The Pediatric Lounge, Where Pediatric Physicians Go to Share Their Stories and Success

101 Cough, Colds, Cancer, and Chickens with Dr. Paul Offit, MD

September 05, 2023 Dr. George Rogu, MD, MBA and Dr. Herb Bravo Season 2 Episode 30
The Pediatric Lounge, Where Pediatric Physicians Go to Share Their Stories and Success
101 Cough, Colds, Cancer, and Chickens with Dr. Paul Offit, MD
Show Notes Transcript Chapter Markers

Dr. Paul Offit is a pediatrician specializing in infectious diseases and an expert on vaccines, immunology, and virology. He is the co-inventor of a rotavirus vaccine, credited with saving hundreds of lives daily. Offit is the Maurice R. Hilleman professor of vaccinology, professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania, and director of The Vaccine Education Center at  Children's Hospital of Philadelphia (CHOP). Offit is currently a member of the National Institutes of Health (NIH) working group on vaccines.

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The Pediatric Lounge - A Podcast taking you behind the door of the Physician's Lounge to get a deeper insight into what docs are talking about today, from the clinically profound to the wonderfully routine...and everything in between.

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Cough, Colds, Cancer,  and Chickens 

[00:00:00] Dr. Rogu: I'll wait till he comes in before you do that.

[00:00:03] Dr. Bravo: I don't know if he can see us yet. No, not yet.

[00:00:06] Dr. Paul Offit MD: The redskins. 

[00:00:09] Dr. Bravo: Oh, I 

[00:00:10] Dr. Rogu: figured this is an interesting way to start a conversation. Meanwhile,

[00:00:15] Dr. Paul Offit MD: I think they're just still getting over Carson Wentz. Aren't they? 

[00:00:19] Dr. Bravo: They're not even the Redskins anymore, but you know what? Good morning. Thank you for joining us. I'd love to see you again. I'm 

[00:00:27] Dr. Paul Offit MD: an Eagles fan, man.

[00:00:29] I 

[00:00:29] Dr. Bravo: understand. Why do you think I pulled that out? But I give you grace because Back when you were growing up in Baltimore, the Colts were the best sleeping pill around you turn that show on Sunday That was true until the late 70s and you were asleep in 15 minutes and you woke up the next day We're just such a terrible team. 

[00:00:55] Dr. Paul Offit MD: See, now, when I was younger when I was younger, it was the remember. First, I'm a child of the 50s. So they won the NFL championship in 1958 and a small child then. But nonetheless, I was there for the Johnny Unitas. Raymond Berry, Jim, Jim Parker years. Those were glory years. We, when the championship in 1965, we're in 66, we were there. We won the Superbowl at one point, so we were there. 

[00:01:22] Dr. Bravo: So I can't even give you grace because you were traumatized by their bad plane. No, 

[00:01:28] Dr. Paul Offit MD:  the cults were religion.  what I used to do to show you how old I am. That was when it was a 14 game schedule. So seven home games, they didn't make you pay for preseason games.

[00:01:36] It was 5 a ticket. So it's $35 for the season ticket. Got it. So what we used to do, my three friends would mow lawns in the summer, and then we would have the 35 we needed to buy a season ticket. We would get on the bus, go down to Memorial Stadium, sit behind a two, a concrete block to two double poles, where there were times when you were sitting in the end zone in the back, where when both teams [00:02:00] were in a huddle, you couldn't see a player on the field. Okay, that's how bad these seats were. But we went every week because we were cult fans and then they left. They left in the early eighties and that was my first lesson that loyalty could be a one-way street. 

[00:02:13] Dr. Bravo: Wow. Wow. We have spies, she’s a dear friend of ours in a pediatrician out there in Philadelphia. She went to St. Christopher's for residency. She said she spotted you at the owner's box, the Eagles games.[00:02:29] 

Dr. Paul Offit MD: Yeah, I was so Jeff Laurie, who's the owner of the Eagles would call me a few times during the early in the pandemic because he wanted to know how to handle himself, how to handle his wife, who had some immunological deficiencies.

[00:02:41] And so he would call me a lot and he, eventually he said Why don’t you come, stay in the box, with my brother, who's also a diehard Eagles fan. So we were in the box. It was really fun because it was like. It was, it was John Middleton was there, who was the owner of the Phillies, Don Borowski was there, who's the general manager of the Phillies, and then you had Howie Roseman there, who was the general [00:03:00] manager of the Eagles.

[00:03:00] It was so completely cool. It's really fun. Although I prefer my regular seats, to be honest, with the people, right? Because these people are a little too wealthy. In the world of labor management, I definitely felt like labor in that in that box. 

[00:03:15] Dr. Bravo: It is very interesting. I had an opportunity I came here in 1977 and in 81, the Redskins were the team with Joe Gibbs.

[00:03:26] In 2003, when I opened up the Pediatric Urgent Care,They're a very gracious family. They're a really humble family. They took me, me, and my son to the owner's box to the game in Dallas.

[00:03:56] And then they took us down to the field to greet everybody in the [00:04:00] pregame. And it was one of the most satisfying days of my life to be able to take care of one of my childhood heroes. 

[00:04:06] Dr. Paul Offit MD: Sure. Now, that is what Doug Williams, right? In the Super Bowl, it was yeah. 

[00:04:11] Dr. Bravo: All right let's get to the business today because 

[00:04:14] Dr. Paul Offit MD: that's it.

[00:04:14] Where there's more, 

[00:04:15] Dr. Bravo: we can go now get a beer. George is totally Oh God, 

[00:04:20] Dr. Rogu: I can never understand these dialogues about football, baseball. What? Oh, I don't know. My partners do that in the office. It's okay, over my head. 

[00:04:30] Dr. Bravo: So we're going to record it and then I'll send you the transcript.

[00:04:57] George is Tuesday morning and we have a [00:05:00] dear friend on the podcast today. Somebody that I consider a genius, a humble leader, a man that exemplifies the American dream. And unhappily for me, an Eagles fan. 

[00:05:11] Dr. Rogu: His topic is going to be a very interesting one. It's called Coughs, Colds, Cancers, and Chickens. It's going to be loosely based off of his book, Vaccinated, which was very interesting to read. 

[00:05:24] Dr. Bravo: Welcome, Dr. Offit. 

[00:05:26] Dr. Paul Offit MD: Thank you. It's my pleasure. Thanks for asking. 

[00:05:28] Dr. Bravo: You've been very busy. I can't keep up reading your books, your substack pages, your podcast. But what I want to know most is how's your granddaughter doing. 

[00:05:38] Dr. Paul Offit MD:  (Baby) Offit could not be cuter. First of all, I wish I could screenshot the picture of her little Eagles outfit, but she's doing great. She is just a cutie. 

[00:05:48] Dr. Bravo: Wow. I'm so glad you have that joy in your life. Is this the 1st grandchildren? 

[00:05:52] Dr. Paul Offit MD: 1st grandchild? Yes, my son, my son's daughter-in-law.

[00:05:56] Dr. Bravo: Oh, wow. What a joy. So we're going to start [00:06:00] talking about someone that you hold very dear, and you are an endowed chair of virology, correct, at the University in Pennsylvania and Philadelphia that is named for Dr. Maurice Hilleman, and that is the topic of your book, Vaccinated.

[00:06:17] Before we dig into that book I want to say to the audience that this is one of the reasons why I love Polofit. He says in his books, real leadership is about sharing success and persevering and being careful with your words. Dr. Offit shares success with all his teams, , the people that discovered the rotavirus vaccine, his mentors, the community neighborhood pediatricians he exemplifies the American dream and what I see as a leader for example, a Dr Sue Kressley, They're immensely humble.

[00:06:55] It is a fascinating story. In his book, he [00:07:00] shares a quote, which I think is 1 important lesson for leadership leaders stand on shoulders of giants and see what's coming without the shoulders of those people. You cannot lead, and you cannot see. Why did you write this fascinating book about this fascinating individual, Dr. Offit? I

[00:07:22] Dr. Paul Offit MD: guess I first came to know Dr. Hilleman 20 years before he passed away. And because of the strains of... Rotavirus that we created that we thought could be a vaccine bovine human reassortant vaccine that became RotaTek in 2006. It was Ultimately the primary research and development was done by Merck. So he was at Merck at the time. And so I came to know him then. And the more I learned about him, the more almost otherworldly he became. Here we had worked for ultimately 26 years to try and create the strains that became RotaTek.

[00:07:55]  Dr. Stanley Plotkin and Dr. Fred Clark formed the team that made these strains. [00:08:00] And so I came to know him early on and so very quickly, here's a man who had really done the primary research or development on nine of the 14 vaccines that we were giving to infants and young children.

[00:08:10] It was like trying to imagine another dimension. Like a fourth or fifth dimension because here we'd spent 26 years trying to create a vaccine and he had in his lifetime created nine of the 14 vaccines, at least the primary research or development. So what happened was he was in 2004 in October 2004 diagnosed with disseminated—pancreatic cancer and given roughly six months to live. And so I thought, here is this amazing man who has these amazing stories. I asked him if it would be okay with him if I could sit down at least once a week and record him and get his story for a book. And He was fine with that.

[00:08:51] So he was given six months to live and live six months. He died in April of the following year 2005. so those stories then became the base of this, [00:09:00] but that I can tell you, it was like a Tuesday called Tuesdays with Morrie, I think got Mitch all blown, but this is that's Tuesdays with Maurice.

[00:09:07] And he's just an amazing human being. I've never met anybody. One who was that smart and that well read. And that Profane, it's like every other word was often, so that was always the challenge for me in writing the book. Do I do the the expletive deleted, do I, the Rosemary Woods plan with some Richard Nixon's comments or do you just do, just do the ellipsis, or do you, the little three dots or do you put it in there?

[00:09:38] So ultimately, I just put it in there. So it's probably the only book in the world that has phrases like polymerase chain reaction in the same sentence with the word fucking. He exemplifies

[00:09:48] Dr. Bravo: The audience knows I'm an immigrant. He exemplifies the best of America, to me. He is the American dream. He was born, I guess I could say, [00:10:00] poor on a farm in the Midwest. He worked his way into a scholarship in college, then went to the University of Chicago. He was an unhappy rebel, and he was not content with staying in academia, They would almost not let him leave academia, and then he came to work for industry. At the beginning is a very sad story, right? The day he was born, he survived, his twin sister was stillborn, they were born on the farm, and his mother died a couple of days later from preeclampsia, correct? 

