https://www.cidrap.umn.edu/cidrap-o...hat-it-takes-know-whether-vaccine-caused-harm
CIDRAP Op-Ed: A gap is not a finding—A lawsuit, a petition, and what it takes to know whether a vaccine caused harm
Jake Scott, MD
Today at 11:08 a.m.
The researchers sequenced a single gene, SCN1A, which encodes a protein that controls electrical signaling in the brain. Eleven of the 14 children carried mutations in it, and in every case that could be checked, neither parent carried the same mutation. The children had not inherited it. It had arisen in them, before birth.
These children had been born with the mutation that caused the disease. The researchers concluded that children with such mutations seem to develop the disorder regardless of whether they are vaccinated in infancy. But they were careful about what they had not shown. Vaccination might still trigger the first seizure, perhaps through fever, and their study had not been designed to answer that question.
Four years later, the same group set out to answer it. Among forty children with SCN1A-related disease, those whose first seizure came on the day of or the day after vaccination had started having seizures about eight weeks earlier, on average, than the others. But their intellectual outcomes and subsequent seizure patterns were no worse. The vaccination may have accelerated the timing of the first seizure, but it did not appear to change how the disease later unfolded.
That distinction mattered enormously to the parents. In the first account, they had taken a healthy baby to a routine appointment, and that act had inflicted a lifetime of seizures and disability on their child. In the second account, the disease was already written into the child's DNA and would have arrived no matter what anyone did. The appointment was just an appointment.
Many of these families had believed the first version for years—some for decades. No one could have told them otherwise: when their children were diagnosed, the genetic test that would eventually answer the question did not exist. The researchers were explicit about what the correct diagnosis offered them: it identified the true cause, guided treatment, allowed realistic planning, and removed the blame of having vaccinated the child.
Not knowing the cause became, in practice, a reason to name one.
The wrong label had cost them something more practical, too. It could not tell them which seizure medications would make things worse, what the risk was for a younger sibling, or what to expect when the child turned 15.
The genetic diagnosis could tell them all of that. But there was another problem with how the original diagnosis was reached. Nobody could say what had caused these children's epilepsy, and so they turned to the most conspicuous thing: the vaccination. It was recent, it was documented, and it was the one event anyone could point to. Not knowing the cause became, in practice, a reason to name one.
That is a specific and seductive error, and it is easy to make in good faith. I see a version of it in my own clinic, in adults who arrive having been told they have chronic Lyme disease, a label without a consistent definition that most infectious disease physicians do not recognize as a distinct illness.
The Lyme disease label resonates for patients precisely because no one has found the real explanation for what they are experiencing. Most of them never had Lyme. When French investigators carefully evaluated about 300 such patients, fewer than one in 10 actually did, and more than 80% turned out to have something else, much of it serious and much of it treatable. Every month spent inside the wrong explanation was a month the right one went unexamined.
That same reasoning is now at work in two places at once: a lawsuit filed in federal court this January, and a petition sent to the Department of Health and Human Services (HHS) in March.
What vaccines have actually done
Before going further, it is worth saying plainly that vaccines can cause harm. Yet serious harm is rare, and the reason we can describe it so precisely is that it has been studied for a century.
Vaccines also work well enough that we give them to nearly everyone. Before the measles vaccine became available, an estimated 3 to 4 million Americans were infected every year, and incidence fell by more than 95% in the years after licensure. Pertussis ran to more than 200,000 reported cases annually before the 1940s, and by 1976, the count had fallen to 1,010. That is precisely why the harms matter so much: A product given to millions of healthy children has to meet a standard that few treatments for the sick are asked to meet. And the history includes real disasters, which no honest account can omit.
In 1942, the yellow fever vaccine given to American troops was stabilized with human blood serum, some of it from donors carrying what we now know was hepatitis B. By July of that year, 28,585 service members had developed jaundice, and 62 had died. In 1955, Cutter Laboratories failed to fully kill the virus in its polio vaccine, and children were injected with live poliovirus. Fifty-one were paralyzed, and five died. The virus then spread from them to family and neighbors, paralyzing 113 more people and killing five of them. Federal oversight of vaccine manufacturing in this country exists because of that disaster.
