Many thanks to the Head of Department of Health and Human Services for this outstanding rebuttal.
Today, a compliant American child receives between 69 and 92 routine vaccines (depending on brand/dictated dosage) from conception to 18 years of age. This is up from 11 shots in 1986. ACIP has recommended each of these additional jabs without requiring placebo-controlled trials for any of them. This means that no one can scientifically ascertain whether these products are averting more problems than they are causing.
Many vaccine promoters have challenged this assertion. They are always wrong. Last week, @CNN, which has devolved into a shameless propagandist for Big Pharma, triumphantly announced that it had proof that RFK, Jr’s pronouncement that “there have been no placebo-controlled safety trials for any routine vaccines” was false. CNN gleefully proclaimed that it had found 257 placebo-controlled studies for routine vaccines.
So, let’s deconstruct CNN’s claims and prove no childhood vaccine was tested against placebo.
CNN is wrong.
No routine injected vaccine on CDC’s schedule was licensed for children based on a placebo-controlled trial. In instances where a vaccine was used as a control, it too was never licensed based on a placebo-controlled trial. That is not conjecture. It is a fact based on FDA’s clinical trial data. (See sirillp.com/noplacebo following this article).
The 257 studies cited by CNN unwittingly reflect the lack of safety trials underpinning CDC’s schedule. Despite CNN’s worldwide effort to crowdsource trials with a placebo control (per @US_FDA/@CDCgov, an “inert substance”*), this list, on its face, reflects that 236 of the studies clearly did not use an “inert” safety comparator in a trial to license an injected routine vaccine for children on CDC’s schedule.**
21 studies CNN’s list claims used an inert injection, 9 plainly did not.
- RCT 251, 252 (Varivax) injected an antibiotic, neomycin – not inert.
- RCT 84, 97 (HPV-16 and 16/18) injected aluminum adjuvant – not inert.
- RCT 215 (Almevax) injected another vaccine – not inert.
- RCT 55 (Lyophilized PedvaxHIB) injected lactose, aluminum adjuvant, and thimerosal – not inert.
- RCT 197 (Salk vaccine) injected 199 solution, synthetic tissue culture, ethanol, phenol red, antibiotics, and formalin – not inert.***
- RCT 168 (Dow’s MMR) injected full vaccine minus virus, including all stabilizers, antibiotics, diluent, preservative, and buffers – not inert.****
- RCT 189 (Menveo) injected Tdap+saline or Menveo+saline – not inert.
CNN lists 12 may have had placebo in a trial, but that trial was not relied upon for approval.
- RCT 170, 171, 172 (MMR VaxPro), 228 (PCV11), 136 (Vaxigrip), 242 (Antitetanus), and 122 (Chinese flu shots) trialed vaccines never licensed in the U.S. nor relied upon to license a U.S. vaccine.
- RCT 124 (Fluzone IIV3), 102 (WVV/SPV), and 188 (Menveo) trials occurred after each respective vaccine was licensed, hence were not relied upon for their licensure.
- RCT 176 (Mumps vaccine) was not relied upon by the FDA to license the current MMR vaccine. (See MMR-II clinical trial report in link above.)
- RCT 53 (PRP-D) was for a vaccine withdrawn soon after its introduction and not relied upon by the FDA to license any U.S. vaccine.
While these 12 studies were not relied upon to license a routine vaccine on the CDC’s schedule, they do reflect that a placebo-controlled trial of a vaccine is possible. They also reflect what can be learned when a placebo trial is performed.
For example: RCT 136 found the vaccine ineffective; RCT 122 found that “severe adverse effects occurred in 69 (0·6%, 95% CI 0·5–0·8) recipients of vaccine compared with one recipient (0·1%, 0–0·2) of placebo.”; and RCT 124 found “the rate of hospitalization was actually higher in the [Fluzone IIV3] vaccine group than in the placebo group.”
The unfortunate reality is that placebo-controlled trials, however, do not occur and have not been relied upon when FDA licenses vaccines for injection during childhood or ACIP recommends the shot for addition to the CDC’s routine schedule.
CNN would have reached the same conclusion had it reviewed the FDA documentation for each vaccine, instead of relying upon a random, crowd-sourced list from the internet. CNN’s list ironically proves the lack of adequate safety trials for routine childhood vaccines.
Again, no childhood vaccine was tested against placebo. It is time to stop playing games, such as CNN’s false gotcha. We have gone from 3 routine injections by age one in 1986 (the year the National Childhood Vaccine Injury Act passed) to 25 routine injections by age one in 2025 (which now does not include Covid-19 vaccine). Because of the 1986 Act, every one of these products, save one, was developed by companies knowing they would almost never be liable for serious harm.