[00:10:40] Dr. Paul Offit MD: That's right. He was and he was, as you said, raised in a rural area in Montana, and one of many brothers and sisters, and what happened was his father essentially gave him away. His brothers and sisters stayed with his father but he was given away to basically his aunt and uncle and so who lives, a few hundred yards down the road so for [00:11:00] him, it was always about watching his brothers and sister grow up with the father. But he was with his aunt and uncle. And there were times when I asked him, to try and understand it.

[00:11:10] Not that I'm an expert in this in any way, but to try and understand what drove him because he was never satisfied. Never. He made one vaccine after the next. And as he would say, on the Montana farms, you would Stop for a minute. If you put up all this fencing and you pass around the ladle with a bucket of water, and then you would climb the next mountain or do the next thing.

[00:11:31] And so that was him. He was never satisfied. And he at one point, he said, I wanted to be seen. I wanted my father to see me. And I think something in that Doug. A hole for him that was unfillable and he was never satisfied and on his deathbed and I saw him in the last couple weeks of his life.

[00:11:47] He still was trying to work things to accomplish things. I've never ever seen anybody as driven or as smart as him. And, the thing that was upsetting in some ways is that Nobody knows who he [00:12:00] is. He's, he's not exactly a household name. And I think for many of the things he did, he could have reasonably won the Nobel prize.

[00:12:06] He won the Lasker Prize, which is the highest biomedical research award in the United States but never won the Nobel prize. And though I think arguably could have for one thing he did it's like, And talking to, to people like Sven Gard at the Karolinska Institute, who's, who was on the Nobel prize committee, I think what happens is that they don't like their heroes to come from industry, they like their heroes to come from academia.

[00:12:27] And the only reason he could do what he did was because he was in industry because then he had the resources and the expertise to take something from, from lab to the bedside. And that, that that's the only reason he could do what he did and he had to do it. He was, he grew up on a farm where he sold eggs and chickens, and made straw brooms and he was always making things and selling them. And so that's what he wanted to do. And he managed to do that in the world of academia and then ultimately in industry. Amazing guy. 

[00:12:56] Dr. Bravo: Then his humility, right? There are [00:13:00] no vaccines or strains of viruses that we use to create a vaccine that is named after him. The most he would do is he would put the name of his daughter on the mumps vaccine, right?

[00:13:15] Dr. Paul Offit MD: On the mumps virus. That's 

[00:13:16] it. So he, so for exampl, there was a, the measles vaccine, the first measles vaccine, which came around in 1963, was made by the team in Boston headed by John Enders. And so what, but the vaccine was problematic in that it still caused a fairly high percentage of children who got it to have a fever and a rash. So it was probably the only vaccine ever given in one arm while you're giving immune serum globulin in the other arms, trying to attenuate the virulence characteristics of that initial strain. So he eventually Further attenuated it by passing it in chick embryo fibroblast cells. And that vaccine then came out in 1968.

[00:13:51] So five years later, which he called the Morton strain, which stood for more attenuated enders. But you're right. He didn't put his name anywhere. Do you have to look [00:14:00] hard to find his name anywhere for all the things he did? The one place you can find it is one of the rhinovirus, zero types. I think it's zero type eight was called the MRH strain, which are his initials.[00:14:09] But [00:14:10] that's it.

[00:14:10] Dr. Bravo:I have a question about the measles vaccine because it's going to come up later in the show again. But he just made it a weaker virus because the first vaccine was tremendously toxic. But, then I got confused. It was also contaminated by a is it a monk, a chimpanzee retrovirus?[00:14:36] Did that have anything to do with his toxicity? 

[00:14:40] Dr. Paul Offit MD: So there are two things going on the polio vaccine was the original polio vaccine Saban and Salks polio vaccine made in the in the mid-fifties up into the early sixties was contaminated with a monkey virus called simian virus 40. Which is actually a polio virus, but could cause cancer in experimental animals.[00:14:59] So [00:15:00] that scared people. So that was actually why Merck actually initially never made a polio vaccine because of that. And that was just Dr. Hilleman's discovery. He was the first one to call it a virus, to realize it was a virus. And Bernice Eddy at NIH had seen that it was that it was, there was an agent that was causing this these sort of holes in cells that was, that we now know of SV40.

[00:15:19] What Maurice found though, Because there were chick cells that were used in these vaccines, that there was chicken leukemia virus, which doesn't cause leukemia in people, but nonetheless, you don't want contaminating viruses. So that's why he ultimately was able to go to Fremont farms in California, where he could find a chicken that was not infected with that virus, which was a common virus.

[00:15:41] And with that, he was able to get those chickens and those chickens were. At Merck for decades. Because they were always leukemia-virus-free, but initially the person who was head of Kimber Farms was unwilling to give him those chickens. But it turns out that the guy who was the head of it had a Montana accent because he was from Montana.

[00:15:59] So [00:16:00] Maurice said, so where are you from? He said, Helena. So Maurice stuck out his hand and said he was from Montana. And so a deal was made. 

[00:16:07] Dr. Bravo: And Merck became one of the largest chicken producers in the world. Because of that, correct? 

[00:16:14] Dr. Paul Offit MD: That was, and that was because of Marek's disease. There was, he was able to make essentially a vaccine to prevent Marek's at which, so they bought essentially Merck then bought Kimber Farms, which or bought I forget the name of the farm that had these sort of big red roosters, these sort of large chickens, and they were able to make them Marek's free.

[00:16:34] And yeah, Merck for a while was the biggest chicken and egg producer in the United States. They didn't stay in that business. They stuck with the pharmaceutical business, but for a while they were, and that was because of Maurice and his interest in chickens. He's, as he said at one point, your chickens were my best friend.

[00:16:48] Dr. Bravo:  so the measles vaccine was tremendously toxic just because it wasn't a weak enough virus and then he just weakened it to the point where it didn't cause some fevers of 103.[00:17:00] 

[00:17:00] Dr. Paul Offit MD: So when you make a live attenuated viral vaccine, it's not like there's a formula for how to do it. It's largely trial and error. So what John Anders had done is he took a measles virus that he isolated from a boy in suburban Boston, whose last name was Edmonton. And so that became the Edmonton strain. And he serially passed it in cells to try and weaken it. The goal of serially passing this human virus in non-human cells is that you introduce a series of genetic alterations in that virus to make it less capable of reproducing itself in people, but still capable enough. to induce an immune response, but it's a fine line. You don't want it to be too attenuated, then it doesn't induce a good immune response. And if it's not attenuated enough, then it can cause side effects. That's what happened with that original strain. It still had a generally unacceptable safety profile, which is why you had to give immune serum globulin in the other arm. So what Maurice did was he just passed it 40 more times and took embryo fibroblast cells. And then that became the final vaccine. And that's been the vaccine really since 1968. [00:18:00] 

[00:18:00] Dr. Bravo: And even back then there was tremendous government interference with the science. They really wanted, they wanted to push this measles vaccines out because of measles epidemics that the more toxic one, right?

[00:18:13] Dr. Paul Offit MD: I think that's right. Measles, before there was a measles vaccine in 1963, every year measles would cause 3 to 4 million cases a year. We cause, 48, 000 hospitalizations a year, primarily from severe pneumonia or severe dehydration or encephalitis, and it would cause 500 deaths a year.

[00:18:28] And So there was a real interest in a vaccine. And actually, if you ask me, what is the thing that worries me the most right now in the current climate, it is that measles will come back. the reason is that measles is the most contagious of the vaccine-preventable diseases, it has a reproducibility index, so-called of 18, which means that.

[00:18:48] If I'm infected with measles, and I go about my normal day, and everybody I come in contact with is susceptible to the virus, I will infect 18 people. To put that in perspective, SARS COVID 2 the virus that [00:19:00] causes COVID, has a reproducibility index of 3. This is a highly contagious virus, and if you look at what's happened recently, we eliminated measles in the United States by the year 2000.

[00:19:10] Because we enforce school mandates, because that's where measles often travels is in the five to nine year old. So by enforcing school mandates, we eliminated measles, but measles has come back. We have five times more cases in the first five months of 2023 than we did in the first five months of 2022.

[00:19:26] There's a couple of cases in Pennsylvania now. if we get to the point where you're again, seeing thousands of cases of measles, we will once again, see children die of measles in this country because it has a case fatality rate of 0. 1%. So one out of every thousand people who get. That's it. We'll die from it. And that's the thing that scares me the most about what's going on right now. 

[00:19:45] Dr. Bravo: There's a lot more things that scare me and we'll talk about the hospitalization later on the show. For a minute, I want, if you be so kind share with the audience to describe how Dr. Hillerman discovered, and produced the [00:20:00] mumps vaccine. And why the strain has his daughter's first and middle name. 

[00:20:07] Dr. Paul Offit MD: So mumps is a common infection. I, as a child of the fifties, I had measles, I had mumps, I had German measles, I had chicken pox, I had all the diseases, the childhood diseases that you got before there were vaccines. it was when it was causing millions of cases every year in this country, it was the most common cause of acquired deafness.

[00:20:26] So there was a real interest in developing a mumps vaccine because, but mumps could also cause neuro neurological disease. It could also cause aseptic meningitis, meaning a viral meningitis. So you wanted to, you hoped that you would be able to make a vaccine that was not neurotrophic, if you will, one that wouldn't do that. Especially if you're going to make a live attenuated viral vaccine, which was actually fortuitous because what happened was Maurice was married. He, but his wife had passed away. They had adopted their daughter Gerald Lynn Hilleman. although she was now [00:21:00] motherless.

[00:21:00] But at the age of five, she walked into his room one night and woke him up, and said, daddy, my neck hurts. And he looked at her and examined her and he pulled out his Merck manual because he wasn't an MD, but he saw that her parotid glands were swollen. And so then he did something no. Father ever does.

[00:21:17] He went to the housekeeper and said, Look, I'm gonna be going into the lab. He went into the lab. He got a broth. He got swabs. He went back, gently woke up his daughter, massaged her parotid gland and then swabbed the inside of her mouth and isolated mumps virus. And there was a mumps vaccine four years later.

[00:21:34] Four years later, up until COVID-19, that was the fastest vaccine ever made. And it was called the Gerald Lynn strain, and it's a strain that we currently use. It became a vaccine in 1967 and has virtually eliminated this virus in this country. There are still cases of mumps, but no longer do you see, for example, homeless for the for the deaf, as much as you did because of that.

[00:21:56] Vaccine. And that was Maurice. So again, this is the point that you make. [00:22:00] He called it the Gerald Lynn strain. And if you look in the package insert or in the physician's desk reference, that's what it says, the Geraldine strain. And that was his daughter, Gerald Lynn Hillman. 

[00:22:09] Dr. Bravo: And you only left one, one side effect or part of the disease of mumps, which is the one that scares me the most.

