Tuesday, May 8, 2012

What is Hepatitis B? Why vaccinate for it? [Part One]

Hepatitis means 'liver inflammation' itself, and there are five prominent strains. One of these is called 'B' virus, therefore, Hepatitis B.

For those who don't know or have forgotten, the functions of the liver are as followed.

  • Helps remove harmful chemicals from your body by filtering the blood
  • Helps fight infections
  • Helps digest food
  • Stores vitamins, nutrients, and energy 
  • Copyright WebMD, LLC 2009
  • Metabolizes drugs
Hepatitis B is caused by a virus. Anyone can catch Hepatitis B however their is a 'high risk' group of people who are at higher risk to catch it. 


Am I 'high risk'? Those at 'high' risk are:

  • Infants born to mothers with Hepatitis B
  • Sexual partners to those with Hep. B
    • Sexually active homosexual men are the most likely to catch it of all sexually active groups
  • Injection drug users
  • Household contact with a person with chronic Hep. B [my own emphasis]
  • Healthcare workers who deal with blood or bodily fluids
  • Hemodialysis, end-stage renal disease patients
  • Travelers in countries with medium-high Hep. B rates
  • Staff in care facilities for the developmentally delayed

You cannot contract Hepatitis B from shaking hands or coming into 'normal' contact with another infected person. It is not airborne. Hepatitis B can live for 7 days outside of the body. The incubation period for Hepatitis B ranges from 60-150 days. [1][2]

What are the symptoms?


Tell-tale symptoms include jaundice, dark yellow urine, light-colored stool, diarrhea, upset stomach, loss of appetite, fatigue, weakness, fever, problems halting bleeding or long time for wounds to cease bleeding, easy bruising, swollen ankles/stomach, angiomas, weight loss, and nausea. [2]

How is it diagnosed?


Hep. B is diagnosed by either a blood test or a liver biopsy, sometimes both. If your doctor tells you that you are positive for Hepatitis B surface antibodies (anti-HBs), this is a good thing, it means you have already recovered or are immune to Hepatitis B. [1][2]

Is it treatable? Is it curable?


It is treatable, but not curable if it becomes chronic. There are three stages. Acute infection, which is asymptomatic or very mild nearly all of the time with full recovery expected of most adults. Acute infection has a death rate of about 0.5%.  Infants and small children are more likely to develop chronic infection from acute infection, with the chances being 90% of infants and 25-50% of children.

With Chronic illness there are medications to help support the condition and those with chronic infection should be screened regularly to make sure liver damage is not occurring and carcinomas are not developing. Then there is perinatal infection which occurs during the birth process transferred from the mother.

Why vaccinate my newborn or infant for Hep. B?


"Infants born to HBV-infected mothers require Hepatitis B vaccine and Hepatitis B immune globulin (HBIG) withing 12 hours of birth to protect them from infection. However, because errors or delays in documenting, testing, and reporting maternal HBsAg status can and do occur, administering the first dose of Hepatitis B vaccine soon after birth to all infants acts as a safety net, reducing the risk for perinatal infection when infection maternal HBsAg status is either unknown or incorrectly documented at delivery. Also, initiating the Hepatitis B vaccine series at birth has been shown to increase a child's likelihood of completeing the vaccine series on schedule." [1]

In layman's terms, they believe that even if a mother tests negative, they may still be positive and it is just an error in testing. Considering pregnant women are tested long prior to delivery, this is highly unlikely. While I'm sure this does happen, it should not happen so often they must administer the vaccine as a safety measure in case they make a mistake.., or else we have a larger issue on our hands. It is also wise to note no such conclusion can be made about the vaccine schedule being completed on time if the Hep. B vaccine is given at birth. They are manipulating this statement. It is possible that it is true that those given Hep. B at birth are more likely to complete the vaccination schedule simply because they have no health contraindications, philosophical, or religious objections. Those who have such objections and contraindications are less likely to vaccinate at birth or to stop immediately thereafter.


An infant is recommended to be vaccinated three times before they are a year and a half. They will receive a shot at birth, one at their 2 month well visit, and another between 6-18 months old. [4]

So, if you, a partner, or a close family member or caretaker have Hepatitis B, you should have your child vaccinated. If not, there is no point as there is an IgG antibody injection that you can get should your child ever become exposed.


