ICAN's No Placebo Table
None of the vaccine doses the CDC recommends for routine injection into children were licensed by the FDA based on a long-term placebo-controlled trial. [Original PDF]
This chart is the result of years of FOIA requests & litigation to force the FDA to turn over the documents used in licensing all of the shots on the childhood vaccine schedule. The Informed Consent Action Network funded this. Click here to help support them!
Vaccine | Total Doses | Age Injected | Brand | Company | Control | Placebo | Safety Review After Injection1 | Long | Source | Notes |
---|---|---|---|---|---|---|---|---|---|---|
Vaccine:
HepB
|
Total
Doses: 3 |
Age
Injected:
|
Brand:
Recombivax HB
|
Company:
Merck
|
Control:
None
|
Placebo:
NO
|
Safety Review
After Injection1: 5 days |
Long:
NO
|
Source:
|
Notes:
Note that to license a vaccine for children, the FDA relies upon the clinical trial conducted with children, not adults, because as the FDA explains, “It’s important that the public recognize that, because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are completed to evaluate the safety and the immune response to a … vaccine in this population. Children are not small adults[.]”
|
Vaccine:
HepB
|
Total
Doses: 3 |
Age
Injected:
|
Brand:
Engerix B
|
Company:
GSK
|
Control:
None
|
Placebo:
NO
|
Safety Review
After Injection1: 4 days |
Long:
NO
|
Source:
|
Notes:
Note that to license a vaccine for children, the FDA relies upon the clinical trial conducted with children, not adults, because as the FDA explains, “It’s important that the public recognize that, because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are completed to evaluate the safety and
the immune response to a … vaccine in this population. Children are not small adults[.]”
|
Vaccine:
DTaP
|
Total
Doses: 15 |
Age
Injected:
|
Brand:
Infanrix
|
Company:
GSK
|
Control:
DTP
|
Placebo:
NO
|
Safety Review
After Injection1: 30 days |
Long:
NO
|
Source:
|
Notes:
DTP was also not licensed based on a placebo controlled trial and it increases mortality. The 6-month Daptacel trial had no control, 1,454 children and “[w]ithin 30 days following any dose of DAPTACEL, 3.9% subjects reported at least one serious adverse event.”
|
Vaccine:
DTaP
|
Total
Doses: 15 |
Age
Injected:
|
Brand:
Daptacel
|
Company:
Sanofi
|
Control:
DT or DTP
|
Placebo:
NO
|
Safety Review
After Injection1: Up to 2 months + 1 trial 6 months |
Long:
NO
|
Source:
|
Notes:
DTP was also not licensed based on a placebo controlled trial and it increases mortality. The 6-month Daptacel trial had no control, 1,454 children and “[w]ithin 30 days following any dose of DAPTACEL, 3.9% subjects reported at least one serious adverse event.”
|
Vaccine:
PCV
|
Total
Doses: 4 |
Age
Injected:
|
Brand:
Prevnar 13, PCV-13
|
Company:
Pfizer
|
Control:
Prevnar 7
|
Placebo:
NO
|
Safety Review
After Injection1: 6 months |
Long:
NO
|
Source:
|
Notes:
Prevnar 7 trial’s control was an “[i]nvestigational meningococcal group C conjugate vaccine.” In Prevnar 13 trial, “[s]erious adverse events reported following vaccination in infants and toddlers occurred in 8.2% among Prevnar 13 recipients and 7.2% among Prevnar 7 recipients.” In Vaxneuvance trial, “serious adverse events…were reported by 9.6% of VAXNEUVANCE recipients and by 8.9% of Prevnar 13 recipients” but deemed “safe” because “no notable patterns or numerical imbalances between vaccination groups.” Prevnar 20 had similar result split into “serious adverse events” and “newly diagnosed chronic medical conditions.”
