March 26, 2019

CDC’s Infant Hep B Vaccine Recommendations—No Proof of Safety?

The CDC’s recommendation for universal hepatitis B vaccination of infants puts most children at unnecessary risk of harm from the vaccine.

[Note: This is the second installment of a three-part Hep B series examining the CDC’s rationale for its universal infant hepatitis B vaccination recommendation. Part 1 explores the risk to infants of a Hepatitis B infection. (The vast majority of children in the US today are not at significant risk of hepatitis B infection.) Part 2 reveals how the agency began recommending vaccination for pregnant women and infants despite a complete lack of randomized, placebo-controlled trials demonstrating that these practices are safe. Part 3 examines the CDC’s 1991 policy shift to recommending that infants be ‘universally’ vaccinated, typically on the first day of their lives, thus placing millions of children at unnecessary risk of neurodevelopmental harm from the vaccine.]

 

By Jeremy R. Hammond, Contributing Writer, Children’s Health Defense 

 

Before the introduction of the vaccine, numerous effective prevention measures had already been implemented to some degree in the US, including blood screening and administration of hepatitis B immune globulin (HBIG) to infants born to HBsAg-positive women. HBIG contains protective antibodies obtained from the blood plasma of selected donors, conferring passive immunity to the infant. It’s estimated to be about 75 percent effective in preventing chronic infection when given soon after exposure. Additionally, newborn infants may have maternal antibodies passively acquired through the placenta.

Nevertheless, the number of cases occurring in the US annually continued to increase until it peaked in 1985 at about 26,000 reported cases. The increase in prevalence was occurring particularly among young adults. The decline seen during the second half of the 1980s through the early 1990s is attributed to a reduction in transmission among gay men and drug users as a result of efforts to prevent transmission of the human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS). From 1990 to 2004, incidence of acute hepatitis B infection declined by 75 percent, with most of the decline occurring among children and adolescents, coinciding with greater vaccination coverage.

Persons considered at “substantial risk” included various categories of health care workers, gay men, illicit injectable drug users, recipients of certain blood products, household and sexual contacts of HBV carriers, Alaskan Eskimos, immigrants or refugees from countries where HBV is highly endemic, and prison inmates.

The hepatitis B vaccine was first licensed for use in the United States in 1981. The following year, the CDC’s Advisory Committee on Immunization Practices (ACIP) issued a recommendation for vaccination of high-risk individuals. The estimated lifetime risk of HBV infection at the time was approximately 5 percent for the US population as a whole, but rose to almost 100 percent for the highest-risk groups. Persons considered at “substantial risk” included various categories of health care workers, gay men, illicit injectable drug users, recipients of certain blood products, household and sexual contacts of HBV carriers, Alaskan Eskimos, immigrants or refugees from countries where HBV is highly endemic, and prison inmates.

For infants born to HBsAg-positive mothers, the CDC recommended administration of HBIG. For infants whose mothers were chronic carriers (positive HBsAg but negative IgM-anti-HBc), the CDC additionally recommended a 3-dose vaccination regimen starting no sooner than 3 months of age. The CDC added that “Studies to determine the immunogenicity and efficacy of vaccine at birth, with or without HBIG, are currently under way.” (Emphasis added.)

The CDC admitted that, with respect to the developing fetus, safety data were not available, but assumed that the risk should be negligible on the grounds that the viral antigen contained in the vaccine was non-infectious. However, since the viral antigen was not the only component of the vaccine, the CDC’s conclusion did not logically follow.

The CDC did not say whether studies were being done to determine the safety of vaccinating infants at birth. This curious oversight was made despite the CDC’s acknowledgment that the vaccine included aluminum—a known neurotoxin—as an “adjuvant”. An adjuvant, as defined by the CDC, is “an ingredient used in some vaccines that helps create a stronger immune response in people receiving the vaccine.” Inasmuch as aluminum is a foreign substance in the body capable of causing disease and which triggers an immune response, aluminum also meets the CDC’s definition of an “antigen”.

Additionally, the hepatitis B vaccine being used at the time included another known neurotoxin: mercury.

Furthermore, the CDC included high-risk pregnant women within the scope of its recommendation by stating that pregnancy “should not be considered a contraindication to the use of this vaccine”.

The CDC admitted that, with respect to the developing fetus, safety data were “not available”, but assumed that the risk “should be negligible” on the grounds that the viral antigen contained in the vaccine was non-infectious. However, since the viral antigen was not the only component of the vaccine, the CDC’s conclusion did not logically follow.

This glaring non sequitur fallacy by the CDC is illustrative of a complete lack of concern among public health officials about the neurotoxicity of mercury and aluminum, both of which are known to pass through both the placental and blood-brain barriers.

In fact, the CDC issued its recommendations that high-risk pregnant women and infants of carrier mothers be vaccinated despite a complete absence of studies demonstrating that either practice was safe. The clinical trials used to obtain licensure for the vaccine had included only gay men.

Additionally, the CDC acknowledged that the duration of protection conferred by the vaccine had “not yet been determined.”

In 1984, the CDC revised its recommendation to include vaccination of infants at birth. Under the new policy, women belonging to high risk groups were to be tested routinely during prenatal visits, and if positive for HBsAg, HBIG was to be administered to the infant as soon as possible after delivery and preferably within twelve hours of birth. Now, instead of waiting until at least a week to initiate the vaccine regimen, the CDC advised giving the first dose within seven days of birth, further implying that this should preferably be done on the very first day of life by stating that the effectiveness of HBIG administered concurrently with vaccination increased the effectiveness of preventing chronic infection from 75 percent up to 90 percent. (According to the Pink Book, vaccination alone is 70 percent to 95 percent effective, while vaccination concurrent with HBIG within twenty-four hours of birth is 85 to 95 percent effective.)

