HEPATITIS A DISEASE AND VACCINE: Hepatitis A is a viral disease that thrives in areas with poor sanitation and is spread when people eat or drink something that has been contaminated with human body waste products. Children often show no symptoms and the disease is more serious in adults. Hepatitis A involves the liver and about 15 percent of people who get it will have relapsing symptoms of jaundice, fatigue, stomach pain, nausea, diarrhea and fever for 6 to 9 months. ¹ Hepatitis A does not cause chronic, long term infection and very rarely causes death. Infection with hepatitis A gives a person lifelong immunity and, in some populations around the world, close to 100 percent of all inhabitants have antibodies to hepatitis A. ²  In this country, the Centers for Disease Control (CDC) reports that 30 percent of Americans have evidence of past infection with hepatitis A and are immune. ¹

The CDC states that persons at high risk for hepatitis A are household and sexual contacts of infected persons; drug users; persons traveling to countries where hepatitis A is common; and persons living in regions where there are "consistently increased rates of hepatitis A." ¹ The best tool for prevention of hepatitis A is to wash your hands with soap and water after using the bathroom, changing a diaper or preparing and eating food.

The hepatitis A vaccine is recommended in selected areas and is currently mandated in 5 states for all children entering kindergarten in those states. ³ The hepatitis A vaccines licensed in the US are HAVRIX manufactured by SmithKline Beecham Pharmaceuticals and VAQTA manufactured by Merck & Co. ^4,5

WHY NVIC OPPOSES A HEPATITIS A VACCINE MANDATE:

· Hepatitis Does Not Cause Chronic Infection and Rarely Causes Death: Hepatitis A has a mortality rate of less than one percent (0.6) and over 70 percent of deaths occur in adults over the age of 49. ⁴

· Hepatitis A Gives Lifelong Immunity But Vaccine Does Not: Children often show no symptoms if they get hepatitis A and then develop lifelong immunity to the infection ², but nobody knows how long vaccine-induced immunity will last. (All vaccines only give temporary immunity). SmithKline Beecham states "At present the duration of protection afforded [by HAVRIX] has not been established. Therefore it is unknown if the protection provided to immunized children will last until adulthood." ⁴

· Child to Child Transmission in School is Rare: According to the CDC, "Child-to-child disease transmission [of hepatitis A] within the school setting is uncommon." ⁶

· Hepatitis A Already Declining: In 1970 the reported cases of hepatitis A in the US were 27.87 per 100,000 population. Since that time the incidence of hepatitis A has been declining so that in1999 the incidence rate was only 6.25 cases per 100,000 population. ⁷

· Hepatitis A Vaccine Can Cause Reactions: In clinical trials conducted by SmithKline Beecham, between 9 and 14 percent of adults and children reported headache after vaccination and between 21 and 56 percent had local reactions. Up to 10 percent had fever, fatigue, malaise, nausea and loss of appetite. Other reported reactions included stomach pain, diarrhea, vomiting, and joint pain. Post marketing vaccine reaction reports have included anaphylaxis, jaundice, convulsions, multiple sclerosis, Guillain-Barre syndrome, and neuropathy. ⁴ Since the vaccine was licensed in 1996, there have been 2,652 reports of hepatitis A vaccine related adverse events made to the government (VAERS), including 476 serious events and 18 deaths. ⁸

· Vaccine Components Not Adequately Evaluated: Hepatitis A vaccines manufactured by SmithKline Beecham and Merck are made using human fetal diploid (lung) cells to propagate the virus. HAVRIX contains aluminum as well as phenoxyethanol as a preservative. Traces of formalin and residual fetal human diploid cellular proteins are also present. ⁴ VAQTA contains aluminum and small amounts of non-viral protein, DNA, bovine albumin, and formaldehyde. ⁵ Both HAVRIX and VAQTA have "not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility."

· No Long Term Studies: There were no long term studies to evaluate whether hepatitis A vaccine given alone or in combination with other vaccines is associated with chronic illness or disability, such as the development of diabetes, asthma, seizure disorders, learning disabilities, ADHD, or autism. The Merck product insert for VAQTA states "Subjects were observed during a 5-day period for fever and local complaints and during a 14-day period for systemic complaints." ⁵

· Voluntary Use of Vaccine Could Be High: When 66 percent of eligible children in Butte County between the ages of two and 12 years old received free hepatitis A vaccinations over six years, the number of reported cases in the country fell from 57 in 1995 to 4 in 2000. ⁹ This indicates that offering free vaccines to parents who wish to give their children the vaccine will result in voluntary uptake. No mandates are needed.

References:
1. CDC Hepatitis A Fact Sheet www.cdc.gov/ncidod/diseases/hepatitis/a/fact.htm
2. WHO Position Paper on Hepatitis A Vaccines: Weekly Epidemiological Record, No. 5. Feb. 4, 2000.
3. Immunization Requirements www.sabin.org/map.htm
4. SmithKline Beecham Product Manufacturer Insert (Hepatitis A Vaccine, Inactivated (HAVRIX). From Physicians Desk Reference (PDR), 2001.
5. Merck Product Manufacturer Insert (Hepatitis A Vaccine, Inactivated (VAQTA). Issued March 2001.
6. CDC. Prevention of Hepatitis A Through Active or Passive Immunization. Recommendations of the ACIP. MMWR. Dec. 27, 1996: Vol. 45, No. RR-15.
7. Selected notifiable disease rates: United States, 1950-99 www.cdc.gov/nchs/products/pubs/pubd/hus/tables/2001/01hus052.pdf
8. Vaccine Adverse Event Reporting System (VAERS) Report data
9. Associated Press press report: More Hepatitis Vaccinations Urged. Dec. 18, 2001.