|
Vaccine:
PCV
|
Total
Doses: 4 |
Age
Injected:
|
Brand:
Vaxneuvance PCV-15
|
Company:
Merck
|
Control:
Prevnar 13
|
Placebo:
NO
|
Safety Review
After Injection1: 6 months |
Long:
NO
|
Source:
|
Notes:
Prevnar 7 trial’s control was an “[i]nvestigational meningococcal group C conjugate vaccine.” In Prevnar 13 trial, “[s]erious adverse events reported following vaccination in infants and toddlers occurred in 8.2% among Prevnar 13 recipients and 7.2% among Prevnar 7 recipients.” In Vaxneuvance trial, “serious adverse events…were reported by 9.6% of VAXNEUVANCE recipients and by 8.9% of Prevnar 13 recipients” but deemed “safe” because “no notable patterns or numerical imbalances between vaccination groups.” Prevnar 20 had similar result split into “serious adverse events” and “newly diagnosed chronic medical conditions.”
|
Vaccine:
PCV
|
Total
Doses: 4 |
Age
Injected:
|
Brand:
Prevnar 20, PCV-20
|
Company:
Pfizer
|
Control:
Prevnar 13
|
Placebo:
NO
|
Safety Review
After Injection1: 6 months |
Long:
NO
|
Notes:
Prevnar 7 trial’s control was an “[i]nvestigational meningococcal group C conjugate vaccine.” In Prevnar 13 trial, “[s]erious adverse events reported following vaccination in infants and toddlers occurred in 8.2% among Prevnar 13 recipients and 7.2% among Prevnar 7 recipients.” In Vaxneuvance trial, “serious adverse events…were reported by 9.6% of VAXNEUVANCE recipients and by 8.9% of Prevnar 13 recipients” but deemed “safe” because “no notable patterns or numerical imbalances between vaccination groups.” Prevnar 20 had similar result split into “serious adverse events” and “newly diagnosed chronic medical conditions.”
| |
Vaccine:
IPV
|
Total
Doses: 4 |
Age
Injected:
|
Brand:
IPOL
|
Company:
Sanofi
|
Control:
None
|
Placebo:
NO
|
Safety Review
After Injection1: 3 days |
Long:
NO
|
Source:
|
Notes:
IPOL is very different than the polio vaccine created by Jonas Salk in the 1950s (used until 1960s). Hence, trials of Salk’s vaccine from the 1950s were not relied upon to license IPOL.
|
Vaccine:
Hib
|
Total
Doses: 3 or 4 |
Age
Injected:
|
Brand:
ActHIB
|
Company:
Sanofi
|
Control:
HepB
|
Placebo:
NO
|
Safety Review
After Injection1: 30 days |
Long:
NO
|
Notes:
Within 30 days of injection in the ActHIB trial, 3.4% experienced a serious adverse event but “[n]one was assessed by the investigators [Sonafi] as related to the study of vaccines.”
Lyophilized PedvaxHIB vaccine, used as the control for Liquid PedvaxHIB, was tested in a trial in which controls were given placebo, OPV, and DTP but there is no indication Lyophilized PedvaxHIB was ever licensed.
| |
Vaccine:
Hib
|
Total
Doses: 3 or 4 |
Age
Injected:
|
Brand:
Hiberix
|
Company:
GSK
|
Control:
HibTITER or other vaccine
|
Placebo:
NO
|
Safety Review
After Injection1: 31 days |
Long:
NO
|
Notes:
Within 30 days of injection in the ActHIB trial, 3.4% experienced a serious adverse event but “[n]one was assessed by the investigators [Sonafi] as related to the study of vaccines.”
Lyophilized PedvaxHIB vaccine, used as the control for Liquid PedvaxHIB, was tested in a trial in which controls were given placebo, OPV, and DTP but there is no indication Lyophilized PedvaxHIB was ever licensed.
| |
Vaccine:
Hib
|
Total
Doses: 3 or 4 |
Age
Injected:
|
Brand:
Liquid
PedvaxHIB
|
Company:
Merck
|
Control:
Lyophilized
PedvaxHIB
|
Placebo:
NO
|
Safety Review
After Injection1: 3 days |
Long:
NO
|
Source:
|
Notes:
Within 30 days of injection in the ActHIB trial, 3.4% experienced a serious adverse event but “[n]one was assessed by the investigators [Sonafi] as related to the study of vaccines.”