Some failures were harder to anticipate and worse in kind. In the 1960s, infants were enrolled in trials of a vaccine against respiratory syncytial virus (RSV), the ordinary winter infection that fills pediatric wards every year and occasionally kills. The vaccine did not protect them. It did something nobody had predicted: it made the illness worse. Among vaccinated children who later caught the virus, 80% had to be hospitalized.
The vaccine had trained their immune systems to respond badly to the very thing it was meant to defend against. The effect is now called vaccine-associated enhanced disease. The RSV vaccines in use today were designed with that failure in mind, and the evidence on them shows nothing of the kind. A related problem emerged decades later with a dengue vaccine that raised the risk of severe illness in children who had never been infected before.
Others were rare harms that emerged only once millions of doses had been given. The first rotavirus vaccine caused a serious bowel obstruction in about one in 10,000 infants, and its recommendation was suspended less than a year after licensure. Pandemrix, an adjuvanted flu vaccine used in Europe during the 2009-10 H5N1 influenza pandemic, was linked to an increase in narcolepsy among children and adolescents in several European countries, a rare and permanent harm.
A product given to millions of healthy children has to meet a standard that few treatments for the sick are asked to meet.
The list for the vaccines in use today is shorter, and we know it in far more detail. Anaphylaxis, a severe whole-body allergic reaction, occurs roughly once per 1 million doses. It is the reason you sit for 15 minutes after a shot and the reason every clinic that gives vaccines keeps epinephrine on hand.
The measles, mumps, and rubella (MMR) vaccine causes about one additional fever-triggered seizure for every 3,000 to 4,000 children vaccinated. Those seizures are frightening to witness but almost always cause no lasting harm. Myocarditis, or inflammation of the heart muscle, after the receipt of the original mRNA COVID-19 vaccines was real, concentrated in young men after the second dose, and identified within months of the vaccine rollout.
Only these original formulations ever showed a statistically significant excess, and the vaccines in use now sit at the background rate. A rare clotting disorder after the Janssen (Johnson & Johnson) COVID vaccine led to restricted recommendations and helped end its use in the United States.
Each of those harms was identified. Some turned up in clinical trials, some in outbreak investigations, and some only after millions of doses had been given and researchers went looking in the data.
Why coincidence is guaranteed
Here is the difficulty at the center of this field. Vaccinate 10 million people and, over the following month, some of them will have strokes, seizures, miscarriages, and deaths—even if the vaccine has no effect on any of those things.
Sudden infant death syndrome (SIDS) peaks between 2 and 3 months of age, which is also when infants receive a large number of their recommended vaccinations. Some of those deaths will therefore occur in the days after a shot, no matter what, and they would occur at the same age even if no vaccine existed.
Researchers have looked hard at this. In 2003, the Institute of Medicine concluded that the evidence favored rejecting a causal relationship between SIDS and both whole-cell pertussis vaccination and the receipt of several vaccines at once.
A later study examined deaths within 60 days after vaccination among more than 13 million people and found no unusual pattern in the causes. Mortality just after vaccination was, in fact, lower than in the general population, which is what epidemiologists call the “healthy vaccinee effect”: people who are gravely ill are less likely to be vaccinated in the first place.
So the fact that something terrible happened after a vaccine tells you very little on its own. Answering the question requires a comparison: whether the event occurs more often than expected, in similar people, during a window when the vaccine could plausibly be responsible.
Sometimes the answer arrives quickly. Myocarditis after mRNA COVID-19 vaccination showed up as a pattern almost immediately in young men, after second doses, within a few days. Other questions take decades to answer, because the suspected injury looks like something that would have happened anyway in people who were already at risk. Severe epilepsy in a toddler looks like many things. That is why those 14 children waited so long for an answer.
How a claim of harm is built
On April 23, 2025, 18-month-old twins in Idaho received three vaccines, one of them the combined diphtheria, tetanus, and acellular pertussis (DTaP) shot. The next day, their mother brought them to an emergency department (ED) because they seemed warm and a little sluggish. The examinations were reassuring. One twin had a temperature of 99º F, made good eye contact, and was drinking fluids; the other was described as very active. Both received acetaminophen (Tylenol) and went home.
Among the diagnoses entered on their charts was a post-immunization reaction. That is one of the most ordinary entries in pediatric medicine, a working explanation for mild symptoms that begin the morning after a shot. Feeling warm and cranky for a day or two after vaccination is common and expected, and it is described on the package insert. The entry records a symptom and when it started, nothing more.
