Vaccinations: Public Health's 'Miracle' Under Scrutiny.

With rare--but real--possible side effects from certain immunizations, lawmakers face an age old public health question.

Arkesea was a healthy, active 15-year-old girl living a normal life in North Minneapolis, until she got hepatitis B. Two weeks later, in July 1998, Arkesea died.

Her family remembers a girl who excelled in math and science and dreamed of becoming a doctor. Neither her doctors nor her parents know how she contracted the disease. She wasn't an IV drug user, she wasn't sexually active, and she didn't receive tainted blood.

Unfortunately, Arkesea was one of the approximately 30,000 children infected with the disease that year. Hepatitis B kills 4,000 to 5,000 people in the United States each year, and approximately 220 people receive liver transplants annually to survive the damage done by the disease. The Centers for Disease Control and Prevention (CDC) estimates that in America today, 1.25 million people are chronically infected. A vaccine to prevent hepatitis B is available and was required during the 1998-99 school year for attendance at elementary schools in 27 states, the District of Columbia and Puerto Rico.

Terry, a beautiful, healthy infant from Alabama, received his first in a series of oral polio vaccines when he was nine weeks old. Less than 72 hours later he was in the hospital and on a respirator. Six months later he died. Terry was one of about 10 children each year whose polio is caused by the vaccine designed to protect them. At its height in 1952, the polio epidemic crippled 21,269 Americans and claimed 3,145 lives. To prevent this ever happening again, the vaccine is required for attendance at elementary schools in all 50 states, the District of Columbia and Puerto Rico. But to ward off cases like Terry's, the CDC now recommends the safer, injected form instead of the oral vacine, even though it is less effective.

As policymakers, legislators must ask if states should require that all children receive vaccines in order to protect individuals and communities from infectious epidemics, or should parents be allowed to refuse immunizations to avoid rare, but sometimes serious, reactions?

As guardians of the public health, legislators determine which vaccines should be mandated, when they are to be used and what groups will be affected. It's a complicated issue. As immunizations become more effective, the diseases they prevent fade from memory, leaving only the vaccines themselves and their rare side effects in the public consciousness.

Proponents such as public health officials, the CDC, the American Academy of Pediatrics, the Food and Drug Administration and child health advocates point out that serious medical problems caused by vaccines occur very rarely--much more rarely than the serious complications and deaths that can be prevented by vaccines. Numerous scientific studies have failed to draw any correlation between vaccines and autism, SIDS, multiple sclerosis or a number of other diseases.

However, the public sometimes has a hard time believing the experts, as we've seen with the Gulf War syndrome and silicone breast implants--cases where experts tried and failed to establish cause and effect. The public believes the experts just haven't tried hard enough, said John Donvan of Nightline in an October 1999 program.

Yet, in our society, pharmaceuticals are tested so stringently that we have devoted an entire federal bureau to the task. In fact, immunizations are subject to a higher standard of safety than other medical interventions because they are given to healthy children. But is this enough?

PUBLIC HEALTH'S ROLE

Vaccines are one of the greatest public health achievements in history. Smallpox has been eradicated worldwide through the use of vaccines. Polio, except for the few cases caused by the vaccine, has been virtually eliminated in the Western Hemisphere and may be eradicated in the rest of the world this year. Vaccines against measles, diphtheria, mumps, rubella and Hib (one kind of infant meningitis) have decreased the number of cases by more than 99 percent. In 1998, this country had only one reported case of diphtheria and no cases of wild polio.

Health and Human Services Secretary Donna Shalala says immunizations are one of the "most cost effective of all preventive public health practices." Wisconsin learned about this the hard way when a 1989 measles epidemic with more than 600 cases claimed the lives of three children and cost the Medicaid program $1.5 million in hospitalizations.

But as they become more effective and the diseases they prevent fade from our memories, the concerns about side effects gain attention. Most parents today don't remember being quarantined with measles or whooping cough; most don't remember the terror of the iron lung.

