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Mandatory Vaccines: Questionable Federal Policy Informing Questionable State Laws [*]

Catherine M. McCarty

“The legitimate powers of government extend to such acts only as are injurious to others.”[1] As these powers relate to the public health, history has supported mandatory medical treatment, namely vaccination against disease, where these diseases were threatening the quality of the public health. I propose below to investigate whether current vaccine policies and laws remain legitimate exercises of government, extending only to acts as are injurious to others.

Establishing a unique system of government

Our government is a system of federalism. By design, federalism consists of a division of powers that preserves both national and state governments. The powers of the national government are delineated in the Constitution, while the state, under the Tenth Amendment[2] keeps the remaining sovereign powers. As stated by James Madison, “The powers delegated by the proposed Constitution to the federal government are few and defined. Those which are to remain in the State governments are numerous and indefinite.”[3]

Among the powers retained by the states are what have become known as the police powers. The police powers include the power of the state government to promote the public welfare by restraining and regulating private individual’s rights to liberty and uses of property.[4] Public health regulation has long been regarded as one of the state’s primary and most important police powers.[5] The validity of public health laws and regulations at both the state and federal level depend on two constitutional questions; first, does the government entity have the constitutional power to act in the interest of the public heath, and secondly and more interestingly, does the specific manner in which the government has acted violate or exceed any constitutional principles or individual rights?[6]

Initially, the courts were highly deferential to the states with regard to their exercise of police powers, validating all rules and regulations of local health authorities where they were reasonably calculated to preserve the health of the public.[7] On the other hand, not all courts were so deferential to the state and local health authorities, and did not allow them free reign over matters of public health. In these instances, the skepticism of the court to the public health actions that purported to protect the public arose from the notion that the action involved an arbitrary interference with private business or imposed an unusually and unnecessary restriction upon a lawful activity.[8] Furthermore, police powers that exceeded the scope of a public health necessity were at time subject to strict judicial review.[9]

While the public health has traditionally been the exclusive province of the state government, federal involvement in public health matters has significantly increased throughout the twentieth century. This increase has been seen primarily as a result of the Court’s broadened interpretations of the Commerce Clause as well as the Taxing and Spending powers in the New Deal era.[10] With this shift, Public Health laws were expanded to include laws and regulations passed, enforced, and adjudicated at all levels of government.[11] However, history demonstrates a gradual centralization and consolidation of government power on the federal level as can be seen through the passing of such laws like The Virus, Serum, and Antitoxin Act,[12] The Food and Drug Act,[13] The Federal Food, Drug, and Cosmetic Act,[14] and the Public Health Service Act.[15] Furthermore, through its ability to condition the receipt of federal funds upon the performance of federal guidelines, standards or requirements, Congress has been able to increase the influence of the federal government over the states.[16]

Vaccines and Public Health Laws:

One of the most timely issues in public health today is vaccination. In particular, vaccinations in light of potential bioterrorism and of childhood immunizations required for entry into the public schools. A vaccine is a preparation of killed microorganisms, living attenuated organisms, or living fully virulent organisms that is administered to produce or artificially increase immunity to a particular disease.[17] The germ of vaccinology, and more largely immunology, grew out of the observation in ancient times that those who survived disease seldom suffered a second, similar sickness.[18] The first step toward achieving an artificial resistance to disease (e.g., smallpox) was the practice of variolation, which involved the deliberate induction of disease by transmission of material from pus or scabs from the contagious disease (e.g., smallpox). One common procedure included grinding scabs taken from a person suffering from smallpox into a fine powder, and together with other ingredients, blowing the mixture into the nostrils of a non-immune person.

Variolation, is believed to have originated in China around 1022 to 1063 AD, and was practiced among the Buddhist Monks.[19] Through the trading routes to the Middle East, variolation spread westward. Not only did the practice save lives, but it was also commercially important.[20] Once the practice of variolation reached Western Europe and England, it was practiced with varying degrees of success.[21]

