Nicholas Hulscher, MPH works for the McCullough Foundation - an organization that profits from the spread of vaccine disinformation. Hulscher is not a physician. He is not a microbiologist, immunologist, infectious disease doctor, biochemist or molecular biologist. He is an epidemiologist who just earned his MPH in 2024. Since then his publication record includes sketchy research that appears in venues that may not follow traditional peer-review processes. Hulscher is notorious for posting blatant disinformation on LinkedIn. Here is one of his recent posts.
In this video, Hulscher states…”NONE of the vaccines recommended by the CDC for routine childhood immunization were licensed by the FDA based on long-term, placebo-controlled trials.”
Is this statement true?
Here’s the factual situation regarding the claim that “none of the current childhood vaccines were tested in placebo-controlled randomized trials”
🔬 1. Hulscher’s Claim Is Misleading and Largely False
That claim is false or misleading. Independent fact–checking organizations have concluded that his statements about vaccine testing are not accurate as presented.
📊 2. Many Childhood Vaccines Have Been Tested in Randomized Trials
Most vaccines recommended for children have undergone randomized clinical trials (RCTs) before licensure. These trials are the standard method to assess both safety and effectiveness.
Some vaccines were tested using placebo controls or inert injections when it was ethical and scientifically necessary to do so. Examples include:
Certain rotavirus vaccines were studied in large placebo-controlled RCTs before licensure.
Early versions of polio and other vaccines historically had randomized and comparison group designs.
Many vaccine trials include either saline placebos or other controls to compare responses.
🤔 3. Why Some Trials Use Non-Placebo Controls
Once a vaccine for a disease is known to be effective and widely recommended, it may be unethical to give a true placebo (i.e., withholding protection) just for trial purposes. That’s a standard scientific and ethical principle. In that case, new vaccine candidates are often compared to:
an existing vaccine
an alternative vaccine schedule
or other active control instead of a pure placebo
This does not mean they are “untested” — it means the comparison is against the best known standard of care, to avoid leaving participants unprotected.
🧠 4. What “Placebo-Controlled” Means
A randomized, placebo-controlled trial is the gold standard in clinical research when practical and ethical. But vaccine science is nuanced:
For new pathogens or vaccines, placebo controls are common and appropriate.
For established vaccines, studies focus on immunological endpoints, safety comparisons, or comparisons to existing vaccines rather than a no-vaccine placebo.
🧪 5. Observational & Post-Licensure Studies
Beyond pre-licensure RCTs, vaccines undergo decades of post-licensure monitoring in millions of people to continually assess safety and effectiveness. This includes active surveillance systems and large databases tracking outcomes after vaccination.
📌 In Summary
Truth about placebo-controlled testing of childhood vaccines:
✔️ Many routine childhood vaccines have been studied in randomized clinical trials.
✔️ Some have included inert placebo arms when appropriate.
✔️ Ethical norms often require active comparators when an effective vaccine already exists, which is scientifically appropriate and standard.
✔️ The claim that none have ever been tested in placebo-controlled trials is not accurate.
Here’s a more detailed, evidence-based look at how some routine childhood vaccines have actually been tested — including examples where true placebo-controlled randomized trials were used, and why in some cases they were not.
🧪 Examples of Placebo-Controlled Randomized Trials in Childhood Vaccines
✅ 1. Rotavirus Vaccines
Several rotavirus vaccines were tested using randomized, double-blind, placebo-controlled trials involving thousands of infants before licensure:
A large Phase III trial of a human-bovine pentavalent rotavirus vaccine (RotaTeq and similar vaccines) showed significant protection against severe disease compared with placebo.
Another randomized, double-blind, placebo-controlled trial of a monovalent human rotavirus vaccine was conducted in infants in India.
Regulatory documentation for Rotarix notes multiple placebo-controlled trials with tens of thousands of doses administered across study groups, demonstrating both safety and efficacy.
These are direct examples of childhood vaccines tested in classic placebo-controlled RCTs.
✅ 2. Varicella (Chickenpox) Vaccine
A placebo-controlled study of the varicella vaccine administered either with or after the MMR vaccine was published in The Journal of Pediatrics in 1989. Healthy children were randomized to receive varicella vaccine or placebo.
This is another clear example where placebo control was used in a pediatric vaccine trial.
✅ 3. Measles-Mumps-Rubella (MMR) — Specific Research Trial
A randomized, double-blind, placebo-controlled trial involving more than 6,000 Danish infants compared early MMR vaccination versus placebo and found no association with atopic disease by 12–24 months.
This demonstrates that at least specific questions about the MMR vaccine have been addressed with placebo controls in modern research settings.