"Although I don't remember the experience well, I know I was quarantined as a child, and I wasn't allowed to leave the house for a long time," says Senator Grant Ipsen, chair of the Health and Welfare Committee in Idaho. "For a young child, that's a hard thing to accept. I think that some of the young parents today don't know what it was like to see these diseases firsthand. They don't always get a clear picture of what immunizations are protecting them from."

COMMUNITY IMMUNITY?

Vaccination of an individual doesn't just protect that one person, it also guards other members of the community. "Herd immunity allows us to eliminate vaccine-preventable disease without needing 100 percent of the population to be immune," says Dr. Walter Orenstein, director of the CDC's National Immunization Program.

Senator Ipsen knows this benefit well; his grandchildren have immune systems that don't function properly so their vaccinations were delayed, then administered under the close supervision of their doctor. "We had to rely on others to get their vaccinations so that our grandchildren could be protected indirectly until it was safe for them to be immunized," Ipsen says.

"There may be some appeal to the idea that immunizations should be an individual decision, but, because vaccines protect both the individual and the community, decisions about opting out of immunizations have both personal and community implications," says Dr. Bruce Gellin, executive director of the National Immunization Information Network. He compared it to a four-way stop sign. "A person who decides to ignore the stop sign knows he has less risk of an accident if others obey it. However, if two drivers make a similar decision, assuming that the other will stop, the outcome becomes much more risky for everyone in the intersection."

VACCINE SAFETY

Some groups that believe vaccines have caused serious illnesses are not "antivaccine," but they do strongly advocate more exemptions from mandates, more research into the connection between vaccines and side effects, and informed consent from parents.

"What American citizens from all walks of life are telling us is that they don't want Big Brother breathing down their necks and telling them what health care choices to make," says Barbara Loe Fisher, president and cofounder of the National Vaccine Information Center. Dr. Jane Orient of the American Association of Physicians and Surgeons, a conservative medical group, says, "... We are concerned that immunization mandates subject patients to medical treatment without their fully informed consent." The risks are not completely known in the absence of long-term safety studies, she contends.

Groups such as these argue that vaccines are not tested enough before mandating coverage and that more research is needed to investigate the connections between immunizations and diseases such as multiple sclerosis and diabetes.

HOW ARE VACCINES MONITORED?

Vaccines are monitored through the Vaccine Adverse Event Reporting System to look for rare events that may not show up in clinical trials. The CDC has also created the Vaccine Safety Datalink study that links computerized vaccination records with medical visit records on 6 million members of four health maintenance organizations. This enables the CDC to continuously examine possible associations between vaccines and serious side effects.

The task of monitoring vaccine safety is not an easy one. Because so many developmental and psychological problems are diagnosed at around the same time that kids are getting their vaccines, sometimes the problems are blamed on the vaccine even when it might not be the cause. The scientific way to determine if a vaccine is causing another disease is to compare the disease incidence in children who were vaccinated to those who were not. However, these studies are long, expensive and difficult to design. The data collected through the Vaccine Safety Datalink should help.

An example of this continued monitoring was recently seen with the new rotavirus vaccine, developed to prevent one of the most common causes of severe diarrhea in children. After testing and review, the Advisory Committee on Immunization Practice recommended in March 1999 the rotavirus vaccine for infants. In July 1999, the CDC recommended that health care providers stop using the vaccine based on reports that a rare type of bowel obstruction had occurred in 15 recently vaccinated children. Upon subsequent review, the committee withdrew its recommendation for use of the vaccine.

Dr. Bruce Gellin points out that ". . . all along the continuum of vaccine development, we learn about its performance and side effects. Should we withhold a vaccine because we can't confidently say that we know every detail about it? It seems that this is a prescription to do nothing."

Groups that question vaccine safety contend that while vaccines are stringently tested by the FDA, they are not always tested on infants and their effects are not followed for long enough periods of time. They also argue that scientists who are looking for vaccine side effects or who have been known to question their safety are not given funding by the government to conduct research on these issues.