During this same period, chronic diseases in our children exploded, most of which are caused by immune system dysregulation. If we are to identify the exposures that are causing this epidemic of autoimmune diseases, we need to rule out products given dozens of times to young children, specifically to modify the immune system, as potential culprits.
Our infants and children deserve the best safety trials possible to keep them safe. We should care as much about every child who could be injured by one of these products as we do every child who could be injured by an infectious disease. We must protect all children.
Notes
* fda.gov/media/130326/download… (“Placebos, defined as inert substances with no pharmacologic activity, are commonly used in double-blind, randomized controlled clinical trials.”); fda.gov/media/71349/download… (“the placebo control design, by … including a group that receives an inert treatment…”); cdc.gov/vaccines/glossary/… (“Placebo: A substance or treatment that has no effect on living beings, usually used as a comparison to vaccine or medicine in clinical trials.”).
** While the above addresses injected vaccines, CNN’s cited list also includes 10 trials for rotavirus vaccine, given by oral drops, but none of these trials used saline only drops. Instead, RCT 205, 207, 208, 209, 210, 213 (Rotarix) contained dextran, sorbitol, amino acids, dulbecco’s modified eagle medium, calcium carbonate, and xanthan; RCT 211, 212 (RotaTeq) contained polysorbate 80, sucrose, citrate and phosphate; and RCT 206, 214 (Rotavac) included neomycin sulphate, kanamycin acid sulphate, trehalose, lactalbumin hydrolysate, human albumin, potassium dihydrogen orthophosphate, dipotassium hydrogen orthophosphate, and trisodium citrate dihydrate. The list also included three trials of an inhaled flu vaccine; the controls in RCT 104 were OPV+saline or LAIV (a vaccine), hence neither inert; in RCT 106 the control “consisted of normal allantoic fluid harvested from uninfected eggs stabilized with sucrose–phosphate–glutamate”; and, in RCT 109, the control was “intranasal spray of egg allantoic fluid containing sucrose-phosphate-glutamate.”
*** Note that the current polio vaccines used in the U.S. are a different product than the polio vaccine developed by Jonas Salk in the 1950s—which was discontinued in the 1960s—including because the currently-used polio vaccines are “grown in vero cells, a continuous line of monkey kidney cells cultivated on microcarriers.”
Hence, the Salk trial was not relied upon to license any current polio vaccine. fda.gov/media/75695/download…; pubmed.ncbi.nlm.nih.gov/6740101/; https://admin.phe-culturecollections.org.ukmedia/122249/vero-cell-line-profile.pdf; atcc.org/products/all/ccl-81.aspx#characteristics….
**** Dow Chemical’s MMR vaccine used different strains than any licensed U.S. MMR vaccine and also, after 14 days of safety review, this trial vaccinated all participants.
From sirillp.com/noplace
CONTROL USED IN EACH TRIAL RELIED UPON TO LICENSE ROUTINE INJECTED VACCINES FOR CHILDREN ON CDC’S SCHEDULE1
- • Hep B vaccine (CDC schedule: birth, 1 month, and 6 months)
o Recombivax HB (Merck): licensed for infants based on trials with no placebo control and
5 days of safety monitoring after injection.2
o Engerix-B (GSK): licensed for infants based on trials with no placebo control and 4 days of
safety monitoring after injection.3
• DTaP vaccine (CDC schedule: 2, 4, 6, and 15 months, and 4 years)
o Infanrix (GSK): licensed for infants based on trials with no placebo control (DTP vaccine
used as control) and up to 30 days of safety review after injection.4 DTP was not licensed in
a placebo-controlled trial and has been repeatedly found to increase mortality in infants.5
o Daptacel (Sanofi): licensed for infants based on trials with no placebo control (DT or DTP
vaccine used as control) and “[w]ithin 30 days following any dose of DAPTACEL, 3.9%
subjects reported at least one serious adverse event.”6
• PCV vaccine (CDC schedule: 2, 4, 6, and 12 months)
o Prevnar 13, PCV-13 (Wyeth, part of Pfizer): licensed for infants based on trials with no
placebo control (Prevnar 7 used as control, which was licensed based on a trial in which the
control was an “Investigational meningococcal group C conjugate vaccine,” meaning
another experimental vaccine) and “[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.”7
o Vaxneuvance PCV-15 (Merck): licensed for infants based on trials with no placebo control
(Prevnar 13 used as control) and “[a]mong children who received VAXNEUVANCE
(N=3,349) or Prevnar 13 (N=1,814) … serious adverse events … were reported by 9.6% of
VAXNEUVANCE recipients and by 8.9% of Prevnar 13 recipients.” Deemed “safe” because
“[t]here were no notable patterns or numerical imbalances between vaccination groups.”8
o Prevnar 20, PCV-20 (Pfizer): licensed for infants based on trials with no placebo control
(Prevnar 13 used as control) and again showed high rates of serious events (this time broken
up into two categories, “serious adverse events” and “newly diagnosed chronic medical
conditions”) in both groups but deemed “safe” because there was “no notable patterns or
imbalances between vaccine groups.”9
• Polio vaccine (CDC schedule: 2, 4, and 6 months, and 4 years)
o IPOL (Sanofi): licensed in 1990 for infants based on trials with no placebo control and 3
days of safety review after injection. Sanofi reports that, “[a]lthough no causal relationship
has been established, deaths have occurred in temporal association after vaccination of
infants with IPV.”10 Because IPOL is a different product than the polio vaccine developed by
Jonas Salk in the 1950s (which was discontinued in the 1960s) including because IPOL is
