Science Vs - Presenting Not Past It: The Vax That Got Axed

Episode Date: August 19, 2021

Today, we’re sharing an episode of a show we love: Not Past It. ​​Did you know there was almost an AIDS vaccine? On June 3, 1998, AIDSVAX VAX004 reached the final stage of trials before widespread approval. Not Past It host Simone Polanen gets the facts on the vax and why it never made it to the masses. Learn more about your ad choices. Visit podcastchoices.com/adchoices

Hey, Wendy here. The Science Versus team is hard at work nerding out for our next season of Science Versus, which is going to be back in your ears in September. We are very excited. But in the meantime, I wanted to get your ears on this brand new Spotify podcast. It's called Not Past It, and it's a show about how these moments in history shape our world today. It's hosted by Simone Palanin, and it's really wonderful. And the episode we're going to play today is about the search for the HIV vaccine. And the moment that I heard it, I really wanted to share it with you guys, because it made me think about the COVID-19 vaccines and how it was not at all inevitable

that we would have them so quickly. All these things had to work out just right. And with HIV, those things really didn't work out. All right, let's jump right in. This is Not Past It with Simone Palanin. My fellow Americans, if the 21st century is to be the century of biology, let us make an AIDS vaccine its first great triumph. That's our first Black president, Bill Clinton. Those are Toni Morrison's words, not mine, okay?

Just Google it. It's June 1997, and President Clinton is giving a commencement speech at Morgan State University in Baltimore, Maryland. And he's got quite a big announcement to make. Today, let us commit ourselves to developing an AIDS vaccine within the next decade. Americans weren't used to hearing their president make such a call to action about AIDS or the acquired immunodeficiency syndrome. It had been recognized as a disease for over 15 years by this point and had already infected over 11 million people around the world. But there hadn't been an Operation Warp Speed-style push for an AIDS vaccine.

So Clinton publicly calling for one? That held a lot of weight. And then, a year later. Good evening. And then, a year later... Good evening. The U.S. Food and Drug Administration gave the go-ahead today for the widest human testing yet of an experimental AIDS vaccine. This is a whole new approach...

On June 3rd, 1998, AIDSVAX, Vax004 made history. It became the first potential AIDS vaccine to reach the final stage of testing before approval. It was a very different time than the one we're living in now. But even this familiar expert weighed in with his signature cautious neutrality. It would be folly for me to say I'm optimistic that this is going to work. And equally so would it be for me to say, oh, this definitely is not going to work. We don't know.

That one's for you, Fauci Hive. Today, we're going to break down why we still don't have a vaccine for AIDS. We're going to take a look at the science, so you can call me doctress. But we're also going to take a deeper look at the narrative surrounding that pandemic because it has a huge bearing on how people were treated. And I'm not just talking

medically. That's coming up. Bumble knows it's hard to start conversations. Hey. No, too basic. Hi there. Still no. What about hello, handsome? Who knew you could give yourself the ick? That's why Bumble is changing how you start conversations.

You can now make the first move or not. With opening moves, you simply choose a question to be automatically sent to your matches. Then sit back and let your matches start the chat. Download Bumble and try it for yourself. What does the AI revolution mean for jobs, for getting things done? Who are the people creating this technology and what do they think? I'm Rana El-Khelyoubi, an AI scientist, entrepreneur, investor, and now host of the new podcast, Pioneers of AI. Think of it as your guide for all things AI with the most human issues at the center. Join me every Wednesday for

Pioneers of AI. And don't forget to subscribe wherever you tune in. So not to flex, but I've never had chicken pox. And I'm not saying that to be like, I'm not like other girls, I'm different. Because I'm actually quite a lot like millions of other girls. The chickenpox vaccine came around when I was a baby. And these days, kids don't really get chickenpox, or smallpox, or any of that stuff. And we have vaccines to thank. Today, humans live almost twice as long as we did 100 years ago.

And we're protected against all these viruses that used to kill millions of people a year. In our public health arsenal, vaccines are the big guns. Or maybe more accurately, the tiny little guns. Injected into our bodies, supercharging our immune system into a mighty disease-fighting army. So when a new infectious disease comes onto the scene, like COVID-19, we turn to vaccines to slow the spread or eliminate it entirely. In 1981, AIDS was a newly recognized infectious disease. There were early clusters of cases, mostly among gay men, so people started calling it gay cancer.