Eight days after the vaccinations, both children were found dead.
Three days later, before any autopsy result was documented, their parents appeared in a video interview with Children's Health Defense, a nonprofit long chaired by HHS Secretary Robert F. Kennedy Jr. and among the most prominent organizations campaigning against vaccines. During the interview, vaccines were repeatedly blamed.
All three vaccines the twins received were non-live, meaning they contain no living virus or bacteria and cannot cause an infection. The recognized mechanism by which such a vaccine can cause death is anaphylaxis, which announces itself within minutes to hours rather than eight days later. I reviewed the available information at the request of The Guardian, as did another infectious disease physician, and we reached the same conclusion independently.
In January of this year, that organization and five other plaintiffs, the children's mother among them, sued the American Academy of Pediatrics in federal court, alleging a decades-long racketeering scheme. The twins appear in the complaint as evidence. It recites the ED diagnosis. It notes that the autopsies are pending. It states that no alternative cause of death has been identified. And it moves from there to the claim that the deaths demonstrate the dangers of vaccines.
By then, police had been treating the case as a homicide for eight months, which the complaint acknowledges one paragraph later before recasting the investigation as further evidence of wrongdoing by the Academy. In June, a grand jury indicted the children's mother on two counts of first-degree murder. She denies the allegations, and the indictment establishes nothing about what caused two deaths.
A claim that no evidence could have disturbed was never resting on evidence to begin with.
The complaint's statement may have been literally true in the narrowest sense. The autopsies were unfinished, and no final alternative had been announced. But what it described was the status of an investigation, and the complaint made that status carry the weight of a finding. A working diagnosis for mild symptoms the morning after vaccination became documentation of a fatal vaccine injury. An unfinished autopsy became the absence of an alternative. And the absence of an alternative became evidence that the vaccines had killed them.
There is a way to tell whether an explanation was reached or assumed. Ask what finding would have overturned it. When the Australian teamstudying the 14 children sent those samples off for sequencing, they did not know what would come back, and a normal result would have left them with nothing.
Their conclusion was exposed to the risk of being wrong, which is what made it a conclusion. The account offered three days after those twins were found carried no such exposure. No autopsy result, no toxicology screen, no police finding was going to change it. A claim that no evidence could have disturbed was never resting on evidence to begin with.
The ledger
Congress created the National Vaccine Injury Compensation Program in 1986, after a wave of lawsuits over the old whole-cell pertussis vaccine nearly drove manufacturers out of business.
Many of those lawsuits rested on the belief that a seizure beginning soon after pertussis vaccination could mark the onset of permanent vaccine-caused brain injury, the very interpretation the Australian study would later overturn in its 14 cases. Encephalopathy following a pertussis-containing vaccine was written into the program's list of recognized injuries, and it is still there.
The program maintains that list so it can pay claimants without requiring anyone to prove a vaccine was the cause. The list is deliberately generous, and that is the point. The program pays out under a schedule Congress set in 1986: $250,000 for a death, and the same cap on compensation for pain and suffering, with medical care, rehabilitation, and lost earnings covered separately. Claims are decided by judicial officers called “special masters,” no more than eight at a time under the statute, and cases often take years.
In March, the Informed Consent Action Network, a nonprofit that funds vaccine-litigation and public-records campaigns, petitioned the government to add more than 300 vaccine-event pairs to that list.
The petition does not claim that these injuries have been shown to be caused by vaccines; it concedes that they have not. Its argument is that causation is the wrong test, because the law speaks of injuries associated with vaccines, and the association has already been officially acknowledged.
The acknowledgment it points to is of two kinds. The first is the government's decision to ask the Institute of Medicine to examine these questions. The petition treats the decision to commission the review as official acknowledgment of an association. It makes the same argument about a follow-up review in 2021: that looking a second time is itself an admission.
A gap in the evidence is not a finding. It is a description of what the evidence cannot yet establish.
The second is package inserts. Open the label for Infanrix, a widely used DTaP vaccine, and turn to the section on postmarketing experience. It opens by explaining that these events were reported voluntarily from a population of uncertain size, so that it is not possible to say reliably how often they happen or whether the vaccine caused them. Then comes the list. Under general disorders, alongside fatigue and injection-site swelling, is SIDS.