[00:22:16] It could cause orchitis. That's right. And I saw architis in Costa Rica in young adults. And I could not imagine. They were bedridden with a sling and ice packs. It is, and then they could be permanently unable to have children after that.

[00:22:37] Dr. Paul Offit MD: It causes sterility. It can cause also oophoritis, which is the same infection of the ovaries, which can also cause a lack of just eliminate fertility.

[00:22:44] So yeah, it was sterilizing. So 

[00:22:46] Dr. Bravo: that's what, so that's what the run through some of the vaccines that he created and who he co-created them with. Because there are a lot of heroes of pediatric infectious disease in it, so the mumps vaccine [00:23:00] was the first one he got involved with? 

[00:23:02] Dr. Paul Offit MD:, I guess the mumps vaccine came out in 67.

[00:23:08] So that was first the measles vaccine, which he had acquired initially from John Enders. And then further attenuation came out in 68. He also made the first rubella. Or the German measles vaccine that came out in 69. And then those three were combined into a single vaccine in 1971—the measles, mumps, rubella, or MMR vaccine.

[00:23:24] He also did really important work on the varicella vaccine, although the original work was done by Dr. Takahashi in Japan. And that virus was initially isolated from a little boy name, whose last name was Oka. So that's called the Oka strain, but it was Dr. Hillman who really brought that to a conclusion by doing the research of development if you will.

[00:23:42] And he was also involved in the hepatitis A vaccine, the hepatitis B vaccine. All 

[00:23:46] Dr. Bravo: Let's stop there just for a second. Who has some of the hepatitis B vaccine? 

[00:23:49] Dr. Paul Offit MD: That, was an amazing story because infectious diseases in children. So Saul Krugman and others. Yeah. So Sam Katz, I actually remember reading that book when I was a resident.

[00:23:59] [00:24:00] Yeah, so hepatitis B is an unusual virus and that it makes when it reproduces itself, it makes far more of one protein, the surface protein that it needs. And that surface protein spills out into the bloodstream of which there are—quadrillions of particles in the bloodstream of an infected person.

[00:24:17] The reason it does that, the advantage of doing that is that when you then make antibodies to the virus, the best way to prevent the virus from attaching to cells is to go up against, is to make antibodies against this surface protein. So it's like. Flacking is where you put out this surface protein out there, which kind of soaks up the antibody.

[00:24:36] So then the whole virus can still attach to and enter a cell. But that's a key protein. And so what Dr. Hillman did was initially in the early eighties, he went to men Men who had sex with men in New York City, who had a high instance of hepatitis B, and he then took the blood and then ultimately purified that hepatitis B surface and it's from that blood and then treated it with a series of [00:25:00] chemical agents, which would have formaldehyde.

[00:25:03] Urea and to basically eliminate any known human virus. He's published a series of papers in the Proceedings of the National Academy of Science showing that these three chemical treatments, formaldehyde, pepsin, and urea would inactivate any known human virus. He did that. He showed that was true.

[00:25:21] And then that became a vaccine. It was called, the plasma-derived hepatitis B vaccine because it came from plasma initially. Now the virus, or the the source of material that he used, the blood that he used, was from men who had sex with men in the early 1980s in New York City.

[00:25:36] That source, that blood source also, not surprisingly, was contaminated with human immunodeficiency virus, which had just come into the United States. And that scared people. Now, Dr. Hillman proved That even the human immunodeficiency virus, which is an envelope virus, would never survive those three treatments and didn't survive those three treatments.

[00:25:55] But it scared people. And so Maurice never entirely understood that. To him, [00:26:00] look, the science shows that you don't need to worry, but perception trumped reality, and ultimately that moved us to the recombinant hepatitis B vaccine, which became available in the early 1990s. But I think the 

[00:26:12] Dr. Rogu: The media caught wind of this and they started to spin it and say that the hepatitis B vaccine was the cause of the HIV epidemic, right?

[00:26:22] Dr. Paul Offit MD: Because I know it's shocking and I'm glad you both are sitting down. The media doesn't always get it right. 

[00:26:27] Dr. Bravo: Sounds very familiar. So that gave birth to the whole biogenetic industry in California, right? That recombinant DNA technology that they used from just a reminiscence story when I was in that back at 92, I was in rural Virginia and I was able to.

[00:26:50] Acquired this vaccine. My sister is 16 years younger than me. I've not been vaccinated and I brought it back to Montgomery County, Maryland. [00:27:00] I get the first shot in the dining room of my dad's house and then I call my body who is now an anesthesiologist who was at NIH. And I said, Hey, Rob, my mom will feed you if you come back in a month and six months and you finish the vaccination series.

[00:27:14] Can I can't I just can't drive to have dinner with them. It's a six-hour drive. And that's how my youngest sister got her hepatitis B. It's all fascinating. So he took the hepatitis B vaccine. After that, he worked on the pneumococcal vaccine, 

[00:27:31] Dr. Paul Offit MD: Right? So the pneumococcal vaccine, the polysaccharide vaccine was developed originally really by Robert Austrian, at the University of Pennsylvania. But, and I think this is what people don't appreciate, it's I remember when our vaccine came out in 2006 there, there was a local Philadelphia Inquirer said, that the vaccine was developed at created or invented at Children's Hospital of Philadelphia, and then it was sold by Merck.

[00:27:57] We're missing. We're missing about 16 years [00:28:00] there of the research of development. If you can create the strains, but you are a long way from having a vaccine. You have to do things like you have to figure out the right buffering agent, and the right stabilizing agent. You have to do real-time stability studies.

[00:28:12] If it's going to be in a vial, you have to show that it's stable in that vial. And then you do the phase one, two, and three studies to show that it works and that it's safe. And then you have to figure out how to mass produce it. You have to work with the FDA. To have to show all the protocols are in place to make sure that every lot is exactly the same as the next lot.

[00:28:30] Only pharmaceutical companies have the resources and expertise to do that the only they have that. And I think we don't appreciate just what it is. That that takes. And but I think that the Philadelphia inquire article showed that it's the company that does the hard part and that's true here too.

[00:28:47] And for the recombinant hepatitis B vaccine, it's just a lot of work proving that what you have is what you think you have. 

[00:28:56] Dr. Bravo: And then which other vaccines did he do after that? Because he didn't stop there.

[00:28:59] Dr. Paul Offit MD:[00:29:00] So the pneumo, so just, we started with pneumococcal vaccine.

[00:29:02] You're right. So he then took that. And so other, he did the Japanese encephalitis virus vaccine which was important certainly for for the military when they were traveling in Southeast and in Asia. And those were the big ones. He had a Marix vaccine, which was to prevent disease in chickens, which is how he was able to then take these the new, this New Hampshire red rooster, which was a very big animal and essentially put Merk in the chicken and egg business.

[00:29:27] And I'm 

[00:29:29] Dr. Bravo: going to repeat the Merrick disease causes a sort of encephalitis or neuropathy on the chicken and stable gate. 

[00:29:39] Dr. Paul Offit MD: That's right. So it's called in the world of farmers, it's being called it's called being down in the leg. So actually, when I was when I would interview with Maurice for this book, he was got very frustrated with me because I was, not very familiar with sort of farm techniques.

[00:29:53] And so he would just always explain things to me about how this works. Look, here you have grain, which is carbohydrate, which is [00:30:00] cheap, you feed it to these chickens, and then they become big. And then You have a lot of protein in their meat, which is not as cheap and that, so that's you're converting something cheap into something more expensive.

[00:30:10] And he would, sometimes he would grab my hand and draw a chicken, so I would try and understand what he was saying because I never quite got it. But he was funny. There's 

[00:30:18] Dr. Bravo: two things in Spanish. There is a saying, you are acting. You are acting like a lame chicken and I never figured out why people say that when I was reading your book is oh, this must be from the farm when the chickens start acting weird like they're falling over.

[00:30:37] And they're like, you're falling off your rocker. You're just, you're not with it anymore. The other thing is, I was not aware that before Hillerman intervened, chicken was a very expensive sort of protein in America. Similar to turkey, you said in your book. And if it wasn't because of his interventions[00:31:00] we wouldn't have chicken that we do right now.

[00:31:03] Dr. Paul Offit MD: I think it was Herbert Hoover that when he ran, ran on this slogan, a chicken in every pot, but you're right. Chickens were like, you would have them at big holidays like Christmas or Thanksgiving because they were a delicacy, but they became much less expensive because essentially because of the marriage vaccine.

[00:31:21] Wow. 

[00:31:21] Dr. Bravo: That's all. That's all very interesting, right? Very interesting story. We have that now. Do not have such joyous occasions. And I'm going to preface this conversation by where I think, and I really didn't think that we would be here today. But I think between 1950 and probably 2006, when you got the approval for the border virus vaccine, we were in the industrial age of medicine, tons of vaccinations, powerful antibiotics better hospitals.

[00:31:55] MRIs, CT scans, da Vinci robot [00:32:00] surgery, minimally invasive surgery, endoscopies, all these really important advancements that have improved not only the lifespan of humans but also the quality of life that we have. And there are some early indicators. I remember this as a medical student, as in the resident the first time I became aware of that was when Dr. Odio and McCracken published their pneumococcal meningitis study, where they gave the children steroids as they pushed the antibiotics. The antibiotics were already powerful enough to kill the bacteria. But yet, children were still dying, or they were being left deaf. So there was something about the way your body responds that inflammation was causing a lot of harm.

[00:32:57] And then I had the opportunity to work [00:33:00] with Dr. Clardy in Chicago, who's a peds nephrologist. And this was back in 90, and he was already studying monoclonal antibodies in the lab. And I think we're now, if we can compare it, we are now in the technological revolution of medicine. So this is like 2000, if we think about, the dot com where we already knew about the assembly line, we already knew how to do cars, we already knew to do just-in-time inventory, build things in China, bring them over here, sell them cheaply.

[00:33:36] And then all of a sudden we had this tremendous boom in technology. And we're seeing that happen. I think it's a great thing, right? For example, I really do believe that they're going to come up with a vaccine against breast cancer. I don't think we're that far away. We're not that far away from a vaccine for RSV.

[00:33:59] We [00:34:00] understand a lot of how we can modulate your body's immune response. But there are going to be some unintended consequences of this new age of medicine. And the conversation is not being had. Do you think that's where we are? Lots of opportunities, but we have to be very thoughtful and mindful of what's coming up.

