Hepatitis B vaccine: due for suspension

 By Tetyana Obukhanych, Ph.D. 

On September 4, 2020, the Informed Consent Action Network’s legal team filed a petition to request the withdrawal or suspension of the approval granted by the FDA for two Hepatitis B vaccines (Engerix-B and Recombivax HB) for infants and toddlers "until a properly controlled and adequately powered double-blind trial of sufficient duration is conducted to assess the safety of these products as required pursuant to applicable federal statutes and regulations for licensing these products."

ICAN’s petition states the following rationale for their request: “The clinical trials relied upon to license these products only assessed safety for up to five days after injection. Therefore, these trials did not comply with the applicable federal statutory and regulatory requirements necessary to prove they were “safe” prior to licensure.”
 
As a WA state resident, I previously petitioned to the WA State Department of Health that they implement additional informed-consent and safety-monitoring safeguards of this state-mandated vaccine due to the fact that the Hepatitis B vaccine is made in baker’s yeast.  You can find my full correspondence with the Department of Health on the InformedChoiceWA.org  website.  Specifically, I requested:
 
a) that the use of yeast-recombinant vaccine brands be avoided, whenever possible;
 
b) that vaccine recipients (and parents/legal guardians of minors) be alerted if they are receiving a yeast-recombinant vaccine brand and be given a list of common foods containing baker’s/brewer’s yeast;
 
c) that gut-related issues and associated behavioral changes be carefully monitored in any infant who has received a yeast-recombinant vaccine, especially after introducing solids that contain baker’s yeast; and
 
d) if gut-related or behavioral complaints ensue, that dietary changes be recommended in order to avoid perpetuating vaccine-induced priming of their immune system with further dietary exposure to yeast antigen. 
 
The basis for my petition to the Department was my personal experience of developing frequent bouts of GI pain after I received the Hepatitis B vaccine in graduate school.  Later on, I learned that the Hepatitis B vaccine is made in baker’s yeast, something I wasn’t notified about at the time of consenting to receive it.  And while suffering from GI pain for more than a decade, I finally became pain-free after dropping all baker’s yeast-containing foods from my diet. 
 
For a deeper dive into the science behind gastrointestinal food allergy (non-IgE-mediated GIFA), please read my previous post HERE.
 
The Department of Health denied that there is a need to take any action based on the 'same old' vaccine narrative.  They replied: “The Department of Health bases all vaccine guidance and information on current recommendations from the Advisory Committee on Immunization Practices (ACIP).”
 
Little do they know that the ACIP recommendations for the Hepatitis B vaccine were based on studies that are patently inadequate for assessing health outcomes in the long term, as outlined in the ICAN's petition. 
 
I further requested the following from the Department: “Please provide all studies you believe ACIP has relied upon to determine that none of the pathological manifestations of non-IgE-mediated gastrointestinal food allergy (such as chronic diarrhea/constipation, delayed gastric emptying, gastroesophageal reflux/projectile vomiting, irritable bowel and gut pain) are related to the use of yeast-recombinant vaccines."
 
To which the Department replied: “Vaccines produced using yeast have an excellent safety record and have been used for decades in the United States. Based on review of the literature, there do not appear to be studies which demonstrate a relationship between the administration of vaccines produced with yeast and development of gastrointestinal food allergies to subsequent dietary yeast consumption or development of inflammatory bowel diseases.”
 
They then proceeded with providing me the studies on IgE-mediated immune reactions, such as anaphylaxis, which I did not request and which are irrelevant to my petition. 
 
The Department's phrasing that “there do not appear to be studies which demonstrate a relationship…” is constructed to cement the narrative that seemingly justifies their lack of action. However, the truth is that the available studies that looked into vaccines and GI issues such as inflammatory bowel diseases (IBD), do not appear to even include yeast-recombinant vaccines, as though studying these particular vaccines with respect to GI issues is being painstakingly avoided or such studies are being deliberately left unpublished. 
 
For example, take a look at this 2015 Systematic Review titled "Vaccination and Risk for Developing Inflammatory Bowel Disease: A Meta-Analysis of Case–Control and Cohort Studies." Eleven vaccines are covered, but you won't find the two that are yeast-recombinant -- the Hepatitis B vaccine and the HPV vaccine.  And this is despite the fact that anti-yeast antibodies are well-known to be associated with Crohn's disease (which is an IBD) and "were retrospectively found in the preserved blood samples of soldiers who became affected by Crohn’s disease years later."
 
What is the rationale for not studying yeast-recombinant vaccines for their potential to induce GI food allergy to baker's yeast or inflammatory bowel diseases, if they are the most biologically plausible suspects?  And what is the rationale for refusing to monitor the health of Hepatitis B-vaccinated infants and children, when the pre-licensure safety monitoring of these vaccines lasted for only 4-5 days?
 
There’s none, other than the fear of uncovering the truth or making it known.
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Tetyana Obukhanych, Ph.D. is Immune Science Educator at BBCH (Building Bridges in Children's Health), an online community of parents, health advocates, and health professionals dedicated to learning the science that impacts children's health and healthy immunity. 

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