Fierce Healthcare's Fierce 15 of 2024

Don't Call Kennedy A Vaccine Skeptic. Call Him What He Is: A Cynic.

The news media labels Robert F. Kennedy Jr. A vaccine skeptic. He's not. I'm an actual vaccine skeptic. In fact, everyone who serves with me on the Food and Drug Administration's vaccine advisory committee is a vaccine skeptic. Pharmaceutical companies must prove to us that a vaccine is safe, that it's effective. Then and only then will we recommend that it be authorized or licensed for use by Americans.

Mr. Kennedy, on the other hand, is a vaccine cynic, failing to accept studies that refute his beliefs. He claims that the measles-mumps-rubella vaccine causes autism, despite more than a dozen studies performed in seven countries on three continents involving thousands of children showing that it doesn't.

He has claimed that "there is no vaccine that is safe and effective." (Childhood vaccines have prevented more than one million deaths and 32 million hospitalizations over the past three decades.) He has encouraged people not to vaccinate their babies: "I see somebody on a hiking trail carrying a little baby, I say to him, 'Better not get him vaccinated.'"

When asked about the polio vaccine, Mr. Kennedy claimed that it caused an "explosion in soft tissue cancers" that killed "many, many, many, many, many more people than polio ever did." Setting aside the fact that an "explosion in soft tissue cancers" hasn't occurred, studies comparing children who received early batches of polio vaccines with unvaccinated children found no differences in cancer incidence. By 1979, paralytic polio was eliminated from the United States. When Mr. Kennedy says he wants vaccines to be better studied, what he really seems to be saying is he wants studies that confirm his fixed, immutable, science-resistant beliefs. That's not skepticism.

Here's what good-faith vaccine skepticism looks like: In June 2022, I was one of the F.D.A. Advisory committee members who voted against authorization of bivalent Covid vaccines (updated vaccines targeting both the original strain and the Omicron variant). I wasn't convinced they were any better than the vaccines we already had, which targeted only the original strain. While the committee ultimately voted to approve the shots, the vigorous debate around the data — as well as the debates my colleagues and I have had on other issues, such as the merits of Covid booster shots for healthy young adults — shows the value of rigorous discussion about vaccines.

Vaccine skepticism is baked into the systems with which health experts monitor vaccines after they're authorized for use. We know that clinical trials are not enough; we need to constantly ask questions and examine new data. That's why we have surveillance systems that can detect problems too rare to be picked up in clinical trials. It's how we know that the mRNA Covid-19 vaccines caused the heart condition myocarditis in about one in 50,000 people and that the Johnson & Johnson Covid-19 vaccine caused dangerous clotting in about one in 250,000 people. Detecting such risks allows us to weigh these rare harms against the enormous benefits of these vaccines.

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The Infamous 'Cutter Vaccine' Changed My Family Forever — But We Still Support Vaccination

By Laurie Maffly-Kipp

Jan. 15, 2025

Maffly-Kipp is the Richard Lyman Bushman professor of religious studies at the University of Virginia.

If anyone should have lobbied against the use of vaccines in this country, it was my family.

My Aunt Jean, my father's older sister, was a victim of the infamous Cutter vaccine, an early variant of the polio vaccine presumed to contain an inactivated version of the live virus. Except that it wasn't inactive. Some 200,000 children in Western and Midwestern states received that vaccine in the spring of 1955. That number included three of my cousins — Aunt Jean's children. The dosages had been administered by my father, then chief resident at Herrick Memorial Hospital in Berkeley, California. His father, my grandfather, was then the hospital's chief administrator. The vaccine had been offered to the young members of the families of health care workers, and so my cousins lined up and were inoculated.

The rest of that tragic story has been recounted in the aggregate: 40,000 cases of polio, 200 children paralyzed to some degree (one of the vagaries of polio is that it attacks everybody differently), several dozen people killed. My cousins all contracted mild cases but emerged without ongoing health issues. My aunt, however — a vibrant 29-year-old mother of three young boys — caught the virus from them. She spent the following six months in an iron lung and nearly died. Her doctors told her that she might make it to age 30 but had little chance of surviving long with the damage to her lung capacity and swallowing muscles.

Easy story, isn't it? Vaccines are the problem. Science isn't perfect and we shouldn't trust it.

Except that's not the lesson that my aunt or my father took from this horrible experience, not by a long shot. 

Polio transmission was supposed to end by 2023. A new report explains why it won't.

They had already seen children dying or permanently disabled by the ravages of the virus. Pediatrician Paul Offit, in his study of the Cutter incident, reminds us that before the vaccine arrived, in all its bumpy and imperfect beginnings, tens of thousands of children were maimed or killed by polio every year. Parents fretted over sending their children to swimming pools for lessons, and by the 1950s feared the frequent summer disease outbreaks almost as much as the atomic bomb. We don't have to wonder what would have happened without the arrival of the vaccine, because so many families lived that reality. We know.

My father knew. I asked him, many years later, what it was like to be the one that distributed that vaccine to his nephews, and then helplessly watch the terrifying illness attack his beloved sister. He answered immediately: "I have no regrets. That vaccine was flawed, but polio was horrible, and there was no other humane choice. Science isn't perfect, but it is the best human beings can do to provide protection."