[00:34:23] Dr. Paul Offit MD: Absolutely. If you look, I actually wrote a book called You Bet Your Life, which is about medical innovations, starting from the early medical innovations, whether it's anesthesia or antibiotics or antivirals

[00:34:35] or gene therapies that got We, I don't think there's ever been a medical innovate innovation where there is not some human price that has had to be paid for knowledge and it right up to the month to today. And I think you never get past that when we I'm on the FDA vaccine advisory committee, but in December of 2021, we reviewed the data   on Pfizer's vaccine, which are Moderna's vaccine.

[00:34:58] Those were big studies, [00:35:00] Pfizer, a little more than 40, 000, Moderna, a little more than 30, 000. Those were confirmed. Typical adult or pediatric vaccine studies in terms of size, but you knew once you got to millions of people or tens of millions of people and have billions of people, you were going to find out something you didn't know.

[00:35:14] Now you knew that and you had to be humble about that because it had to happen because you can't. Pick up very rare side effects in pre-licensure studies, or in this case, pre-authorization studies. You can't do that. So it's not practical. You can't study tens of millions of people pre-licensure.

[00:35:31] So the only question is not whether it was going to happen is what was it going to be and how serious and how common. And so that's what we found. We found out that with the mRNA vaccines, it was myocarditis and pericarditis. And you found out with the vectored virus vaccines, like the Johnson and Johnson vaccine, which is now not sold in the United States, or the AstraZeneca vaccine, that it was the clotting, including fatal clotting because suddenly you, you'd activated platelet factor four.

[00:35:57] Nobody predicted that. And now [00:36:00] actually, if you look back, you can see that there, there was a recent. Publications New England Journal of Medicine, where there was, I think, a child who had an adenovirus infection who had that activation of platelet factor for so-called vaccine-induced thrombotic thrombocytopenia who severely suffered from that nobody knew that adenovirus could do that until you had an adenovirus-based vaccine, and then that sort of Clue you on the fact that is possible.

[00:36:23] And so you learn as you go. And sometimes the price that you pay for that knowledge is high. And so that's why the thing you said right at the beginning, I think, is the most important to be humble because know that you don't know everything. And I think you have to be very good when you talk to the public about explaining that you're learning as you go and that we're making decisions Based on what we know now and that there may be changes as we learn more, and I think if you look what's happened over the last four years or so during this pandemic there's been a real loss in trust, I think, in public health agencies and scientists and doctors, because people feel that we didn't tell them the truth when all that was happening was you were learning as you went, but [00:37:00] you needed to make that clear at the beginning, and maybe we should have made it clearer.

[00:37:03] Dr. Bravo: Yeah. I know you're, you have tremendous respect for Dr. Fauci and I used to too. And I still do. He's a great scientist and a great leader. I think the communication world of today with this 24-hour cycle, of news channels, Instagram, Facebook Twitter. It's a media for young people they're just, it's just very hard to succeed in that and perhaps a younger person that was not such a bright intellect, but a better communicator would have helped because it didn't hurt.

[00:37:38] It didn't really help us. For example, when he said, if you're wearing one mask, it's probably better to wear two. That  may be true, but we didn't know that was not the science. And people took that small, innocent misstatement and they just hammered him with it till there was no end.

[00:37:55] I recently saw a post of Instagram on someone that's [00:38:00] trying to be a leader in pediatrics and he's doing the right thing. He's advocating for vaccinations, but he closes with, in all my time as a pediatrician, I have never seen a side effect from vaccines. That is just monstrously false. And that just gives ammunition to Mr. Kennedy to pound those behind the head. You don't have to be a scientist, you only have to do is taking a COVID shot. My arm hurt and I stayed in bed for a day. You're not telling me that's a side effect of the vaccine, but it's much better than getting the disease. So it's a very tricky world as far as communication is very difficult.

[00:38:41] You know what 

[00:38:42] Dr. Rogu: I heard before, what I noticed with all these people that develop these vaccines, all these scientists, all these great people, they believe in their vaccine. They believe so much that they give it to their own children first. Do they do that as an example, or do they do it because they're more afraid of the illness and they [00:39:00] want to, treat their children first? I think it's because they want to prove that they believe in their vaccine. They even gave it to their own family first. Is that how it works? 

[00:39:10] Dr. Paul Offit MD: Yeah, if you look, first of all, my son, when he was nine months of age, got a rotavirus vaccine before it was licensed. Yes, I didn't want him to suffer that disease.

[00:39:20] If you look at Jonas Salk, he inoculated his boys, because he believed in that vaccine. And if you look, actually, a guy wrote a book, which is actually right over your right shoulder there, if you Talk to the people who were involved in manufacturing of that vaccine, which told you they believed in it, which told you they didn't think they had a problem.

[00:39:39] And the problem with the cutter vaccine was that at least several lots of that vaccine were not adequately inactivated. So 120,000 children, mostly in the West and Southwest, were inoculated with live, fully virulent poliovirus. I think it was probably the worst biological disaster in this country's history.

[00:39:55] You had 40, 000 people. Children who developed abortive or short-lived [00:40:00] polio, meaning partial muscle weakness and paralysis. You had 164 children who were permanently paralyzed and 10 who were killed. It was, the worst biological disaster in this country's history—those people who worked in manufacturing and gave that vaccine to their children.

[00:40:14] They believed in that vaccine even when you're wrong. So you're right, but you do it because you think you're helping. And the other thing that I think gets lost in this is. People like people like Saul Krugman and others had, or even Dr. Plotkin, with whom I trained were criticized for in the, for studies in the fifties or even sixties at places like Willowbrook, were criticized for doing studies on those children because they were in homes for the mentally disabled.

[00:40:41] And now when you look through the prism of. Today, back at that time, you're thinking, why did you do that? Did you do it because you thought these children were more expendable? And that wasn't the reason. The reason that those children were given those vaccines first often was because they were the most vulnerable because the sanitary and hygiene situations in [00:41:00] those institutes were awful.

[00:41:01] And when viruses would sweep through communities like measles or mumps or rubella or hepatitis B, it was those children who were often the most likely to suffer. But that's a very hard message to get forward today. And one other thing I think, Herb, because you're right, I mean, I've been a friend of Dr.

[00:41:16] Fauci 30 years and I have an enormous amount of sympathy for what he just went through. I think he became the face of trying to explain decisions that often were CDC's decisions, those weren't NIH's decisions, but Yeah, he was the face. I think the reasonably Dr. Walensky also could have, who was the head of the CDC during this.

[00:41:34] And is the, I think also a brilliant communicator and researcher and teacher and clinician could have also shared that responsibility, but I can tell you, or anybody who commented on this pandemic at some point was dead wrong. And I'm including myself. Absolutely. Yes. In the first week in March of 2020, when the virus had just came in, I think the first person who died, I was on the Christian Amanpour program on CNN International.

[00:41:59] So she [00:42:00] asked me how many people did I think we're going to die from this fire? So I'm thinking, okay, here's China, which has a population that's, five times bigger than ours where 3000 people have died. Here's Italy. Which has a population is a fifth of ours where, X number of people that died and I thought and doesn't have the health system that theory we have, especially in northern Italy.

[00:42:19] And I thought, I said, I can't imagine that, once we when this starts to come into this country that we're going to not have some quarantine and isolating procedures where I don't think it would be any worse than influenza's worst year, which would be about 60, 000 deaths. So I was only off by one.

[00:42:36] 1.1 million deaths, right? So, if you're going to be wrong on international television. That's what

[00:42:42] Dr. Bravo: I was wrong too. At the very beginning, I thought that this was just another fire alarm going off in the bureaucracy of DC. To spend more money and spin wheels and get on TV shows. And then I was in Miami with Dr. Mary Ann [00:43:00] Jackson. And she's no Herb; this is real. And it's coming. It's coming and it's gonna be, it's gonna be hard. And I had to rewire my thinking. So yes. It was a terrible, terribly tricky job to do. But it did hurt us, and we continue to take self-inflicted wounds right now.

[00:43:24] So you're in this committee that has a fancy name for the FDA and it basically reviews vaccines. Whether they're safe, and if I understand it correctly, we are also supposed to know if they're cost effective, because I don't want to be giving vaccines a thousand dollars per arm that really does not decrease the burden on society and humanity of being sick.

[00:43:55] For example, the common cold, or the common cold, most people have it for three days. They [00:44:00] recover. They don't need anything. Nobody ends up in the hospital as a general rule, trying to vaccinate people against 100 different viruses that cost common cold that cost a thousand dollars every year.

[00:44:11] Doesn't improve humanity. It improves my life because I don't want to have to go. And so you review all these. So the last 1 you've reviewed, if I'm not incorrect, is something that I think is a miracle, which is the vaccine. Vaccine. As it pertains to pregnant women, what are your thoughts on that vaccine?

[00:44:32] Dr. Paul Offit MD: Okay, this is a complicated subject and I'm going to go through it for you. Okay. So there, there are three levels of this, I think. RSV is an important pediatric pathogen, arguably the most important. This is arguably the most common reason to come to the hospital as a young child. So every year, respiratory syncytial virus causes 1. 5 million outpatient visits. 500, 000 emergency department visits roughly 60 to 80, 000 hospitalizations 80% of which [00:45:00] are in otherwise healthy children. So you don't have to be in a high-risk group to be hospitalized and 100 to 300 deaths every year. It is an important pediatric pathogen. So how to prevent it.

[00:45:09] And 

[00:45:09] Dr. Bravo: I will interrupt you just one second. And mostly, these are children under a year of age. 

[00:45:14] Dr. Paul Offit MD: It's mostly under six months. And frankly, it's primarily children under three months old. Okay. This is why an active vaccine is going to be hard to have, makes a difference because it's too, when you vaccinate, for example, children at two, four and six months of age against Haemophilus influenzae B or pneumococcus or rotavirus, those diseases are diseases of the six to 24-month-old .

[00:45:32] So you really want to be immune by the time you're six months of age here, you're really talking about a disease that happens in the first few months of life. And so what do you do? You can have, 

[00:45:41] Dr. Bravo: I'm going to interrupt you one more, one more time, because I don't know. I don't know how much the audience knows about this.

[00:45:46] Especially if the press listens to this, 70 plus percent of hospital admissions for Children in the United States are for kids under one year of age. 80 some percent of them are not preventable [00:46:00] because they're live newborns. We don't want to prevent that. And the majority of those kids that get admitted to the hospital during the first year of life, predominantly even younger than that, have respiratory disease.

[00:46:15] predominantly RSV. Okay. 

[00:46:19] Dr. Paul Offit MD: So the virus RSV affects the lining of the nose and throat, causing a cough and congestion. It affects the small breathing tubes causing something called bronchiolitis, which is associated with wheezing. And then it can affect the lung causing pneumonia. It's a, it is the most important pediatric pathogen, but if you're going to prevent it, you have to prevent it very early in life.