I'm pregnant or nursing. Is it safe for me to be vaccinated for Hep. B?

"Yes. Hepatitis B vaccine contains no live virus, so neither pregnancy nor lactation should be considered a contraindication to vaccination of women. On the basis of limited experience, there is no apparent risk of adverse effects to developing fetuses when Hepatitis B vaccine is administered to pregnant women. Meanwhile, new HBV infection in a pregnant woman might result in severe disease for the mother and chronic infection for the newborn." [1]

The CDC has really no idea whether or not it is actually safe, but they are making an assumption based on mostly epidemiological and animal studies. It is not known whether it would affect nursing but it is probable the infant will be slightly affected as other pharmaceutical drugs are deposited in small amounts into the milk via the mother's blood.

There is a system set up, called VAERS (Vaccine Adverse Event Reporting System) which is not analyzed or monitored by the CDC. The number of adverse events are only 1% of the projected 10% of adverse events due to care providers not knowing when an adverse event is occurring. The number of associated adverse events related to the Hepatitis B vaccine number over 50,275, including 979 deaths as of October 2011. There have also been spontaneous abortions (miscarriages), and birth defects listed in VAERS as adverse events to Hepatitis B vaccinations. [3]

Also noted, however, is that on the manufacturer package inserts of the vaccines manufactured by the two vaccine-makers who make Hep. B vaccines, Merck and GlaxoSmithKline, list inadequate or a lack of safety trials done on expecting or nursing women.

"Pregnancy Category C: Animal reproduction studies have not been conducted with the vaccine. It is also not known whether the vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The vaccine should be given to a pregnant woman only if clearly needed. -- "It is not known whether the vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when the vaccine is administered to a nursing woman." Recombivax, Merck [5]
----
"Pregnancy Category C: Animal reproduction studies have not been conducted with COMVAX. It is also  not known whether COMVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. COMVAX is not recommended for use in women of childbearing age." Comvax, Merck [6]
 ----
"Safety and effectiveness of ENGERIX-B have not been established in pregnant women and nursing mothers. ENGERIX-B should only be given to a pregnant woman if clearly needed." Engerix-B, GlaxoSmithKline [7]
 ----
"No clinical data on use during pregnancies are available with Fendrix. 
Animal studies do not indicate direct or indirect harmful effects wit respect to pregnancy, embryonal/foetal development, parturition, or postnatal development. 
Vaccination during pregnancy should only be performed if the risk-benefit ration at individual level outweighs possible risks for the foetus." -- "Adequate human data on use during lactation are not available. In a reproductive toxicity study in animals which included post-natal follow-up until weaning (see section 5.3), no effect on the development of the pups were observed. Vaccination should only be performed if the risk-benefit ration at individual level outweighs possible risks for the infant." Fendrix, GlaxoSmithKline [8]
 ----
 "Pregnancy Category C -- Animal reproduction studies have not been conducted with PEDIARIX. It is not known whether PEDIARIX can cause fetal harm when administered to a pregnant woman or if PEDIARIX can affect reproduction capacity." Pediarix, GlaxoSmithKline [8] 
---- 
"The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival development has been assessed in rats. This study did not indicate direct or indirect harmful effects with respect to fertility, embryonal/fetal development, parturition or post-natal development."
The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials. 
Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any adverse effects of Twinrix Adult on pregnancy or on the health of the fetus/newborn child. While it is not expected that the recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery unless there is an urgent need to protect the mother againts hepatitis B infection." -- "It is unknown whether Twinrix Adult is excreted in human breastmilk. The excretion of Twinrix Adult in milk has not been studied in animals. A decision on whether to continue/discontinue breastfeeding or continue/discontinue therapy with Twinrix Adult should be made taking into consideration the benefit of breastfeeding to the child and the benefit of Twinrix Adult therapy to the woman." Twinrix, GlaxoSmithKline [9]
 ----
"The effects of Ambirix on foetal development has not been assessed. Ambirix should not be used during pregnancy unless clearly necessary." -- "The effect on breastfed infants on Ambirix administered to the mothers has not been evaluated in clinical studies. Ambirix should not be used during lactation unless clearly necessary." Ambirix, GlaxoSmithKline [10]

What are the ingredients? Is it true fetal cells and aluminum are used?


