Vaccination: Hep B Vaccine

Vaccinating infants for hepatitis B is a controversial topic. Vaccinating each infant for hepatitis B involves injecting 3 separate shots. Newborns in NZ are routinely vaccinated at 6 weeks, then again at 3 months, and 5 months.1 Newborns in the US are routinely vaccinated at birth, than again at 2 - 3 months, and 6 - 15 months.2  

How necessary is this vaccine?
The A.D.A.M. Medical Encyclopedia states: 3

"Risk factors for hepatitis B infection include:
- Being born, or having parents who were born in regions with high infection rates (including Asia, Africa, and the Caribbean)
- Being infected with HIV
- Being on hemodialysis
- Having multiple sex partners
- Men having sex with men."

"Infection can be spread through:
- Blood transfusions (not common in the United States)
- Direct contact with blood in health care settings
- Sexual contact with an infected person
- Tattoo or acupuncture with unclean needles or instruments
- Shared needles during drug use
- Shared personal items (such as toothbrushes, razors, and nail clippers) with an infected person."

Does this include your child? No? Then it's safe to say your child is NOT at risk of contracting hepatitis B and vaccinating your child is NOT necessary.

Does the benefit of its use outweigh the risks?
A number of studies have shown that the hepatitis B vaccine is associated side effects, in particular autoimmune disorders:

"HBV was associated with a number of serious conditions and positive re-challenge or significant exacerbation of symptoms following immunization. There were…
• 415 arthritis
• 166 rheumatoid arthritis
• 130 myelitis
• 4 Systemic lupus erythematosus (SLE)
• 100 optic neuritis
• 101 Guillain-Barré syndrome (GBS)
• 29 glomerulonephritis
• 283 pancytopenia/thrombocytopenia
• 183 Multiple sclerosis (MS)
…events reported following HBV." 4

"This analysis revealed that hepatitis B vaccination has been associated both in the VAERS database and in the scientific literature with a number of cases of serious conditions, positive re-challenge or significant exacerbation of symptoms, and adverse events in identical twins following immunization." 4

"One would have to consider that there is causal relationship between HBV and serious autoimmune disorders among certain susceptible vaccine recipients in a defined temporal period following immunization." 4

"The combination of thimerosal, aluminum hydroxide, yeast (and other extraneous proteins) and the hepatitis B surface antigen, may work synergistically to produce severe adverse reactions insusceptible hepatitis B vaccine recipients." 4

Adults receiving HBV had significantly increased odds ratios (likelihood) for…
• multiple sclerosis 5.2 fold
• optic neuritis (inflammation of the optic nerve) 14 fold
• vasculitis (inflammation of blood vessels) 2.6 fold
• arthritis 2 fold
• alopecia 7.2 (loss of hair) fold
• lupus erythematosus 9 fold
• rheumatoid arthritis 18 fold
• thrombocytopenia (decreased blood platelet count) 2.3 fold
….in comparison to the TCV (control) group. 5

"Hepatitis B vaccine contains yeast, aluminium, thimerosal and hepatitis B surface antigen epitopes, which may result in hepatitis B vaccine being associated with autoimmune diseases among susceptible adult vaccine recipients." 6

"The odds ratios (likelihood) of CNS inflammatory demyelination (central nervous system, inflammatory-related, degeneration of the outer layer of neurons, resulting in loss of nerve function) associated with HB vaccination were estimated. HB vaccine exposure more than 3 years before index date (the date that CNS inflammatory demyelination occurred) was associated with an increased trend (increased likelihood of 50%), essentially from the Engerix B vaccine (increased likelihood of 74%). The odd ratio was particularly elevated for this brand in patients with confirmed multiple sclerosis (increased likelihood 2.8 fold)." 7

"The attributable risk of chronic arthritis following adult rubella vaccine ranged from 32 to 53 and from 5.1 to 9.0 following adult hepatitis B vaccine in comparison to the adult vaccine control groups. This study revealed that adult rubella and adult hepatitis B vaccines were statistically associated with chronic arthritis which persisted for at least one year." 8

"Hepatitis B vaccination was statistically associated by chi 2 analysis with gastrointestinal reactions including: hepatitis, gastrointestinal disease and liver function test abnormalities in comparison to our vaccine control groups." 9

"Autoimmune inflammatory polyneuropathy (PN) can be triggered by vaccination (polyneuropathy is the simultaneous malfunction of numerous nerves). We report 3 such cases: 10
• It is likely that in the first 2 cases, an autoimmune reaction against some axonal (nerve fiber) or neuronal (nerve cell) components was triggered by the Hep B vaccination. It induced an acute sensory ataxic (loss of body control) polyneuropathy (simultaneous malfunction of numerous nerves) in case 1 and an acute motor and sensory axonal neuropathy (AMSAN) (degeneration of nerve fibers resulting in loss of body control) in case 2.
• The third patient had a chronic inflammatory demyelinating (degeneration of the outer layer of neurons) polyneuropathy (simultaneous malfunction of numerous nerves), likely triggered by yellow fever vaccination." 