1 Note this document only addresses trials FDA relied upon to determine the product is safe for licensure.
2 See § 6.1 at https://www.fda.gov/media/74274/download.
3 See § 6.1 at https://www.fda.gov/media/119403/download.
4 See § 6.1 at https://www.fda.gov/media/75157/download.
5 See https://archive.org/details/2021.01.28-letter-to-special-rapporteur-on-poverty.
6 See § 6.1 at https://www.fda.gov/media/74035/download; https://www.fda.gov/safety/reporting-serious-problems-
fda/what-serious-adverse-event.
7 See § 6.1 at https://www.fda.gov/media/107657/download; https://www.fda.gov/media/76076/download.
8 See § 6.1 at https://www.fda.gov/media/150819/download.
9 See § 6.1 at https://www.fda.gov/media/149987/download; https://www.fda.gov/media/150459/download.
10 See pp. 14-17 at https://www.fda.gov/media/75695/download.“grown in vero cells, a continuous line of monkey kidney cells cultivated on microcarriers,”
the Salk trial was not relied upon to license IPOL.11
Hib vaccine (CDC schedule: 2, 4, 6, and 12 months)
o ActHIB (Sanofi): licensed for infants based on trials with no placebo control (Hep B vaccine
used as control) and 30 days of safety review after injection during which 3.4% experienced
a serious adverse event but “[n]one was assessed by the investigators [Sanofi] as related to
the study of vaccines.”12
o Hiberix (GSK): licensed for infants based on trials with no placebo control (ActHIB used
as control) and 31 days of safety review after injection.13
o Liquid PedvaxHIB (Merck): licensed for infants based on trials with no placebo control
(lyophilized PedvaxHIB used as control) and 3 days of safety review after injection.14 (Note
that lyophilized PedvaxHIB was tested in a trial in which the control group received an
injection of lactose, aluminum adjuvant, and thimerosal, along with OPV, and DTP.15)
• Flu vaccine (CDC schedule: 6 and 7 months and then annually)
o The formulation for each influenza vaccine changes annually and there is no clinical trial
carried out for each new formulation.
• MMR vaccine (CDC schedule: 12 months and 4 years)
o M-M-R-II (Merck): licensed based on a trial with a total of 834 children, no control group,
and that reviewed safety for 42 days during which one-third of vaccinated participants
developed gastrointestinal issues and one-third experienced respiratory issues.16
o Priorix (GSK): licensed based on trials with no placebo control (M-M-R-II used as control)
and 6 months of safety review after injection in which both vaccine groups had a high rate
of serious adverse events (2.1% of Priorix group and 1.9% of M-M-R-II group), emergency
room visits (10.1% of Priorix group and 10.4% of M-M-R-II group), and new onset of
chronic diseases (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac
disease, thrombocytopenia, and allergies) (3.4% of Priorix group and 3.7% of M-M-R-II
group).17
• Varicella vaccine (CDC schedule: 12 months and 4 years)
o Varivax (Merck): licensed based on trials with no placebo control (the purported “placebo”
was an injection of neomycin, an antibiotic) and 70 days of safety review after injection
11 See p. 1 at https://www.fda.gov/media/75695/download; https://pubmed.ncbi.nlm.nih.gov/6740101/; https://admin.phe-
culturecollections.org.uk/media/122249/vero-cell-line-profile.pdf; https://www.atcc.org/products/all/ccl-
81.aspx#characteristics.
12 See § 6.1 at https://www.fda.gov/media/74395/download; see p. 8 at
https://web.archive.org/web/20170723144656/https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/Appro
vedProducts/UCM244597.pdf.
