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A ’revolutionary’ RSV vaccine and monoclonal antibody · 20-Minute Health Talk

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After recording today's show,
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the Centers for Disease Control and Prevention
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issued an update to address shortages of the
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monoclonal antibody for RSV called umab.
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Our guest discusses this along
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with the new RSV vaccine.
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The CDC is advising that doctors reserve the 100
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milligram doses of nisevimab for babies
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at the highest risk of severe RSV.
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This includes infants under six months
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who are born prematurely,
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or who have health conditions such as lung
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disease, heart issues, or are immunocompromised.
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Note that there is also a lower 50 milligram
0:29
dose of Nirsevimab available and the CDC
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recommendations for that injection
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remain unchanged.
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Now here is our interview with pediatric
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infectious disease expert Dr. Mundeep Kainth.
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Dr. Mundeep Kainth: We've been looking for a solution for RSV for a
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very long time. My mentor, when I was a fellow,
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Carolyn B. Hall,
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worked her entire life on RSV and it was going
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unrecognized as something that
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needed to be prevented.
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So having a vaccine in addition
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to a monoclonal antibody,
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this is something that is actually combined.
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Um,
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something that hopefully will change how we see
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respiratory viruses circulate in the population.
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Sandra Lindsay (host): Hello and welcome to 20 Minute Health Talk.
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I'm Sandra Lindsay.
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Every year up to 80,000 children under the age
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of five are hospitalized for respiratory
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syncytial virus or RSV.
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It causes mild cold like symptoms
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in most people,
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but can lead to severe illness
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in kids under two,
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especially newborns in their first year of life,
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as well as in those over 60.
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While there is no treatment for RSV,
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once someone gets the virus,
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there are some preventative measures parents
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can take and now that includes a vaccine,
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the first ever for some pregnant mothers.
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And those older than 60,
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there's also a new preventive
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therapy for newborns,
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a monoclonal antibody called
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nirsevimab.
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Both were approved by the FDA and CDC in recent
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months and come at a critical time,
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says Dr. Mundeep Kainth.
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Dr. Kainth: RSV is so, um, ubiquitous when it circulates.
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So I, we don't typically test everybody,
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like we test people for flu or for, um,
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covid as we have, you know, home testing.
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Now we don't have home testing for RSV.
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Sandra: The pediatric Infectious Disease specialist at
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Cohen Children's Medical Center explains what
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everyone should know about both
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of these new therapies,
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which she calls revolutionary.
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We also discuss the convergence of RSV with
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the flu and covid 19,
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A troubling phenomenon.
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We saw stretch hospitals thin last winter,
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known as the tripledemic.
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These three viruses can have similar symptoms
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and are dangerous for certain vulnerable groups.
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We began our conversation with
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Dr. Kainth reflecting on its impact last year and what
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we can expect this fall and winter season.
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Dr. Kainth: So yes, traditionally RSV is a winter virus and,
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um, in the last few years we had seen, um,
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with this overlap with covid that we saw
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respiratory viruses pop up in the summertime and
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in the early fall, which was quite unusual.
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So far we've actually been okay
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seeing a slight bump,
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but that typically happens with respiratory
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viruses in general with the start
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of school and the cold season.
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Sandra: By contrast, the spike in 2022 was unprecedented.
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Likely the results of relaxing mass mandates and
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public health precautions from covid 19.
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Many hospitals, including Cohen Children's,
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saw the number of RSV cases more than double year over year.
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Dr. Kainth: We had to, um, open beds on the adults, uh,
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side of the hospital of LIJ and, uh, we,
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it was called a tripledemic.
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It was RSV influenza and covid 19,
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not to mention our other friends,
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parainfluenza and other respiratory viruses.
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I, as I had mentioned,
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all happening at the same time.
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and it was overwhelming 'cause children were
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coming in with respiratory distress
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with dehydration.
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And even those one or two
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days in the hospital can definitely overwhelm
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the number of beds that we have.
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So this is something that we're hoping to avoid this year.
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Sandra: This year clinicians have two new tools
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to help protect people against RSV.
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The first is the monoclonal antibody
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nirsevimab (brand name Beyfotus),
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which was FDA, approved in July.
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Dr. Kainth: Now we have this new monoclonal antibody,
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which is spectacular because it's only one shot
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and it can protect you throughout the RSV season
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For infants under eight months old,
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it's revolutionary in the terms that we can
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finally get enough lasting immunity,
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that it would protect you long enough that
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you wouldn't need more than one shot.
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And it's a monoclonal antibody,
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which mean it's a way to passively protect you.
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So it's not like an immunization where you get
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a shot and it boosts your own
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immunity for protection.
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As you have more years of exposure to RSV virus,
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you're able to build your own antibodies.
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This product is basically creating antibodies for children to be
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used temporarily until they're able to get past
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that age where their lungs are not so tiny.
