Josh Hamburger

Yesterday, I retired 17 members of the Advisory Committee on Immunization Practices or ACIP, the @CDCgov external panel that wields the grave responsibility of adding new vaccines to the recommended childhood schedule. Over the coming days, I will use this platform to announce new members to populate ACIP. None of these individuals will be ideological anti-vaxxers. They will be highly credentialed physicians and scientists who will make extremely consequential public health determinations by applying evidence-based decision-making with objectivity and common sense. I will also be tweeting examples of the historical corruption at ACIP to help the public understand why this clean sweep was necessary. The most outrageous example of ACIP’s malevolent malpractice has been its stubborn unwillingness to demand adequate safety trials before recommending new vaccines for our children. 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 my 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, allow me a moment to deconstruct CNN’s claims. Warning: this post may only be sufferable for science geeks like myself. 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). As Secretary of @HHSGov, acknowledging this lamentable truth is part of my promise of radical transparency. 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.** For the remaining 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. For the remaining 12 listed studies which may have had an inert injection, none was a trial relied upon to license a routine vaccine on CDC’s childhood schedule: • 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. 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/d… (“Placebos, defined as inert substances with no pharmacologic activity, are commonly used in double-blind, randomized controlled clinical trials.”); fda.gov/media/71349/do… (“the placebo control design, by … including a group that receives an inert treatment…”); cdc.gov/vaccines/gloss… (“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/do…; pubmed.ncbi.nlm.nih.gov/6740101/; https://‌admin.phe-culturecollections.org.uk‌media/1222‌49/‌vero-cell-line-profile.pdf; #characteristics" target="_blank" rel="nofollow noopener">atcc.org/products/all/c…. **** 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.