[00:46:38] And it's hard to do that with an active vaccination program. So you're talking about passive vaccination, which can occur in three ways. One, and most importantly, is breastfeeding. Breastfeeding does protect. If you look at the data on breastfeeding, it's those who get hospitalized invariably either aren't breastfed or are breastfed for fewer than [00:47:00] two months.

[00:47:01] Breastfeeding protects. But you can't really say that. The World Health Organization says it. The World Health Organization says babies should be exclusively breastfed for the first six months of life. They say it, but it's hard to say that in this country, I think because what you're implying for mothers who don't do that is that they're being lesser mothers.

[00:47:20] And so you can't say that. But what you can say is that breastfeeding clearly is protected because it is the second thing now nirsevimab-alip. So this is now a licensed and recommended monoclonal antibody directed against the RSV vaccine—fusion protein. The C. D. C. Has now had a clear recommendation that all babies less than eight months of age should receive this prior to the R. S. V. Season, which 

Because I think the maternal vaccine is fraught with problems but let me just, I'll get, that's why I'm trying to, okay.[00:48:00] 

 [00:48:01] Dr. Paul Offit MD: you there are other things that work So Nev or be Fortis is a monoclonal antibody that. given in the first right before the RSVC season clearly lessens the risk by about 80% or so of severe disease, which is, I can say the kind of disease that causes you to be hospitalized. So that's good.

[00:48:18] Now you have the maternal vaccine. 

[00:48:20] Dr. Bravo: so I'm going to interrupt you there just to level set for the audience. So, this monoclonal antibody that it has a long half-life is not a vaccine. It costs 500 a dose, which is extremely expensive. And it reduces outpatient visits by about 90%, hospital care by about 90% with RSV low or respiratory tract infection, ICU care, and it also reduces hospitalizations of all respiratory natures, what they call bronchitis by 50%.

[00:48:59] That's what was [00:49:00] published in the New England Journal of Medicine. So it's an extremely effective intervention. 

[00:49:05] Dr. Paul Offit MD: I think the key thing there is it's long-acting. It's an antibody has something called an FC receptor, which, if you modify it, you can make it so that it's much more long-acting as compared to, say previous monoclonal antibody called palivizumab or synergist, which had to be a given monthly because it wasn't long acting.

[00:49:21] So this will basically eliminate palovizumab from the map here. And I think now we'll have a long-acting and by long-acting, you still had very high titers 150 days later. Okay. Five months later. So it's even longer acting than that. So you just have to get it to give it before the RSV season, which starts in October and then peaks in around January, December, January, and then starts to fade around March.

[00:49:42] So this takes you through the RSV season. So it's a value. Okay, the maternal vaccine. So it's the same thing. It's essentially as nirsevimab-alip. It's passively transferred antibodies. You're not inducing an active immune response in the child. You're giving him the antibodies that would have been induced had you given them a vaccine.

[00:49:59] [00:50:00] So here you give the mother the vaccine and the vaccine is and this if I'm getting too much in the weeds here, stop. 

[00:50:05] Dr. Bravo: No. Excellent. Because this is a very important communication for pediatricians and mothers. Okay, 

[00:50:12] Dr. Paul Offit MD: so we considered this vaccine. We, the FDA Vaccine Advisory Committee, considered this vaccine in May of this year, 2023.

[00:50:19] There, the way this vaccine works is it's given as a single dose between the way the studies were done, I should say. It was given as a single dose of 120 micrograms of this pre-fusion protein of RSV. So that's the protein that induces an immune response which is protective. And that was a 7,000-person study.

[00:50:41] Prospective. A placebo-controlled study was done in throughout the world. What they found was that the vaccine was protected about against lower respiratory tract infection, meaning bronchitis or bronchiolitis or pneumonia was about 80% effective [00:51:00] for those first three months of life and 70% effective for those first six months of life.

[00:51:04] So, between three and six months, it dropped a little bit down to 70%, but that's still excellent. So what was effective, clearly effective, what worried people, and there were some no votes and I was no, just full disclosure, I was one of the no votes on safety. So everybody, I think 12 of us voted yes on efficacy, worked , but there were there were four no votes on safety, including the chairman of the committee.

[00:51:28] And here's why. Pfizer wasn't the only one making this vaccine; GSK also made this vaccine, and it's made in an identical manner. 120 micrograms, pre-F protein, unadjuvanted, given to pregnant women or given to women during between 24 and 36 weeks of gestation. Same vaccine, same program, but they abandoned that program.

[00:51:51] And they abandoned it because of a fear of prematurity. They had clearly... a statistically significant increase in [00:52:00] prematurity in those people who got the vaccine as compared to those who didn't. And where in the cases where there was severe prematurity, and there was, there were 12 deaths. That was a 5,000-person study, prospective placebo control, but it was two to one vaccine to placebo.

[00:52:14] But there were 12 deaths from prematurity, severe prematurity in the vaccine group as compared to three in the placebo group. That was a statistically significant difference, and they killed that program. Now, these companies don't abandon programs for no reason. They abandon them because they think they have a problem.

[00:52:30] So here you have an identical vaccine that's being given by Pfizer. So one of two things is true. Either one. Both of them have a problem, but Pfizer hasn't realized it yet, or neither of them have a problem. 

So I'm going to give you information on both sides that argue for both sides of that. I'll start with both of them have a problem.

[00:52:50], if you look at Pfizer's program, 3 500 get the vaccine, 3, 500 get placebo. There were 30 excess cases of [00:53:00] prematurity in the vaccine group as compared to the placebo group. That was about a 1% difference, which wasn't statistically significant, but nonetheless, there were more cases of prematurity in the vaccine group than in the placebo group.

[00:53:11] And I think the, if you looked at their phase two studies, which included only about sort of 115 or 120 per arm, there were five arms, placebo was one, and then it was high dose, normal dose, and then high dose, normal dose adjuvanted. So there were five. In every case, there were more cases of prematurity in the vaccine group than in the placebo group.

[00:53:31] And in the case of the final dose and non-adjuvanted, it was six versus three vaccines to placebo. So, nothing was reassuring. I think the FDA saw this. And so typically, when a company submits for licensure, and this was a licensed product, they basically license it for the way the study was done.

[00:53:50] This was 24 to 36 weeks. But that's not what this was licensed for. It was licensed for the 32 to 36 weeker because I think what they did was they said, okay, if [00:54:00] prematurity ends up being a problem, at least you're talking about children who are not severely premature. It's the 32 to 36, which makes a lot of sense because when you develop an immune response as a pregnant person, you then actively transport immunoglobulin G across the placenta into that baby's bloodstream at around 32 weeks.

[00:54:18] There's not really a big advantage to giving early. You just because you're not transferring it to the baby, and we have a pregnancy platform you get to that you get COVID, you get flu vaccines, the vaccine is for the baby. Thank you. It's really, you're trying to protect that baby. Mother, not so much.

[00:54:36] For COVID and flu, you're protecting both the mother and the baby. But for RSV, you're protecting the baby. It's interesting that the CDC presented data showing you're not any more likely to be hospitalized or killed by RSV if you're a pregnant person than if you're a woman of the same age who's not pregnant.

[00:54:50] The RSV vaccine is for the baby. You better make sure it's safe for the baby. And I think that's where that was coming from. Now, it was never statistically significant. [00:55:00] And you may, when we do now millions of people or tens of millions of people, you may find that all disappears and that it's not a risk of prematurity.

[00:55:07] So what happened to GSK? So here again, I'm trying to make the case that maybe the second thing I proposed was true, which is that neither of them had a problem. So, look closer at GSK's data. And I really wish. Frankly, we had been presented those data on the committee because otherwise, you had to search for them yourself to make yourself feel better, but there was a meeting in Lisbon, Portugal, that occurred a week, before we met the FDA Vaccine Advisory Committee, met, and so you could go back and see that meeting where GSK did present their data in about 20 slides, which I now have copied and I'm going to be giving when I give talks about this.

[00:55:41] And so here's what they found. Prematurity was a problem in lower-middle, low, and middle-income countries, but not high-income countries like ours. Thank you. And if you sub-stratified it and said, okay, I just want to look at people who either got that vaccine or didn't get that vaccine. But I don't want anybody to have received any other [00:56:00] vaccines during that time.

[00:56:01] Not the flu vaccine, not the COVID vaccine, nothing. Just that vaccine. If you did that, there was not a prematurity problem. It was only a prematurity problem if you looked at people who got other vaccines. So those other vaccines are things like COVID or flu and if you catch COVID or you catch flu during when you're pregnant, you also increase the risk of prematurity.

[00:56:23] So that was the implication. And if you really look closer at the data, what you find is that it's not that the vaccine group had a higher rate; it's that the placebo group had a lower rate. That's why there was a difference. You lessen the rate, and the placebo group, the presumption being the placebo group was getting one or more vaccines, COVID or flu vaccines, that was protecting them against getting those infections and therefore decreasing the risk of prematurity.

[00:56:47] That's likely what happened. Begging the question, why did GSK bail? Why did they leave? If that's true, if it really was a decrease in the placebo group because they were receiving other vaccines, why did they leave that program? [00:57:00] And only they can answer that question. So I don't know. It's that is way too complicated to ever explain to parents.

[00:57:06] I think,  frankly, it's way too complicated to ever explain to doctors. And I think we now have a pregnancy vaccine with Pfizer's vaccine that I think very quickly; we have to do the kinds of studies through the vaccine safety data link or the visa program to show that this doesn't cause prematurity because the pregnancy platform is a fragile platform, only about half of mothers who are recommended to receive these vaccines like COVID Tdap and flu get it.

[00:57:33] the reason that it's a fragile platform is that Women, when they're pregnant and they are asked to be injected with a biological, think about one thing and one thing only. Am I going to hurt my baby? And if this vaccine is shown to actually increase the risk of prematurity, and I certainly hope that's not true.

[00:57:49] And I think it may well not be true. But if that is true, I think you're gonna affect the whole platform, not just the R S V and, flu's an important vaccine for women when they're pregnant because they [00:58:00] are at a two to threefold, increased risk of being hospitalized and dying as is also true for Covid then women of the same age who aren't pregnant.

[00:58:06] Wow. Wow. 

[00:58:07] Dr. Rogu: That's a lot to unfold, 

[00:58:09] Dr. Paul Offit MD: isn't it? That's so 

[00:58:11] Dr. Bravo: Thank you for that explanation. because that's it. There's also a safety signal on the Pfizer study. Regarding preeclampsia, I don't think it's statistically significant, but the arm that received the vaccine at 1. 8% instead of preeclampsia, the arm that received placebo, 1. 4%. It worries me when we talk about maternal mortality in maternal-infant mortality because it affects poor people of color to a much greater degree than it does. Those of us who are blessed with a little bit of money, and I don't know what else makes us less susceptible to see to see that.