That entry means SIDS was reported after a vaccination and was included among the postmarketing reactions in the label. It does not mean the report was validated or that the vaccine caused the death. The sentence directly above the list says exactly that. The petition cites the list and does not mention the sentence.
The Institute of Medicine was equally clear about its own work. When it could not reach a conclusion, it wrote, that meant the studies were too few, too weak, or too conflicting to support any answer in either direction, and it warned readers explicitly not to read it as evidence one way or the other. It reached that verdict for 135 of the 158 questions it examined.
A gap in the evidence is not a finding. It is a description of what the evidence cannot yet establish.
What we owe people
What the record actually shows is a system capable of finding harm. Some harms became visible within months, others took years of epidemiologic and laboratory work, and the difference between them has to do with how closely the injury resembles something that happens anyway.
Childhood vaccines remain among the most closely monitored medical products in existence, and the honest summary of a century of scrutiny is that serious risks are rare, identifiable, and vastly outweighed by the diseases the vaccines prevent.
That is not the same as saying every question is settled. Some are not. The right response to an open question is to investigate it: fund the work, design the study so that it can come out either way, and wait for the answer.
What people who believe a vaccine harmed them deserve is the work: a study built so that it can come out the other way and the willingness to say, for as long as the evidence requires, that we do not yet know. What they usually get instead is one of two things: either reassurance offered before anyone has looked or a fast explanation that feels like being believed, delivered by people whose conclusion cannot change.
The families in the Australian study waited years for something better than either. The answer, when it came, did not undo what had happened to their children. What it did was tell them that the appointment they had blamed for years was not the cause. That is what the work can do, but only when the evidence is allowed to come before the verdict.
Dr. Scott is a clinical associate professor of infectious diseases at Stanford University School of Medicine, and a coauthor of "Updated evidence for COVID-19, RSV, and Influenza Vaccines for 2025-2026" in the New England Journal of Medicine.
The opinions voiced in CIDRAP Op-Ed pieces are the authors' own and do not necessarily represent the official position of CIDRAP.
CIDRAP Op-Ed: A gap is not a finding—A lawsuit, a petition, and what it takes to know whether a vaccine caused harm
Jake Scott, MD
Today at 11:08 a.m.
In 2006, an Australian-led research team studied 14 children who had all been given the same diagnosis years earlier—some of them decades earlier. Each had suffered a catastrophic seizure within 72 hours of a pertussis (whooping cough) vaccination, all of them before their first birthday, and had gone on to develop severe epilepsy that never improved. No other cause had ever been found. By the standards of the time, they were said to have vaccine encephalopathy, meaning brain injury caused by the vaccine.The researchers sequenced a single gene, SCN1A, which encodes a protein that controls electrical signaling in the brain. Eleven of the 14 children carried mutations in it, and in every case that could be checked, neither parent carried the same mutation. The children had not inherited it. It had arisen in them, before birth.
These children had been born with the mutation that caused the disease. The researchers concluded that children with such mutations seem to develop the disorder regardless of whether they are vaccinated in infancy. But they were careful about what they had not shown. Vaccination might still trigger the first seizure, perhaps through fever, and their study had not been designed to answer that question.
Four years later, the same group set out to answer it. Among forty children with SCN1A-related disease, those whose first seizure came on the day of or the day after vaccination had started having seizures about eight weeks earlier, on average, than the others. But their intellectual outcomes and subsequent seizure patterns were no worse. The vaccination may have accelerated the timing of the first seizure, but it did not appear to change how the disease later unfolded.
That distinction mattered enormously to the parents. In the first account, they had taken a healthy baby to a routine appointment, and that act had inflicted a lifetime of seizures and disability on their child. In the second account, the disease was already written into the child's DNA and would have arrived no matter what anyone did. The appointment was just an appointment.
Many of these families had believed the first version for years—some for decades. No one could have told them otherwise: when their children were diagnosed, the genetic test that would eventually answer the question did not exist. The researchers were explicit about what the correct diagnosis offered them: it identified the true cause, guided treatment, allowed realistic planning, and removed the blame of having vaccinated the child.
Not knowing the cause became, in practice, a reason to name one.
The wrong label had cost them something more practical, too. It could not tell them which seizure medications would make things worse, what the risk was for a younger sibling, or what to expect when the child turned 15.