In NZ the hep B vaccine is combined with other vaccines into one combined vaccine, which has the brand name Infanrix Hexa. As opposed to the side effects above which list longer term disorders, more immediate side effects are listed on the Infanrix Hexa data sheet:

Events are listed within body systems and categorised by frequency according to the following definitions:
Very common events: ≥10% (more than 100 per 1000);
Common events: ≥1% and <10% (100-10 per 1000);
Uncommon events: ≥0.1% and <1% (1-10 per 1000);
Rare events: ≥0.01% and <0.1% (1 per 10.000 - 1 per 1000);
Very rare events: <0.01% (less than 1 per 10,000).

Injection site: 
Very common: pain, redness, local swelling at the injection site  ≤ 50mm*
Common: injection site mass,  local swelling at the injection site >50mm*, injection site reactions, including induration, fever > 39.5 oC.
Uncommon: diffuse swelling of the injected limb, sometimes involving the adjacent joint*

Body as a whole: 
Very common: fatigue
Common: unusual crying, restlessness  
Rare: rash
Very rare: allergic reactions (including pruritus**) and anaphylactoid reactions (including dermatitis and urticaria**)

Central Nervous System: 
Common: nervousness  
Uncommon: somnolescence
Very rare: convulsions (with or without fever)

Gastrointestinal system: 
Common: diarrhoea, vomiting, enteritis, gastroenteritis,
Uncommon: abdominal pain, constipation

Metabolism and nutrition disorders:
Very common: loss of appetite

Resistance mechanism: 
Common: upper respiratory tract infection

Respiratory system: 
Common: bronchitis, rhinitis
Uncommon: bronchospasm, laryngitis, stridor, cough**

Vision: 
Uncommon: conjunctivitis
*During clinical trials, it has been observed that children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines.  These reactions resolve over an average of 4 days.

Post marketing experience

During post marketing surveillance, other reactions have been reported in temporal association with  INFANRIX hexa.  None of the reactions were reported with a frequency higher than 0.01% (1 per 10,000 people). Note that exact incidence rates cannot be calculated under post-marketing experience.

Administration site conditions:    
Very rare:  injection site mass, extensive swelling reactions, swelling of the entire injected limb, vesicles at the injection site.

Blood and lymphatic system disorders:
Very rare: lymphadenopathy, thrombocytopenia.

Body as a whole: 
Very rare:  allergic reactions (including  anaphylactic and anaphylactoid reactions).

Neurological disorders: 
Very rare: convulsions (with or without fever), collapse or shock-like state (hypotonic-hyporesponsiveness episode).

Respiratory, thoracic and mediastinal disorders: 
Apnoea** [see Precautions for apnoea in very premature infants (≤28 weeks of gestation)]

Skin and subcutaneous tissue disorders: 
Angioneurotic oedema **
** observed with other GSK DTPa-containing vaccines 

Experience with hepatitis B vaccine:Paralysis, neuropathy, Guillain-Barré syndrome, encephalopathy, encephalitis and meningitis have been reported during post-marketing surveillance following GlaxoSmithKline Biologicals' hepatitis B vaccine in infants < 2 years old.  The causal relationship to the vaccine has not been established.

The really damning evidence
A report on the Infanrix Hexa vaccine from GlaxoSmithKline discloses that within a two-year period, a total of 36 infants died after receiving the 6-in-1 vaccine, Infanrix Hexa. The 1271 page document reveals that GlaxoSmithKline received a total of 1,742 reports of adverse reactions between October 23, 2009, and October 22, 2011, including 503 serious adverse reactions and 36 deaths.14

Does Infanrix contain aluminum?
Yes it does, alot infact. Infanrix contains 500mcg of Aluminium hydroxide, and 320mcg Aluminium phosphate.12 This amount is well over recommended levels for infants. Aluminum is a well known neurotoxin, see this post for more info. A 2004 statement by the American Society for Parenteral and Enteral Nutrition (ASPEN), a group that monitors oral and injectable nutritional products for safety and side effects, states the daily limit of aluminum is 5 mcg per kilogram of body weight. 13

Using the ASPEN recommendations, for an average 6 week old infant, the daily allowable limit of injectable aluminum is 22.5mcg. A 6 week old infant receiving the Infanrix Hexa vaccination as per NZ schedule, will receive 820mcg of aluminum in one sitting. This grossly exceeds the daily allowable limit 36 times over. This will be repeated at 3 months with a final dose at 5 months, adding up to a total 2460mcg of aluminum. Ofcourse this dosen't take into consideration the other aluminum containing vaccines that a child on the NZ vaccine schedule would also receive, often at the same time. See this post for a copy of the NZ vaccine schedule and a list of NZ vaccines that contain aluminum.