Jean Wight Courtesy Laurie Maffly-Kipp

I have hesitated to write this story for many years, ever since vaccines themselves became the object of suspicion and fear. Won't this story simply give fuel to anti-vaxxers, so ready to latch onto a tale of vaccines gone wrong?

But that is exactly why this story needs to be told. It is a tale of personal tragedy, yes, but also of a faith in public health, in the greater good, and in the ability of science to self-correct as it pushes toward cures for horrible diseases. Those who have died from polio can't tell that tale. We are left, then, with stories from critics, most of whom do not have evidence to back their claims of scientific failure. And they are too often led by those looking to benefit from unregulated "cures" with even less of an evidentiary basis.

My aunt was the victim of regulatory failure. Yet she saw the greater good that was at stake and chose to remain focused on that. She lived to age 70, disabled but enjoying the presence of her children and grandchildren, building a rewarding career as a counselor, and knowing that her life, while forever altered by polio, was not defined by it. My father and grandfather also kept their eyes on the possibility for self-correction in health care. Other vaccine companies, following Jonas Salk's protocol, produced viable vaccines that saved a generation of children, including me, from having to fear swimming pools or public skating rinks. We lined up for our sugar cube vaccines at school to contribute to the public good that would, we knew, save many more individuals from the ravages of the virus.

I don't share Jean's story to suggest that disease has redeeming possibilities for those who survive. Perhaps it can, but when we have the means of prevention in front of us, we should celebrate and seize that victory, however imperfect.  It is a shoutout from the front lines to celebrate the breakthroughs of research, recognizing that not everything will be an unqualified win. Public health requires us to think beyond individual needs, to recognize that unless vaccines are widely distributed (and yes, even required in some cases) they will be of no use to anyone. It also urges us to recognize that some battles have already been litigated and do not need to be revisited when the evidence of success is overwhelming.

People from India remember life before the polio vaccine. They don't want to go back

The recent back-and-forth between Robert F. Kennedy Jr. And President Trump regarding the polio vaccine reflects a lack of logic in both respects. In responding to Kennedy's vaccine criticism, Trump recently remarked that he would want to end some childhood vaccines "if I think it's dangerous." But dangerous for whom? For the one, the 200, or the millions who might benefit? I hate to contemplate harm to anyone, but as my aunt would have attested, there are lesser and greater risks in life. All that science can do is mitigate risks, not eradicate them.

Similarly, clear success of vaccine use, demonstrated by years of health statistics in the case of polio, gives lie to the notion that we should relitigate all decisions regarding vaccination, as Kennedy and others might have it. This is not to say that we should eliminate robust regulatory mechanisms that detect potential problems and question methods. But it does raise the obvious question of what sort of proof is being sought. What qualifies as adequate scientific evidence of failure or success? I have not heard any vaccine critics answer that question clearly and precisely. Until they can and do, we are left with little more than fearmongering without a clear goal in mind.

My aunt would have had no patience for these debates. Perhaps because of her close and prolonged brush with death, she always kept the bigger picture in mind. She vaccinated her family on recommended schedules. In her later years she developed post-polio syndrome, a pernicious condition that gradually robbed her of the gains her health had made since the 1950s. Still, she kept her eyes on the present and future, never turning her anger on the faulty vaccine that had altered her life. Millions of children lived long and healthy lives because of the polio vaccine, and public memory of the horrible history of a previously uncontrollable virus faded from view for many. Science is what removed that scourge, and despite its imperfections, she knew it was an ally to be nurtured and even questioned with precise evidence, but never dismissed without cause.

Laurie Maffly-Kipp is the Richard Lyman Bushman Professor of Religious Studies at the University of Virginia.

The Real Benefits Of Annual Covid-19 Booster Shots

Peter Hotez has made every effort to stay up to date with Covid-19 vaccines, starting with the initial two doses and continuing through each booster iteration. "I've gotten every one possible," he said.

Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, has followed the guidance from the Centers for Disease Control and Prevention, which currently recommends annual shots for everyone over six months of age. For high-risk groups such as adults over 65 and people who are immunocompromised, the CDC recommends an additional booster six months later.

The U.S. Appears to be alone in adopting its universal approach. Other countries, particularly in Europe, recommend a more tailored strategy. For example, Sweden and Germany now only recommend that high-risk groups get boosted. And the World Health Organization has adopted a similar approach, stratifying groups and adjusting advice based on comorbidities and age.

Some researchers suggest that additional yearly vaccines may not be necessary for most people given that Covid-19 cases, hospitalizations, and deaths are overall on a downward trend, and infections are much less severe than a few years ago. But others, like Hotez, agree with the CDC guidance, pointing out that additional vaccines help boost waning immunity and protect against chronic conditions such as long Covid and heart complications. "One of the best ways to protect your heart health is to keep up with your boosters," Hotez said.

