🕗 Beyond mRNA: Novavax Gets FDA Approval Ep. 296

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The FDA has granted full approval to Novavax's COVID-19 vaccine, providing an alternative to mRNA vaccines that works through a different mechanism using proteins and adjuvants. Despite being four years into the pandemic, COVID-19 remains a significant health concern, causing approximately 1 in 200 deaths in the US in 2025.

• Novavax uses bioengineered spike proteins combined with an adjuvant rather than mRNA technology
• FDA approved Novavax for all Americans over 65 and those 12-64 with at least one risk factor
• Risk factors include conditions like asthma, diabetes, and obesity
• Northeast Florida contributed 500 patients to the original Novavax clinical trials
• Encore Research Group is currently enrolling participants for an oral COVID vaccine clinical trial
• Participants in the oral vaccine trial will receive compensation for their time

For more information about participating in the oral COVID vaccine study, visit EncoreDocs.com or call 904-730-0101.

Be a part of advancing science by participating in clinical research.

Have a question for Dr. Koren? Email him at [e-mail]

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Music: Storyblocks - Corporate Inspired

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Episode Transcript

Kathy, WSOS (00:00):
Hey, good morning.
St.
Augustine.
You're listening to 103.9 WSOS,Kathy with you.
So this morning we have Dr.
Michael Koren with us.
He's with ENCORE Research Groupand operates a very interesting
research platform and, Dr.
Koren, you've been very patientas we tried to get you on the
air.
You've got interesting stuff totalk about today.

Dr. Michael Koren (00:22):
Sure, hey, thanks, Kathy, and thanks for
filling in for Kevin.
He needs a vacation, like allof us.

Kathy, WSOS (00:28):
He definitely does.

Dr. Michael Koren (00:30):
Yeah, helping him out, so it's terrific.
So Kevin and I usually have adiscussion about a hot topic in
medicine, and this week, I think, a particularly interesting
topic is the FDA approval of aCOVID-19 vaccine from a company
called Novavax, and it's goingto be marketed under the name of
Nuvaxovid.

Kathy, WSOS (00:52):
Yeah, okay.

Dr. Michael Koren (00:55):
We've talked about this before, but let me
sort of brief you in theaudience on what this means and
why it's so interesting.
So first remember there werelots of different COVID-19
vaccines that were beingdeveloped and studied in
research during the pandemic.
Our organization was involvedin many of them.
We were involved with thePfizer program, which is a

(01:15):
messenger RNA vaccine.
We were involved with theModerna program, which was
another type of messenger RNAvaccine, and we were also
involved with Novavax, which isnot a messenger RNA vaccine.
And we're also involved withNovavax, which is not a
messenger RNA vaccine, and weactually put in 500 patients
into the Novavax study inNortheast Florida.
So there's a lot of people inNortheast Florida that got the

(01:36):
advantages of this Novavaxvaccine before it was on the
market.
So that's a neat thing aboutgetting involved in research.
Let me tell you a little bitmore about this particular
vaccine.
So Novavax works by actuallyusing a protein to elicit an
immune response.
So there's a bioengineeredprotein called the spike protein

(01:57):
that helps people become immuneto the effects of COVID-19.
And the Novavax vaccinecombines this spike protein with
something called an adjuvant.
An adjuvant is a medical wordfor something that helps the
immune system recognize a badprotein so that the immune
system is prepared to fight itoff if and when that particular

(02:19):
virus protein becomes somethingthat starts to attack the immune
system.
So again, novavax is a neat newtechnology for doing this that
does not involve messenger RNA.
Now Novavax has actually beenavailable, but it's only been
available in what's called anemergency authorization and,
believe it or not, we're alreadyfour plus years out from the

(02:42):
crisis of COVID-19.
And Novavax was not fullyapproved until last Friday this
past Friday and so now Novavaxis a fully approved medical
product.
So people have that choice Ifyou want to protect yourself or
your family from COVID-19, youcan use the messenger RNA
vaccine or you can use thisNovavax vaccine.

(03:05):
There's another one on themarket from Johnson Johnson.
They use a different technology, but these are going to be the
big players Novavax versus themessenger RNA vaccines.

Kathy, WSOS (03:14):
That's simply fascinating.