The genetic diagnosis could tell them all of that. But there was another problem with how the original diagnosis was reached. Nobody could say what had caused these children's epilepsy, and so they turned to the most conspicuous thing: the vaccination. It was recent, it was documented, and it was the one event anyone could point to. Not knowing the cause became, in practice, a reason to name one.
That is a specific and seductive error, and it is easy to make in good faith. I see a version of it in my own clinic, in adults who arrive having been told they have chronic Lyme disease, a label without a consistent definition that most infectious disease physicians do not recognize as a distinct illness.
The Lyme disease label resonates for patients precisely because no one has found the real explanation for what they are experiencing. Most of them never had Lyme. When French investigators carefully evaluated about 300 such patients, fewer than one in 10 actually did, and more than 80% turned out to have something else, much of it serious and much of it treatable. Every month spent inside the wrong explanation was a month the right one went unexamined.
That same reasoning is now at work in two places at once: a lawsuit filed in federal court this January, and a petition sent to the Department of Health and Human Services (HHS) in March.
What vaccines have actually done
Before going further, it is worth saying plainly that vaccines can cause harm. Yet serious harm is rare, and the reason we can describe it so precisely is that it has been studied for a century.
Vaccines also work well enough that we give them to nearly everyone. Before the measles vaccine became available, an estimated 3 to 4 million Americans were infected every year, and incidence fell by more than 95% in the years after licensure. Pertussis ran to more than 200,000 reported cases annually before the 1940s, and by 1976, the count had fallen to 1,010. That is precisely why the harms matter so much: A product given to millions of healthy children has to meet a standard that few treatments for the sick are asked to meet. And the history includes real disasters, which no honest account can omit.
In 1942, the yellow fever vaccine given to American troops was stabilized with human blood serum, some of it from donors carrying what we now know was hepatitis B. By July of that year, 28,585 service members had developed jaundice, and 62 had died. In 1955, Cutter Laboratories failed to fully kill the virus in its polio vaccine, and children were injected with live poliovirus. Fifty-one were paralyzed, and five died. The virus then spread from them to family and neighbors, paralyzing 113 more people and killing five of them. Federal oversight of vaccine manufacturing in this country exists because of that disaster.
Some failures were harder to anticipate and worse in kind. In the 1960s, infants were enrolled in trials of a vaccine against respiratory syncytial virus (RSV), the ordinary winter infection that fills pediatric wards every year and occasionally kills. The vaccine did not protect them. It did something nobody had predicted: it made the illness worse. Among vaccinated children who later caught the virus, 80% had to be hospitalized.
The vaccine had trained their immune systems to respond badly to the very thing it was meant to defend against. The effect is now called vaccine-associated enhanced disease. The RSV vaccines in use today were designed with that failure in mind, and the evidence on them shows nothing of the kind. A related problem emerged decades later with a dengue vaccine that raised the risk of severe illness in children who had never been infected before.
Others were rare harms that emerged only once millions of doses had been given. The first rotavirus vaccine caused a serious bowel obstruction in about one in 10,000 infants, and its recommendation was suspended less than a year after licensure. Pandemrix, an adjuvanted flu vaccine used in Europe during the 2009-10 H5N1 influenza pandemic, was linked to an increase in narcolepsy among children and adolescents in several European countries, a rare and permanent harm.
A product given to millions of healthy children has to meet a standard that few treatments for the sick are asked to meet.
The list for the vaccines in use today is shorter, and we know it in far more detail. Anaphylaxis, a severe whole-body allergic reaction, occurs roughly once per 1 million doses. It is the reason you sit for 15 minutes after a shot and the reason every clinic that gives vaccines keeps epinephrine on hand.
The measles, mumps, and rubella (MMR) vaccine causes about one additional fever-triggered seizure for every 3,000 to 4,000 children vaccinated. Those seizures are frightening to witness but almost always cause no lasting harm. Myocarditis, or inflammation of the heart muscle, after the receipt of the original mRNA COVID-19 vaccines was real, concentrated in young men after the second dose, and identified within months of the vaccine rollout.
Only these original formulations ever showed a statistically significant excess, and the vaccines in use now sit at the background rate. A rare clotting disorder after the Janssen (Johnson & Johnson) COVID vaccine led to restricted recommendations and helped end its use in the United States.
