"For the past two weeks, we have waited for the biomedical community to bring forward studies that demonstrate that vaccination of neonates is safe.

Our extensive review of the basis of the inclusion of aluminum in vaccines has revealed some disturbing facts:

(1) The amount of aluminum in vaccines is not based on safety studies.  Instead, the levels are based on the amount required to activate the immune system.

(2) The safety studies that have been conducted have been primarily dietary studies in adult mice, who do not have developing brains.

(3) Only 0.2-0.3% (a tiny portion) of aluminum from diet is absorbed.  In contrast, all of the aluminum in vaccines must be processed or stored internally. 

(4) Past studies have shown unacceptable rates of serious adverse events, including mortality, due to vaccination of neonates.

(5)  The FDA has failed to act adequately to render safe guidelines. Current guidelines are not science-based, and we are giving babies that weigh as little at 1.8 kg 250 mcg of aluminum on a routine basis in the Hepatitis B shot. 

(6) Infants receiving HepB shots receive 15 days' worth of the safe limit of 4-5 mcg aluminum/kg/day hydroxide form parenteral (non-dietary) sources in one day.

(7) Due to accumulation, our calculations tell us that exposure durations are likely unacceptable for newborns, especially for low birth weight babies.

It is worth pointing out that combine vaccine visits exceed the 850 mcg limit.

As a result of our findings, I am calling for an immediate cessation of the practice of vaccination of premature and low-birth weight infants born to mothers without HepB infections, and I am calling for renewed prospective studies of the rate of adverse event of the use of HepB so early in the CDC schedule.

Dr. Paul Thomas recommends that families to skip the Hepatitis B vaccine, and anyone who looks at the pediatric dosing can see why." [Vaccine Friendly Plan, Amazon.com]


.PDF of this press release 

PRESS RELEASE – April 30, 2017

Pittsburgh, PA


For Immediate Release

Biomedical researchers at The Institute for Pure and Applied Knowledge (IPAK) are calling upon all Vaccine Risk Aware Americans to join them in their call of a ban on vaccination of infants in the NICU.  The reasons?  A lack of science demonstrating safety of the practice, and a concern over increasing death rates in infants born prematurely.

“We’ve asked the biomedical community to produce studies that show ill effect of vaccines on neonates, and they have not produced them. Aluminum is a serious neurotoxin, and body weight matters” says Dr. James Lyons-Weiler, PhD, CEO and Director of IPAK, “and our government agencies have slacked off in protecting our young from toxic doses of aluminum in vaccines.”

The Hepatitis-B, or HepB vaccine, contains 250 micrograms of aluminum hydroxide, an additive that is present to stimulate the immune system. Lyons-Weiler says that considering birthweight, the amount in pediatric vaccines exceeds the established safe levels of exposure of 4-5 mcg/kg/day, and are not based on safety studies, but rather on the levels needed to produce the desired immune stimulation.

While that sounds important, aluminum is widely known in the scientific community to be a potent neurotoxin.  For an average-sized American male (3.3 kg), the amount of aluminum in HepB produces an acute exposure equal to 15 days’ worth of exposure at FDA safe limit of aluminum exposure in a single day for an adult.

“Our scientists have scoured the literature, and they have studied the provenance of aluminum levels in vaccines. They were surprised to find errors and gross mistakes, and to find that the levels set for aluminum in vaccines are not based on safety studies.  What is known about aluminum safety is based mostly on dietary exposures to adult animals, not injected aluminum in mouse and rat pups with developing brains. The single study we found that did look at rat pup dietary exposures found developmental delays. Our agencies have allowed these levels to be used in babies regardless of body weight, and regardless of time units or duration of exposure” says Lyons-Weiler.

The safe levels 4-5 mcg/kg/day were derived for adult receiving aluminum via non-oral exposures, such as dialysis solutions via intravenous drip. Side effects include increased morbidity and mortality due to multiple molecular mechanisms, include neurotoxic effects.

Other individuals point out that the acute exposure is not the same as long-term exposure, but that does not change the IPAK position.  They are calling for an immediate cessation of exposure of infants in the NICU to all injected forms of aluminum because, they say, no studies exist that show that the high levels of aluminum are safe for low-weight, premature infants.

The current guidelines suggest that vaccines may be delayed for infants who weigh less than 2 kg (4.4 lbs), but Lyons-Weiler says these guidelines are too loosely followed, and are not based on science.

“Until independent studies are conducted that reliably show that 250 micrograms of aluminum hydroxide are harmless to the long-term neurodevelopment of infants, we really should not wait for the FDA to act. We are calling on all NICU directors in the US to look at the math, and to see for themselves that we are arbitrarily exposing our children to such massive doses of a neurotoxin needlessly. We are calling on all NICU directors and pediatricians to stop vaccinating all neonates and low-birthweight babies who not born to mothers with HepB infections. Acute toxicity from high aluminum doses is well established. We need to act now. We are also calling on all organizations who care about vaccine safety to sound this alarm”.

Hepatitis B infection status is usually known for mothers, and so each infant born is not likely to be exposed to Hepatitis B until they are much older.

Dr. Lyons-Weiler’s statement:


Background Facts:

  • Aluminum is the most abundant element from the Earth’s crust.
  • Humans and living organisms were not exposed to aluminum until after the Industrial Age – it was tied up as aluminum silicate in the Earth’s crust. 
  • Aluminum is toxic to biological systems.

Supporting articles and studies:

Demeo, S. et al., 2016. Adverse Events After Routine Immunization of Extremely Low Birth Weight Infants. JAMA Pediatr. 2015 169(8): 740–745. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4523398/

Dr. Jose F. Bernardo, MD, MPH. Aluminum Toxicity. Medscape. April 15, 2015. http://emedicine.medscape.com/article/165315-overview

Bonhoeffer J et a., 2006. Immunisation of premature infants. Arch Dis Child. 2006 Nov; 91(11): 929–935. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2082954/

Sens, S. 2001. Adverse events following vaccination in premature infants. Acta Paediatr. 2001 Aug;90(8):916-20. https://www.ncbi.nlm.nih.gov/pubmed/11529542

Seneff, S et al, 2012. Empirical Data Confirm Autism Symptoms Related to Aluminum and Acetaminophen Exposure. Entropy 14:2227-2253. http://www.mdpi.com/1099-4300/14/11/2227


  • HepB vaccine contains 250 mcg Aluminum hydroxide
  • FDA/CFR Safe Levels are 4-5 mcg/kg/day
  • Average birthweight of male infants 7.5 lbs (3.3 kg)
  • HepB vaccine leads to 75.75 mcg/kg/day = 15 days' of the safe limit
  • Pediatric aluminum dosing in vaccines ignores body weight
  • No studies have demonstrated the safety of this level of exposure
  • FDA has no firm guidelines based on science on how to modify aluminum dosage in vaccine for body weight (cutoff of 2kg is loosely followed)
  • No studies on neonates (e.g., vaxxed vs unvaxxed) have been conducted, and therefore the safety profile of this level of exposure on that population is unknown.