The next significant step towards developing artificial resistance to disease occurred around 1800. Jenner, a rural English doctor, observed that people who had acquired cowpox from milking infected dairy cows were subsequently unaffected by smallpox outbreaks.[22] With this observation, Jenner used infectious matter of a cow disease, to transmit cowpox to humans. The experiment successfully conferred to the subjects immunity against smallpox. Subsequently, Jenner proposed that cowpox virus should be used to vaccinate persons instead of using live vaccina virus.[23] While Jenner’s method was less aggressive than earlier practices of variolation, creating significant advantages, Jenner’s method of vaccination was limited, in that it was only applicable to smallpox.[24] (As a permanent reminder of Jenner’s contributions, the word vaccination is derived from the word “vacca” meaning cow.[25] )

Pasteur made the third significant step towards the development of vaccines. His contribution was through his development of germ theory.[26] Considered the first great experimental immunologist, Pasteur discovered (by accident) a means of changing the properties of live microbes so that their potential for causing disease was greatly reduced, a process which became known as attenuation.[27] Pasteur’s contribution, together with other discoveries in the twentieth century such as the Salk’s use of tissue culture, resulted in what is referred to as the golden age of vaccination.[28]

Today vaccines have been developed for a large number of diseases ranging from primarily mild ailments such as rotavirus and the flu to more serious diseases such as polio and the measles. According to a World Health Organization report, about 80% of the world’s children are immunized against DT, BCG, polio, and measles.[29] In the US, the Recommended Childhood Immunization Schedule includes immunization against eleven different diseases before the age of two years.[30] While vaccines are regarded as a relatively safe and efficient way to protect against disease, vaccination is a medical act that always entails a certain danger. While the danger is generally thought to be remote, there is no such thing as a zero risk vaccine.[31]

The large number of vaccinations occurring today together with the recognition that no vaccine is 100% safe has renewed the debate over the risks and benefits of vaccines.[32] , [33] Special questions are raised with childhood vaccinations; in particular, a large and increasing number of vaccinations given to children who lack a fully developed immune system. In order to further contribute to the ongoing conversation about vaccines, I propose to look into current laws and polices (both at the state and federal levels) relating to vaccines. Additionally, through those laws, I propose to see who and what factors inform vaccine policy (e.g., risks and benefits), what interests are at stake, and how are those interests should be weighed. Like most laws and regulatory schemes, those relating to vaccines are complex and can be best understood in the context from which they have developed. Therefore, I shall begin with the early state laws relating to vaccinations, eventually addressing the current federal laws and regulations that oversee the many aspects of vaccines through areas such as public health laws and also agencies such as the Center for Disease Control and the Food and Drug Administration.

State Vaccine Laws:

One of the early and most prevalent cases regarding vaccines involved a question over compulsory vaccination against smallpox.[34] The commonwealth of Massachusetts statute provided that “the board of health of a city or town, if, in its opinion, it is necessary for the public health or safety, shall require and enforce the vaccination and revaccination of all the inhabitants thereof, and shall provide them with the means of free vaccination. Whoever, being over twenty-one years of age and not under guardianship, refuses or neglects to comply with such requirement shall forfeit $5.” Proceeding under this statute, the city of Cambridge adopted the following regulation in 1902: “Whereas, smallpox has been prevalent to some extent in the city of Cambridge, and still continues to increase; and whereas it is necessary for the speedy extermination of the disease that all persons not protected by vaccination should be vaccinated; and whereas, in the opinion of the board, the public health and safety require the vaccination or revaccination of all the inhabitants of Cambridge; be it ordered that all the inhabitants habitants of the city who have not successfully vaccinated since March 1st, 1897, be vaccinated or revaccinated.”[35]

Jacobson refused vaccination and was charged criminally under the above referenced regulation. The case eventually went to the Supreme Court, where the Constitutionality of the provisions was addressed. While the court upheld the regulations as a valid exercise of the commonwealth’s police power, the court went on to note that those police powers were not without limit, but rather “must be held to embrace, at least such reasonable regulations established directly by legislative enactment as will protect the public health and the public safety.”[36]

On the facts of the case, the court, in 1905, found little difficulty in upholding the Massachusetts regulation. However, the decision was made easier due to the City of Cambridge’s eminent fear of a smallpox outbreak. Notably, smallpox was once the most feared disease, with the highest mortality rate in human history.[37] The courts perception of the potential danger of a smallpox outbreak is evident in its description of the necessity of the law. “Upon the principle of self-defense, of paramount necessity, a community has the right to protect itself against an epidemic of disease which threatens the safety of its members. It is to be observed that when the regulation in question was adopted smallpox, according to the recitals in the regulation adopted by the board of health, was prevalent to some extent in the city of Cambridge, and the disease was increasing.”[38] Since deciding Jacobson, the Court has reaffirmed its position regarding compulsory vaccination,[39] and has cited Jacobson favorably in many other cases.[40] A number of these cases involved compulsory vaccination of children as a prerequisite for entering school.