In these early years, authorities didn't know how it was spread or even what exactly was causing it. Good afternoon, ladies and gentlemen. Then, in 1984, Reagan-era Secretary of Health and Human Services, Margaret Heckler, called a press conference. First, the probable cause of AIDS has been found, a variant of a known human cancer virus.

We now have a blood test for AIDS. With the blood test, we can identify... Researchers figured out that a virus was causing AIDS, eventually dubbed, as you know, HIV, the human immunodeficiency virus. At the same press conference, Heckler set a goal. She wanted to develop an AIDS vaccine and start testing it within two years. They ended up doing it in three. The first HIV vaccine trials in the United States came about in 87. Over the years, a few more took place in the U.S. and abroad, but the first one to actually reach phase three trials, the final crucial stage of large-scale human testing, came in 1998. It's down to the wire for the biotech firm VaxGen, the only company to bring the testing of an AIDS vaccine

to its final stage. That's our gal, AIDSVaxVax004. Today's approval by the FDA to begin testing of an AIDS vaccine is the most promising sign yet that people may one day be immunized against the disease. The vaccine was developed after 17 years of research... For this final stage, over 5,000 volunteers agreed to test the vaccine over the course of several years.

The participants were people with an elevated risk of contracting the virus. Most were white gay men and some women, predominantly Black and Latina, many of whom had HIV-positive partners. The measure of success is very straightforward. Do the individuals who get the vaccine have less HIV infection than those that don't? For a vaccine against any disease, it's a big deal to make it to this stage. For HIV-AIDS, it was even more so, because it's an especially challenging disease to create a vaccine for.

The way vaccines typically work is that a small amount of a virus, watered down enough for the immune system to handle, is injected into the body. When the immune system attacks that small amount of the virus, it creates antibodies. It learns how to recognize the virus so it can fight off any amount of it in the future. But you can't actually do that with HIV. Previous efforts to create a vaccine have been thwarted by the virus's complexity and unique ability to evade the immune system.

That's because of the sneaky ways HIV behaves in the body. HIV sits in a quiescent mode in protected parts of the body, like lymph nodes, for example. And the immune response doesn't kill all the HIV because a lot of it's hiding out. I spoke with Dr. Sten Vermund, dean of Yale's School of Public Health. He's an infectious disease epidemiologist. Say that three times fast. And at the time of AIDSVax, he headed up the AIDS vaccine trials branch of the National Institute of Allergy and Infectious Diseases. Sten says your body can't

fight off a virus it can't see. There is an immune cell called the T helper cell. And T helper cell is one of the most vital cells in the human body to fight off invaders. And that's the cell that HIV infects. It goes into the very cell that's designed to find it and attack it. No offense, but it's pretty effed up how this virus operates. It spreads between people through certain bodily fluids like blood, semen, or breast milk. It then hijacks these very important immune system T cells, rendering them useless. It takes control of their DNA, creates copies of itself, and takes off into the bloodstream where it keeps hijacking more of these important immune cells.

How is a vaccine supposed to stimulate protection with a pernicious little virus like that? So it's been devilishly difficult to figure out a vaccine strategy against HIV because of this characteristic of it getting into the human being and very quickly evading the immune system. On top of the way HIV evading the immune system.

On top of the way HIV eludes the immune system, it also mutates like crazy, quickly changing its genetic code. So for vaccine developers, it's essentially a moving target. But if they could crack the vax, they could save millions of lives. In the phase three trials for AIDS vax, two-thirds of the participants were given a series of seven injections over three years, while the other third were given the same number of a placebo. Then, in 2003, the results were published. A U.S. biotechnology company called VaxGen had conducted the first major study of an AIDS vaccine.

