Saturday, March 9, 2013

ActHIB

I've started with ActHIB because it happened to be the first in a large stack of pamphlets for recommended vaccines given to me by our pediatrician.  

I've bolded my conclusion right next to the short name of the vaccine for easy reference. What follows is a much more in depth analysis of the information comparing concerns of taking the vaccine as well as not taking it.

Please be aware that my main concern is my daughter and what's right or wrong for her very well may not be the same for you or yours. I am by no means claiming medical expertise and do not presume to make any recommendations for anyone else. I am merely documenting my findings and reporting my personal conclusions. I also welcome civil comments, corrections, and debate.

Haemophilus b Conjugate Vaccine
(Tetanus Toxoid Conjugate)
ActHIB - DECLINE

0.5 ml dose
(conversion 1.0ml = 1,000,000mcg)

Unless cited otherwise, quoted lines are From sanofi pasteur(manufacturer of vaccine) pamphlet given to us by our pediatrician:

Unvaccinated risk:
“Estimated before vaccine 1/200 children under 5 years old got H. Influenza.”
1/300-1/600 infected died(1/60000 - 1/120000 for all kids under 5)

“60% of infected meningitis was the clinical syndrome and permanent sequelae ranging from mild hearing loss to mental retardation affecting 20 to 30% of survivors.”(3/1000 children get meningitis, up to 1/1000 children get mild hearing loss to mental retardation)
Currently these figures have dropped 95%(claimed due to immunization).



Concerns:

In general:   “...has not been evaluated for its carcinogenic, mutagenic potential or impairment of fertility.”
“SAFETY AND EFFECTIVENESS OF TRIHIBIT VACCINE, ACTHIB VACCINE RECONSTITUTED WITH TRIPEDIA VACCINE, IN INFANTS BELOW THE AGE OF 15 MONTHS HAVE NOT BEEN ESTABLISHED.”

“ADVERSE REACTIONS:
“Of these(7000...children <2years) 1064 subjects 12 to 24 months of age ...reported no serious or life threatening adverse reactions.

Adverse reactions commonly associated with a first ActHIB vaccine immunization of children 12 to 15 months of age who were previously unimmunized with any Haemophilus b conjugate vaccine, include local pain, redness and swelling at the injection site.  Systemic reactions include fever, irritability and lethargy.

...Percentage of infants 2-6months, after 48 hrs still showed adverse effects -  avg. 1% had fevers >100.8degrees, 3.3% avg anorexia, 4.5% Diarrhea, 2.4% vomiting”

Out of 5000 infants(plus 5000 in control), 2 definite and 3 possible seizures were observed after ActHIB and DTP in comparison with none after Hepatitis B and DTP.  
(1/1000 infants get seizures)



1.  Formalin
“...exposure is highly irritating to the eyes, nose, and
throat and can make anyone exposed cough and
wheeze. Subsequent exposure may cause severe
allergic reactions of the skin, eyes and respiratory
tract. Ingestion of formaldehyde can be fatal, and
long-term exposure to low levels in the air or on
the skin can cause asthma-like respiratory problems and skin irritation such as dermatitis and
itching. Concentrations of 100 ppm are immediately dangerous to life and health (IDLH).

The National Institute for Occupational
Safety and Health (NIOSH) considers 20 ppm of
formaldehyde to be IDLH.”
http://www.osha.gov/OshDoc/data_General_Facts/formaldehyde-factsheet.pdf

This is for full grown adults.

0.5 mcg formaldehyde in dosage (1ppm)

Is 1ppm really safe for an infant weighing 1/10th of a full grown adult?
TLV is .3ppm (ceiling limit for a worker with lifetime exposure)
https://www.mathesongas.com/pdfs/products/threshold-limit-values-(tlv).pdf

The EPA RfD(safe daily dosage) is .2 mg(200mcg)
The Reference Dose (RfD) for formaldehyde is 0.2 milligrams per kilogram body weight per day (mg/kg/d)
http://www.epa.gov/ttnatw01/hlthef/formalde.html

Conclusion:  Acceptable.  20ppm is IDLH for a full grown adult so an infant at roughly 1/10th the weight and less immune function may be expected to be at immediate risk at 2ppm.  If this was combined with another vaccine with similar dosage of Formalin it would reach the theoretical IDLH for an infant, but not for a grown adult.
If we take the EPA’s RfD of .2mg/kg/d, my 14lb daughter could theoretically have 1.31mg/day or 1310mcg/day.  The 0.5mcg of formaldehyde shouldn’t be an issue by a long stretch.



2. Haemophilus type b
Roughly 50,000 children from 3 months to 5 years old received H. Influenza vaccine.
50,000 in the control group received a fake vaccine.  First year 0 H vaccine children got H. flu, while 11 in control group got H.flu.  2nd year, 2 in first group contracted disease, and 5 in control group contracted.
“The serum antibody response to the H. influenzae type b polysaccharide, measured by radioimmunoassay, was poor in children below 18 months of age and good in those above it. No effect of the vaccine could be seen on the nasopharyngeal carriage of H. influenzae type b, which was approximately 6% in this age group. Adverse effects of the vaccine were mild.”
http://pediatrics.aappublications.org/content/60/5/730.short

Conclusion:  Wait until 18months as it seems to have no effect before, but significant protection afterward with minimal adverse effects.



3. Thimerosal
<=0.3mcg mercury/dose(0.5ml) - 0.6ppm

“U.S. EPA uses a RfD of 0.1 µg/kg body weight/day as an exposure without recognized adverse effects.”
http://www.epa.gov/hg/exposure.htm

1kg = 2.2lbs
My daughter, Melody, at the time of writing this article, is 14.375lbs, so her Reference Dose(RfD safe daily dosage) would be 14.375/2.2 = 6.53 or .653mcg/per day

Conclusion:  Acceptable.  By itself one dose of this vaccine does not exceed one of the more stringent RfD values I’ve found for safe daily mercury dosage.


4. Additional Risks not reported by pamphlet
After 7 years vaccinated children had a 25% higher risk of Diabetes I.  54 more vaccinated children(out of 100,000) contracted Diabetes than the unvaccinated control group.  (1/2000 more kids)  
Other possible long term effects have not been tested for.

http://www.vaccineinjury.info/haemophilus-influenza-hib/vaccination.html
(an obviously anti-vaccine site, but the reference is for a study they quote, not their opinion)

ActHIB Conclusion: Before this vaccination was available, most everyone got infected.  It was estimated 1/60,000-1/120,000 children died from H. Influenza.  1/1000 for mild hearing loss to mental retardation.  
-Currently the risks are 95% less, claimed due to immunization(although occurrences were dropping before immunization so this claim is inconclusive).
-Mercury and Formaldehyde were surprisingly found to be relatively insignificant.  One can argue that no amount of such proven toxic substances are good, but our bodies deal with far more mercury(fish) and formaldehyde(naturally metabolized from methanol in blood, saliva, etc) from other sources to really be concerned about this rather insignificant amount.
-Currently, those immunized have a 1/1000 chance of seizures, among other complications, and unstudied long term risks, as well as increased chance of diabetes(also known to be genetically influenced).  

Although the risks for the unvaccinated seem to be close or even lower than the risks of getting vaccinated in this case, I would be inclined to accept due to the, albeit extremely small, chance of death/mental retardation.  Since my daughter has a family history of deaths due to diabetes from both her parents’ sides, and we are not in any of the higher risk categories(Native American, Eskimo, black, and/or lower income communities) I personally must DECLINE ActHIB for my daughter.