Federal Vaccine Laws:

Regulation of the safety, effectiveness, and proper labeling of vaccines

Vaccines have not only developed through state common law and regulations, for example requiring childhood immunizations prior to entering school, but vaccines and vaccine policy have also come to be regulated at the federal level. The first federal attempt at vaccine regulation was in response to the emergence of imitation smallpox vaccines in the market. Congress attempted to insure a genuine product to the public through a Vaccine Agent, who was empowered to preserve and furnish genuine vaccine material to any citizen of the United States.[41] However, the act was repealed in less than ten years due to an outbreak of smallpox attributed to vaccine distributed through the national program,[42] leaving the Federal Government out of the picture for the next 80 years.

The Virus, Serum, and Antitoxin Act, passed in 1902, was the beginning of modern vaccine regulation, more generally the regulation of biologics.[43] While this law predates both the enactment of the Food and Drug Act[44] as well as the Federal Food, Drug, and Cosmetic Act,[45] the statues are intertwined and have some areas that overlap. The law governing vaccines ultimately evolved into a complex regulatory scheme both under the Food and Drug Administration (FDA) through the Center for Biologics Evaluation and Research (CBER) as well as the Public Health Service Act (PHS Act).[46]

Section 262 of the Public Health Service Act, (reenacting the1902 Act) is one mode of regulation of vaccines, (a biological product).[47] Section 262 regulation is set up in the form of a license, which is required together with marking requirements, prior to the introduction or delivery of a biological product into interstate commerce.[48] Standards for obtaining the license require that the product is “safe, pure, and potent.”[49]

Section 262 also requires manufacturing standards be met, in order to acquire a license.[50] Specifically, the facility in which the biological product is manufactured, processed, packed, or held must meet the standards designated to assure that the biological product continues to be safe, pure, and potent. Additional safety precautions under Section 262 include false labeling provisions,[51] establishment of inspection of preparation establishment,[52] and a recall provision to be used when the product presents an imminent or substantial hazard to the public health.[53]

Initially, the regulation of biologics was under control of the NIH. However, after a controversy within the NIH regarding subpotent vaccines,[54] control of biologics was shifted to control under the FDA.[55] Once under control of the FDA, the Commissioner of Food and Drugs set up nine panels of non-FDA experts to review all biological products licensed prior to 1972[56] . The FDA procedures required preparation of a report to the agency that (1) evaluated the safety and effectiveness of the biological product; (2) reviewed the labeling of the biological product; and (3) advised FDA on which biological products under review were safe, effective, and not misbranded.[57] The products reviewed were to be classified into Categories I, II, and III.[58] Category I designated products determined safe, effective and not misbranded. Category II designated products determined unsafe. And, Category III designated products falling outside of either Category I or Category II due to insufficient data. Category III products were then split into two subcategories, IIIA and IIIB. Category IIIA products were allowed to remain on the market, whereas Category IIIB products were those of which it was recommended the licenses be revoked. This remains essentially the current manner of review used when determining the safety and efficacy of new vaccine products.[59] , [60]

Setting a federal public health policy

Another example of federal involvement related to vaccines is The National Vaccine Program.[61] The National Vaccine Program’s goal is to achieve optional prevention of human infections diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines.[62]

Together with the National Vaccine Program, the National Vaccine Advisory Committee was also established.[63] The directive of this committee is to study and recommend ways to encourage the availability of an adequate supply of vaccination products, recommend research priorities and other measures to enhance the safety and efficacy of vaccines, advise the Director of the program regarding implementation of the National Vaccine Program, and identify the most important government and non-government areas to be considered in implementing the program.[64] Publications and recommendations from the advisory committee are published in the Morbidity and Mortality Weekly Report and are also posted on-line by the CDC under the heading “CDC Recommends.”[65] While the recommendations and guidelines set by these committees are not binding on the states, they are very influential in the determination of states policies.