Each of those harms was identified. Some turned up in clinical trials, some in outbreak investigations, and some only after millions of doses had been given and researchers went looking in the data.
Why coincidence is guaranteed
Here is the difficulty at the center of this field. Vaccinate 10 million people and, over the following month, some of them will have strokes, seizures, miscarriages, and deaths—even if the vaccine has no effect on any of those things.
Sudden infant death syndrome (SIDS) peaks between 2 and 3 months of age, which is also when infants receive a large number of their recommended vaccinations. Some of those deaths will therefore occur in the days after a shot, no matter what, and they would occur at the same age even if no vaccine existed.
Researchers have looked hard at this. In 2003, the Institute of Medicine concluded that the evidence favored rejecting a causal relationship between SIDS and both whole-cell pertussis vaccination and the receipt of several vaccines at once.
A later study examined deaths within 60 days after vaccination among more than 13 million people and found no unusual pattern in the causes. Mortality just after vaccination was, in fact, lower than in the general population, which is what epidemiologists call the “healthy vaccinee effect”: people who are gravely ill are less likely to be vaccinated in the first place.
So the fact that something terrible happened after a vaccine tells you very little on its own. Answering the question requires a comparison: whether the event occurs more often than expected, in similar people, during a window when the vaccine could plausibly be responsible.
Sometimes the answer arrives quickly. Myocarditis after mRNA COVID-19 vaccination showed up as a pattern almost immediately in young men, after second doses, within a few days. Other questions take decades to answer, because the suspected injury looks like something that would have happened anyway in people who were already at risk. Severe epilepsy in a toddler looks like many things. That is why those 14 children waited so long for an answer.
How a claim of harm is built
On April 23, 2025, 18-month-old twins in Idaho received three vaccines, one of them the combined diphtheria, tetanus, and acellular pertussis (DTaP) shot. The next day, their mother brought them to an emergency department (ED) because they seemed warm and a little sluggish. The examinations were reassuring. One twin had a temperature of 99º F, made good eye contact, and was drinking fluids; the other was described as very active. Both received acetaminophen (Tylenol) and went home.
Among the diagnoses entered on their charts was a post-immunization reaction. That is one of the most ordinary entries in pediatric medicine, a working explanation for mild symptoms that begin the morning after a shot. Feeling warm and cranky for a day or two after vaccination is common and expected, and it is described on the package insert. The entry records a symptom and when it started, nothing more.
Eight days after the vaccinations, both children were found dead.
Three days later, before any autopsy result was documented, their parents appeared in a video interview with Children's Health Defense, a nonprofit long chaired by HHS Secretary Robert F. Kennedy Jr. and among the most prominent organizations campaigning against vaccines. During the interview, vaccines were repeatedly blamed.
All three vaccines the twins received were non-live, meaning they contain no living virus or bacteria and cannot cause an infection. The recognized mechanism by which such a vaccine can cause death is anaphylaxis, which announces itself within minutes to hours rather than eight days later. I reviewed the available information at the request of The Guardian, as did another infectious disease physician, and we reached the same conclusion independently.
In January of this year, that organization and five other plaintiffs, the children's mother among them, sued the American Academy of Pediatrics in federal court, alleging a decades-long racketeering scheme. The twins appear in the complaint as evidence. It recites the ED diagnosis. It notes that the autopsies are pending. It states that no alternative cause of death has been identified. And it moves from there to the claim that the deaths demonstrate the dangers of vaccines.
By then, police had been treating the case as a homicide for eight months, which the complaint acknowledges one paragraph later before recasting the investigation as further evidence of wrongdoing by the Academy. In June, a grand jury indicted the children's mother on two counts of first-degree murder. She denies the allegations, and the indictment establishes nothing about what caused two deaths.
A claim that no evidence could have disturbed was never resting on evidence to begin with.
The complaint's statement may have been literally true in the narrowest sense. The autopsies were unfinished, and no final alternative had been announced. But what it described was the status of an investigation, and the complaint made that status carry the weight of a finding. A working diagnosis for mild symptoms the morning after vaccination became documentation of a fatal vaccine injury. An unfinished autopsy became the absence of an alternative. And the absence of an alternative became evidence that the vaccines had killed them.
There is a way to tell whether an explanation was reached or assumed. Ask what finding would have overturned it. When the Australian teamstudying the 14 children sent those samples off for sequencing, they did not know what would come back, and a normal result would have left them with nothing.
