CDC Vaccine Schedule — How It's Changed Over Time

The CDC has a recommended schedule of vaccines for children, which US states use as the basis for school enrollment mandates. The schedule has grown dramatically since 1986, from 3 injections by age 1 to 25 by 2025. This expansion was driven by vaccinologists who worked for the large pharmaceutical companies developing these vaccines. They participated in the development, clinical trials, FDA licensure committees, and CDC recommendation committees. This is a huge conflict of interest — not to mention that none of the vaccines added to the schedule were licensed on a true placebo-controlled safety trial.

The Growth of the Schedule

The schedule is set by CDC's Advisory Committee on Immunization Practices (ACIP). States use the CDC schedule to determine school enrollment vaccine mandates.

Note on injection count: The CDC schedule calls for approximately 25 injections by age one. Some counts reach 29 depending on whether annual flu shots or combination vaccine components are counted separately.

Foundational Problem: No True Placebo Controls

The FDA's own definition of "placebo" (via CDC Vaccine Glossary): "A substance or treatment that has no effect on living beings, usually used as a comparison to vaccine or medicine in clinical trials." Per FDA guidance: "Placebos, defined as inert substances with no pharmacologic activity, are commonly used in double-blind, randomized controlled clinical trials."

Not one routine injected childhood vaccine on the CDC schedule was licensed based on a trial that included a true inert placebo control group. Every trial used another vaccine, an unlicensed experimental vaccine, an active adjuvant, or no control at all. This is documented in FDA package inserts and company disclosures for each product.

Paul Offit — a prominent vaccinologist, Merck RotaTeq patent-holder, and one of Stanley Plotkin's most well-known protégés — claimed on June 22, 2023 that "all vaccines are tested in placebo-controlled trials before licensure." Aaron Siri, the vaccine safety attorney behind the Plotkin Deposition 2018 and ICAN's FOIA campaigns, publicly refuted this with primary FDA sources. Offit quietly revised his claim to "most vaccines" — also false. Offit separately claimed the Salk polio trial used "salt water" as a control; the official Salk trial report shows the control contained "199 solution" (synthetic tissue culture + ethanol), "phenol red," "antibiotics," and "formalin" — not salt water.

The House of Cards

Because each vaccine is licensed as "as safe as" the prior vaccine, and the prior vaccine was never validated against a placebo, the safety of the entire schedule rests on no baseline.

Vaccines Given in the First Six Months of Life

Hepatitis B Vaccine — Recombivax HB (Merck)

• Licensed: 1986
• Schedule: Birth, 2 months, 6 months
• Control: No control
• Safety monitoring window: 5 days after each injection (solicited and unsolicited reactions)
• Trial population: 147 infants and children (up to age 10)
• Notable: First vaccine ever licensed using recombinant DNA technology. Section 6.1 of the FDA-approved package insert confirms: "147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose." ICAN FOIA of FDA clinical trial reports confirmed no safety data beyond 5 days. A 1986 Merck study published in a peer-reviewed journal confirms: "Participants … recorded their temperature and any complaints they had for 5 days following each injection."
• Downstream evidence of harm: Heplisav-B (a newer Hep B vaccine for adults, licensed 2017) used Engerix-B as its control and found a 6.2% serious adverse event (SAE) rate in the Heplisav-B group vs. 5.3% SAE rate in the Engerix-B group. Both rates were deemed acceptable because they were similar. A 5.3% and 6.2% serious adverse event rate in the control and test groups respectively — both alarmingly high — raised no regulatory red flags because the two rates were similar to each other.
• FDA SAE definition: Death; life-threatening; hospitalization; disability or permanent damage; congenital anomaly/birth defect; required intervention to prevent permanent impairment; other serious important medical events.

Hepatitis B Vaccine — Engerix-B (GSK)

• Licensed: 1989
• Schedule: Birth, 2 months, 6 months
• Control: No control
• Safety monitoring window: 4 days after each injection
• Trial population: Not specified in this source passage
• Notable: Stanley Plotkin claimed in deposition that safety data was surely collected beyond 4 days, then admitted: "Yes, that's speculation based on experience." ICAN sued FDA over Engerix-B; after years of litigation, FDA never produced a single document showing safety review beyond a few days. Used as the control for Havrix (Hep A) — meaning the safety of Hep A was benchmarked against a vaccine licensed with 4-day monitoring.