Lyophilized PedvaxHIB vaccine, used as the control for Liquid PedvaxHIB, was tested in a trial in which controls were given placebo, OPV, and DTP but there is no indication Lyophilized PedvaxHIB was ever licensed.
|
Vaccine:
RV2
|
Total
Doses: 2 or 3 |
Age
Injected:
|
Brand:
Rotarix
|
Company:
GSK
|
Control:
Dextran, Sorbitol, Amino
Acids, Dulbecco’s
Modified Eagle Medium, and Xanthan
|
Placebo:
NO
|
Safety Review
After Injection1: 31 days + 1 year for intussusception |
Long:
NO
|
Notes:
“[T]here were 68 (0.19%) deaths following...ROTARIX...and 50 (0.15%) deaths following placebo... The most common...cause...was pneumonia...observed in 19 (0.05%) recipients of ROTARIX and 10 (0.03%) placebo recipients.” Its clinical review admits “[t]he placebo consisted of all components of Rotarix, but without any RV particles.” The package insert for RotaTeq similarly admits its “placebo” contains multiple ingredients as seen to the left.
| |
Vaccine:
RV2
|
Total
Doses: 2 or 3 |
Age
Injected:
|
Brand:
RotaTeq
|
Company:
Merck
|
Control:
Polysorbate-80, Tissue Culture Medium, Fetal Bovine Serum, and
Sodium Phosphate
|
Placebo:
NO
|
Safety Review
After Injection1: 42 days + 1 year for intussusception |
Long:
NO
|
Notes:
“[T]here were 68 (0.19%) deaths following...ROTARIX...and 50 (0.15%) deaths following placebo... The most common...cause...was pneumonia...observed in 19 (0.05%) recipients of ROTARIX and 10 (0.03%) placebo recipients.” Its clinical review admits “[t]he placebo consisted of all components of Rotarix, but without any RV particles.” The package insert for RotaTeq similarly admits its “placebo” contains multiple ingredients as seen to the left.
| |
Vaccine:
Covid19
|
Total
Doses: 3 |
Age
Injected:
|
Brand:
Comirnaty
|
Company:
Pfizer
|
Control:
Placebo
|
Placebo:
YES
|
Safety Review
After Injection1: 6 months |
Long:
NO
|
Source:
|
Notes:
Comirnaty licensed for only 12+ (Spikevax, Moderna, only 18+). Placebo controls unblinded and most vaccinated during the trial. All data 16+ is combined but 12-15 data is separate, had 1,131 vaccinated children, and one participant shows how this trial was conducted.
|
Vaccine:
Flu
|
Total
Doses: 19 |
Age
Injected:
|
Brand:
Various
|
Company:
Various
|
Control:
Flu shots change annually without any clinical trial
|
Placebo:
NO
|
Safety Review
After Injection1: Flu shots change annually without any clinical trial |
Long:
NO
|
Source:
|
Notes:
The trials of the original flu shot formulations for children also did not have a placebo control (see pp. 13-14) even though some adult trials did. The one inhaled influenza vaccine had a placebo but, again, it changes every year and is not safety tested in any trial.
|
Vaccine:
MMR
|
Total
Doses: 6 |
Age
Injected:
|
Brand:
M-M-R-II
|
Company:
Merck
|
Control:
None
|
Placebo:
NO
|
Safety Review
After Injection1: 42 days |
Long:
NO
|
Source:
|
Notes:
M-M-R-II trials totaled only 834 children and a third developed gastrointestinal issues and a third respiratory issues. In Priorix trial, both vaccine groups had high rate of serious adverse events, emergency room visits, and new chronic diseases (e.g., autoimmune disorders,
asthma, type I diabetes, celiac, and allergies). See Table 6 of the Supplementary Materials.
|
Vaccine:
MMR
|
Total
Doses: 6 |
Age
Injected:
|
Brand:
Priorix
|
Company:
GSK
|
Control:
M-M-R-II
|
Placebo:
NO
|
Safety Review
After Injection1: 6 months |
Long:
NO
|
Notes:
M-M-R-II trials totaled only 834 children and a third developed gastrointestinal issues and a third respiratory issues. In Priorix trial, both vaccine groups had high rate of serious adverse events, emergency room visits, and new chronic diseases (e.g., autoimmune disorders,
asthma, type I diabetes, celiac, and allergies). See Table 6 of the Supplementary Materials.