Their conclusion was exposed to the risk of being wrong, which is what made it a conclusion. The account offered three days after those twins were found carried no such exposure. No autopsy result, no toxicology screen, no police finding was going to change it. A claim that no evidence could have disturbed was never resting on evidence to begin with.
The ledger
Congress created the National Vaccine Injury Compensation Program in 1986, after a wave of lawsuits over the old whole-cell pertussis vaccine nearly drove manufacturers out of business.
Many of those lawsuits rested on the belief that a seizure beginning soon after pertussis vaccination could mark the onset of permanent vaccine-caused brain injury, the very interpretation the Australian study would later overturn in its 14 cases. Encephalopathy following a pertussis-containing vaccine was written into the program's list of recognized injuries, and it is still there.
The program maintains that list so it can pay claimants without requiring anyone to prove a vaccine was the cause. The list is deliberately generous, and that is the point. The program pays out under a schedule Congress set in 1986: $250,000 for a death, and the same cap on compensation for pain and suffering, with medical care, rehabilitation, and lost earnings covered separately. Claims are decided by judicial officers called “special masters,” no more than eight at a time under the statute, and cases often take years.
In March, the Informed Consent Action Network, a nonprofit that funds vaccine-litigation and public-records campaigns, petitioned the government to add more than 300 vaccine-event pairs to that list.
The petition does not claim that these injuries have been shown to be caused by vaccines; it concedes that they have not. Its argument is that causation is the wrong test, because the law speaks of injuries associated with vaccines, and the association has already been officially acknowledged.
The acknowledgment it points to is of two kinds. The first is the government's decision to ask the Institute of Medicine to examine these questions. The petition treats the decision to commission the review as official acknowledgment of an association. It makes the same argument about a follow-up review in 2021: that looking a second time is itself an admission.
A gap in the evidence is not a finding. It is a description of what the evidence cannot yet establish.
The second is package inserts. Open the label for Infanrix, a widely used DTaP vaccine, and turn to the section on postmarketing experience. It opens by explaining that these events were reported voluntarily from a population of uncertain size, so that it is not possible to say reliably how often they happen or whether the vaccine caused them. Then comes the list. Under general disorders, alongside fatigue and injection-site swelling, is SIDS.
That entry means SIDS was reported after a vaccination and was included among the postmarketing reactions in the label. It does not mean the report was validated or that the vaccine caused the death. The sentence directly above the list says exactly that. The petition cites the list and does not mention the sentence.
The Institute of Medicine was equally clear about its own work. When it could not reach a conclusion, it wrote, that meant the studies were too few, too weak, or too conflicting to support any answer in either direction, and it warned readers explicitly not to read it as evidence one way or the other. It reached that verdict for 135 of the 158 questions it examined.
A gap in the evidence is not a finding. It is a description of what the evidence cannot yet establish.
What we owe people
What the record actually shows is a system capable of finding harm. Some harms became visible within months, others took years of epidemiologic and laboratory work, and the difference between them has to do with how closely the injury resembles something that happens anyway.
Childhood vaccines remain among the most closely monitored medical products in existence, and the honest summary of a century of scrutiny is that serious risks are rare, identifiable, and vastly outweighed by the diseases the vaccines prevent.
That is not the same as saying every question is settled. Some are not. The right response to an open question is to investigate it: fund the work, design the study so that it can come out either way, and wait for the answer.
What people who believe a vaccine harmed them deserve is the work: a study built so that it can come out the other way and the willingness to say, for as long as the evidence requires, that we do not yet know. What they usually get instead is one of two things: either reassurance offered before anyone has looked or a fast explanation that feels like being believed, delivered by people whose conclusion cannot change.
The families in the Australian study waited years for something better than either. The answer, when it came, did not undo what had happened to their children. What it did was tell them that the appointment they had blamed for years was not the cause. That is what the work can do, but only when the evidence is allowed to come before the verdict.
Dr. Scott is a clinical associate professor of infectious diseases at Stanford University School of Medicine, and a coauthor of "Updated evidence for COVID-19, RSV, and Influenza Vaccines for 2025-2026" in the New England Journal of Medicine.
The opinions voiced in CIDRAP Op-Ed pieces are the authors' own and do not necessarily represent the official position of CIDRAP.