Establishing a national system of liability and compensation for vaccines

One of the most recent significant areas of federal legislation related to vaccines is The National Childhood Vaccine Injury Act.[66] This legislation was designed to protect manufacturers from strict liabilities due to the unavoidable risks of their products.[67] Under the restatement, subject to certain exceptions, manufacturers are held strictly liable for injuries caused by a defective product.[68] One of these exceptions applies to products that are incapable of being made safe for their intended and ordinary use (e.g., vaccines).[69] Therefore, under section k, the manufacturer is liable only in instances of negligence in manufacturer or in failing to supply adequate warnings.[70]

Even in the face of section k, courts were finding means to impose liability on manufactures of vaccines that have caused injury. One of the most popular means plaintiff’s used to bring suit against the manufacturer was a claim of failing to provide adequate warning. While some court adopted the ‘learned intermediary’ rule, where the duty to warn is fulfilled by providing adequate information to the health care provider,[71] not all courts followed in this direction.

For example, the court in Davis v. Wyeth Laboratories interpreted the duty to provide adequate warning as requiring the manufacturer to directly warn the patient when vaccinations are performed at a mass immunization clinic.[72] In Reyes v. Wyeth Laboratories, the Fifth Circuit also moved away from the ‘learned intermediary’ rule.[73] Although the manufacturer enclosed a package insert and the nurse had read the warning, the nurse failed to convey the warning to the parents of the vaccinated child. The court held that this direct warning was required, even in the case of a compulsory vaccination such against polio. The court reasoned that because two vaccines were available on the market and they had different risk profiles, the parents should have been warned about the possible adverse effects of the vaccination that was administered.[74]

The Fifth Circuit departed even further from the ‘learned intermediary’ in Givens v. Lederle Laboratories, where a mother contracted polio subsequent to her child’s vaccination.[75] The package insert stated that there had been reports of individuals in close contact with the vaccine recipients having contracted polio, but that this happened in only one in every three million cases. While the FDA had approved the labeling, the court held that the warning was insufficient because, in the view of the physician, the label suggested the vaccine was safe.[76] Note that the outcome would have been the same regardless of whether the package insert had been directly provided to the patient.[77]

Furthermore, aside from compensatory damages, in the 1980’s punitive damages became more commonly awarded in suits against pharmaceutical companies.[78] Not only did they become more common, but they also became significantly larger.[79] This increase in litigation costs caused a large increase in the price of insurance premiums for the manufacturers and subsequently was reflected in the price of vaccinations. Often times this increase was an order of magnitude in price, and occurred over a relatively short period of time, e.g., five years.[80]

Congress, fearing exiting from the market by manufacturers together with a decrease in incentives for new product development, responded by passing the National Childhood Vaccine Injury Act.[81] The Act limits liability in three ways. First, the manufacturer does not have a duty to provide direct warnings to patients with regard to the risks associated with the vaccine.[82] Secondly, the Act provides for a limited preemption of state law, through FDA regulations.[83] And, lastly, the code limits the availability of punitive damages to cases where the manufacturer committed fraud or intentional misconduct.[84]

Section 300aa-14 provided Vaccine Injury Table containing a list of vaccines, together with the injuries, disabilities, illnesses, conditions, and deaths resulting from the administration of such vaccines. The table provides the time period in which the first symptom or manifestation of onset or of the significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths is to occur after vaccine administration for purposes of receiving compensation under the Program.[85] In order to gain entitlement to compensation a petitioner must establish a vaccine-related injury or death, either by showing an event listed on the Table, and therefore presumed to be caused by a vaccine, or by proving causation in fact.[86] In addition, a petitioner must show (except in cases of death) 6 months of residual effects of the injury or inpatient hospitalization and surgery resulting from the injury.[87] With regard to a Table injury case, the patient must show that he suffered an injury of the type enumerated in the "Vaccine Injury Table" corresponding to the vaccination in question, and that the onset of such injury took place within a time period from the vaccination also specified in the Table. If these facts are established, as set out in sections 300aa-11(c)(1)(C)(i), 300aa-13(a)(1)(B), and 300aa-14(a), the Table injury is in effect given the legal presumption that it was caused by the vaccination, and the petitioner is entitled to compensation. However, the Secretary can defeat that reward of compensation by affirmatively showing that the injury was caused by some factor unrelated to the vaccination.