13 See § 6.1 at https://www.fda.gov/media/77017/download; see pp. 20-21 at http://wayback.archive-
it.org/7993/20170722072902/https:/www.fda.gov/
downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182550.pdf.
14 See pp. 6-8 at https://www.fda.gov/media/80438/download.
15 See pp. 6-8 at https://www.fda.gov/media/80438/download.
16 See clinical trial reports for M-M-R-II at https://www.sirillp.com/wp-content/uploads/2023/07/MMRII-FOIA.pdf;
package insert; see package insert for M-M-R-II https://www.fda.gov/media/75191/download (The package insert for M-
M-R-II does not list any trial as a basis for determining this product was safe for licensure, presumably because the trial
relied upon to license this product could not establish it was safe for licensure.).
17 See § 6.1 at https://www.fda.gov/media/158941/download; see p. 12 at https://pmc.ncbi.nlm.nih.gov/
articles/instance/7192400/bin/piz010_suppl_supplementary_materials.docx.
(https://perma.cc/N3PL-JT9J)which included only one controlled trial of 956 children in which approximately half
received Varivax and half received an injection of neomycin.18
• Hep A vaccine (CDC schedule: 12 and 18 months)
o Havrix (GSK): licensed based on trials with no placebo control (Engerix-B used as
control).19
o Vaqta (Merck): licensed based on trials with no placebo control (injection of aluminum
adjuvant and thimerosal used as control).20
• Tdap vaccine (CDC schedule: 11 years)
o Adacel (Sanofi): licensed based on trials with no placebo control (Td, for adult use, was used
as a control).21
o Boostrix (GSK): licensed based on trials with no placebo control (Decavac or Adacel was
used as control).22 (Note Decavac was licensed based on trial with no control.23)
• HPV vaccine (CDC schedule: 9 and 9 ½ years)
o Gardasil 9 (Merck): licensed based on trials with no control, Gardasil 4 as control, or, for
306 participants, placebo plus Gardasil 4 as control.24 (Note that Gardasil 4 was licensed
based on trials in which controls were injected with aluminum adjuvant or, in 594 subjects,
l-histidine, polysorbate 80, and yeast protein.25)
• Men4 vaccine (CDC schedule: 11 and 16 years)
o Menactra (Sanofi): licensed based on trials with no placebo control (Menomune used as the
control).26 Note Menomune was licensed without a placebo-controlled trial; rather,
Menomune’s package insert lists the trial used to license Menactra, in which Menomune was
the control, as the basis for the safety of Menomune.27
o Menveo (GSK): licensed based on trials with no placebo control (Menactra, Boostrix, or
other vaccines used as a control).28
o MenQuadfi (Sanofi): licensed based on trials with no placebo control (Menveo or other
vaccines used as a control).29 Thus, Menomune was licensed without a placebo-controlled
trial and then used as control to license Menactra; Menactra then used as control to license
Menveo; and Menveo then used as control to license MenQuadfi.
18 See § 6.1 at https://www.fda.gov/media/76000/download; see p. 2 at https://pubmed.ncbi.nlm.nih.gov/6325909/.
19 See § 6.1 at https://www.fda.gov/media/119388/download.
20 See § 6.1 at https://www.fda.gov/media/74519/download (using term “placebo”); see clinical trial report at 454
https://www.nejm.org/doi/pdf/10.1056/NEJM199208133270702?articleTools=true (explains the purported “placebo”
included the foregoing ingredients).
21 See § 6.1 at https://www.fda.gov/media/119862/download.
22 See § 6.1 at https://www.fda.gov/media/124002/download.
23 See https://www.sirillp.com/decavac-package-insert.
24 See pp. 17-19 at https://wayback.archive-
it.org/7993/20190423065200/https:/www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/
UCM429166.pdf.
25 See https://www.fda.gov/media/74350/download (While this insert states 594 controls received a “saline placebo,”
Merck’s peer reviewed publication explains the “placebo used in this study contained identical components to those in
the vaccine, with the exception of HPV L1 VLPs and aluminum adjuvant,” which means it was not in fact at “placebo”
but rather an injection that contained, among other ingredients, l-histidine, polysorbate 80, and yeast protein.
https://www.ncbi.nlm.nih.gov/pubmed/17484215).
26 See § 6.1 at https://www.fda.gov/media/75619/download.
27 See https://archive.org/details/menomune-a-c-y-w-135-prescribing-information.
28 See § 6.1 at https://www.fda.gov/media/78514/download.
29 See § 6.1 at https://www.fda.gov/media/137306/download.
(https://perma.cc/E8MU-D4A5)
