Beyond mRNA: Novavax Gets FDA Approval

Transcript Generated by AI.

Kathy, WSOS: 0:00

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 Group and operates a very interesting research platform and, Dr. Koren, you've been very patient as we tried to get you on the air. You've got interesting stuff to talk about today.

Dr. Michael Koren: 0:22

Sure, hey, thanks, Kathy, and thanks for filling in for Kevin. He needs a vacation, like all of us.

Kathy, WSOS: 0:28

He definitely does.

Dr. Michael Koren: 0:30

Yeah, helping him out, so it's terrific. So Kevin and I usually have a discussion about a hot topic in medicine, and this week, I think, a particularly interesting topic is the FDA approval of a COVID-19 vaccine from a company called Novavax, and it's going to be marketed under the name of Nuvaxovid.

Kathy, WSOS: 0:52

Yeah, okay.

Dr. Michael Koren: 0:55

We've talked about this before, but let me sort of brief you in the audience on what this means and why it's so interesting. So first remember there were lots of different COVID-19 vaccines that were being developed and studied in research during the pandemic. Our organization was involved in many of them. We were involved with the Pfizer program, which is a messenger RNA vaccine. We were involved with the Moderna program, which was another type of messenger RNA vaccine, and we were also involved with Novavax, which is not a messenger RNA vaccine. And we're also involved with Novavax, which is not a messenger RNA vaccine, and we actually put in 500 patients into the Novavax study in Northeast Florida.

Dr. Michael Koren: 1:32

So there's a lot of people in Northeast Florida that got the advantages of this Novavax vaccine before it was on the market. So that's a neat thing about getting involved in research. Let me tell you a little bit more about this particular vaccine. So Novavax works by actually using a protein to elicit an immune response. So there's a bioengineered protein called the spike protein that helps people become immune to the effects of COVID-19. And the Novavax vaccine combines this spike protein with something called an adjuvant.

Dr. Michael Koren: 2:08

An adjuvant is a medical word for something that helps the immune system recognize a bad protein so that the immune system is prepared to fight it off if and when that particular virus protein becomes something that starts to attack the immune system. So again, novavax is a neat new technology for doing this that does not involve messenger RNA. Now Novavax has actually been available, but it's only been available in what's called an emergency authorization and, believe it or not, we're already four plus years out from the crisis of COVID-19. And Novavax was not fully approved until last Friday this past Friday and so now Novavax is a fully approved medical product. So people have that choice If you want to protect yourself or your family from COVID-19, you can use the messenger RNA vaccine or you can use this Novavax vaccine. There's another one on the market from Johnson Johnson. They use a different technology, but these are going to be the big players Novavax versus the messenger RNA vaccines.

Kathy, WSOS: 3:14

That's simply fascinating.

Dr. Michael Koren: 3:16

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 call indications the way that physicians should use them. Now, by the way, physicians can use things that are approved by the FDA off-label, meaning not exactly the way the FDA approved it, but by and large, physicians go along with what the FDA approves. So Novavax vaccine was approved for all Americans over the age of 65, and that makes a lot of sense because those people are more vulnerable to the effects of COVID-19. But the approval also was for people between ages 12 and 64, as long as they had one additional risk factor, and this gets into the whole concept of who is truly at risk for COVID-19. So if you're older, you're at bigger risk, and if you have a preexisting condition such as asthma or diabetes or you're significantly overweight, you have a higher risk also.

Dr. Michael Koren: 4:18

So some of the people in the media, especially the types of media outlets that are more left-oriented, have been saying that this was an unusual step by the FDA to limit access to this product.

Dr. Michael Koren: 4:34

Well, number one, it's only limiting access, quote-unquote, to people who are less than 65, who don't have any risk factors and, quite frankly, most people that would be getting the vaccine had at least one, so it's really not much of a restriction, quite frankly. But the other thing is that it's talking about it in sort of political terms rather than in medical terms. So the truth is that people who are less than 65, who absolutely have no other risk factor, tend to not get very severe problems when they get COVID-19. Unfortunately, people who are over 65 or people who have these other risk factors, can get really, really sick, including dying. And here's a fact for you, Kathy Even though COVID-19 is not nearly as bad as it was a few years ago, it's still significant. In fact, I was just looking up data over the weekend and one in 200 deaths in the United States now in 2025 are due to COVID-19.

Dr. Michael Koren: 5:29

My in the United States now, in 2025, are due to COVID-19. So while it's not the absolute devastating thing that we're seeing a few years ago, it is a still a significant health concern.

Kathy, WSOS: 5:36

Sure, and I can tell you that you know, and I'm sort of a nervous ninny about illness, I do suffer from asthma and terrible allergies and things like that. I tell you, even though we're not in the thick of you know, the year 2020 and the height of COVID these days, I certainly don't want to get it again.

Dr. Michael Koren: 5:55

No absolutely not. Who wants to be sick?

Kathy, WSOS: 5:58

That's right.

Dr. Michael Koren: 6:00

Who wants to be sick, and again the COVID-19, especially in vulnerable people is a source for many emergency room visits and it's not fun, you know, and people can have long COVID and just feel lousy for months or years. Even so, certainly taking a vaccine would be much wiser for people who are at higher risk. But here's the other really interesting thing we're actually enrolling in a clinical trial right now that involves an oral vaccine, a pill you can take that's not a messenger RNA that can help people protect themselves and their family from COVID. So we would encourage everybody to give us a call. There's numbers that they can call or just get on the website, which is encoredocs. com encoredocs. com.

Dr. Michael Koren: 6:45

We also have a phone number of 904-730-0166, and people can get in touch with us that way, but probably the best way is just on the website, EncoreDocs. com. And if you're interested in this oral COVID vaccine study that we're running, which again is not a message, RNA but is addressing this really important issue of protecting yourself and your family against COVID-19,.

Dr. Michael Koren: 7:11

it's a nice opportunity for you, and an additional feature of it is that we do compensate patients for this program. It's not a lot, but it's enough to cover your expenses, which is a nice additional benefit.

Kathy, WSOS: 7:21

That's a great benefit. I love hearing this, and people can find out more about that at EncoreDocs. com.

Dr. Michael Koren: 7:29

You got it. e- n-c-o-r-e-d-o-c-s dot com. Encoredocs. com with an E.

Kathy, WSOS: 7:35

Fabulous Doctor. I'm so glad we got to hear from you today and I hope I get to talk to you again sometime. Everybody you heard from Dr. Michael Koren at Encore Research Group. You can see all about the new study, the possibility of participating at EncoreDocs. com. Doctor, thank you for being with us today.

Dr. Michael Koren: 7:56

It's my pleasure. Kathy, have a great day.

Kathy, WSOS: 7:58

You do the same. Everybody you're listening to 103.9 WSOS.