At the end of the day we need to ask the question: does the benefit of this vaccine outweigh the risk? In this instance, it doesn't seem to be the case.  

Sources:

1. New Zealand Immunisation Schedule, Ministry of Health NZ
http://www.health.govt.nz/our-work/preventative-health-wellness/immunisation/new-zealand-immunisation-schedule

2. Immunization Schedules Birth to 15 months, CDC
http://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html

3. Hepatitis B, A.D.A.M. Medical Encyclopedia
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001324/

4. A case-series of adverse events, positive re-challenge of symptoms, and events in identical twins following hepatitis B vaccination: analysis of the Vaccine Adverse Event Reporting System (VAERS) database and literature review.
Geier MR, Geier DA.
The Genetic Centers of America, MedCon, Inc., Silver Spring, Maryland 20905, USA.
Clin Exp Rheumatol. 2004 Nov-Dec;22(6):749-55.
http://www.autismtreatmentclinics.com/uploads/ClinExpRheumatol2004_1.pdf

5. A case-control study of serious autoimmune adverse events following hepatitis B immunization.
Geier DA, Geier MR.
MedCon, Inc., Silver Spring, MD 20905, USA.
Autoimmunity. 2005 Jun;38(4):295-301.
http://www.ncbi.nlm.nih.gov/pubmed/16206512

6. A review of hepatitis B vaccination.
Geier MR, et al, 2003
The Genetic Centers of America, 14 Redgate Ct, Silver Spring, MD 20905, USA. mgeier@erols.com
Expert Opin Drug Saf. 2003 Mar;2(2):113-22.
http://www.ncbi.nlm.nih.gov/pubmed/12904111

7. Hepatitis B vaccine and the risk of CNS inflammatory demyelination in childhood.
Mikaeloff Y, et al. Neurology. 2009 Mar 10;72(10):873-80.
http://www.ncbi.nlm.nih.gov/pubmed/18843097

8. A one year followup of chronic arthritis following rubella and hepatitis B vaccination based upon analysis of the Vaccine Adverse Events Reporting System (VAERS) database.
Geier DA, Geier MR.
MedCon, Inc., Silver Spring, Maryland, USA.
Clin Exp Rheumatol. 2002 Nov-Dec;20(6):767-71.
http://www.ncbi.nlm.nih.gov/pubmed/12508767

9. Hepatitis B vaccination and adult associated gastrointestinal reactions: a follow-up analysis.
Geier DA, Geier MR.2002
Genetic Centers of America, Silver Spring, MD, USA.
Hepatogastroenterology. 2002 Nov-Dec;49(48):1571-5.
http://www.ncbi.nlm.nih.gov/pubmed/12397738

10. Postvaccinal inflammatory neuropathy: peripheral nerve biopsy in 3 cases.
Vital C, Neuropathology Department, Victor Segalen University, Bordeaux, France. J Peripher Nerv Syst. 2002 Sep;7(3):163-7.
http://www.ncbi.nlm.nih.gov/pubmed/12365564

11. Infanrix Hexa, GlaxSmithKline
http://www.gsk.com.au/resources.ashx/vaccineproductschilddataproinfo/409/FileName/0FD94C27068AFB01C6EA060995A8E1EC/Infanrix_Hexa_(Preservative_free)_v4_0_clean_PDF.pdf

12. Vaccine ingredients, Immunisation Advisory Centre (IMAC) NZ
http://www.immune.org.nz/sites/default/files/resources/ConcernVaccineIngredients20111028V12Final.pdf

13. P. Charney, The American Society for Parenteral and Enteral Nutrition (ASPEN) Aluminum Task Force, "A.S.P.E.N. Statement on Aluminum in Parenteral Nutrition Solutions," Nutrition in Clinical Practice 19 (August 2004): 416-417.

14. Infanrix hexa Summary Bridging Report, GlaxoSmithKline
http://ddata.over-blog.com/3/27/09/71/2012-2013/confid.pdf