Fact-Checking the “Placebo Control” Fact Checkers

The fact is, not a single routine injected childhood vaccine on the CDC schedule was licensed based on a placebo-controlled trial, nor was any vaccine used as a control to license any such vaccine.

I was recently sent the following two links which claim that placebo-control groups were used to license routine childhood vaccines:

• Children’s Hospital of Philadelphia - Technically Speaking: 75 Years of Placebo-Controlled Vaccine Testing in the U.S.

• American Academy of Pediatrics - Fact Checked: Childhood Vaccines Are Carefully Studied—Including with Placebos—to Ensure They’re Safe and Effective

If you read these two articles, you will notice they contain no actual evidence and no link to any clinical trial. That is because the reality is that not a single routine injected childhood vaccine on the CDC schedule was licensed based on a placebo-controlled trial. Nor, when another vaccine was used as the control, was that vaccine licensed based on a placebo-controlled trial. And so on and so forth down the chain.

Unlike these two nonsense articles, which claim to be “fact checks,” below is the actual facts with the actual evidence from the FDA showing exactly what the control was when licensing each routine childhood vaccine. (You can also read a more fulsome, fun, narrated version of this list in Chapter 10 of Vaccines, Amen.)

One last thing, as for the definition of what is a “placebo,” per the FDA, in its guidance regarding placebo-controlled trials: “Placebos, defined as inert substances with no pharmacologic activity.” Also see this FDA source: “placebo control … group that receives an inert treatment…” And per the CDC, “A substance or treatment that has no effect on living beings.” With that, here is the list:

• HepB vaccine (Birth 1M 6M)

  • Recombivax HB (Merck) licensed for babies based on trials with no placebo control & 5 days of safety monitoring after injection. See Package insert § 6.1.

  • Engerix B (GSK) licensed for babies based on trials with no placebo control & 4 days of safety monitoring after injection. See Package insert § 6.1.

• DTaP vaccine (2M 4M 6M 15M 4Y)

  • Infanrix (GSK) licensed for babies based on trials with no placebo control (DTP vaccine used as a control) & up to 30 days of safety review after injection. See Package insert § 6.1. (Note that DTP was not licensed in a placebo-controlled trial and increases mortality.)

  • Daptacel (Sanofi) licensed for babies based on trials with no placebo control (DT or DTP vaccine used as control) & 2 months of safety review after injection except one trial which was 6 months with 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.” See Package insert § 6.1. (See note regarding DTP under Infanrix, above.)

• PCV vaccine (2M 4M 6M 12M)

  • Prevnar 13, PCV-13 (Wyeth, part of Pfizer) licensed for babies based on trials with no placebo control (Prevnar 7 used as a control, and Prevnar 7 was licensed based on trial in which the control was another experimental vaccine) & 6 months of safety review after injection which found, “Serious adverse events reported following vaccination in infants and toddlers occurred in 8.2% among Prevnar 13 recipients and 7.2% among Prevnar 7 recipients.” See Package insert § 6.1. (Note the package insert for Prevnar 7 states the control in its licensing trial was an “Investigational meningococcal group C conjugate vaccine.”)

  • Vaxneuvance PCV-15 (Merck) licensed for babies based on trials with no placebo control (Prevnar 13 used as the control) & up to 6 months of safety review after injection, finding that, “Among children who received VAXNEUVANCE (N=3,349) or Prevnar 13 (N=1,814) … serious adverse events up to 6 months following vaccination with the 4-dose series 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.” See Package insert § 6.1.

  • Prevnar 20, PCV-20 (Pfizer) licensed for babies based on trials with no placebo control (Prevnar 13 was used as the control) & up to 6 months of safety review after injection that again showed high rates of serious events (this time broken up into two categories – “serious adverse events (SAEs)” and “newly diagnosed chronic medical conditions (NDCMCs)”) in both vaccine groups but deemed “safe” because “no notable patterns or imbalances between vaccine groups.” See Package insert § 6.1; Clinical Review.