[00:58:57] Do you think that was just a blip and [00:59:00] nothing to be concerned about, or is that something that needs to be watched carefully? If I remember correctly, African American women have a higher rate of preeclampsia than white women, and they significantly have a higher rate of maternal-infant mortality. 

[00:59:17] Dr. Paul Offit MD: It certainly needs to be watched.

[00:59:19] And that's why you do pharmacovigilance studies. I think that's what's special about vaccines that often isn't the case on the drug side where you have systems in place like the vaccine safety data link or the vaccine adverse events reporting system or the v safe system when this vaccine rolls out.

[00:59:33] And it's given to tens of thousands, then hundreds of thousands, then millions of people, you can, in real-time, see whether there was a problem. Look how quickly myocarditis was picked up as something that generally occurs in 1 in 50,000 people or the J& J's clotting vaccine, a clotting problem, which occurs in 1 in 200, 000 people.

[00:59:49] You're not going to pick those up and Pre-approval studies, but you can pick them up quickly once you look at hundreds of thousands of millions of people, and it is picked up. So the system is there to pick it up. And, of course, that [01:00:00] needs to be looked at, but it is the tyranny of small numbers in an extensive database.

[01:00:04] I can give you this experience with rotavirus. The rotavirus vaccine trial was a 70,000-person prospect of a controlled trial. So 35 000 in each group, there were five cases of Kawasaki disease in the vaccine group. And none in the placebo group. That was a statistically significant difference.

[01:00:20] And there was a task force in place when that vaccine rolled out to answer the question, did this vaccine cause Kawasaki's disease? And once large numbers of people were given, the answer was no. There were nine cases of seizures throughout the 42-day safety window in the vaccine group and two in the placebo group. there was no sort of recognizable pattern to the seizures, but that, again, was studied very carefully when that vaccine rolled out.

[01:00:42] There were also five cases of arm and leg fractures in the placebo group and none in the vaccine group. Got it? So, our vaccine prevented arm and leg fractures. That's right. So this is the problem with small numbers. In large databases is, the joke at the time was, I think, Merck should ask for a [01:01:00] licensure for arm and leg fracture prevention, but They didn't get that.

[01:01:03] They didn't get that as an indication because they didn't ask. But no, that's a problem with small numbers. So, I think it looks at COVID trials. In the Pfizer vaccine the, there wasn't a statistically significant increase in Bell's balls in the vaccine group as compared to a placebo.

[01:01:16] That disappeared too when large numbers were cited. So that's the good news is there are systems in place to see that very quickly; you're going to know whether this is a problem. So that's reassuring. 

[01:01:25] Dr. Bravo: what is this vaccine going to cost? A C D C price list. Have they announced that?

[01:01:32] Dr. Paul Offit MD: First, the C d C hasn't recommended it yet. That's not gonna happen until October. So it's licensed by the F FDA. It's not Umab was interesting in that. You're right. I think 

[01:01:40] Dr. Bravo: I'm gonna go there in a second, but I just wanted to be new to price on that. So on this committee, you didn't review Beyfortus  at the F D A, there's 

[01:01:51] Dr. Paul Offit MD: seven about the Be Fortis?

[01:01:52] No. Why not? 

[01:01:54] Dr. Bravo: No. Is it a vaccine? 

[01:01:57] Dr. Paul Offit MD: It's a passive immunization. Now, technically, the [01:02:00] name of the the committee is VRBPAC, V R B P A C, which stands for Vaccine and Related Biologicals Product Advisory Committee. You could argue that Nercevumab is a related biological, but nonetheless, we didn't consider it.

[01:02:13] Dr. Bravo: Okay. And then it did go to ACIP, at the CDC, who made it part of the immunization schedule. Okay. 

[01:02:21] Dr. Paul Offit MD: And they did that for a reason. The reason that they put 

[01:02:25] Dr. Bravo: They put lipstick on the pig, and they called it a vaccine. 

[01:02:29] Dr. Paul Offit MD: I don't say lipstick on a pig. I think it's tremendously valuable. They did that because the private insurers now it's a routine recommendation by putting on the routine vaccine schedule.

[01:02:38] They now have basically made it so that private insurers should cover it. Okay. 

[01:02:43] Dr. Bravo: Here's the problem. Okay. We didn't have this conversation at a national level, which is very important. We're at a transition point between industrial medicine and technological interventions that prevent disease [01:03:00] that are highly valuable miracles but are not the way we are set up to finance healthcare.

[01:03:08] And so we just went around. And we figured out how we get this to be paid. The problem is that the health plans have 18 months to adopt this, according to the law under ACA. So now the general pediatrician is looking at buying a vial that costs $2, 500 to give to their patients. And the health plan can turn around for the next 18 months and say, Not a cover service, you eat it.

[01:03:40] In Idaho, which is an all-VFC state, the state told pediatricians they're not covering COVID vaccines, and they're not covering the monoclonal antibody, and they're going to have to buy it themselves. Give it to the patients. And then file for reimbursement[01:04:00] One-half of the hospitals that have maternity wards did not participate with VFC. So there are hospitals that are saying we can't afford to vaccinate the baby and the nursery let the pediatricians do it. 

[01:04:15] Dr. Paul Offit MD: The price that the ACIP considered when they were considering this was $445 for the vaccine for the less than eight-month-old and then $890 for the greater than eight-month-old, put it on the vaccine for children.

[01:04:29] Program. So, it is, in theory, covered by the Vaccine for Children's Program, and they put it on the routine schedule so that clearly private insurers would do it. Here's what I would say, though. You're well beyond my expertise. I'm trained as a pediatrician, but really, even functionally, a virologist immunologist.

[01:04:43] People like me sit on the FDA Vaccine Advisor Committee or the ACIP, meaning people who are infectious disease experts, but they're not economists. You could argue that there should be one people Group that says, look, I think this is medically valuable. And then there's another group that meets that are [01:05:00] that do consider the things that you just mentioned, and then figures out how to make it viable for the working physician in terms of.

[01:05:08] Payment because you're right. The system is complex and arguably somewhat broken. We don't have a national healthcare system. So, not really, not functionally. So you're right. I think, but see, people like me shouldn't consider that. I think that's why you should arguably have, and people have been arguing this for more than 20 years.

[01:05:25] How about a second committee, that has that kind of economic expertise or public health expertise that can answer healthcare expertise that can answer those questions? 

[01:05:33] Dr. Bravo: The conversation which you've never had in the U.S. Is what is public health? Traditionally, the pediatrician has been the public health officer, and on a miracle drug like this, it should be funded like we fund K through 12; it should be available for every kid in America without a cost to their parent without means of testing.

[01:05:57] It is our [01:06:00] obligation to invest in the young, just like Dr. Hilleman, pick out the best seeds of his corn, set it aside, not sell it in the market to harvest next season. And that's a conversation that wasn't had, and we need to have it because it's not fair to the middle-class family that has a baby and is going through the RSV season and shows up to the doctor's office, and the doctor says, Plop 600 in your credit card if you want me to give it to you because I'm not eating the cost of it.

[01:06:31] Dr. Paul Offit MD: I agree. I think we, it's not fair. 

[01:06:34] Dr. Bravo: I think we, and we missed the opportunity to have that conversation. The AAP they did when they put out that quick statement on thimerosal and vaccines should have stood up and said, let's have a conversation. About how every child deserves to get this and how only the federal government has a deep pockets to make sure every county, the counties in Alabama that are poor in Mississippi that are poor.

[01:06:58] The counties in New York [01:07:00] and D. C. and Baltimore that are poor have access to this. As soon as it's available, because it is a miracle and we didn't have a conversation, so that agrees me a great deal. 

[01:07:12] Dr. Rogu: I think they put it on the VFC program, so it's going to be available. It's the other side that's the problem, 

[01:07:17] Dr. Bravo: or the commercial side.

[01:07:19] George, it's not, it's a problem, the VFC, because 50% of the hospital maternity wards don't want to deal with the paperwork, so they're not going to give it. And the states are all VFC, like Idaho are saying, this is not, we can't manage this. If you want to give it to your patients, give it to your patients, build it, bill us for it, and we'll send you a reimbursement.

[01:07:41] That's how VFC works. VFC gives you the vaccine, and you give it, and there's no cost to the parent, no cost to the practice. 

[01:07:49] Dr. Rogu: Yeah, I don't think this is 

[01:07:50] ready for prime time. Anyhow, and so now I'm even more thoroughly confused because. I don't know what to tell if I had a [01:08:00] daughter that was pregnant, what to do about this vaccine or not.

[01:08:03] What do I do? If the mother's been vaccinated, do I still give her Beyfortus? Do I still get the baby before it is? 

[01:08:12] Dr. Paul Offit MD: So you don't generally time when you get pregnant. So you may, so for example, my granddaughter was born in February. So she's born really towards the end of the RSV season. She then becomes by the time she's eight months of age; she's already largely just entering that her, what will be her first RSV season.

[01:08:31] So, does she get Bayford? It's probably not. She, because she's managed to miss that. Now, the good news about my granddaughter was she was. And remains exclusively breastfed. So, she was protected in that sense. I think where she born in, say August, July, August. And so now she's going to be less than eight months of age, heading into the RSVC season, getting her seven men.

[01:08:51] That's get Beyfortus. That's an easy decision. Even if 

[01:08:55] Dr. Bravo: My mom's vaccinated. 

[01:08:56] Dr. Paul Offit MD: Okay, so so so if the mom's vaccinated, she [01:09:00] will passively transfer antibodies that will last for about six months. let's say that she that's so let's say that my daughter-in-law was vaccinated and then delivered her baby in February.

[01:09:12] So by the time RSV season starts those antibodies have largely faded. So I think she should get Beyfortus or before just heading into the RSV season. 

[01:09:21] Dr. Bravo: She wouldn't need to get Beyfortus in the nursery before discharge, 

[01:09:25] Dr. Paul Offit MD: Right? That's right because she's just gotten the vaccine. Okay, mother.

[01:09:28] Dr. Bravo: Alright. And then this is I think I understand the science, but I'm not as genius as you are. I'm not a genius at all, but neither am 

[01:09:36] Dr. Paul Offit MD: I That's any consolation, but yeah. 

[01:09:38] Dr. Rogu: No, you're 

[01:09:38] Dr. Bravo: a genius. You're a humble genius. And you're not gonna take that joy away from me. I will say it over and over again.