While emphasizing that studies had shown vaccination to be effective, the CDC mentioned no studies demonstrating that it was safe to vaccinate newborn babies or to expose developing fetuses to mercury and aluminum by vaccinating pregnant women.

In an updated recommendation the following year, the CDC explicitly recommended vaccinating infants born to infected mothers concurrently with HBIG within twelve hours of birth. Once again, safety studies were not forthcoming.

In 1986, a new version of the hepatitis B vaccine was licensed for use in all ages. The older version was manufactured by isolating and purifying HBsAg from the blood plasma of infected individuals. The new vaccine, Merck’s Recombivax HB, instead contained viral proteins that were genetically engineered, manufactured by cloning the virus’s genetic coding for HBsAg into “recombinant” yeast.

Under federal law, vaccine manufacturers are required to include package inserts with their products providing adequate warnings about the risks of using them. These are publicly available on the FDA’s website. The current package insert for Recombivax HB, with respect to its effectiveness, states that “The duration of the protective effect of RECOMBIVAX HB in healthy vaccines is unknown at present and the need for booster doses is not yet defined.” The vaccine may also be ineffective if administered to an individual who is already infected.

It’s not known whether the vaccine’s contents are excreted in human milk, and there are no studies of the effects on breastfed infants or milk production. There are no studies to determine whether the vaccine can cause genetic mutations or cancer, or whether it can impair fertility.

With respect to its safety, Merck states that “There are no adequate and well-controlled studies designed to evaluate RECOMBIVAX HB in pregnant women.” Additionally, “Developmental toxicity studies have not been conducted with the vaccine in animals.” It’s not known whether the vaccine’s contents are excreted in human milk, and there are no studies of the effects on breastfed infants or milk production. There are no studies to determine whether the vaccine can cause genetic mutations or cancer, or whether it can impair fertility.

Merck does refer to post-licensure clinical studies relevant to pregnant women, but these were not actually designed to test the safety of the vaccine for this group. Instead, twenty-three pregnant women were vaccinated “inadvertently” early in their first trimester, four of whom ended up having a miscarriage. Merck states that this 17 percent miscarriage rate is “consistent with estimated background rates”, but given the fact these studies weren’t designed to determine whether fetal harm might occur, included a very small number of pregnant women, and didn’t include a placebo control group, this information is totally worthless in terms of risk assessment.

The only information about safety with respect to vaccinating infants refers to three clinical trials including a total of only “147 healthy infants and children (up to 10 years of age)”. Since the infants were grouped with older children and their number unspecified, this information is uninterpretable with respect to the safety of vaccinating infants still in the earliest stages of childhood development. The number of children included was also too low for these studies to have the statistical power necessary to detect any harms apart from those that occur very frequently. There was no placebo control group even to determine the statistical significance of reported adverse events, such as fever or rhinitis. Furthermore, these children were monitored for adverse events for only five days, so any adverse events occurring after that period of time were entirely missed.

This is particularly concerning given that symptoms of neurological damage from toxins like mercury and aluminum might not be noticeable for many weeks, months, or even years following exposure—not to mention the fact that it is not only single exposures that need to be taken into consideration, but the cumulative impact of all environmental toxic exposures.

Despite the total inadequacy of the clinical trials for determining the safety of vaccinating pregnant women and infants, a microbiologist from the Food and Drug Administration (FDA), Richard Daemer, assured the public of the new vaccine’s safety by stating that it “just can’t do any damage, period”.

The sole premise upon which that fallacious conclusion was based was, once again, that the vaccine did not contain a live virus capable of infection. It was a statement that once again demonstrated the complete lack of consideration among public health officials that mercury and aluminum, both of which were also included in Recombivax HB, could potentially cause neurodevelopmental harm to vulnerable fetuses and young infants.

That same year, the US Congress passed the National Childhood Vaccine Injury Act, which granted broad legal immunity against vaccine injury lawsuits to the pharmaceutical industry and established the Vaccine Injury Compensation Program, funded by an excise tax on each vaccine dose, to effectively shift the financial burden for vaccine injuries away from the manufacturers and onto the taxpaying consumers. The Supreme Court in 2011 upheld legal immunity for vaccine manufacturers on the grounds that adverse reactions are “unavoidable” and design defects are “not a basis for liability”.

In 1988, the CDC once again revised its policy by recommending screening for all pregnant women, not just those in high risk groups, in an effort to reduce the number of perinatally infected infants who become chronic carriers. The number of such infants born each year was estimated to be about 3,500, which represented about one-fifth of the estimated number of births to HBsAg-positive women annually (16,500). A study done ten years later estimated that 97 percent of pregnant women in the US receive prenatal screening.

Once again, there was no placebo control group, and the researchers solicited only certain pre-selected adverse events by providing a symptom checklist. Once again, subjects were monitored for a very short term, which was only four days.

In 1989, a second recombinant HepB vaccine was licensed for use in all ages: GlaxoSmithKline’s Engerix‑B. Its package insert includes similar warnings as are included with Merck’s product. In thirty-six clinical trials, Engerix‑B was administered to 5,071 healthy adults, children, and newborn infants. Once again, including the unspecified number of infants with older children and adults renders this information uninterpretable with respect to the risks of vaccinating infants. Once again, there was no placebo control group, and the researchers solicited only certain pre-selected adverse events by providing a symptom checklist. Once again, subjects were monitored for a very short term, which was only four days.

[Part 3 examines the CDC’s 1991 policy shift to recommending that infants be ‘universally’ vaccinated, typically on the first day of their lives, thus placing millions of children at unnecessary risk of neurodevelopmental harm from the vaccine.]

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