Dr. Michael Koren (03:16):
Yeah, it's a really interesting thing.
So when the approval came out,it's very typical for approvals
to come out with what we callindications the way that
physicians should use them.
Now, by the way, physicians canuse things that are approved by
the FDA off-label, meaning notexactly the way the FDA approved
it, but by and large,physicians go along with what

(03:38):
the FDA approves.
So Novavax vaccine was approvedfor all Americans over the age
of 65, and that makes a lot ofsense because those people are
more vulnerable to the effectsof COVID-19.
But the approval also was forpeople between ages 12 and 64,

(03:59):
as long as they had oneadditional risk factor, and this
gets into the whole concept ofwho is truly at risk for
COVID-19.
So if you're older, you're atbigger risk, and if you have a
preexisting condition such asasthma or diabetes or you're
significantly overweight, youhave a higher risk also.
So some of the people in themedia, especially the types of

(04:23):
media outlets that are moreleft-oriented, have been saying
that this was an unusual step bythe FDA to limit access to this
product.
Well, number one, it's onlylimiting access, quote-unquote,
to people who are less than 65,who don't have any risk factors
and, quite frankly, most peoplethat would be getting the

(04:44):
vaccine had at least one, soit's really not much of a
restriction, quite frankly.
But the other thing is thatit's talking about it in sort of
political terms rather than inmedical terms.
So the truth is that people whoare less than 65, who
absolutely have no other riskfactor, tend to not get very
severe problems when they getCOVID-19.
Unfortunately, people who areover 65 or people who have these

(05:08):
other risk factors, can getreally, really sick, including
dying.
And here's a fact for you,Kathy Even though COVID-19 is
not nearly as bad as it was afew years ago, it's still
significant.
In fact, I was just looking updata over the weekend and one in
200 deaths in the United Statesnow in 2025 are due to COVID-19

(05:29):
.
My in the United States now, in2025, are due to COVID-19.
So while it's not the absolutedevastating thing that we're
seeing a few years ago, it is astill a significant health
concern.

Kathy, WSOS (05:36):
Sure, and I can tell you that you know, and I'm
sort of a nervous ninny aboutillness, I do suffer from asthma
and terrible allergies andthings like that.
I tell you, even though we'renot in the thick of you know,
the year 2020 and the height ofCOVID these days, I certainly
don't want to get it again.

Dr. Michael Koren (05:55):
No absolutely not.
Who wants to be sick?

Kathy, WSOS (05:58):
That's right.

Dr. Michael Koren (06:00):
Who wants to be sick, and again the COVID-19,
especially in vulnerable peopleis a source for many emergency
room visits and it's not fun,you know, and people can have
long COVID and just feel lousyfor months or years.
Even so, certainly taking avaccine would be much wiser for
people who are at higher risk.
But here's the other reallyinteresting thing we're actually

(06:22):
enrolling in a clinical trialright now that involves an oral
vaccine, a pill you can takethat's not a messenger RNA that
can help people protectthemselves and their family from
COVID.
So we would encourage everybodyto give us a call.
There's numbers that they cancall or just get on the website,
which is encoredocs.

(06:42):
com encoredocs.
com.
We also have a phone number of904-730-0166, and people can get
in touch with us that way, butprobably the best way is just on
the website, EncoreDocs.
com.
And if you're interested inthis oral COVID vaccine study

(07:02):
that we're running, which againis not a message, RNA but is
addressing this really importantissue of protecting yourself
and your family againstCOVID-19,.
it's a nice opportunity for you,and an additional feature of it
is that we do compensatepatients for this program.
It's not a lot, but it's enoughto cover your expenses, which
is a nice additional benefit.

Kathy, WSOS (07:21):
That's a great benefit.
I love hearing this, and peoplecan find out more about that at
EncoreDocs.
com.

Dr. Michael Koren (07:29):
You got it.
e- n-c-o-r-e-d-o-c-s dot com.
Encoredocs.
com with an E.

Kathy, WSOS (07:35):
Fabulous Doctor.
I'm so glad we got to hear fromyou today and I hope I get to
talk to you again sometime.
Everybody you heard from Dr.
Michael Koren at EncoreResearch Group.
You can see all about the newstudy, the possibility of
participating at EncoreDocs.
com.
Doctor, thank you for beingwith us today.

Dr. Michael Koren (07:56):
It's my pleasure.
Kathy, have a great day.

Kathy, WSOS (07:58):
You do the same.
Everybody you're listening to103.9 WSOS.