It is true that most vaccines are cultured using human diploid cells and also true that nearly all vaccines contain aluminum. Many of the ingredients are common in each of the following vaccines and other vaccines. Ingredients used in the culture medium but is removed or is left in trace amounts are marked with an asterisk (*). [11-16]

Recombivax: Yeast protein, soy peptone, dextrose, amino acids, mineral salts, potassium aluminum sulfate, amorphous aluminum hydroxyphosphate sulfate, formaldehyde, thimerosal, gelatin.

Comvax: Yeast protein, nicotinamide adenine dinucleotide, hemin chloride, soy peptone, dextrose, mineral salts, amino acids, formaldehyde, potassium aluminum sulfate, amorphous aluminum hydroxyphosphate sulfate, sodium borate.

Engerix-B: Aluminum hydroxide, yeast protein, phosphate buffers.

Fendrix: 3-O-desacyl-4'-monophosphoryl lipid A (MPL), yeast protein, sodium chloride, aluminum phosphate, water.

Pediarix: Aluminum hydroxide, formaldehyde, glutaraldehyde, neomycin, 2-phenoxyethanol, polymyxin B, polysorbate 80, yeast protein, Bovine protein*, Lathan medium (bovine casein)*, Linggoud-Fenton medium (bovine extract)*, monkey kidney tissue vero (Vervet or African Green monkies)*, Stainer-Scholte medium*.

Twinrix: Formalin, yeast protein, aluminum phosphate, aluminum hydroxide, amino acids, phosphate buffer, polysorbate 20, neomycin sulfate, MRC-5 human diploid cells, 2-phenoxyethanol.

Ambirix: Aluminum phosphate, hydrated aluminum hydroxide, sodium chloride, MRC-5 human diploid cells, yeast protein, water.

My child or I have an allergy to one of the ingredients. What should I do?


If you or your child has an allergy to one of the ingredients in any vaccine you should alert your care provider and refuse any vaccines with the ingredient. If your allergy is not serious and you would like to vaccinate, talk to your care provider about your options. Unfortunately, there are not many for those who are allergic.

My child's school/my work requires me to be vaccinated for Hepatitis B. I have a health/religious/philosophical contraindication or objection. What should I do?

Check your local or state laws of exemption. All states have medical exemptions, 48 states have religious exemptions, and 18 states have philosophical exemptions.

Information on your state's exemptions can be found here.

My child goes to private school/I work in a privately-funded workplace. Can I still use an exemption?

Yes and no. If the private school or workplace receives any government funding at all, then they must accept an exemption. Unfortunately, if they are exclusively privately funded, they can accept or reject an exemption on their own basis.


Resources


[2] http://digestive.niddk.nih.gov/ddiseases/pubs/hepb_ez/
[3] http://vaers.hhs.gov/data/data
[4] http://www.cdc.gov/vaccines/recs/schedules/downloads/child/0-6yrs-schedule-pr.pdf
[5] http://www.merck.com/product/usa/pi_circulars/r/recombivax_hb/recombivax_pi.pdf
[6] http://www.merck.com/product/usa/pi_circulars/c/comvax/comvax_pi.pdf
[7] http://us.gsk.com/products/assets/us_engerixb.pdf
[8] http://www.medicines.org.uk/EMC/medicine/16906/SPC/Fendrix/
[8] http://us.gsk.com/products/assets/us_pediarix.pdf
[9] http://www.medicines.org.uk/EMC/medicine/2061/SPC/Twinrix+Adult+Vaccine/
[10] http://www.medicines.org.uk/EMC/medicine/20491/SPC/Ambirix+suspension+for+injection/
[11]http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/excipient-table-2.pdf
[12] http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-1.pdf
[13] http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000550/WC500021704.pdf
[14] http://www.medicines.org.uk/guides/fendrix/hepatitis%20(all%20types)
[15] http://www.medicines.org.uk/guides/ambirix/Vaccinations%20(all)/
[16] http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000426/WC500024579.pdf