• Polio vaccine (2M 4M 6M 4Y)

  • IPOL (Sanofi) licensed in 1990 for babies based on trials with no placebo control & 3 days of safety review after injection. Sanofi reports that, “Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants with IPV.” See Package insert at 14-17. (Note that IPOL is an injected polio vaccine and is the only polio vaccine used in the U.S. for over two decades. It is a very different product than the polio vaccine developed by Salk in the 1950s—and, as noted above, ceased being used in the U.S. in the 1960s—and hence the trials of Salk’s vaccine from the early 1950s were not relied upon to license IPOL.)

• Hib vaccine (2M 4M 6M 12M)

  • ActHIB (Sanofi) licensed for babies based on trials with no placebo control (Hepatitis B vaccine used as control) & 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.” See Package insert § 6.1; Basis of Approval at 8.

  • Hiberix (GSK) licensed for babies based on trials with no placebo control (ActHIB used as the control) & 31 days of safety review after injection. See Package insert § 6.1; Clinical review at 20-21.

  • Liquid PedvaxHIB (Merck) licensed for babies based on trials with no placebo control (Lyophilized PedvaxHIB used a control) & 3 days of safety review after injection. See Package insert at 6-8. (Note that Lyophilized PedvaxHIB was tested in a trial in which controls were given lactose, aluminum adjuvant, and thimerosal and there is no indication Lyophilized PedvaxHIB was ever licensed.)

• Rotavirus vaccine (2M 4M 6M) (Note that every vaccine on the CDC childhood schedule is given via injection, except for one flu vaccine given by nasal spray and the rotavirus vaccines, which are given by oral drops .)

  • Rotarix (GSK) licensed for babies based on trials without a placebo control (the control group received an oral drop that included Dextran, Sorbitol, Amino Acids, Dulbecco’s Modified Eagle Medium, and Xanthan) & 31 days of safety review after oral dose and up to a year in some trials for cases of intussusception. There were more deaths in the group receiving Rotarix than the purported placebo. As disclosed by the FDA and GSK: “During the entire course of 8 clinical studies (Studies 1 to 8), there were 68 (0.19%) deaths following administration of ROTARIX (n = 36,755) and 50 (0.15%) deaths following placebo administration (n = 34,454). The most commonly reported cause of death following vaccination was pneumonia, which was observed in 19 (0.05%) recipients of ROTARIX and 10 (0.03%) placebo recipients (RR: 1.74, 95% CI: 0.76, 4.23).” See Package insert § 6.1 (claims used a placebo); Clinical review at 23-24 (admits the purported “placebo” included all the foregoing ingredients).

  • RotaTeq (Merck) licensed for babies based on trials without a placebo control (the control group received an oral drop that included Polysorbate-80, Tissue Culture Medium, Fetal Bovine Serum, and Sodium Phosphate) & 42 days of safety review after each oral dose and up to a year for cases of intussusception. See Package insert § 6.1 (claims used placebo); Clinical reports at 445 etc. (admits the purported “placebo” included all the foregoing ingredients).

• Covid-19 vaccine (6M 8M and then Annually)

  • Comirnaty (Pfizer) authorized for emergency use in babies based on trial with a placebo control (finally!) & 6 months of safety review after injection. See Package insert § 6.1. (Note that Pfizer’s EUA was revoked and it is not currently licensed for children under age 5.) Also, while Comirnaty’s trial had a placebo control group, that group was unblinded and most were vaccinated during the 6-month safety review period. The 16- and 17-year-old data is not separated from the adult data, but the 12- to 15-year-old data is separated and included only 1,131 children who received a vaccine, and the case of one participant reflects how this trial was conducted.)