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And their mucus that's produced by RSV
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doesn't cause so much of
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what we call bronchiolitis or inflammation
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in the lungs. It's basically for
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preventing hospitalization, right?
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And this is going back to what we
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were speaking about before.
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We were so overwhelmed in the previous season.
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and we're trying to prevent kids from needing
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respiratory support and IV hydration support.
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And we wanna make sure that people are aware that it's
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going to be available for patients as soon as they're born.
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It's now something that we're thinking is
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necessary to boost our herd immunity
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in the population.
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Sandra: Prior to nirsevimab's recent approval,
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doctors used another monoclonal antibody
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palivizumab, which Dr. Kainth pointed out had a few limitations.
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Dr. Kainth: It's only very short lasting.
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And we did this for high risk children.
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Usually those who were in the NICU and were
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born premature or had heart disease
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or chronic lung disease.
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We did not have anything available
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for the general population.
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We only had pembrolizumab for, um,
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this various high risk population.
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So we are getting
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basically two ways to protect the population.
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We're able to do this on a widespread basis,
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and we're doing it in a 83% effective way.
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Sandra: Dr. Kainth is referring to nirsevimab's efficacy, supported
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by three clinical trials.
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Manufacturers. AstraZeneca and Sanofi say the new therapy
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reduced hospitalizations from RSV by 83.2%.
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Another way to protect infants against RSV this
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season is the first ever RSV vaccine,
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which was also approved this year.
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And Dr. Kainth notes for expecting mothers
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There's a very limited window to get the shot.
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Dr. Kainth: RSV vaccine is actually called our Arexvy
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it's approved for actually adults 60 years
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and older and for pregnant women.
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And the idea behind this vaccine for at least,
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my patient population for pediatrics is that
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when given at 32 to 36 weeks gestation for a pregnant mom,
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you're able to confer those same protective
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antibodies to the baby.
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Because all mommies are basically doing that, um,
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for their babies as long as the baby's still
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in that uterus by 32 to 36 weeks.
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they're basically always getting those passive antibodies.
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And there's other vaccines that
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are also approved for moms who are pregnant
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That's also influenza vaccine and TDAP vaccine.
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so this is basically a way to offer protection
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for infants by vaccinating moms Asked why the
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vaccine is administered to mothers at that particular stage of pregnancy.
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Dr. Kainth had this to say
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Dr. Kainth: it's That specific stage because that's, the study was done in this, um,
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in this, uh, gestational age framework.
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most likely because that's the age to
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confer antibodies to babies.
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we also could potentially look back at the data and see that
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it was effective earlier.
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But if your baby's being born in the RSV season,
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you would actually wanna confer those antibodies
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as close to when that birth is going to happen.
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Sandra: Like the younger population,
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those age 60 and older have waning immune
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systems and therefore are more vulnerable
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to serious illness and hospitalization.
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Dr. Kainth: We do see, unfortunately,
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hospitalizations and deaths from RSV pneumonias,
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in older individuals.
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And so this is why we have this sort of
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really, really young and really, really old
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protective mechanism in the RSV vaccine.
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Sandra: And there's more good news for those eligible to
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take the new RSV vaccine when
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they roll up their sleeve.
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They can also get the Covid 19 vaccine
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and flu shot -- all three at once.
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Not only does it come at a critical time
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following last year's dramatic spike in cases,
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but the RSV vaccine, along with the monoclonal antibody
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is the culmination of decades of research.
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Dr. Kainth: I think this is fairly significant
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for a viral vaccine that we,
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we've been looking for a solution for RSV for a very long time. My mentor, when I was a fellow,
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Carolyn B. Hall, worked her entire life on RSV.
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And she, like all of us, were incredibly frustrated that for so many
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years it was the one virus that had alluded,
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alluded us for so long.
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And yet again, it was causing the common cold in
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a certain swath of populations,
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but in the elderly and the very young,
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it was causing much more severe illness and it
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was going unrecognized as something that needed to be prevented.
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So having a vaccine in addition to a monoclonal
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antibody and having this simultaneously
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so we don't have to,
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so we have options, we have ways,
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different ways of protecting our patients in
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different stages of people's lives.
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This is something that is actually combined. something that hopefully will change how we see.
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Respiratory viruses circulate in the population.
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Sandra: The American Academy of Pediatrics recommends
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that all infants whose mothers did
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not receive the maternal vaccine
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receive the new preventive antibody,
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especially those at high risk for RSV.
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But if the mother did receive the RSV vaccine
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is her newborn eligible to get this antibody.
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Dr. Kainth: It's one or the other.
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If you didn't receive the vaccine,
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basically you should get the monoclonal
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antibody. Um, but if you've gotten the vaccine,
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you basically may not need the monoclonal antibody.
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So it's one form of a protection or
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the other one, we can catch you. Basically,
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if we didn't catch you at 30 to 32
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to 36 weeks with the vaccine,
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then you're baby is a prime candidate
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for the monoclonal antibody.
