WASHINGTON - Five-week old Lyla Rose Belkin died within 16 hours of her hepatitis B vaccination in 1998. Nurse Betty Fluck has severe physical exhaustion and uses leg braces and crutches due to chronic joint and leg pain she believes is caused by the same vaccine. Lindsay Kirshner, 16, has daily headaches, nausea, joint pain, dizziness, fatigue and seizures which started the day after a hepatitis B shot she received in 1997.
Critics point to tragedies like these as evidence that the vaccine is not as safe as it should be. Yet it is mandatory in 41 states and the District of Columbia for children entering daycare, kindergarten, sixth grade, high school or college.
Hepatitis B is a viral disease that attacks the liver and can remain dormant without symptoms for years, but can emerge later in the form of chronic liver disease, cirrhosis and cancer. It is transmitted through the exchange of infected blood and other body fluids, including "perinatal" transmission -- from a hepatitis B-infected mother to her child at the time of birth.
Those at high risk of contracting the disease are needle-using drug addicts, those who engage in unprotected sex with infected partners, prison staffers and medical emergency and health care workers exposed to infected blood, according to the Centers for Disease Control. The agency said that 4,000 to 5,000 people die per year because of liver complications associated with the disease.
When the vaccine was first approved in 1986, many health workers were the first to get it because of their risk of being exposed to infected blood. In 1991, the CDC recommended that three doses of hepatitis B vaccine be given to all infants as part of the routine immunization schedule, and in 1995 was recommended for routine use in all adolescents. Statistics show that almost 90 percent of kindergarten-age children now receive the vaccine.
The move to recommend that infants -- with immature immune systems -- receive the vaccine has caused considerable controversy.
"It is highly improbable in the U.S. that a newborn has any significant risk of contracting hepatitis B as a child...newborns are not likely to engage in intravenous drug use or promiscuous sex," said Bonnie Dunbar, a cellular biologist and vaccine researcher at Baylor College of Medicine in Texas.
Dunbar also has a theory that some people are more likely to have a reaction than others based on their genetic makeup and the state of their immune system at the time of vaccination. She calls for government funding to determine who falls into such high-risk categories.
According to the CDC, the decision to vaccinate all children was made because there is a small risk of some children being exposed to the disease in early childhood. Such as "from a bite from another child in a nursery," or through an infected family member, said Dr. Walter Orenstein, director of the CDC's National Immunization Program.
The CDC points to studies that they say show about 30 percent of patients don't know where they acquired their infection, which would make it difficult to identify all people at risk.
Dunbar and other concerned researchers and parents say that no long-term, clinical U.S. studies have been released showing the efficacy and safety of the vaccine when used on infants, nor they say, has it been proven how long the vaccine is effective. Further, they ask why all infants receive a vaccine for a disease that affects mostly adults partaking in risky social behavior.
The CDC estimates that 200,000 people, mostly young adults, are infected with hepatitis B each year, but symptoms can be slow to surface. The agency's official figures, published in their own "Morbidity and Mortality Weekly Report" show 10,416 new cases of the virus were actually reported in 1997, 306 of which were in children below the age of 14.
The package insert of the vaccine, which is manufactured by pharmaceutical giants Merck and SmithKline Beecham, says the length of time the vaccine is effective is "indeterminate," according to Manhattan statistician Michael Belkin, who has been doing research on the vaccine since his daughter Lyla died last September after receiving her second hepatitis B vaccine. Package inserts also alert physicians that serious adverse events reported during the commercial use of the vaccine include multiple sclerosis, arthritis and Guillain-Barre Syndrome.
Dr. Harold S. Margolis, chief of the CDC's hepatitis branch, said that the CDC "feels comfortable" saying the effects of the vaccine last 15 years.
"What evidence is there that the protection will last into adulthood? If there is no evidence that the vaccine causes long-term protection, than why the heck are we doing it?" said Clifford Shoemaker, a Northern Virginia lawyer who handles vaccine reaction cases.
Some critics propose screening pregnant women for hepatitis B instead of subjecting all babies to a possibly dangerous vaccine. At present 14 states require expectant mothers be screened for the disease: California, Delaware, Florida, Hawaii, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Missouri, Nevada, New York, North Carolina and Tennessee.