[01:09:45] Some of our colleagues, Dr. Josh and Dr. Kristen, one in Florida and one in Arizona, had a concern because of what we saw with the resurgence of RSV last year because [01:10:00] we keep the children isolated. So if we give them passive immunity, will we see a tsunami of kids and their first year of life being admitted for RSV?

[01:10:11] Dr. Paul Offit MD: First of all, the uptake is not going to be all that amazing, would be my guess., Although it will be recommended for all babies, not all babies will get it. I don't think so what happened with RSV in 2020 We eliminated respiratory viruses from this country. It's very little RSV, very little flu, which has happened.

[01:10:29] All you have to do to eliminate respiratory viruses is just, shut her school, close businesses, restrict travel and isolate and quarantine everybody. How hard can that be other than shutting down the entire economy of this country, but so you can't do that? But so what happened then was that the RSV season is always very predictable, starts in October, peaks in December, January phase in February, March.

[01:10:51] But not last year. Last year it came up in the mid-summer and then peaked a little earlier and then came back down. When we were presented data at the F D A vaccine Advisory Committee [01:11:00] concerning the maternal R S V vaccine, the c d C believed that we are moving back to what that last season really is starting to move back to where what you would expect so that this year you see the same thing.

[01:11:11] But I guess you're wondering about an immunity debt, right? That by providing a passively transferred antibody, what we're doing is we're not allowing for an active immune response and therefore creating an immunity debt, which then may be that the child in the second year of life or third year of life, because they have not been exposed, have not developed an active immune response to the virus that you would see, say the disease showing up in older age groups.

[01:11:34] That is theoretically possible. The only thing I would argue against that is that. I just think up taking this with this is not going to be that dramatic to allow for something like that. 

[01:11:43] Dr. Bravo: And I think I'm not an expert in infectious disease, but I think we had an experience with vzig. And at some point, we're giving vzig only because it's the only thing we had.

[01:11:53] Then we were giving v sig and varicella vaccine only to children with leukemia. [01:12:00] And we didn't see any untoward effects of that. So my suspicion is you're going to give passive immunity. They will get infected because it seems to be a mucosal rapid incubation virus. You're not preventing all disease.

[01:12:15] You're just preventing severe disease. They're going to have a wild exposure to zA and B RSV. They will develop their own memory cells. And we will not see the severe disease coming down the line at two or three years of age. that's how I explained it to myself. I may be wrong. 

[01:12:36] Dr. Paul Offit MD: I think that's right.

[01:12:37] The one thing I do worry about a little bit is that it's a monoclonal. And if it really was, let's say it was taken up. And 100% of babies who were recommended to receive it got it. That's a lot of pressure on the virus. And you look what happened with the SARS CoV 2 monoclonal antibodies. They eventually became obsolete.

[01:12:53] And I that I can say that the FDA does have a group in place that is going to be monitoring to see whether this virus in [01:13:00] any way evolves away from that. Monoclonal. And that's one big advantage of vaccinating mothers, by the way, when during pregnancy, is you're giving the whole protein, the whole fusion protein, so that you're inducing a polyclonal response against several different epitopes, critical epitope, many different critical epitopes on that protein.

[01:13:17] So you're not going to have that kind of escape mutant if you will, that you would have with a monoclonal. 

[01:13:23] Dr. Bravo: All right. And so I just for me to make it simple, if I were advising a pregnant mom, I would wait, say, wait till you're 36 weeks. because then the risk of prematurity is nil. 32. 32. I would say 36.

[01:13:35] Then you're gonna have a you won't have a premature baby. And if you don't get it, if you don't get the 36 weeks, that's okay. I got the monoclonal antibody and the nursery ready for you. So that would just make me feel like I am going to do absolutely no harm. 

[01:13:50] Dr. Paul Offit MD: So you want to wait until hundreds of thousands of people are vaccinated, and then you'll feel better.

[01:13:55] No, 

[01:13:56] Dr. Bravo: I'm just saying that the data is that, if you just move on a little bit, to [01:14:00] 34, 35 weeks, and if it does somehow induce a delivery, you're getting close to 36 weeks, 36 to 36 to 40 weeks to me, it's pretty much term baby. They're going to do. Okay. So if you can wait till 36, that's when you give it to you.

[01:14:17] And if you deliver it 35 weeks, don't worry about it. We'll give you monoclonal, the monoclonal antibody. Either way, the baby's protected.don't, one 

[01:14:26] Dr. Paul Offit MD: option 36. So you pick the later range. That's fine. The 

[01:14:28] Dr. Bravo: regular range. That would make me more comfortable. And now your  your favorite topic, and it's the one that's very irritating to all of us

[01:14:37] More covid boosters. How do you feel about it? Boosting everybody in the world and their cat

[01:14:45] Dr. Paul Offit MD: The same way I felt last year, and I think I disagree with last year's recommendation with the bivalent vaccine that everybody over six months of age should be boosted. I don't think that was consistent with the data. If the goal of this vaccine is to prevent severe disease, then the question [01:15:00] is, who was getting severe disease? Who was being hospitalized? Who was dying from this virus? And if you look at the CDC's own data, there were certain high-risk groups, people who are older, primarily people over 75.

[01:15:10] The elder, what Dr. Walensky was referred to as the elderly, which I appreciate since I'm still younger than 75, but people who had multiple comorbidities, people who were immune-compromised and pregnant people. So, those four groups were the most likely to be hospitalized because they had the greatest risk.

[01:15:25] So why vaccinate a healthy young person? I was against that and took a fair amount of slack for that, actually from. I will not name but people who were in positions of authority. I didn't like it that I was in public saying, I don't see why we have a universal recommendation here. I had three doses of the vaccine, the Wuhan one strain, the original vaccine.

[01:15:45] Then I had a mild infection in May of 2022. So six months after my third dose of that Wuhan one strain, I think I'm protected; I think I have high frequencies of memory B and T cells. I don't have any comorbidities. And so I think I have high frequencies of memory BNT [01:16:00] cells that will protect me against severe disease.

[01:16:02] I think that's true because that's what the data are on that may be that over time, I will be someone like me getting hospitalized, in which case, then I do want to get a booster dose. But I think the most important thing at this point is if you're in a high-risk group, get a booster dose.

[01:16:17] But if you're in a high risk group, you and you have upper respiratory tract symptoms, test yourself. And if you have COVID, Take Paxlovid or Remdesivir if you can't take Paxlovid, but that's the most important thing because I think what you find when people are being hospitalized in those high-risk groups, they didn't take antivirals.

[01:16:35] And that, I think that's under-emphasized here a lot. 

[01:16:39] Dr. Bravo: To that point, cause my dad's 85 years old, get your flu vaccine and get your RSV vaccine because they will take you down just like COVID will at that age range. Totally 

[01:16:49] Dr. Paul Offit MD: For the over 60-year-old. If you look at it increases, you compare to the 18 to 50 year old, you start to see an increase around 60 or 70.

[01:16:58] Then it really increases 70  [01:17:00] Then really increases over 80. But 98% of people who are hospitalized with RSV and  are in the elderly group have comorbidities. If you're an otherwise healthy 65 year old, you could argue for waiting for an RSV vaccine, which is why I think it got a soft recommendation, meaning it should be considered for use in conjunction with your healthcare provider because your healthcare provider knows your comorbidities.

[01:17:20] Dr. Bravo: I'm 57 years old, and every time I get RSV, I'm sick for six weeks, and I've been doing pediatrics since 1992. I want the monoclonal antibody and the vaccine at the same time. Give me everything you can so I can be spared of that misery. 

[01:17:34] Dr. Paul Offit MD: Frequencies of memory cells, I predict when you get it, you don't get severe disease.

[01:17:39] Dr. Bravo: And in my mind, please correct me again. I'm not a pediatric infectious disease. I would only be urging children who are 6 months that I've not been vaccinated to go through a 2-shot  series. 8 weeks apart, and I'm done because I'm all likelihood they're going to get natural infection. Before long, and they don't [01:18:00] need any more boosters.

[01:18:01] If you already had, I can't imagine anybody that hasn't had covid SARS yet and is over the age of one. I think almost everybody has been infected at this point. But would that be where I focus my energy in practice, getting those six month olds vaccinated against 

[01:18:20] Dr. Paul Offit MD: COVID? Yeah, although you could argue, it depends on which vaccine it is, whether it's a three-dose or two-dose vaccine, but you could argue, if you look at sort of other vaccines like the polio vaccine, hepatitis A vaccine if you have a four to six-month interval between one dose and the next, that's when you develop your highest frequencies of memory cells.

[01:18:37] So I have a now six month old Granddaughter, I'm going to ask, remembering that I have no influence on either of my children, but I'm going to ask my son and daughter in law to get a to get a three dose series. We're at least the third dose is at least four to six months after the next because she'll get it.

[01:18:52] She'll get COVID at some point. And she's much, much less likely to get COVID severely because of her age. But there's been about 2000 [01:19:00] deaths in children from this virus. And this virus is going to be circulating for the rest of her life. 

[01:19:06] Dr. Bravo: It's an economic ethical problem because. The vaccine is expensive. It's 100 per shot. And the HPV vaccine is more expensive. And then we'll PCV13 vaccine is more expensive, but you're giving it to every child every winter, which is a tremendous burden in the financial. The well-being of the society and the people that are vaccinating, which are the pediatricians, and for the life of me, I don't understand what the fascination on boosters for everybody as a political campaign every year is meant to do for us.

[01:19:47] Dr. Paul Offit MD: I agree with you. I think that we're gonna find out in September, I think on September the 12th, the CDC, I think it's pretty sure it's September the 12th AC webinar. Yeah, September the [01:20:00] 12th, they're going to meet to discuss COVID. So that's when they're going to make the recommendation, the CDC.

[01:20:05] I fear that what they're going to say is that everybody over six months old should get it. And what's going to happen is what happened last year, is most people will ignore that recommendation. I think the uptake was only about 17 to 20% or so of those who were recommended to receive it received it. And I think you lose credibility.

[01:20:18] When you don't make a case for why it is important for a healthy 12-year-old to get the vaccine because most parents of healthy 12-year-olds thought, I don't see why this applies to me. So then what happens is you tune out to what the CDC is saying. And it's like the boy who cried wolf  because there's going to come a time when there may come a time when we do need to increase the boosters for all, which would be if it sees that the virus.

[01:20:40] Ever since Omicron, BA1, the original Omicron at the end of 2021, ever since that came into the United States that was an immune invasive strain, but it was immune invasive for protection against mild disease, meaning if you've been vaccinated or naturally infected or both, even recently, you may get a mild infection with Omicron.