⚠️ 4. Hepatitis B Vaccine
Historical randomized, double-blind, placebo-controlled trials of hepatitis B vaccines were conducted (e.g., ~1,000 subjects randomized to vaccine vs. placebo in the 1980s) assessing efficacy and safety.
❓ If There Are Placebo Trials, Why Do Some Vaccines Use Other Comparators?
There’s an important ethical and scientific reason:
➤ Once an effective vaccine already exists…
Researchers typically do not randomize children to an inert placebo because:
It would mean denying them a proven prevention against a serious disease, which raises ethical concerns.
Instead, new vaccines are tested against the standard of care (another approved vaccine) to show they are as safe and effective — which is also scientifically valid.
This is why more recent trials of vaccines like DTaP, pneumococcal, meningococcal, and others might use active controls rather than inert placebos.
📌 Polio Vaccine Example (Historical)
Even in the 1950s, before effective polio vaccines were widely adopted, one of the largest placebo-controlled field trials in history randomly assigned over a million children to vaccine, placebo, or no treatment to assess efficacy — and clearly showed protection from polio.
🧠 Key Takeaways
✔️ Many routine childhood vaccines have been tested in randomized clinical trials that included placebo arms when appropriate.
✔️ Rotavirus and varicella vaccines are well-documented examples of pediatric vaccines evaluated against placebo.
✔️ MMR and hepatitis B vaccines have also been studied in placebo-controlled designs in specific contexts.
✔️ For vaccines where an effective prevention already exists, active comparators instead of placebo are used — not because of lack of testing, but because giving a placebo when an effective vaccine exists is not ethically accepted.
Placebo-controlled randomized trials become unethical when an effective, established therapy already exists and withholding it would expose participants to avoidable harm.
1️⃣ The Ethical Framework
Modern clinical research is governed by:
Declaration of Helsinki
Belmont Report (U.S.)
Federal IRB regulations (45 CFR 46)
Clinical equipoise doctrine
The key principle is clinical equipoise:
A randomized trial is ethical only if there is genuine uncertainty in the expert medical community about which intervention is better.
If we already know a vaccine prevents a serious disease safely, there is no equipoise between:
Vaccine
Saline placebo
That makes randomizing a child to placebo ethically problematic.
2️⃣ The Risk Calculation
Imagine a disease with known morbidity/mortality (e.g., measles pre-vaccine):
Measles encephalitis risk ~1 in 1,000
Mortality ~1–3 per 1,000 in developed settings
Higher globally
If an effective vaccine exists, assigning a child to placebo knowingly exposes them to preventable risk.
That violates:
Beneficence (minimize harm)
Nonmaleficence (“do no harm”)
Pediatric protection standards (children are a protected research population)
IRBs generally will not approve a design that withholds standard prevention without strong justification.
3️⃣ When Placebos Are Ethical
Placebo control is ethical when:
✔️ No proven effective intervention exists
✔️ Disease risk is low and temporary
✔️ Participants are fully informed adults
✔️ There is genuine uncertainty about benefit
That’s why:
Early polio vaccine trials used placebo
Rotavirus trials used placebo
COVID-19 vaccines initially used placebo
At that time, no licensed preventive vaccine existed.
4️⃣ Why New Childhood Vaccines Often Use Active Comparators
Once, for example, a measles vaccine is standard of care:
Testing a new measles vaccine vs saline would mean:
Intentionally leaving some children unprotected
During a time measles still circulates
Instead, regulators require:
Immunogenicity non-inferiority studies
Safety comparisons vs existing vaccine
Large post-licensure surveillance
That design protects participants while still generating robust safety and efficacy data.
5️⃣ Important Nuance
Critics sometimes argue:
“But we should retest everything against placebo.”
That would only be ethical if:
There were serious doubts about efficacy
Or new evidence suggesting harm outweighs benefit
Without that, deliberately withholding proven prevention is considered unethical under modern research standards.
6️⃣ Analogy from Other Fields
We don’t test:
Insulin vs placebo in type 1 diabetics
Antibiotics vs placebo in bacterial meningitis
Seatbelts vs no seatbelt in crash trials
Because withholding known protection would be harmful.
Vaccines fall into the same ethical category once effectiveness is established.
7️⃣ What This Does Not Mean
It does not mean:
Vaccines aren’t tested
Safety isn’t studied
Long-term data aren’t collected
It means that the type of control group changes once prevention is established.
Safety is then assessed through:
Large pre-licensure RCTs
Vaccine Safety Datalink
VAERS
Active surveillance
International pharmacoepidemiology databases
Hulscher violates basic principles of ethics and professionalism. He is actively misinforming the public, discouraging vaccination and introducing risk of morbidity and mortality to milions of children. This is not a matter of freedom of speech, it is active deception of the public and it is dangerous.