Recovery is provided from the government to the injured child, once he established that he developed in injury listed on the Vaccine Injury Table within a specified period of time.[88] The party need not establish either negligence or causation.[89] Once the party has accepted damages under the act, he is then barred from a subsequent civil suit against the manufacturer of the vaccine.[90] While the purpose of the Act is twofold; protecting vaccine manufacturers, as well as provide a means of compensation to injured parties, the Department of Health & Human Services has issued new rules making it more difficult to receive compensation.[91]

Vaccine Problems through the years: The Swine Flu

Although vaccinations have been credited as “out most powerful weapon in the war against infectious disease,[92] the history of vaccination has also had some dark chapters. For example, many research investigators developing vaccines have become lethally infected and there have been many episodes of sickness and death following vaccination. Some of the causes of vaccine injuries have been attributed to imperfectly prepared and tested products (e.g., polio, rabies, bacilli Calmette-Guerin, diptheria, smallpox, and yellow fever), faulty injection techniques (e.g., repeated use of needles and syringes), and simply unforeseen consequences.[93]

One of the early failures of public health laws and vaccination programs is the National Influenza Immunization Program.[94] In 1976, a number of soldiers at Fort Dix, New Jersey contracted a strain of the flu, one of who died as a result. The characteristics of the influenza identified at Fort Dix were very similar to the strain responsible for the swine influenza A pandemic, which was one of the most lethal outbreaks of the disease in recorded history.[95] Fearing an epidemic similar to that in 1918, Congress dedicated itself to a program immunizing “every man, woman and child” in the country.[96]

Congress’ action resulted in the National Swine Flu Immunization Program of 1976 Act.[97] However, the bill was stalled in the face of the refusal of the American Insurance Association to insure the manufacturers of the vaccines, due to its concern over a potentially large number of lawsuits relating to the immunizations. While the bill did eventually pass, this was not before Congress took on accepting liability for the vaccinations. The bill allowed individuals to file claims of vaccine related injuries directly against the government, much like the current law today with respect to certain childhood vaccinations.[98]

While a very large number of subjects were vaccinated in a very short period of time, the program was recognized as a failure in part because no epidemic of the flu ever surfaced, and in part because the vaccinations were determined to be connected to Gullian-Barr Syndrome (GBS).[99] Preliminary estimates calculated roughly 0.7 cases of GBS per million of non-vaccinated subjects as opposed to 8.3 cases per million in vaccinated subjects. In addition to these statistics, those non-vaccinated subjects were far more likely to have been sick prior to the syndrome than those who were vaccinated, further suggesting that the vaccine contained a trigger effect that was not usually present in healthy individuals.[100]

Although the vaccines were determined to be the cause for the GBS, the manufacturers were not liable to the victims, but rather the government, through the taxpayers compensated the victims.[101] Nearly 80 million dollars was awarded in damages, and it is thought that this number would have been higher if not for the federal intervention.[102] This shielding from suit is particularly relevant in light of the fact that one of the manufacturers of the vaccine made millions of the wrong kind if influenza vaccine.[103]

Viewing the National Influenza Immunization Program with hindsight, Congress, through a highly public campaign, instituted a mass vaccination program to offset an epidemic against a disease (influenza) that in its common form is not recognized as fatal, under circumstances where no epidemic actually developed. The only injuries to individuals were from the vaccination program itself. Yet, the manufacturers faced no liability for their product.

While the National Influenza Immunization Program was halted and the corresponding statute repealed, the issues and lessons learned from the Swine Flue remain prevalent today. For examples, one could foresee, after the events of September 11, 2001, a similar emergency vaccination program against smallpox, (securing a supply of smallpox vaccine in a relatively short period of time,[104] and establishing emergency health procedures[105] ). However, memory of the swine flu could give the legislators pause, remembering that not all feared epidemics come to pass, yet all vaccinations come with risks of harm.

Evaluation of Vaccine Programs :

The goal of the National Influenza Immunization Program was to protect the general population from a potentially deadly flu outbreak. However, the fact that the outbreak did not materialize eliminated the intended benefit of the program, leaving it with substantially only risks to individuals receiving the vaccinations.[106] The risks materialized into development of a debilitating, and sometimes deadly disease.[107] Therefore, looking back from the standpoint of the vaccinated individual, the risks of an increased chance in contracting a debilitating and sometimes deadly disease easily outweighed the benefit of protection from an epidemic that did not materialize. Thus from the standpoint of the individual, the program was a clear failure.