Today, they published, ABC's Ned Potter, on the disappointing results. The vaccine was called AIDS Vax. After thousands of volunteers and hundreds of millions of dollars, it was official. AIDS Vax, Vax004, had failed. AIDS vax didn't produce enough of an immune response to justify approval. The people who got the vaccine during the trials basically had the same immunity

as those who had taken the placebo. That's to say, the vaccine was about as effective as taking nothing. It's now 23 years into the epidemic. I think the real tragedy is that this is the first vaccine that has gone through wide-scale testing. The future research will continue.

That's the story of the failed AIDS vax. Seems straightforward, right? A new disease shows up, scientists try to fix it, they fall short and go back to the drawing board. If you're only looking at the clinical results, that is the story. But these researchers weren't just up against the complicated science. They were up against a slew of other interests, political interests, economic interests, cultural interests. And unfortunately, the people caught in the middle were the ones who should have been at the center And unfortunately, the people caught in the middle

were the ones who should have been at the center of attention, the people with HIV, people like Richard. I went to my doctor, who I often saw regularly for sexually transmitted disease checkups. We wanted to be responsible, you know, and I said to him, you know, am I going to die? To understand the full story of AIDSVax, let's take off our lab coats and goggles and step into the real world. That's after the break. Welcome back. Before the break, you heard the story of how AIDSVAX, VAC-004,

the most promising AIDS vaccine of its time, failed. But vaccine development doesn't happen in a vacuum. So what was going on in the broader culture? And what was it like from the perspective of someone who actually had AIDS? We're going back to the 80s to tell another version of this story. But this time, we're going to look at what was happening outside of the lab. And our first stop is the Big Apple. I've lived in Manhattan, your Grange Village in New York City

for the last 42 years. I'm still in the same apartment. That's Richard Berkowitz. He's a writer and an activist, and I'm assuming pays the lowest rent in New York City. He co-wrote a booklet called How to Have Sex in an Epidemic in 1983. The story of the AIDS crisis is also his story.

When Richard moved to Greenwich Village in 1978, he found a thriving queer community. It was something he could only dream of as a kid in New Jersey. Coming into the city as a teenager, I'd see gay men kissing on the street. And that alone was life-changing. The notion that there was a place where gay men of all different backgrounds,

where they didn't have to hide who they were, and they weren't ashamed to be who they were, was absolutely life-changing. Richard settled into a life in the village. He studied at NYU for a while, but had to drop out because he couldn't afford it. He started sex work to make some extra money. Think leather, whips, chains. Rihanna S&M vibes.

Most of it wasn't actual sex. It was more about psychological fantasies. And I learned so much about all the different ways that people can experience and express their sexuality. Then suddenly AIDS started to appear. These were the early days before people were even using the term AIDS. Richard watched as many of his friends started to develop rare and mysterious illnesses. Otherwise young and healthy people were getting very sick and dying. In the media, they talked about it

like it was a lifestyle disease. The lifestyle of some male homosexuals has triggered an epidemic of a rare form of cancer. Like I mentioned earlier, most of what was known was that the disease was spreading quickly among clusters of gay men, but also sex workers and people who used intravenous drugs. Most of these people, they're not fit, they're not human beings, they have emotional problems.

Investigators have examined the habits of homosexuals for clues. I was in the fast lane at one time in terms of the way that I lived my life, and now I'm not. And then, in the summer of 1981, Richard started to notice his lymph nodes were swollen. His doctor urged him to get a blood test and a biopsy. I said, I have a gland cut out of my neck. I was mortified. were swollen. His doctor urged him to get a blood test and a biopsy. I said, have a gland cut out of my neck? I was mortified. And he said, it's the only way to know if you have something. And I'm like, have something like what? The tests revealed Richard had a number of health concerns, including hepatitis A, hepatitis B, and a viral infection.

These are all the classic symptoms of the early onset of AIDS. And I basically went to bed for three days and was convinced I was dying. The Centers for Disease Control and Prevention had officially labeled AIDS an epidemic. In the fall of 82, reporters were looking for more information from the government. But as you'll hear in this next exchange, between a reporter named Lester Kinsolving and Deputy White House Press Secretary Larry Speaks, they weren't getting much.

The reporter speaks first. Does the president have any reaction to the announcement of the Center for Disease Control in Atlanta that AIDS is now an epidemic. We have over 600 cases. It's known as gay plague. No, it is. I mean, it's a pretty serious thing.