  • Spikevax (Moderna) authorized for emergency use in babies based on trial with placebo control. Depending on the age group, the median duration of blinded safety follow-up was 51 to 71 days. Placebo controls were unblinded and mostly vaccinated during the trial. See Package insert at § 6.1; FDA Briefing at 10.

• Flu vaccine (6M 7M and then Annually)

  • The formulation for each influenza vaccine changes annually and there is no clinical trial carried out for each new formulation. (In any event, none of the clinical trials for the original formulation of any injected influenza vaccine for children had a placebo control group, see letter pp.13-14, even though some adult trials did, showing it could have been done. See FDA documentation and compare child and adult portions of Section 6.1 of each flu vaccine package insert. The one inhaled influenza vaccine’s original trial had a placebo but, again, its formulation changes every year and is not safety tested in any trial.)

• MMR vaccine (12M 4Y)

  • M-M-R-II (Merck) licensed based on a trial with no placebo control & 42 days of safety review after injection in a trial with a total of only 834 children of which a third developed gastrointestinal issues and a third respiratory issues. See Clinical reports. (This patently deficient, underpowered, unblinded, and non-randomized trial is unsurprisingly not even listed in the safety section of M-M-R-II’s package insert. Also note that the original MMR’s clinical trial was similarly deficient and also showed a high and concerning rate of gastrointestinal, respiratory and other issues, as compared to the small untreated control group—see pages 12 and 13. In any event, the original MMR was a different product that did not include millions of pieces of human DNA and cellular debris, as does M-M-R-II, which is likely why it was not used as a control in the trial for M-M-R-II).

  • Priorix (GSK) licensed based on trials with no placebo control (M-M-R-II used as the control) & 6 months of safety review after injection in which both vaccine groups had a high rate of serious adverse events, emergency room visits, and new onset of chronic diseases (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, thrombocytopenia, and allergies). See Package insert § 6.1; Sup materials at 12.

• Varicella (chicken pox) vaccine (12M 4Y)

  • Varivax (Merck) licensed based on trials with no placebo control & 70 days of safety review after injection. In the one controlled trial of 956 children, around half received Varivax and half received the “placebo” injection of 45 mg of neomycin per milliliter. There was one trial in which 32 children received Varivax and 29 children received nothing and then received Varivax eight weeks later; during this eight-week period, the Varivax group had double the rate of ear infection and a 50% increase in respiratory infection. As for serious adverse events, Merck did not consider any related to Varivax. See Package insert § 6.1; Merck study at 2; Clinical reports.

• HepA vaccine (12M 18M)

  • Havrix (GSK) licensed based on trials with no placebo control (Engerix-B was used as a control) & 31 days of safety review after injection with a phone call follow-up at 6 months. See Package insert § 6.1.

  • Vaqta (Merck) licensed based on trials with no placebo control (an injection of AAHS, an aluminum adjuvant, and thimerosal, a form of mercury, were used as a control) & up to 42 days of safety review after injection. See Package insert § 6.1 (using term “placebo”); Merck study at 454 (admits the purported “placebo” included all the foregoing ingredients). (Note that trials for Havrix and Vaqta occurred at roughly the same time and, because there was no licensed Hepatitis A vaccine at that time, there was no excuse for not using a placebo control in these trials. It is also startling that Engerix-B, which had 4 days of safety monitoring in its trial, was used as the control for Havrix, and that an injection of known cyto-and-neuro toxic substances, AAHS and thimerosal, were used as a control for Vaqta instead of just a saline injection.)

• Tdap vaccine (11Y)

  • Adacel (Sanofi) licensed based on trials with no placebo control (Td, for adult use, was used as a control) & up to 6 months of safety review after injection. See Package insert § 6.1.

  • Boostrix (GSK) licensed based on trials with no placebo control (DECAVAC or Adacel was used as a control) & up to 6 months of safety review after injection. See Package insert § 6.1.