However, the individual was not the only party of interest in the program. Another significant party was the manufacturer of the vaccines. The influence of this interested party was demonstrated in its successful lobbying effort. As noted, the government, through special legislation, accepted liability for vaccinations,[108] eliminating financial risk to the manufacturer.

While the Swine Flu program was a national one, most current vaccination requirements are imposed by the state, e.g., through childhood immunization requirements prior to entering school. However, these state laws are not without influence from the federal government. Therefore, in order to evaluate current vaccine requirements imposed by the state, the analysis must with the underlying federal policy and programs. I propose evaluating these programs using a risk/benefit analysis. These factors will be evaluated for a particular vaccine or vaccine program within the relevant legal framework set forth above. Only after this policy is evaluated, can the state laws be properly understood and analyzed. I propose evaluating the state laws and programs by asking the question whether the current vaccination requirements are a valid exercise of the state police powers as delineated in the case law, in particular, under the principles articulated in Jacobson.

Vaccines in the context of Bioterrorism :

Since the acts of terror perpetrated on September 11, 2001 and the rash of anthrax that followed,[109] the public awareness of a potential bioterroist attack launched from within the United States has dramatically increased. In response, security at airports and at the boarders has been tightened and immigration laws have become more restricted.[110] Additionally, Jeffery P. Koplan, the Director of the CDC has addressed the public health response to the threat bioterrorism.[111]

Although the CDC had previously outlined steps for strengthening public health and healthcare capacity to protect the nation against bioterrorist threats,[112] since September 11, 2001 HHS Secretary Tommy Thompson has announced seven new initiatives to accelerate bioterrorism research and help strengthen the nation’s ability to deal with the public threat posed by bioterrorism.[113] These initiatives fund research investigating high-priority, “Category A” biological diseases as defined by the CDC.[114] Among these incentives is an Anthrax Vaccine Contract.

In addition to HHS action, the CDC has provided funding and direction to Lawrence Gostin, with The Center for Law and the Public’s Health at Georgetown and Johns Hopkins Universities, for the preparation of a Model State Emergency Health Powers Act (Model Act).[115] Included in the Model Act is the power for public health officials to mobilize and use all or any part of the organized militia to isolate, quarantine and force vaccination and medical treatment on citizens in states where a Governor has called a “state of emergency” for 30 days or more. Specifically, Article VI covers Protection of Persons, with Section 603 specifically covering vaccinations. Section 603 provides, during a state of public health emergency, the public health authority to vaccinate personas as protection against infectious disease and to prevent the spread of contagious or possibly contagious disease.[116] The vaccination may be performed by any qualified person, and must not be such as to be reasonably likely to lead to serious harm to the affected individual.[117] Those individuals unwilling to undergo vaccinations for reasons of health, religion or conscious may be isolated or quarantined.[118]

Is the policy of forced vaccination proposed above the most effective way to protect individuals during a public health emergency? If adopted by a state or local government, would the above provision (Section 603) be a valid exercise of the police powers? I propose that the answers to these questions are context dependent. While not all scenarios can be evaluated, or even imagined, I propose to answer these questions as they relate to specific vaccines; in particular as this proposal relates to vaccination against anthrax in light of a possible terrorist attack, and vaccination against smallpox in light of a possible terrorist attack.

Anthrax :

Anthrax infection is a disease acquired following contact with infected animals or contaminated animal products or following the intentional release of anthrax spores as a biological weapon.[119] Anthrax was developed in the second have of the twentieth century as part of biological weapons programs by several countries. The number of countries believed to have biological weapons programs has risen steadily. While it was believed 17 countries had such programs in 1995, the number of countries currently working with anthrax is uncertain.[120]