FEDERAL HELP AND OVERSIGHT

In 1986, Congress passed the National Childhood Vaccine Injury Act in response to concerns about the safety of a particular type of whooping cough vaccine. Negative publicity about the shot occurred in this country and also spread in Japan and the United Kingdom, which led to a serious decline in vaccine coverage. In Japan, where the pertussis vaccination rate fell from 80 percent to 20 percent in 1979, the resulting epidemic caused more than 13,000 cases and 41 deaths. The United Kingdom suffered several whooping cough epidemics, one of which caused more than 100,000 cases and 36 deaths. In this country, pertussis vaccine rates remained high, but numerous lawsuits were filed against manufacturers, which resulted in higher prices for vaccines. Several companies decided to stop production, causing temporary shortages.

The congressional program provides for independent review of the available scientific evidence on adverse effects to vaccinations, mandates the reporting of vaccine-associated problems to the Department of Health and Human Services, provides financial compensation to families affected by side effects and creates the Vaccine Adverse Event Reporting System to monitor vaccine side effects.

STATE LAWS AND EXEMPTIONS

Recommendations from the Advisory Committee on Immunization Practice, a federally chartered group, and the Committee on Infectious Diseases of the American Academy of Pediatrics give states the option of passing a law or adding a regulation requiring that a vaccine be administered as recommended for children entering school or day care. No federal laws exist requiring immunization for school or day care entry, although some federal programs tie immunizations to services such as day care subsidies.

State laws requiring immunization have been around since the early 1800s when Massachusetts enacted a smallpox vaccination requirement. Widespread school and day care vaccination laws came about in the 1960s and '70s during the effort to eradicate measles. Specific vaccines and requirements differ from state to state.

All states allow vaccine exemptions for medical reasons. Religious exemptions exist in 48 states, the District of Columbia and Puerto Rico, but not in Mississippi or West Virginia. These laws vary. In Texas, the family must belong to a recognized religious group that opposes all immunizations and must present a letter from a religious leader. California, on the other hand, requires only that a parent sign an affidavit declaring a personal belief against immunization.

Fourteen states allow philosophical or personal exemptions. Overall, less than 1 percent of the population claims exemptions, but this small group can have a dramatic impact on a community. The issue of allowing exemptions is highly controversial.

The Journal of the American Medical Association reports that exempted children, who tend to cluster within communities, were 35 times more likely to contract measles than vaccinated children. Several vaccine-preventable disease outbreaks have originated in groups with high numbers of exemptions. In a 1996 measles outbreak in Utah, 45 percent of cases were among families who had claimed exemptions. However, concerned groups believe that parents should be allowed to decide if their children should be vaccinated.

All sides of this debate have the same concerns at heart. They all want children to be healthy and protected. It's just the ways to achieve this goal that are contentious. The fact that vaccines prevent a huge number of illnesses, but have some side effects, makes for a difficult policy question, but not one that hasn't been solved in other areas.

"All states require that children use seat belts or car seats to prevent injuries even though there are certainly instances when wearing a seat belt actually causes more serious injuries or even death. In making decisions about public health issues such as seat belt laws or immunizations, we as policymakers must constantly weigh the public benefits against individual freedoms combined with the newest research to ensure that the policies are providing the largest benefit to the largest group. Immunizations for children clearly fall into this same category," says Representative Marcy Morrison, chair of Colorado's Health, Environment, Welfare and Institutions committee. "Above all, we must make decisions that protect the public health."

Gretchen Flanders is NCSL'S expert on childhood immunization policy.

