Informed Consent: Hepatitis B

I am a pro-choice doctor.  Vaccines are a very controversial topic these days.  I, as a chiropractor, do not give out vaccines.  Unfortunately, there is so much pressure from both sides of the debate, pro- and anti- vaccine camps, that it’s hard to find the right answers for your family.  In these posts I am just giving you the facts…using only reliable resources that are free and accessible for anyone with an internet connection.  You can do this research and more, but this is a good place to start.  Here we go with the first vaccine in the US schedule and the first in this series.

Hepatitis B

What is this disease?

This is a liver infection with both acute and chronic forms.  You contract the disease from body fluids, but the virus can survive outside the body for 7 days and during that time can infect anyone that encounters it and is not immune.  

The acute form in most cases is asymptomatic.  If symptoms appear they are:  fever, yellowing of the skin and eyes (jaundice), joint pain, dark urine, extreme fatigue, nausea, loss of appetite, vomiting, clay-colored stools and abdominal pain. A small subset of persons with acute hepatitis can develop acute liver failure which can lead to death. Fatality rates with acute hepatitis are 0.5-1% of cases.

The chronic form is usually asymptomatic.  Patients can develop complications such as cirrhosis or liver cancer (25% of patients).  It is most common for those that contract the virus before age 1 to develop chronic hepatitis B (80-90%).  By age 6 chronic infection rate drops to 30-50%.  Adults are even less (<5%).

The asymptomatic nature of this disease is the most concerning as it leads to spread of the infection.  Only a blood test can tell who has it.  If you are considering not giving this vaccine, it’s a good idea to get the household tested.

Hepatitis B Stats

In the United States, it is estimated that 850,000-2.2 million people have chronic hepatitis.  The population of the US is 319.8 million.  In 2014, there were an estimated 19,200 cases of acute hepatitis B in the US.  Incidence of acute hepatitis B in 2014:  0.9 cases/100,000 people.  Cases were reported in 48/50 states.

Chronic hepatitis B affects 240 million people worldwide.  Hepatitis B prevalence is highest in sub-Saharan Africa and East Asia (5-10% of adults chronically infected).  Other high rates of chronic infection are in the Amazon, southeast and south central Europe.  In the Middle East and India 2-5% are chronically infected.  In Western Europe and North America less than 1% is chronically infected.  Annually, over 686,000 people die due to complications of hepatitis B.

Vaccines for hepatitis B became available in the US in 1982.  At that time, vaccinations were for high-risk people such as healthcare workers or participating in high-risk body fluid exchange situations such as needle sharing or unprotected sex.  Routine vaccination of infants began in 1991.

usincidenceofhbv-chart

How do you treat this disease?

Acute:  No treatment.  Managed with fluids, nutrition, and comfort.  See above for likelihood of becoming chronic.

Chronic:  Life-long oral antiviral drugs can help slow progression and improve long-term survival.  No cure.

How long is a typical course of this disease?

Several weeks to 6 months for acute, life for chronic.

How effective is this vaccine?

95% (77-99%) effective for protective antibodies with 3 injection series.  Protection lasts 20 years.  Since vaccination began, areas where 8-15% of children had chronic Hepatitis B infections, now have 1% chronic infections.

The rate of new hepatitis B infections has declined by approximately 82% since 1991, when a national vaccination program for infants was implemented in the United States.

Side-effects of vaccine

Do not have this vaccine if you have a serious allergic reaction to any prior Hepatitis B vaccine or yeast.  Use with caution if you have a latex allergy, many versions have latex in their delivery devices.

CDC recommends not getting this vaccine if you are not well, it is best to wait until you are recovered from an illness before receiving this vaccine.

Side-effects:  soreness at injection site, low-grade fever, diarrhea, loss of appetite, fatigue, mild fussiness or crying, runny nose, fainting, dizziness, headache, insomnia, tingling, itching at site, sore throat, cough, paresthesias, hypotension, rash, sweating, pain and/or stiffness, swollen lymph nodes

Other side effects may be version specific.  You are encouraged to read the inserts on the FDA site.

Vaccine Injury Data 9/2/2016

Claims filed:  638 injury, 56 death; 260 were compensated (Hepatitis B only data, not combination vaccine)

Adverse Reaction and reporting interval for VAERS:

  1. Anaphylaxis or anaphylactic shock (7 days)
  2. Any acute complications or sequelae (including death) of the above event (interval – not applicable)
  3. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval – see package insert)  Insert is available on FDA website.

There has been some link investigated into multiple sclerosis with some case studies being reported, but no larger studies finding causal relation.

Different versions of this vaccine

Single-antigen hepatitis B vaccines

ENGERIX-B®

RECOMBIVAX HB® has half the antigen of engerix-B or pediarix.

Combination vaccines

PEDIARIX®: Combined hepatitis B, diphtheria, tetanus, acellular pertussis (DTaP), and inactivated poliovirus (IPV) vaccine. Cannot be administered before age 6 weeks or after age 7 years.

TWINRIX®: Combined Hepatitis A and hepatitis B vaccine. Recommended for persons aged ≥18 years who are at increased risk for both Hepatitis A virus and HBV infections.  Not for children.

It is highly recommended that you read the inserts for all of these vaccines before choosing to use one for your child if you have decided to vaccinate.  The most up-to-date versions can be found on the FDA’s website.

There is some concern out of there about aluminum in vaccines, this one does typically contain it.

Timelines

In the US, the recommended schedule of 3 doses begins at birth.

In Canada, the recommendations differ across provinces and have the first dose at any time from infancy to 7th grade.  

Alternative schedules will place this vaccine’s first dose as late as between 12-14 years of age in order to decrease aluminum doses and delay until child is entering a higher-risk period in their life.  Others will place it as a child enters pre-school environment, whenever that may be.

Where did this information come from?

  • CDC
  • Drugs.com
  • FDA
  • Healthycanadians.gc.ca
  • Immunization Action Coalition
  • National Vaccine Injury Compensation Program Data Report-9/2/2016
  • Peto, TJ, et al.  2014.  Efficacy and effectiveness of infant vaccination against chronic hepatitis B in the Gambia hepatitis intervention study (1986-90) and in the nationwide immunisation program.  BMC Infect Dis.  14: 7.
  • WHO
  • Alternative schedule information from various pediatrician websites in US.
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