• HPV vaccine (9Y 9 ½Y)

  • Gardasil 9 (Merck) was licensed based on trials in which safety was reviewed after injection for 1 month in five of the clinical trials, 6 months in a lot consistency trial, and 4 years in one trial of women aged 16 to 26 years (reflecting that a safety trial of a more appropriate duration is possible). These Gardasil 9 trials were either not controlled or used Gardasil 4 as the control, except for one trial in which 306 participants received a placebo but only after receiving the full series of Gardasil 4 injections. See Clinical review at 17-19. (Note that in Gardasil 4’s clinical trial, controls received an aluminum adjuvant, AAHS, except 320 people labeled “Saline Placebo” that actually received all vaccine ingredients except antigens and AAHS. Also, across all these trials, 2-3% of participants receiving vaccine or aluminum adjuvant—used to induce autoimmunity—had a suspected autoimmune disorder.)

• MenACYW vaccine (11Y 16Y)

  • Menactra (Sanofi) licensed based on trials with no placebo control (Menomune used as the control, and amazingly the safety section of the package insert for Menomune lists this same trial in which it is being used as a control) & up to 6 months of safety review after injection. See Package insert § 6.1.

  • Menveo (GSK) licensed based on trials with no placebo control (Menactra, Boostrix, or other vaccines used as a control) & up to 6 months of safety review after injection. See Package insert § 6.1.

  • MenQuadfi (Sanofi) licensed based on trials with no placebo control (Menveo or other vaccines used as a control) & up to 6 months of safety review after injection. See Package insert § 6.1. (The three Men4 vaccines provide another good example of the vaccine safety pyramid scheme because Menomune was 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. The actual safety profile, putting aside the limited 6-month safety period, is unknown since Menomune’s safety baseline was never established in a placebo-controlled trial.)

• NON-ROUTINE VACCINE: MenB vaccine (16Y 16 ½Y + if indicated)

  • Bexsero (GSK) licensed based on trials with no placebo control group (either uncontrolled or control group was given an injection of aluminum hydroxide and, in one trial involving 120 adolescents, a saline injection followed by an injection of Menveo and hence FDA labels this an “active control” and not a “placebo control” trial) & 30 days of safety review after injection. See Summary basis at 14-15; Clinical review at 40.

  • Trumenba (Pfizer) licensed based on trials with no placebo control group other than 12 people in a dose ranging phase II study (otherwise the controls were injection of Gardasil+placebo, dTaP-IPV+placebo, HepA+placebo, or Menactra+Adacel+placebo) & 30 days of safety review after injection for one of the three trials and up to 11 months in the other two trials. See Summary basis at 4; Clinical review at 9-10.

• NON-ROUTINE VACCINE: PPSV23 vaccine (2Y+ if indicated)

  • Pneumovax 23 (Merck) is 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 FDA documentation.

• NON-ROUTINE VACCINE: Dengue vaccine (6Y+ if previously had dengue and live in area dengue is endemic)

  • Dengvaxia (Sanofi) licensed based on a trial with 11,474 children receiving a placebo control (saline injection) & 5 years of safety review after injection. Meaning, the 17th and last vaccine on the CDC’s childhood vaccine schedule, is apparently the first vaccine that underwent a longer-term placebo-controlled trial prior to licensure! This trial stands as the proof that a longer-term placebo-controlled trial of a childhood vaccine is possible! See Statistical review at 10; Package insert at 4. (Note for this vaccine, it was learned that children under 6 years old had an increased risk of severe harm and death from this vaccine—harm that would likely never have been uncovered by the trials performed for any of the other 16 vaccines. It was also found that children older than 6 who had never had dengue and received this vaccine likewise had a seriously increased risk of severe harm and death. Hence, this vaccine is only to be given to older children who have previously had dengue. As disclosed by the FDA and Sanofi: “Those not previously infected are at increased risk for severe dengue disease when vaccinated and subsequently infected with dengue virus.” This vaccine is only recommended for children in endemic dengue areas and dengue is not endemic in the United States.)