                           VACCINATED CHILDREN,
                            19-35 MONTHS, 1998
                   Percent of
State by Rank       Children
                  Immunized [*]
Connecticut           90.0
South Carolina        87.9
Massachusetts         86.7
Maine                 86.3
Rhode Island          86.3
Vermont               85.8
Missouri              84.5
New York              84.5
Mississippi           83.7
Pennsylvania          83.2
North Carolina        82.8
West Virginia         82.4
New Jersey            82.3
Minnesota             82.2
New Hampshire         82.2
Alabama               82.1
Montana               81.9
Kansas                81.8
Iowa                  81.7
Kentucky              81.6
Tennessee             81.5
Alaska                81.3
Washington            80.8
Virginia              80.4
Georgia               80.1
Wyoming               79.9
Hawaii                79.3
North Dakota          79.1
Delaware              78.9
Florida               78.7
Louisiana             78.4
Ohio                  78.0
Michigan              77.7
Wisconsin             77.7
Illinois              77.5
Indiana               77.5
Maryland              77.0
Idaho                 76.4
Nebraska              76.4
Arizona               75.9
California            75.9
Colorado              75.8
Nevada                75.7
Utah                  75.6
Oregon                75.5
Oklahoma              75.3
Texas                 74.3
South Dakota          73.5
Arkansas              73.1
Dist. of Columbia     71.4
New Mexico            71.1

(*.)Received four or more doses of diphtheria, tetanus and pertussis or diphtheria and tetanus, three or more doses of polio, one or more doses of measles vaccine, three or more doses of Hib (Haemophilus influenzae, type b).

Source: Centers for Disease Control National Immunization Survey; 1998.

            COMPARISON OF MAXIMUM AND CURRENT CASES OF VACCINE
                         PREVENTABLE DISEASES [*]
Disease                    Cases before vaccine [**] Cases in 1998
Diptheria                       206,939 (1921)             1
Measles                         894,134 (1941)            100
Mumps                           152,209 (1968)            666
Pertussis (Whooping cough)      265,269 (1934)           7,405
Polio (WiId [***])               21,269 (1952)             0
Rubella (German measles)         57,686 (1969)            364
Congenital Rubella [****]      20,000+ (1964-65)           7
Tetanus                          1,560+ (1948)            41
Hib disease                      20,000 (1984)            129
Disease                    Percent Change
Diptheria                      -99.99
Measles                        -99.99
Mumps                          -99.56
Pertussis (Whooping cough)     -97.21
Polio (WiId [***])            -100.00
Rubella (German measles)       -99.37
Congenital Rubella [****]      -99.96
Tetanus                        -97.64
Hib disease                    -99.36
(*.)Numbers of diseases have been rounded to the nearest 10
(**.)Total number of cases reported during the year specified
(***.)Not caused by the polio vaccine
(****.)Severe birth defects resulting from a pregnant woman
contracting German measles during her pregnancy
Source: CDC National Immunization Program

FEDERAL PROGRAM OFFERS COMPENSATION

Created as a part of the National Childhood Vaccine Injury Act of 1986, the National Vaccine Injury Compensation Program assists families who have suffered from vaccine side effects and helps stabilize the vaccine supply by cutting down on the number of lawsuits against manufacturers.

The compensation program provides financial assistance to families to care for children injured by vaccines and helps those families who have lost a child to a severe side effect. Designed as a "no-fault" system, claimants don't need to establish that the vaccine was defective or that the doctor or clinic was negligent. Families are granted the presumption that the vaccine caused the child's injury or death if no other medical cause can be found for a specific list of known vaccine-associated side effects. However, if the injury or cause of death is not one of a list of known vaccine side effects, the families must provide proof that the ailment was caused by the vaccine.

EXEMPTIONS FROM IMMUNIZATION REQUIREMENTS

Every state, the District of Columbia, Guam, the Northern Mariana Islands and Puerto Rico excuse children with medical reasons from vaccination requirements to attend school. All except Mississippi and West Virginia excuse the requirement for religious reasons.

Fourteen states and territories have a liberal policy that excuses children for philosophical or personal reasons. They are California, Colorado, Idaho, Louisiana, Maine, Massachusetts, Michigan, New Mexico, the Northern Marianas, Ohio, Utah, Vermont, Washington and Wisconsin.