Despite the guidance, only about 20 percent of American adults have gotten the latest vaccine to date. This concerns experts like Jessica Malaty Rivera, an infectious disease epidemiologist and senior science communication adviser at the deBeaumont Foundation, which focuses on public health, but she said it doesn't surprise her: "Covid vaccine fatigue is very real."

Other concerns, such as what guidance will look like with the new Trump administration, are also beginning to bubble up.

The argument against yearly Covid-19 vaccines, according to some experts, is not that they are damaging, but rather that they may, at this point, be unnecessary for healthy individuals. Most Americans are not getting the yearly vaccination, yet hospitalizations and deaths are still declining, said Paul Offit, a pediatrician specializing in infectious diseases at the University of Pennsylvania School of Medicine. Instead, the boosters appear to most benefit at-risk groups: elderly people, individuals who are immunocompromised, patients who have chronic medical conditions, and people who are pregnant.

"Those are the four big groups who really do benefit from a yearly vaccine," he said. "Because what they all share, frankly, is they don't make great immune responses, so they need that sort of repeat dosing."

"One of the best ways to protect your heart health is to keep up with your boosters."

Offit's hunch is that the current U.S. Guidance is a way to convince those vulnerable groups to get vaccinated. "The public health community has decided that the best way to get those people who are in high-risk groups vaccinated is to recommend it for everybody," he said. "I think that they should explain that, if that's their thinking."

(In a response to a request for comment, an email sent to Undark by CDC spokesperson Jasmine Reed noted that in developing recommendations, the agency considers "balance of benefits and harms, type or quality of evidence, values and preferences of the people affected, and health economic data analyses.")

Ultimately, though, the extra vaccinations provide a tinge of extra protection, even if it isn't necessary, Offit pointed out. "For healthy young people, I think it's kind of low risk, low reward," he said, though he acknowledged such people might need boosters in the future if immunity from both natural infection and previous vaccinations begin to fade and they start experiencing more severe disease.

Other experts stand by the CDC guidelines, mainly because they recognize that immunity brought on by Covid-19 vaccination, infection, or both dwindles within the year, especially with evolving variants of the virus. The recommendations are "based on the fact that the durability of protection using this mRNA technology is not as robust as we'd like it to be," Hotez said.

For all of Undark's coverage of the global Covid-19 pandemic, please visit our extensive coronavirus archive.

Additional yearly vaccinations can also influence the development of long-term consequences beyond just getting infected with Covid-19, Rivera emphasized. "Covid is a virus that affects your cardiovascular health and your neurological health and your overall physical health; it can debilitate people and disable people," she said. "If you can reduce your risk of having severe outcomes and long-term health complications and deaths, it just seems like a much better way to do that."

One study published in Nature Communications in 2024 looked at health records from 45.7 million adults in England and found that heart events such as stroke decreased after each vaccine dose. Other studies suggest that receiving a Covid-19 booster vaccine also reduces the risk of developing long Covid. "It's really more about keeping you out of the hospital, protecting your heart health, and reducing your likelihood of long Covid," said Hotez.

Kathryn Edwards, a pediatrician who specializes in infectious diseases and vaccines at Vanderbilt University, also agrees with the current CDC Covid-19 booster guidance. Still, she emphasized that higher risk groups in particular "should preferentially get the booster."

What does the future of Covid boosters look like? Although people in the United States are getting the 2024-2025 Covid vaccine, the 20 percent of vaccinated adults and 11 percent of vaccinated children pales in comparison to the 70 percent of people who got the first round of vaccines. And a survey conducted in October by the Pew Research Center shows that 60 percent of Americans say they will probably not get the latest vaccine. Much of that, experts say, is due to fatigue, concerns about potential side effects, and the fact that people don't think about harm reduction as a spectrum. "People just want to hear that there's either no chance of getting it or 100 percent chance," Rivera said. "And that's just not how this data work."

"For healthy young people, I think it's kind of low risk, low reward."

Meanwhile, comparing recommendation outcomes across countries can be tricky given the differences in health care, co-morbidities, and ethnicities, she added: "It's not a one-to-one comparison."

Despite the nuanced debates on booster guidance, there are a few things that U.S. Experts agree on. First, every expert that Undark talked to agreed that boosters provide much needed protection to at-risk populations. Some also emphasized the need for improved messaging from agencies like the CDC on their decisions and ongoing epidemiological studies to continue improving understanding of how the different boosters match up against the current and emerging variants.

For example, Offit would like to see collaborations between the CDC, which generates the epidemiological studies, and academic immunologists to further understand how long immunity really lasts so then vaccinations can be recommended accordingly.

Every expert that Undark talked to agreed that boosters provide much needed protection to at-risk populations.

Many experts are also worried about what guidance and vaccine availability will look like under the new Trump administration, especially given the influence of vaccine skeptic Robert F. Kennedy, Jr., who has been tapped to head the Department of Health and Human Services. Recently, Kennedy's lawyer petitioned the U.S. Government to revoke approval of the polio vaccine, signaling potential changes to come. "I think everybody's holding their breath and waiting to see what the fallout is going to be," said Offit.

Hotez's next Covid-19 vaccination is due in February. But, he said in December, "I probably would get it in early January, just because of the uncertainty whether it's going to be available or not."

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