WASHINGTON -- An Arizona group of physicians has called for a moratorium on controversial hepatitis B immunizations for schoolchildren pending further research about dangerous side effects from the vaccine, and accuses school districts that require the shots of "practicing medicine without a license."
Forty-one states and the District of Columbia mandate that children receive the hepatitis B vaccine in order to attend daycare, kindergarten, sixth grade, high school or college. The Centers for Disease Control and Prevention (CDC) has recommended since 1991 that infants receive the immunization at birth, and in 1995 recommended the vaccine's use in all adolescents. But, states mandate the use of vaccines, and individual school districts enforce those mandates.
"Mandates effectively use schoolchildren as research subjects subjected to unproved medical treatment without informed consent, in violation of the Nuremberg Code," said Dr. Jane M. Orient, executive director of the Association of American Physicians and Surgeons, based in Tucson, Ariz., which called for the moratorium.
"It's one thing to bar a student from school if he is carrying an infectious disease posing a threat to other children. But to require a questionable medical treatment as a condition of attendance crosses over the line to practicing medicine," she said.
Hepatitis B is a serious disease that attacks the liver and is most commonly spread through infected blood and body fluids exchanged through sexual activity and the sharing of infected needles. The virus can also be spread from an infected mother to her child at birth.
The Vaccine Adverse Event Reporting System, managed by the CDC and the Food and Drug Administration, received reports of 43 deaths in babies under two who received the shot in 1997, although none have been causally linked to the vaccine yet, according to Susan S. Ellenberg, director of the Food and Drug Administration's Biostatistics and Epidemiology Division.
Recipients of the vaccine have complained of other serious side effects including autoimmune and neurological disorders such as chronic joint pain, fatigue, dizziness, nausea and seizures.
Orient said serious adverse events after the vaccine are reported three times as frequently as cases of hepatitis B in children under the age of 14.
"We find it shocking that government health officials cavalierly dismiss reports of serious adverse vaccine effects as coincidental and that school officials ignore them altogether," she said.
At a federal hearing on the safety of the hepatitis B vaccine in May, concerned researchers testified that no long-term, clinical U.S. studies have been released showing the efficacy and safety of the vaccine when used on infants.
In a seperate development last week, the U.S. Public Health Service and the powerful American Academy of Pediatrics recommended that the first dose of hepatitis B vaccine be postponed from birth until two to six months of age unless the infant's mother tests positive for the virus.
The surprise announcement was part of a larger concern that the use of the mercury-based preservative and bacteria killer thimerosal -- used in vaccines and eyedrops and contact-lens solutions -- can be dangerous if small infants receive too much of the chemical.
Thimerosal is used in vaccines that are not made from live viruses such as the hepatitis B, whooping cough, diphtheria, tetanus and bacterial meningitis vaccines.
U.S. Surgeon General David Satcher said "the risk of devastating childhood diseases from failure to vaccinate far outweighs the minimal risk of exposure to cumulative levels of mercury in vaccines."
He said that children should continue to receive all vaccines according to currently recommended schedules, but stressed that physicians and parents continue to vaccinate infants "within the flexibility of today's schedule."
This translates into postponing the hepatitis B vaccination until an infant reaches two to six months of age, according to a statement made by the U.S. Public Health Service and the American Academy of Pediatrics (AAP).
Infants born to a hepatitis B-positive mother should continue receiving the vaccine at birth, it said. Currently only 14 states require that pregnant women are screened for the disease before they give birth.
The AAP and the U.S. Public Health Service have requested that vaccine manufacturers reduce or eliminate the mercury-based preservative from vaccines as soon as possible, and conduct studies to examine the risks of thimerosal.
Until the CDC makes a formal recommendation to postpone the use of the hepatitis B vaccine, state health departments may hold off telling physicians to stop immunizing infants with it at birth.
"We are really waiting for a specific statement by the CDC. Until then we are transmitting the information to the local level so that doctors can make their own decisions," said Phyllis Yambor, a nurse consultant with the Florida Bureau of Immunization.
To read more about the hepatitis B vaccine and which states mandate its use, go to stateline's story: Critics Question Safety Of Hepatitis B Vaccine.