DTaP Vaccine — Infanrix (GSK)

• Licensed: ~1997
• Schedule: 2, 4, 6 months (plus boosters at 15–18 months and 4–6 years)
• Control: DTP (whole-cell pertussis vaccine)
• Safety monitoring window: 8 days solicited reactions, 30 days unsolicited
• Trial population: Not specified in this passage
• Notable: DTP (the control) was not licensed based on a placebo-controlled trial. Multiple post-licensure studies have found DTP increases infant mortality — vaccinated infants die at higher rates than unvaccinated peers in the same circumstances. In other words, the safety baseline for licensing Infanrix was a vaccine (DTP) that multiple post-licensure studies had associated with increased infant mortality.

DTaP Vaccine — Daptacel (Sanofi)

• Licensed: 2002
• Schedule: 2, 4, 6 months (plus boosters)
• Control: DT or DTP vaccine
• Safety monitoring window: 14 days solicited reactions, 6 months unsolicited
• SAE rate: 3.9% of previously healthy infants had at least one serious adverse event within 30 days of vaccination
• Notable: "Within 30 days following any dose of Daptacel, 3.9% subjects reported at least one serious adverse event." (Package insert, FDA-approved.) Because there was no placebo control, this 3.9% SAE rate was dismissed — the standard applied was that Daptacel was deemed safe as long as its death rate did not exceed that of DTP, a vaccine already linked to increased infant mortality. The benchmark for "safe" was not an inert baseline but a product with known serious risks.

Hib Vaccine — ActHIB (Sanofi)

• Licensed: 1993
• Schedule: 2, 4, 6, 15–18 months
• Control: Unspecified Hep B vaccine (itself not licensed on a placebo trial)
• Safety monitoring window: 3 days solicited, 30 days unsolicited
• SAE rate: 3.4% of babies had a serious adverse event within 30 days
• Notable: Package insert (FDA-approved): "within 30 days … 50 of 1,455 (3.4%) participants [babies] experienced a serious adverse event" — "[n]one was assessed by the investigators [Sanofi] as related to the study of vaccines." The determination that zero of the serious adverse events were vaccine-related was made by Sanofi's own paid researchers.

Hib Vaccine — Hiberix (GSK)

• Licensed: 2009
• Schedule: 15–18 months booster (also used for primary series)
• Control: ActHIB (itself not licensed on a placebo trial)
• Safety monitoring window: 4 days solicited, 31 days unsolicited
• Notable: Safety certified only as "as safe as" ActHIB, which was certified only as "as safe as" an unspecified Hep B vaccine with 5-day monitoring.

Hib Vaccine — PedvaxHIB (Merck)

• Licensed: 1989
• Schedule: 2, 4, 12–15 months
• Control: Unlicensed lyophilized PedvaxHIB (an experimental vaccine — the same product in a different formulation)
• Safety monitoring window: 3 days solicited, 3 days unsolicited
• Notable: 3-day safety window; licensed against an unlicensed form of itself.

PCV (Pneumococcal Conjugate) Vaccine — Prevnar 7 (Pfizer/Wyeth)

• Licensed: 2000 — the first-ever PCV for children in the US
• Schedule: 2, 4, 6, 12–15 months
• Control: Unlicensed experimental meningococcal group C conjugate (MnCC) vaccine
• Safety monitoring window: 30 days (hospitalization: 60 days)
• Notable: The control was literally "an investigational meningococcal group C conjugate vaccine" — an unlicensed experimental vaccine. Even FDA and CDC scientists conceded: "the control group in [Prevnar 7's] main study received another experimental vaccine, rather than a placebo. If both vaccines provoked similar adverse effects, little or no difference between the 2 groups might have been evident."

PCV Vaccine — Prevnar 13 (Pfizer)

• Licensed: 2010
• Schedule: 2, 4, 6, 12–15 months
• Control: Prevnar 7 (itself licensed against an unlicensed experimental vaccine)
• Safety monitoring window: 6 months
• SAE rate: 8.2% in Prevnar 13 recipients vs. 7.2% in Prevnar 7 recipients
• Notable: Pfizer's own FDA-approved package insert acknowledged the 6-month window "may have resulted in serious adverse events being reported in a higher percentage of subjects than for other vaccines" — offered as an excuse for the elevated SAE rate. That is not an excuse — it is an indictment. The FDA accepted this reasoning and licensed the product.

PCV Vaccine — Vaxneuvance (Merck, PCV-15)

• Licensed: 2022
• Control: Prevnar 13
• Safety monitoring window: 14 days solicited, 6 months unsolicited
• SAE rate: 9.6% in Vaxneuvance recipients vs. 8.9% in Prevnar 13 recipients
• Notable: Deemed "safe" because "no notable patterns or numerical imbalances between vaccination groups." Pyramid: Vaxneuvance → Prevnar 13 → Prevnar 7 → unlicensed experimental vaccine → no baseline.