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Sandra: When it comes to side effects,
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Dr. Kainth said they are minor and resemble the
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typical discomfort experienced after getting any shot.
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Dr. Kainth: Every vaccine,
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has temporary side effects.
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We also don't want to downplay the fact that
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yes, you might have some soreness at your arm.
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Yes, you might feel fatigued,
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you might have a fever.
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but these are small prices to pay to prevent you from being
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hospitalized with you or your baby. during the RSV season,
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Sandra: Like most other vaccines,
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the new RSV vaccine protects against serious
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illness and hospitalization, not transmission,
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a concept that has become better understood.
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Thanks to the covid 19 vaccines.
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There's some vaccines that are so good,
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they actually prevent transmission as well.
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measles vaccine is known for that
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because it's such a contagious virus.
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but yes, most vaccines for respiratory viruses are
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the ones that like influenza, COVID, RSV.
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We're trying to prevent hospitalizations and severe disease.
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Sandra: While those between the ages of two and 60 are
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less likely to require hospitalization. For RSV,
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Dr. Kainth reminds us that they can
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still transmit the virus,
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which is most often spread by contact transfer,
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meaning touching a surface that someone with RSV touched
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beyond the RSV vaccine and monoclonal antibody.
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Dr. Kainth explains what everyone can do to help
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prevent RSV and other winter viruses.
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Dr. Kainth: Probably the most
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important thing that any infection preventionist
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will tell you is to wash your hands,
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wash your hands, wash your hands, .
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So don't forget your hand sanitizer.
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now that we don't wear masks and
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children don't wear masks,
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we have to go back to learning how to cover our
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cough and cover our sneezes, which.
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Somehow we've forgotten how to do so.
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using tissues, disposing of them properly,
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and making sure that you know,
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if you are high risk, that you're protecting yourself with a
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monoclonal antibody and vaccine this year,
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Sandra: Dr. Kainth added that wearing a mask remains an
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effective way to slow the spread of these
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respiratory viruses and encourage families to do
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so when they're circulating in the population.
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The annual flu shot and the new monovalent
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covid 19 booster are also critical tools in
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our defense against serious illness.
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This fall and winter.
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Dr. Kainth: The highest risk for influenza hospitalization
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is actually under five years of age.
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however, the highest risk for covid hospitalization
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is actually in the geriatric population.
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and we're seeing that also in pediatrics, it's, it's very interesting.
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severe covid illness was actually shown in
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children 12 years and older because their
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immune systems behave more like adults.
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and whereas for flu
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we've traditionally known this as,
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much higher risk under five,
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most risk under two years old.
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but that doesn't mean that we haven't
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seen really sick kids who are older.
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so it definitely behooves us if we have
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both age groups in our household,
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but even otherwise exposures in our community,
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to get both vaccines.
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Sandra: RSV season kicks into high gear
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from October to November,
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and with these two new protections
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against RSV now available,
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she explained why it's so important to take
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advantage and get vaccinated or to immunize your
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newborn with the new monoclonal antibody.
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Dr. Kainth: So It's important because we do not a,
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want to see children hospitalized because
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if they're hospitalized it's a
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burden for that patient's immune system.
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they can get very ill. they actually can become at higher
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risk for asthma later in life.
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It becomes a burden for the family to
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have a young baby hospitalized.
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and also we don't want for the public health reasons,
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we don't wanna shortchange our patients that are
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in the hospital because we're so overwhelmed.
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Unfortunately, we did see this happen
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with Covid and we just saw, you know,
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terrible things like diversions
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for traumas happen, you know,
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just things that we systemically probably
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have a better handle on.
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But if there's a way to prevent
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all of it in the first place,
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and maybe even prevent,
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you know,
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pockets of transmission in the communities and
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households and schools, wouldn't that be great?
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Because then we wouldn't have so many people
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miss work, miss school, and miss life,
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miss fun things and events because
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they're not feeling well.
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Halloween is come.
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We don't wanna miss trick or treating
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this year . So,
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um, and those holidays, you know, Thanksgiving,
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Christmas, unfortunately,
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are also times when people are gathering
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together and also transmitting viruses,
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so we want to do a lot less of that.
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This,
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Sandra: The RSV vaccine is widely available at
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pharmacies and doctors' offices,
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and the new monoclonal antibody near Seima is
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also available at pediatrician's
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offices in limited quantities.
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Parents and others can also ask their
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local hospital about availability.
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As we wrap up,
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I wanna thank Dr.
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Kath for joining us and sharing this important
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information as we head into the height
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of colds and flu season.
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On our next episode,
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we'll talk more about the triple
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demic of c Ovid 19 Flu and RSV,
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and how everyone can protect themselves
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this fall and winter.
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Breaking it all down for us will be Dr.
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Eric Asher,
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a family medicine doctor at
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Lennox Hill Hospital.
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Until then,
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thank you for tuning in.
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I'm Sandra Lindsay,
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and this has been another episode
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of 20 Minute Health Talk.