands,
face, space and vaccinate, and it will serve them well.
Dr. Halena Gazelka: Our thanks to Dr. Greg Poland for being
here today to be our virology and vaccine expert, and to give
us our COVID-19 updates. I hope that you learned something. I
know that I did. We wish each of you a very wonderful day.
Dr. Gregory Poland: Be safe everyone.
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