One in every three people that get this have died, and I wonder if the president is aware of it. I don't have it. Are you? Do you? You don't have it. Well, I'm relieved to hear that, Larry. Do you? You didn't answer my question. How do you know? In other words, the White House looks on this as a great joke. No, I don't know anything about it, Lester.

As the president, does anybody in the White House know about this epidemic, Larry? I don't think so. I don't think there's been any. Nobody knows. There's been no personal experience here, Lester. No patients suffered from AIDS or whatever it is. The president doesn't have gay plague. Is that what you're saying or what? Nope. Didn't say that. Didn't say that. I thought I heard you on the State Department over there. Why didn't you stay over there?

Because I love you, Larry. Oh, I see. Let's go put it those times, Lester. Oh, I see. That's what I put it those times last year. Oh, I retract that. I hope so. This tape is hard to listen to, but it's not surprising. I mean, Ronald Reagan himself refused to even say the word AIDS in public for years. And this dismissive and derogatory attitude wasn't just coming from

the White House briefing room. That sentiment had permeated. Homosexuality is a sin. California Republican William Dannemeyer leads a group of conservative Republicans who hope to make AIDS a political issue, to prohibit those with AIDS from working in health care, to make it a felony for those in an AIDS high-risk group to knowingly donate blood, and to prohibit children with AIDS from attending school. In New York City... The good news that AIDS may be leveling off in the gay community is tempered for some by a new fear, that this virus could spread to straight America.

This narrative around AIDS had a real impact on the research being done. Scientists at the CDC complained that funding was inadequate, which was hampering their progress. They only got their first federal dollars when it was coupled with toxic shock syndrome and Legionnaire's disease in a larger public health emergency trust fund. In a 1983 memo, one CDC staffer wrote that the lack of funding presumably deepened the invasion of the disease into the American population. By the end of 1984, there had been nearly 8,000 AIDS cases and over 3,500 AIDS deaths in the U.S. It's around this time that Richard first heard about the possibility of an AIDS vaccine. Do you remember when you heard the news of a possible AIDS vax?

Do you remember your reaction to that? I've become cynical about vaccines because from 1984, when President Reagan's Secretary of Health, Margaret Hepler, held this big press conference declaring that the cause of AIDS had been discovered, she concluded by saying, and we should have a vaccine in one to two years. This press conference Richard's talking about, it's the same one we told you about at the top of the show, when Heckler announced that ambitious goal to start a vaccine trial within two years. Richard's doctor told him not to get his hopes up, that this is how the game was played.

This is how money gets raised. This is how funding gets released. This is how you have to talk in public to the corporations and the government institutions that have the funds to get money released. And it wasn't that they didn't want to get a vaccine. It's that you've got to be a salesman and you've got to sell things. And so they sold it. But Richard says when you sell a promise you can't deliver on, you don't just disappoint people at risk. You could be putting them in even more danger.

They raised a lot of people's hopes with no basis for doing that. Oh, my God, there could be a vaccine in two years. You know, I'm going to be OK. Maybe I don't need to save sex. And nothing came out of it in two years. And then in three years, another company came out, handed out press releases, had press conferences. Every year, there was some institution or business, you know, coming forward, raising people's hope that they have the lead on some research that's going to produce the HIV vaccine. And none of it went anywhere. Over the next decade,

the public narrative around AIDS started to shift little by little. AIDS activists were doing a lot of work on the ground. Some were spreading resources and information, raising awareness through events like World AIDS Day. Some were actively pushing back against the misinformation being spread about the infectious disease, like that you could get it from swimming in a public pool

or using a public restroom. Others were protesting in the streets, fighting against discrimination and lack of action from the government. Meanwhile, a series of very public stories captured the public's attention, starting with the death of Hollywood heartthrob Rock Hudson in 1985. Good evening, I'm Roger Grimsby. Here now the news.