Symptoms of anthrax infection vary, however they usually occur within 7 days of exposure.[121] Serious forms of anthrax include inhalation anthrax, cutaneous anthrax, and intestinal anthrax. Initial symptoms of inhalation anthrax infection may resemble a common cold. After several days, the symptoms may progress to severe breathing problems and shock and are often fatal.[122]   Cutaneous anthrax, the most common form of anthrax infection (95%), occurs when the bacterium enters a cut or abrasion on the skin.[123] A skin infection will occur and lymph glands in the adjacent area may swell. While about 20% of untreated cutaneous anthrax cases result in deaths, deaths are rare with antibiotic treatment.[124] The intestinal disease form of anthrax may follow the consumption of contaminated food and is characterized by an acute inflammation of the intestinal tract.[125] Intestinal anthrax results in death in 25% to 60% of cases.[126] Direct person-to-person spread of anthrax is extremely unlikely, if it occurs at all. Therefore, there is no need to immunize or treat contacts of persons ill with anthrax unless they also were also exposed to the same source of infection. [127]

Antimicrobial susceptibility patterns for the anthrax bacteria isolated during the outbreak of late 2001 were determined to be susceptible to the following agents: ciprofloxacin (Cipro® ), doxycycline, rifampin, and vancomycin.[128] While there is an Anthrax vaccine, it is currently only recommended to military personnel and high risk groups. However, the department of defense routinely vaccinates military personnel with a series of six shots over an 18 month period.[129] In fact, disobedience of a superior officer’s order to be inoculated with anthrax vaccine can result in a bad-conduct discharge and confinement for 2 months.[130]

Side effects occurring with the anthrax vaccine used for military personnel include the following: mild local reaction in about 30% of men and 60% of women; moderate local reaction in 1% to 5% of the subjects; large local reactions in about 1% of subjects; muscle aches, joint aches, headaches, rash, chills, fever, nausea, loss of appetite, and malaise. Serious events requiring hospitalization occur in about 1/200,000 doses wherein the immunization series is a series of six doses.[131] However, CDC and academic partners are continuing to support the development of the next generation of anthrax vaccines.[132] The most frequent reported side effects in patients treated with intravenous Cipro® and Cipro® tablets, (the most commonly prescribed agent to treat patients exposed to anthrax), include nausea, diarrhea, vomiting, abdominal pain/discomfort, headache, rash, restlessness, CNS disturbance, local I.V. site reactions, abnormalities of hepatic enzymes, eosinophilia.[133]

Is Section 603 of the Model State Emergency Health Powers Act noted above the correct policy for the federal government to adopt (through the CDC) with regard to an anthrax vaccine? I suggest, based on the vaccine currently used by the Department of Defense, that it is not. The following factors weigh heavily against vaccinating persons as protection against anthrax disease during a state of public health emergency: the frequency of required vaccinations,[134] the adverse effects of the vaccine described above (most notably the serious events occurring in 1 of every 200,000 doses), the uncertainty of the possibility of contracting anthrax disease, and the effectiveness of the current protocol.[135]

Assuming that the vaccine had no adverse effects other than mild local swelling and low grade fever, an individual being vaccinated must be inconvenienced with these reactions a minimum of six times. However, the current vaccine is associated with serious adverse events, and they occur in with relative frequency. This frequency, when combined with the number of doses required for the vaccine to achieve the desired effectiveness, subjects the individual to a significant risk of vaccine-induced injury. Because it cannot be determined with any certainty, the likelihood of a widespread attack, these certain vaccine risks outweigh any certain benefits that can be gained through a mandatory vaccination policy. And, finally, even if a successful widespread attack were launched, the current protocol has proven to be effective, and can more efficiently deal with those exposed to the disease, while eliminating any risk to those who escaping exposure.

Furthermore, only requirement by Section 603 with regard to the vaccination is that it must not be such as to be reasonably likely to lead to serious harm to the affected individual. This is far lower standard than required under other federal laws.[136] And more than that, Section 603 has no effectiveness requirement for the vaccine, nor does it have a requirement to inform the patient of any potential risks. Additionally, because anthrax disease is not contagious the authority to isolate or quarantine those individuals unwilling to undergo vaccination lacks any logical justification and seems questionable at best.

While anthrax vaccine under the model act is not a “required childhood vaccination” and therefore would not fall under the National Childhood Vaccine Injury Act,[137] looking back to the special legislature passed with National Swine Flu Immunization Program of 1976 Act,[138] it is very likely that the manufactures would successfully lobby to Congress for a similar provision to avoid traditional tort law principles of strict liability with respect to their product. Thus it would be the federal government, through the taxpayers, who would bear the financial costs of injuries resulting for the vaccination program. Combining the arguments outlined above, all factors lead to the conclusion that a policy of mandatory vaccination against anthrax is a bad federal policy.