PCV Vaccine — Prevnar 20 (Pfizer, PCV-20)

• Licensed: 2023
• Control: Prevnar 13
• Notable: High rates of serious adverse events in both vaccine groups, now split into two categories ("serious adverse events" and "newly diagnosed chronic medical conditions") to obfuscate the total harm rate. Deemed "safe" because "no notable patterns or imbalances between vaccine groups."

IPV (Inactivated Polio Vaccine) — IPOL (Sanofi)

• Licensed: 1990
• Schedule: 2, 4, 6–18 months, 4–6 years
• Control: No control
• Safety monitoring window: 3 days solicited, 3 days unsolicited
• Notable: The package insert acknowledges: "Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants." No causal relationship could be established in a trial with no control group and only three days of observation — the trial design made safety assessment structurally impossible. IPOL uses "vero cells, a continuous line of monkey kidney cells cultivated on microcarriers" — cells rendered immortal (essentially cancerous) — and these cells end up in every vial. This is a completely different product from Salk's 1950s vaccine, which was withdrawn from the market in the 1960s. The Salk vaccine's trials were therefore not relied upon to license IPOL.

Vaccines Given Between 6 Months and 18 Months

Children receive additional doses of the above vaccines plus new ones.

Influenza (Flu) Vaccine — All Brands

• Schedule: 6 months (first dose), 7 months (second dose), then annually
• Controls: All brands tested against prior flu vaccine formulations or no control; never a true placebo

• Critical problem: The formulation changes every year. Each new annual formulation is licensed with no clinical trial whatsoever — it is assumed safe based on the original trial for that brand. The entire safety chain rests on Fluzone IIV3, licensed in 1980 with no control.
• When a placebo was used post-licensure (Fluzone IIV3 efficacy trial): The rate of hospitalization was higher in the vaccine group than in the placebo group, with 60% more vaccinated than unvaccinated children hospitalized for insertion of ear drainage tubes. This finding came from a post-licensure study not required for licensure.

Hepatitis A Vaccine — Havrix (GSK)

• Licensed: 1995 — the first-ever Hep A vaccine in the US
• Schedule: 12–23 months (2 doses, 6 months apart)
• Control: Engerix-B (Hep B vaccine licensed with 4-day monitoring, no control)
• Notable: Despite being the first Hep A vaccine, no placebo was used. The "safety baseline" was a Hep B vaccine with 4-day safety monitoring.

Hepatitis A Vaccine — Vaqta (Merck)

• Licensed: 1996 — the second Hep A vaccine
• Schedule: 12–23 months (2 doses, 6 months apart)
• Control: Injection of AAHS adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate, a proprietary Merck aluminum adjuvant) + thimerosal
• Notable: The control was an injection of two active, non-inert substances — a proprietary aluminum adjuvant known to induce autoimmunity in lab animals, and a mercury-containing preservative. Neither is inert.

Varicella (Chickenpox) Vaccine — Varivax (Merck)

• Licensed: 1995 — the first-ever varicella vaccine
• Schedule: 12–15 months (booster at 4–6 years)
• Control: Package insert claims "placebo" — a lyophilized stabilizer containing approximately 45 mg neomycin per mL
• "Placebo" population: Only 465 children received this "placebo"
• Notable: Neomycin is an antibiotic. It is not inert. In oral form it causes hearing loss, kidney damage, and nerve damage. Merck's own peer-reviewed journal article describes the control as "lyophilized stabilizer containing approximately 45 mg of neomycin per milliliter" — not saline, not water. An injection of neomycin is without any question not a placebo. The package insert's label of "placebo" is false.

MMR Vaccine — MMR-II (Merck)

• Licensed: 1978
• Schedule: 12–15 months (booster at 4–6 years)
• Control: No control group whatsoever
• Safety monitoring window: 42 days
• Trial population: 834 children
• Notable: During the trial, approximately one-third of participants developed GI issues and one-third developed respiratory issues — dismissed without a control group to compare against. Every vial of MMR-II contains, according to available evidence (and conceded by Plotkin), hundreds of billions of pieces of human DNA and cellular material from a cultured cell line of an aborted fetus. The CDC's own Vaccine Information Sheet originally acknowledged "brain damage" as a potential outcome; after the Plotkin Deposition 2018, Plotkin worked to have "brain damage" removed from the VIS. Between the 1970s and 1986, liabilities from measles-containing vaccine harms caused the number of manufacturers to drop from at least six companies to one (Merck), driving passage of the 1986 Act (National Childhood Vaccine Injury Act).