[01:20:57] And now you've had all these other Omicron sub-variants [01:21:00] up through EG5 now, or the BA2. 86, which continues to be immunovasive, but not for protection against severe disease, because protection against severe disease is mediated by T cells, primarily cytotoxic T cells, and those sites recognized by cytotoxic T cells have been relatively well conserved.

[01:21:17] From Wuhan 1, up to BA286 or EG5 are relatively well conserved. That's why you're still protected against severe disease. If it comes to be that this virus evolves away from that, away from T cell recognition, then we're starting all over again. then everybody would need to be vaccinated.

[01:21:34] So you get into this sort of boy who cried wolf situation where we keep saying everybody needs to be vaccinated. Now people have tuned out to that, that if a virus evolves to be too away from T cell recognition. Then I think you've lost the public, which is a big price to pay. 

[01:21:48] Dr. Bravo: Yes. And then I have two, two questions from Dr.

[01:21:52] Gary in Long Island and I'm, we're almost done. I have 

[01:21:56] Dr. Paul Offit MD: The two minutes, but okay, 

[01:21:58] Dr. Bravo: Good. So [01:22:00] he wants to know why hasn't the vaccine gotten full approval. EUA?

[01:22:04] Dr. Paul Offit MD: First of all, it doesn't matter. Just so, first of all, when we were considering this vaccine, I hated the term emergency use authorization because it makes it sound like you're not holding this to the kinds of same sort of rigor you would in terms of licensure. But it really has been.

[01:22:21] There's no difference, but there are some people out there that believe there's a difference between the EUA-approved vaccine or authorized vaccine and a licensed vaccine. They're the same product. When you license a vaccine, and we went through this with the rotavirus vaccine, you're licensing three things.

[01:22:35] You're licensing the product. You're licensing the process by which the product is made. all the protocols have to be in place for exactly how you're making this product. And you're licensing the building in which the vaccine is made. That's true for this vaccine. It was true right from the beginning.

[01:22:49] You just were doing it in real-time. You didn't do it the way it normally does, which is a company submits for licensure. Then there's a 10-month period during which the, you go through the license, the process license, the [01:23:00] building that was all happening in real-time. So there was no difference, really.

[01:23:03] And some of these vaccines now are licensed. I think Novavax might still be authorized, but I'd need to go back. It doesn't matter. The point is, it doesn't matter. You have people like Tucker Carlson or Ron Johnson from Wisconsin saying, I'm going to wait until this vaccine is licensed.

[01:23:16] It's the same product, which shows you they have no idea how these vaccines are made. 

[01:23:21] Dr. Bravo: And then his other question is, you still think that the virus. Was did not escape from the Wuhan lab. No, 

[01:23:31] Dr. Rogu: this 

[01:23:31] Dr. Paul Offit MD: it is not a scientific controversy. I'll give you reasons why actually I think I wrote them out. Yeah, don't go away 

[01:23:40] Dr. Bravo: Don't go away.  They're in the best filing cabinet known to man 

[01:23:46] Dr. Paul Offit MD: I'm going to give you the reasons. Okay, the six reasons why this was not a lab lead.

[01:23:52] Number one, photographs taken from the western section of the Huanan seafood wholesale market showed raccoon [01:24:00] dogs and a red fox, both of which were known to be infected with SARS CoV 2. A consumer at the market, knowing it was illegal to sell certain wild animals, took these photos on December 1st. 3rd 2019 before the first case and posted them on Weibo, a Chinese micro-blogging website.

[01:24:15] The photos were immediately deleted, but not before a CNN reporter was able to pass them on to scientists in the United States. Number two, in that same area of the market sores, Co V two virus was detected in carts, drains a feather and hair remover a metal cage, and machines that process animals after they've been slaughtered.

[01:24:33] Number three, the first known case of COVID occurred on December 10th, 2019, about a week after those photos were taken in a female vendor at the Hunan market in the western section of that Hunan market, right where the virus was detected. Two of the first three cases had direct contact with the western section of that market.

[01:24:51] Indeed, more than half of the early cases had direct or indirect exposure to the Hunan market. Wuhan is a city of 11 million people. There are probably 10,000 places where a [01:25:00] new virus could have arisen. Nonetheless, The first cluster of cases were restricted to the western section of a market that was selling live animals susceptible to the virus, exactly where you would have expected an animal-to-human spillover event to occur.

[01:25:13] The estimated chance that this pattern had occurred randomly and not as a direct result of animals infecting people is about 1 in 10 million. 

Four. The WHO, the Huon Seafood wholesale market is north, located north of the Yangs Sea, er River about nine miles from the Wuhan Institute of Virology, which is south of the river.[01:25:30] If the pandemic virus leaked from the Wuhan lab, why did it leap across the river without infecting anybody in between? 

Number five, the emergence of the SARS COVID-19 two virus bears a striking resemblance to the emergence of SARS1 in China in 2002 and again in 2003. 

And finally, on March 17, 2023, a discovery by three prominent researchers, Michael Warby, an evolutionary biologist at the University of Arizona, Christian Anderson, a virologist at Scripps in California, and Eddie Holmes, a biologist at the University of Sydney, should [01:26:00] have ended the controversy, examining samples from the Hunan seafood market, first taken in January 2020 just a month after that virus spillover event, the international researchers found genetic evidence of SARS CoV 2 in raccoon dogs that had been sold illegally.

[01:26:14] This is not a scientific controversy, but two-thirds of Americans believe that it's a lab leak. And it's just hard to watch. 

[01:26:23] Dr. Bravo: Wow. Thank you. That was like Jay Letterman.

[01:26:26] And then one final, so we can get deep into the weeds of politics because I don't like the Kennedy brothers. One ate dinners with U Chavez and made business with oil, and the second one is a cheap charlatan that comes on TV without a shirt and does pushups. What is the harm of people with big legacy names?[01:26:51] Big trust funds? Educations that Georgetown Prep Montgomery County and Harvard are misinforming our families and our [01:27:00] parents and causing deaths of children throughout the world. 

[01:27:04] Dr. Paul Offit MD: Exactly right. He's a he is prominent because of his name. Robert F. Kennedy was beloved. He's his son. And he's prominent because he's running for president.

[01:27:13] He puts terrible information out there about vaccines and he's paid to do it. His group, Children's Health Defense, at least the last time they posted the information which they have to post because they're nonprofit, he was given roughly 500, 000 to promote the notion. That vaccines caught nothing needs money, but that vaccines cause autism and diabetes and multiple sclerosis.

[01:27:33] He has said quote I think there is no vaccine that has ever been made where the benefits outweigh the risks He has said that many and that's his quote More people died from the polio vaccine than died from polio, which is completely false. He says the COVID vaccine is the most dangerous vaccine ever made.

[01:27:48] He said that the COVID vaccine is specifically designed as if it was created, which it wasn't, to target blacks and Caucasians, but to spare Ashkenazi Jews and and Chinese. He is a one man [01:28:00] wrecking ball. He gets it wrong again and again. And I think To show you how disinformation kills, there's no better example than Robert F.

[01:28:07] Kennedy Jr. Because what happened in Samoa in 2018 shows you exactly how disinformation kills. There were, there was in July of 2018 the measles mumps rubella vaccine was distributed, is distributed in Samoa as a powder. And so it has to be reconstituted in. water. So you put in distilled water, you reconstitute it, then you inject it.

[01:28:27] There were two children who both 12 months of age, both of whom were vaccinated by two separate nurses who died immediately after getting the vaccine immediately within minutes of getting the vaccine. And what was found very quickly within a few weeks was that they had, instead of diluting it with water, they diluted it with a muscle relaxant, a lethal dose of a muscle relaxant.

[01:28:48] Those children stopped breathing and died. That's why they died. A nursing error. Those nurses actually were ultimately jailed, which I think is way over the top. But nonetheless, that was true. That was all known. [01:29:00] Nonetheless, Robert F. Kennedy Jr. put out on this avalanche of Facebook posts that the children in Samoa had died of the measles vaccine.

[01:29:08] He went to Samoa. He met with an anti vaccine activist named Taylor Winterstein. He ultimately met with the prime minister and kept hammering the notion that this vaccine was killing children. And what happened because of his Quote unquote advocacy was immunization rates dropped from 70% to 30% and predictably an outbreak occurred.

[01:29:27] There were between September and December of 2019. There were 5700 cases of measles in this island nation of 200, 000 people and 83 deaths. Virtually all in young children. 83 deaths in a population of 200, 000. First of all, the death rate for measles is about one in a thousand. When you have 5, 700 cases, you would expect five or six deaths.

[01:29:49] When you have 83 deaths, that tells you that the healthcare system was inadequate. To treat severe dehydration inadequate to treat severe pneumonia encephalitis and so which is to say was a [01:30:00] particularly fragile population, a population that really needed that vaccine and nonetheless after that, and so what the so then he went, he wrote a letter to the Samoan Prime Minister and said.

[01:30:10] I don't think the virus, the wild type virus is causing this. I think it's a defective vaccine virus. That's causing this again, wrong. And then when fortunately nobody was listening to him anymore in Samoa. And tens of thousands of people were vaccinated correctly. The measles vaccine, the measles outbreak ended and even it was over.

[01:30:27] He said, I think it wasn't the vaccine that really stopped that outbreak. It was, cleaner water and better nutrition. He is a nightmare. He never admits he's wrong, which is often true, actually, of anti vaccine activists. They never say when they're so clearly and definitively wrong. His advocacy.

[01:30:43] Killed children in Samoa. That's what happened. And were he any kind of man, he would go back to Samoa and apologize to each one of those families that lost a child and apologize to the prime minister of Samoa. But he's not going to do that. Rather, he's going to continue to put out his bad information.

[01:30:58] That is the most direct example [01:31:00] of how disinformation kills. And when people talk about limiting free speech, that's where free speech should get limited. 

[01:31:07] Dr. Bravo: There is no right to yell fire in a crowded venue. That is not a free speech, right? When your speech causes harm to others, there is no free speech right to that.

[01:31:19] And this man is dangerous and he portrays himself to be a leader, but he is no leader. He has no humility and he has nothing but his self interested heart. And he is just, I will stop at that because the next words I'm going to say will sound like Dr. Maurice Hilleman. Dr. Offit, it's such a joy to have you.

[01:31:44] Thank you very much. Thank you. I know we strained your time, but thank you so much. This is the most, most important conversation. 

[01:31:52] Dr. Rogu: All right. Take care, guys. All right. Bye bye. 

Introduction Dr. Offit MD
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