A federal hearing on the safety of the hepatitis B vaccine -- the first such hearing on vaccine safety in over 10 years -- was convened recently by U.S. Rep. John Mica (R-Fla.) chairman of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources, to hear testimony from researchers, aggrieved parents and some health workers who say they were injured by the vaccine, and by federal health officials who stand by the safety of the vaccine.
"If hepatitis B vaccine was recommended in 1991 without scientific proof that it was safe in a broad sample of babies less than 48 hours old, then the CDC has been experimenting on babies at birth like guinea pigs, and this committee should suspend that universal immunization policy," said Michael Belkin.
Belkin was told his daughter died of Sudden Infant Death Syndrome (SIDS), but the autopsy report showed Lyla had a swollen brain, a sign that pathologists told him is a classic adverse reaction to vaccination in the medical literature.
Milwaukee immunologist Burton A. Waisbren, a clinical investigator and specialist in infectious diseases, also labeled the use of the hepatitis B vaccine an experiment by the CDC "designed to determine if vaccination at birth of all babies in the United States will eventually decrease the frequency of cancer of the liver" sometimes caused by hepatitis B infection.
He claims that parents are often not consulted before their newborns receive the vaccine. CDC information sheets on the vaccine, which by law are supposed to be given to parents before their infant is vaccinated, say the only risks associated with the vaccine are soreness where the shot was administered, mild to moderate fever, and on "rare occasions" a "serious allergic reaction."
The sheets also don't tell parents that certain exemptions for vaccination exist in every state for parents wanting to opt-out of vaccinating their children. All states allow for medical exemptions; religious exemptions are allowed in every state except Mississippi and West Virginia, and philosophical exemptions are allowed in 17 states.
The CDC has released no results from long-term studies investigating debilitating or lethal reactions. Seven studies are underway looking at possible adverse events associated with the vaccine, including multiple sclerosis, diabetes and death, Orenstein said.
He said the decision to recommend use of the vaccine on infants was "based on other studies, experience to date, expert opinion and licensure and experience from the Food and Drug Administration." Studies performed in Britain and France do not show a correlation between the vaccine and symptoms that mimic multiple sclerosis, although these results have not yet been published in peer-reviewed medical journals.
According to Barbara Loe Fisher, co-founder and president of the Vienna, Va.-based National Vaccine Information Center, a parental advocacy group, drug companies that market the hepatitis B vaccine in the U.S. performed safety studies that only monitored children for four or five days after vaccination. Some researchers feel that those were inadequate.
"It takes weeks and sometimes months for autoimmune disorders, such as rheumatoid arthritis, to develop following vaccination. No basic science research or controlled, long-term studies into the side effects of this vaccine have been conducted in American babies, children or adults," testified Dr. Bonnie Dunbar of Baylor College of Medicine.
The CDC says: "It is possible that these MS case reports are purely coincidental to hepatitis B vaccination. Carefully controlled studies (currently underway) are needed to determine the nature of these reports," according to the agency's Web site.
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.
"With 10 million doses of hepatitis B vaccine administered each year, a certain amount of children will die of coincidence alone," said the CDC's Dr. Harold S. Margolis.
The National Vaccine Injury Compensation Program, a program set up in 1988 to compensate parents of children killed or injured by mandated vaccines has received 33 petitions so far claiming damage from the vaccine, only one has been adjudicated and it was dismissed.
"I am convinced that I am only seeing the tip of the iceberg, I can't imagine how many cases there are out there where people have no clue that they have been injured by the vaccine," said Virginia lawyer Clifford Shoemaker, who is getting ready to file 40 more cases.
Those who were administered the vaccine between August 1988 and August 1997 and believe they have suffered a severe reaction must file a petition by this August. Otherwise, petitions must be filed within three years from receiving a vaccine.
Shoemaker said that to prove that the vaccine is the cause of the reaction he will show that those injured had worsening conditions after each of the subsequent booster shots.
The problem with giving it to infants, before they even leave the hospital, is that parents may ignore signs of a reaction when the child comes home, as they have no means of comparison with the child's "normal" behavior, and "babies can't tell you where it hurts," he said.
"The parents should be given the information to make an informed decision. As long as the child is not partaking in these behaviors the child should not get it," Shoemaker said.