Actor Rock Hudson dead. His year-long battle with AIDS at an end. He was 59. Hudson died quietly in his... Brian White, the Indiana teenager who gained widespread celebrity support from Hollywood in his fight against AIDS, died yesterday in an Indianapolis hospital. Because of the HIV virus that I have attained, I will have to retire from the Lakers today. NBA superstar Magic Johnson came out as HIV positive in 1991, one year after the death of teenager Ryan White. AIDS was moving from the fringes of society to the more mainstream. During

this time, AIDS also continued to spread outside of the U.S., but especially across sub-Saharan Africa, where by 1993, as many as 9 million people were infected with HIV. As for Richard, he had managed to stay relatively healthy since he tested positive in the 80s. But by 95, he was starting to see his health deteriorate fast. My blood counts began to plummet and I just thought, well, I made it to 40 years old. Maybe this is all I'm going to get. I had my living will made up, drawn up, and I just thought this is it. But in late 1995, they started opening up study sites to give people this new protease inhibitor. Protease inhibitors were an experimental new drug treatment for HIV. Richard got enrolled in a study and began taking them.

My blood counts started jumping back towards the normal range. And in two months, my blood counts were close to normal. I felt reborn. These drugs are able to stop or slow the rate at which HIV makes copies of itself in the body. They basically stop HIV from multiplying. It wasn't the perfect solution. In the early days, some of these meds had really intense side effects, and they were complicated to take. But it really felt like they were saving people's lives. Within a year, the New York Times Sunday magazine published an article by Andrew Sullivan,

AIDS, is it over? And what it really meant was for wealthy people and white people, it was. We now had a manageable disease that could be controlled by medications if you had health care, if you had health insurance. By the late 90s, AIDS stopped being an immediate death sentence to those with access. The wealthy, the famous, the insured. And this brings us back to Bill Clinton's announcement at Morgan State University.

He was pushing for a vaccine within the context of all of this. Medications were already starting to save people's lives. So calling to focus efforts on a vaccine, people felt like it was counterproductive. Part of the president's proposal is to take 30 to 50 NIH researchers from existing programs and reassign them to vaccine research. That drew immediate criticism from AIDS activists who fear resources will be taken away from the search for a cure. It leaves us with the real possibility that we could be robbing Peter to pay Paul.

So when the AIDSVAX, VAX004 trials came around the following year, in 98, Richard was over it. It was like, oh no, here we go again. We were desperate for something, hoping it would work. Researchers are working on a dozen other potential AIDS vaccines. Next time they pray, they will do better. In the years since AIDS vax, there have been multiple attempts at an AIDS vaccine, and they've all failed. But the science is ongoing. Moderna, the makers of one of the COVID-19 jabs, is sending their HIV vaccine into phase one trials later this year.

And when it comes to drugs, there have been revolutionary new meds like PrEP, a daily pill that prevents transmission up to 99%. But a vaccine would still be a game changer, especially, Richard says, in communities that may not have great access to meds. There are still tens of thousands of people in rural America where hospital and healthcare has been decimated by budget cuts. People stuck in certain prisons are denied HIV medication. There are immigrants who don't have access to health care who get infected with HIV. There are people without health insurance who live really horribly impoverished lives.

People are still getting infected and people are still dying of AIDS. That's America. We don't always see the whole picture. The HIV-AIDS crisis continues. It continues in the gay community and the trans community. It continues in rural America and across parts of Africa. It continues among people who use intravenous drugs. AIDS still claims around 700,000 lives per year.

In some ways, we've come a long way from the days of the giggling White House press briefing room. But the stigma implanted in the culture from the very beginning, it remains in many ways. Celebrities like Billy Porter and Jonathan Van Ness have publicly come out as HIV positive in an effort to reduce that stigma. But they've shared that this was after years of agonizing over the decision. I wonder if there's a lesson we'll take from a universal experience like COVID

that we don't seem to have taken from the 40 years and counting AIDS pandemic. Ending a crisis for some is not enough. And our comfort with the loss of certain people, I hope we now have the fortitude to confront that. That was from the podcast Not Past It. You can find it on Spotify. Just search for Not Past It. Science Versus is going to be back in September.

To keep in touch with us while we're out, you can head to our Instagram, science underscore VS, or we're on Twitter at science VS. I'm Wendy Zuckerman. We'll back to you soon.