MMR Vaccine — Priorix / MMR-RIT (GSK)

• Licensed: 2022
• Control: MMR-II (itself licensed with no control, 42-day monitoring, 834 children)
• Safety monitoring window: 6 months
• Results (buried in supplemental table of journal article):

NOCDs included: autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, thrombocytopenia, and allergies.

• Notable: 10.1% of children receiving MMR-RIT visited the ER. 3.4% developed a new chronic disease within 6 months. Both vaccine groups showed nearly identical rates — so the FDA deemed it "safe." These serious harms were not disclosed in the package insert given to medical professionals or parents; GSK buried them in a supplemental table in a journal article.

Vaccines Given Between 18 Months and 18 Years

HPV Vaccine — Gardasil (Merck)

• Licensed: 2006 — first-ever HPV vaccine
• Schedule: Recommended starting at age 9 (2 or 3 doses)
• Trial population: 10,706 girls and women received Gardasil
• Control groups:

- 9,092 received injection of AAHS (225 mcg or 450 mcg Amorphous Aluminum Hydroxyphosphate Sulfate) — a proprietary Merck adjuvant that is neurotoxic, cytotoxic, and used to induce autoimmunity in lab animals

- 320 received injection labeled "Saline Placebo" in the package insert — actual contents: L-histidine, polysorbate 80, sodium borate, and yeast protein (not saline; not inert)

• Safety monitoring window: 6 months
• SAE / autoimmune disorder rate: 2.3% systemic autoimmune disorders in the Gardasil group and 2.3% in the combined control group (AAHS + "Saline Placebo")

Gardasil Table 9 — Systemic Autoimmune Disorders (6-month trial):

• Critical manipulation: Merck used three separate columns (Gardasil / AAHS Control / Saline Placebo) for minor injection-site reactions (pain, swelling, erythema) — where AAHS's effects would not distort the comparison. But for the serious systemic autoimmune conditions (Table 9), Merck combined the AAHS and Saline groups into one column, hiding the fact that AAHS itself may have caused the autoimmune disorders in the "control" group.
• Injection-site data (three columns shown):

• Slate investigation: An 8-month investigation by Slate (a pro-vaccine outlet) found trial participants who reported serious life-altering reactions were told by Merck's paid researchers: "This is not the kind of side effects we see with this vaccine." Researchers used their "judgment" to discard these reports — enabled by the absence of a placebo control.

HPV Vaccine — Gardasil 9 (Merck)

• Licensed: 2014
• Control: Gardasil (7,000+ subjects) + Gardasil followed by saline (305 subjects)
• Notable: The only saline injection in Gardasil 9's trial was administered to 305 women after they had already received Gardasil. The only saline injection in the Gardasil 9 trial was given to just 305 women — and only after they had already received the original Gardasil vaccine, making any comparison to a true unvaccinated baseline impossible.

Tdap Vaccine — Adacel (Sanofi) and Boostrix (GSK)

• Licensed: 2005 (both)
• Schedule: 11–12 years (booster) and for adults/pregnant women
• Control (both): Decavac (Td vaccine, Sanofi) — not licensed on a placebo trial
• Notable: Adacel contains 12.5× less diphtheria toxoid and 10× less pertussis toxin than Infanrix DTaP — formulated weaker because DTaP causes too many adverse reactions in older children and adults.

MenACWY Vaccine — Menactra (Sanofi)

• Licensed: 2005
• Control: Menomune (licensed 1981, no placebo trial)
• Notable (circular licensing): The safety section of Menomune's own package insert references the Menactra trial — meaning the same clinical trial was used to certify the safety of both Menomune (as a control) and Menactra (as the test vaccine). The same clinical trial was used to certify the safety of both the control and the test vaccine — neither has an independent safety validation.

MenACWY Vaccine — Menveo (GSK)

• Licensed: 2010
• Control: Menomune and Menactra

MenACWY Vaccine — MenQuadfi (Sanofi)

• Licensed: 2020
• Control: Menveo and Menactra

MenACWY pyramid: Menomune (no placebo) → used as control for Menactra → Menactra + Menomune used as controls for Menveo → Menveo + Menactra used as controls for MenQuadfi. No baseline of safety exists at any point in this chain.

Complete No-Placebo Summary Table

Injected 3× in First 6 Months

Later Childhood Vaccines

18 Months–18 Years

Safety Monitoring Duration Table

Comparison — Pfizer's top 4 drugs (all with placebo controls):

Pfizer conducted multi-year placebo-controlled trials for drugs with full tort liability — and 3–14-day trials for vaccines with zero liability.