| |
Vaccine:
VAR
|
Total
Doses: 2 |
Age
Injected:
|
Brand:
Varivax
|
Company:
Merck
|
Control:
45 mg of
neomycin per milliliter
|
Placebo:
NO
|
Safety Review
After Injection1: 70 days |
Long:
NO
|
Notes:
One controlled trial with 956 children, half Varivax and half neomycin, and one trial with 32
vaccinated and another 29 vaccinated 8 weeks later, during which the first group had double the ear infections and 50% more respiratory infections.
| |
Vaccine:
HepA
|
Total
Doses: 2 |
Age
Injected:
|
Brand:
Havrix
|
Company:
GSK
|
Control:
Engerix-B
|
Placebo:
NO
|
Safety Review
After Injection1: 6 months |
Long:
NO
|
Source:
|
Notes:
Trials for both occurred at the same time when there was no licensed Hep A vaccine and
hence no excuse for not using a placebo control. It is also startling Engerix-B, see above, was
the control for Havrix, and an injection of cyto-and-neuro toxic substances, AAHS and thimerosal, were used as a control for Vaqta instead of a saline injection.
|
Vaccine:
HepA
|
Total
Doses: 2 |
Age
Injected:
|
Brand:
Vaqta
|
Company:
Merck
|
Control:
AAHS and
Thimerosal
|
Placebo:
NO
|
Safety Review
After Injection1: 42 days |
Long:
NO
|
Notes:
Trials for both occurred at the same time when there was no licensed Hep A vaccine and
hence no excuse for not using a placebo control. It is also startling Engerix-B, see above, was
the control for Havrix, and an injection of cyto-and-neuro toxic substances, AAHS and thimerosal, were used as a control for Vaqta instead of a saline injection.
| |
Vaccine:
Tdap
|
Total
Doses: 3 |
Age
Injected:
|
Brand:
Adacel
|
Company:
Sanofi
|
Control:
Td, for adults
|
Placebo:
NO
|
Safety Review
After Injection1: 6 months |
Long:
NO
|
Source:
|
Notes:
Due to reactions, Tdap (Adacel) given at 11Y has 12.5 times less diphtheria toxoid (25Lf v 2LF)
and 10 times less pertussis toxin (25mcg v 2.5mcg) than DTaP (Infanrix) given to babies.
|
Vaccine:
Tdap
|
Total
Doses: 3 |
Age
Injected:
|
Brand:
Boostrix
|
Company:
GSK
|
Control:
Decavac or Adacel
|
Placebo:
NO
|
Safety Review
After Injection1: 6 months |
Long:
NO
|
Source:
|
Notes:
Due to reactions, Tdap (Adacel) given at 11Y has 12.5 times less diphtheria toxoid (25Lf v 2LF)
and 10 times less pertussis toxin (25mcg v 2.5mcg) than DTaP (Infanrix) given to babies.
|
Vaccine:
HPV
|
Total
Doses: 2 or 3 |
Age
Injected:
|
Brand:
Gardasil 9
|
Company:
Merck
|
Control:
Gardasil 4 (see note)
|
Placebo:
NO
|
Safety Review
After Injection1: 1 month in five trials, 6 months in one trial, and 4 years in one trial |
Long:
NOYES
|
Source:
|
Notes:
Gardasil 9 trial gave 306 people placebo after full series of Gardasil 4. In Gardasil 4’s trial, controls received aluminum adjuvant, AAHS, except 320 people labeled “Saline Placebo” that actually received all vaccine ingredients except antigens and AAHS. Across trials, 2-3% receiving vaccine or aluminum adjuvant (used to induce autoimmunity) had a suspected autoimmune disorder.
|
Vaccine:
Men4
|
Total
Doses: 2 |
Age
Injected:
|
Brand:
Menactra
|
Company:
Sanofi
|
Control:
Menomune
|
Placebo:
NO
|
Safety Review
After Injection1: 6 months |
Long:
NO
|
Source:
|
Notes:
Incredibly, the safety section of the package insert for Menomune lists the trial in which it was used as a control for the trial of Menactra. This provides another good example of the safety pyramid scheme in which Menomune is licensed without a placebo-controlled trial and then used as the control to license Menactra; Menactra is then used as the control to license Menveo; and then Menveo is used as the control to license MenQuadfi. What is the actual safety profile? Putting aside the limited 6-month safety period, it is unknown since Menomune’s safety baseline was never established in a placebo-controlled clinical trial.