Trial Size Problem

Most childhood vaccine trials enrolled only hundreds to a few thousand children — far too few to detect rare but serious harms. Example: Recombivax HB used 147 children. Even with a 10-year placebo-controlled trial, a trial of 147 could not statistically detect a harm occurring in 1 in 40 children.

The US has 3.5 million births per year. If Hep B vaccine causes a chronic condition in 1 in 1,000 babies, that is 3,500 new cases per year. A trial of 147 is statistically invisible to that signal.

Maddie de Garay's case illustrates this: in a trial of only 1,131 vaccinated children, a harm occurring in 1 in 1,000 children would be statistically undetectable even against a true placebo.

Pharma Decides Its Own Safety Outcomes

In the absence of a placebo control, determination of whether adverse events are "related to the vaccine" is left to the pharma company's own paid researchers. Documented examples:

• ActHIB: 3.4% SAE rate in babies — "None was assessed by the investigators [Sanofi] as related to the study of vaccines." Case closed.
• Gardasil: Women reporting severe brain and immune dysfunction symptoms after vaccination were told "This is not the kind of side effects we see with this vaccine" — uncovered only by an 8-month Slate investigation.
• Maddie de Garay (Pfizer Covid-19 trial): Pfizer reported her wheelchair + feeding tube injuries as "functional abdominal pain." After Steve Kirsch emailed the FDA commissioner and prompted an inquiry, Pfizer disclosed more injuries — but its paid investigator (Dr. Robert Frenck, Cincinnati Children's Hospital) concluded he did not "feel" the injuries were vaccine-related. FDA accepted this and took no further action.
• Pfizer Covid-19 vaccine (adult trial): When the placebo was actually used and 21 deaths occurred in the vaccinated group vs. 17 in the placebo group, the FDA permitted Pfizer to explain away each death individually rather than requiring a statistical comparison. But when counting efficacy (symptom prevention), the FDA permitted Pfizer to use a statistical comparison showing 95% efficacy. Asymmetric standards: death → case-by-case explanation; symptom reduction → statistical comparison.

The One Exception: Dengue Vaccine (Dengvaxia)

The dengue vaccine (Sanofi) is the only routine vaccine licensed with a placebo-controlled trial and long-term safety review (5 years). It is not on the routine US childhood schedule (only for endemic areas).

What the 5-year placebo-controlled trial found:

• Children under 6 years old had increased risk of severe harm and death from the vaccine
• Children of any age who had never had dengue (seronegative) had significantly increased risk of severe harm and death upon subsequent dengue infection
• The vaccine is now restricted to children over 6 who have previously had dengue

FDA and Sanofi warning: "Those not previously infected are at increased risk for severe dengue disease when vaccinated and subsequently infected with dengue virus."

The dengue vaccine example demonstrates what proper trial design can reveal: had similar placebo-controlled, multi-year trials been required for all childhood vaccines, dangerous products could have been identified before reaching millions of children.

Moderna RSV infant vaccine: Used a placebo control → found more harm in the vaccinated group → Moderna abandoned the vaccine. Without a placebo, this vaccine would likely have been licensed and deemed "safe."

Who Drove the Expansion

The schedule expansion was controlled by Stanley Plotkin's protégés, who:

• Conducted the pharma-funded clinical trials for the new vaccines
• Voted on FDA's VRBPAC to license them
• Voted on CDC's ACIP to add them to the schedule
• Worked for or received financial payments from the pharma companies earning billions from sales

The period when most vaccines were added — the 1990s — coincides with the documented conflicts described in the 2000 Congressional Report on FDA-CDC Conflicts.

Significance

The 25-injection schedule represents 25 separate pharmaceutical products, none of which was licensed based on a properly designed safety trial. The safety of each vaccine in the house of cards rests ultimately on no validated baseline.

The 25 routine injections administered to infants by age one should rest on objective clinical evidence — not on the assumption that each product is safe because it performed similarly to a predecessor that was itself never validated against an inert control.

See Also

CDC, FDA, Pre-Licensure Safety Testing, Regulatory Capture, Childhood Chronic Disease Trends, Conflicts of Interest, Stanley Plotkin, Paul Offit, Kathryn Edwards, Maddie de Garay, VAERS, Post-Licensure Safety Monitoring, Financial Immunity for Vaccine Makers, 1986 Act (National Childhood Vaccine Injury Act), 2000 Congressional Report on FDA-CDC Conflicts

Frequently Asked Questions

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