|
Vaccine:
Men4
|
Total
Doses: 2 |
Age
Injected:
|
Brand:
Menveo
|
Company:
GSK
|
Control:
Menactra or other vaccine
|
Placebo:
NO
|
Safety Review
After Injection1: 6 months |
Long:
NO
|
Source:
|
Notes:
Incredibly, the safety section of the package insert for Menomune lists the trial in which it was used as a control for the trial of Menactra. This provides another good example of the safety pyramid scheme in which Menomune is licensed without a placebo-controlled trial and then used as the control to license Menactra; Menactra is then used as the control to license Menveo; and then Menveo is used as the control to license MenQuadfi. What is the actual safety profile? Putting aside the limited 6-month safety period, it is unknown since Menomune’s safety baseline was never established in a placebo-controlled clinical trial.
|
Vaccine:
Men4
|
Total
Doses: 2 |
Age
Injected:
|
Brand:
MenQuadfi
|
Company:
Sanofi
|
Control:
Menveo or other vaccine
|
Placebo:
NO
|
Safety Review
After Injection1: 6 months |
Long:
NO
|
Source:
|
Notes:
Incredibly, the safety section of the package insert for Menomune lists the trial in which it was used as a control for the trial of Menactra. This provides another good example of the safety pyramid scheme in which Menomune is licensed without a placebo-controlled trial and then used as the control to license Menactra; Menactra is then used as the control to license Menveo; and then Menveo is used as the control to license MenQuadfi. What is the actual safety profile? Putting aside the limited 6-month safety period, it is unknown since Menomune’s safety baseline was never established in a placebo-controlled clinical trial.
|
Vaccine:
MenB
|
Total
Doses: 0 or 2 |
Age
Injected:
|
Brand:
Bexsero
|
Company:
GSK
|
Control:
See note
|
Placebo:
NO
|
Safety Review
After Injection1: 30 days |
Long:
NO
|
Notes:
Bexsero’s controls injected with aluminum hydroxide and, in one trial with 120 adolescents, saline injection followed by injection of Menveo and hence FDA labels this an “active control,” not a “placebo control” trial. Trumenba’s trials had no placebo control group other than 12 people in a dose ranging phase II study; otherwise, the controls were injected with
Gardasil+placebo, dTaP-IPV+placebo, HepA+placebo, or Menactra+Adacel+placebo.
| |
Vaccine:
MenB
|
Total
Doses: 0 or 2 |
Age
Injected:
|
Brand:
Trumenba
|
Company:
Pfizer
|
Control:
See note
|
Placebo:
NO
|
Safety Review
After Injection1: 30 days in 3 trials + 11M in 2 trials |
Long:
NO
|
Notes:
Bexsero’s controls injected with aluminum hydroxide and, in one trial with 120 adolescents, saline injection followed by injection of Menveo and hence FDA labels this an “active control,” not a “placebo control” trial. Trumenba’s trials had no placebo control group other than 12 people in a dose ranging phase II study; otherwise, the controls were injected with
Gardasil+placebo, dTaP-IPV+placebo, HepA+placebo, or Menactra+Adacel+placebo.
| |
Vaccine:
PPSV23
|
Total
Doses: 0 or 2 |
Age
Injected:
|
Brand:
Pneumovax 23
|
Company:
Merck
|
Control:
See note
|
Placebo:
NO
|
Safety Review
After Injection1: See note |
Long:
NO
|
Source:
|
Notes:
Licensed for children 2 years and older but there is no indication that there was any clinical trial involving anyone younger than 16 years of age that the FDA relied upon to license this
vaccine. See all FDA documentation for this vaccine linked.
|
Vaccine:
DEN
|
Total
Doses: 0 or 3 |
Age
Injected:
|
Brand:
Dengvaxia
|
Company:
Sanofi
|
Control:
Placebo
|
Placebo:
YES
|
Safety Review
After Injection1: 5 years |
Long:
YES
|
Notes:
Finally, a longer-term placebo-controlled trial (35k+ children). Children under 6 had severe harm and death – harms the above trials would likely miss – and older children “not previously infected are at increased risk for severe dengue.” Hence, it is only given in endemic areas (not in U.S.) to children 6+ who had dengue (Note: 5 years insufficient for vaccine for babies.)
|