Aside from the question of federal policy, there remains the question of constitutionality.[139] If a state, for example Massachusetts, adopted Model State Emergency Health Powers Act, would Section 603 be a valid exercise of its police powers,[140] withstanding an as applied constitutional challenge to an anthrax vaccine? Using the principles outlined in Jacobson,[141] I suggest that Section 603 as applied to an anthrax vaccine should not be upheld as constitutional.

While the court in Jacobson did uphold the Massachusetts law requiring and enforcing vaccination and revaccination, it noted that the police power was not without limit.[142] The court held that the police power of a state must be held to embrace, at least, such reasonable regulations established directly be legislative enactment as will protect the public health and the public safety.[143] And the court went on to state that as [public health] laws went beyond the necessity of the case, violating rights secured by the Constitution, its duty was then to hold such laws invalid.

Section 603 of the Model Act as applied to an anthrax vaccine could be easily distinguished from Jacobson. The most significant distinction is that the law in Jacobson was applied to smallpox, a very contagious disease, whereas anthrax is not contagious. Secondly, when the regulation in Jacobson was passed in Cambridge, Massachusetts, smallpox was prevalent in the city, and the disease was increasing.[144] With anthrax, it remains to be seen the extent to which terrorists will be able to launch a successful widespread attack that affects a large segment of the public. And thirdly, the Court viewed the smallpox vaccine in Jacobson as an effective, if not best-known way to deal with smallpox.[145] Currently, anthrax disease can be successfully treated with antibiotics.[146]

I suggest a course of antiboitics is a superior method of dealing with anthrax disease relative to mandatory vaccinations. Like all vaccines, each anthrax vaccine comes with risk. Because the anthrax vaccine is a series of six shots followed by annual boosters, a person must subject himself to the risks of the vaccine many times over, some of which are serious, and yet that person might never be exposed to anthrax bacteria. Antibiotic treatment, on the other hand, can be limited to those individuals actually exposed to anthrax, therefore limiting unwanted side effects to only those individuals actually exposed to the disease. Because of the reasons stated above, I suggest that requiring anthrax vaccination under Section 603 of the Model Act would not be a reasonable regulation in the face of a possible bioterrorist attack, and furthermore would go beyond the necessity of the case. Therefore, Section 603, should not be adopted as a means to protect persons against the disease of anthrax.

Smallpox :

The World Health Organization declared smallpox eradicated in 1980.[147] However, smallpox did remain, at least in United States and Soviet Union labs, as leftover remains from earlier bioterrorism programs. Furthermore, there is evidence that some of the remaining virus may have been supplied from the Soviet Union to countries hostile to the United States such as Iraq, North Korea, and China.[148] In the words of Secretary of HHS, Tommy Thompson, “While the probability of an intentional release of the smallpox virus is low, the risk does exist and we must be prepared.”[149]

Smallpox is considered a highly contagious disease. However, “historically, the rapidity of smallpox contagion was generally slower than for such diseases as measles and chickenpox. Patients spread smallpox primarily to household members and friends; large outbreaks in schools, for example were uncommon.”[150] Smallpox is infectious from a day before the rash appears (about 10 to 14 days after infection) until all lesions have healed and the scabs have fallen off.[151] It is estimated that in infected person may transmit the disease to between 5 and 10 other persons in populations with no natural or vaccine-induced immunity.[152] From here is where an epidemic can begin.

Smallpox symptoms first appear during the incubation of the disease and include fever, extreme fatigue, severe headache, back pain, and sometimes, abdominal pain and vomiting. After the fever subsides, a rash appears on the face and forearms, then spreads to other parts of the body.[153] Papules (hard lumps) then form under the skin, swell, then turn into vesicles and finally turn into pustules (open skin lesions filled with pus). This phase is also often accompanied by a fever.[154] The smallpox lesions can become infected and lead to bacterial superinfections. Other complications of smallpox include conjunctivitis, bacterial pneumonia, viral arthritis, sepsis, encephalomyelitis, and osteomyelitis.[155] The CDC estimates the mortality rate of smallpox at roughly 30%.[156] Unlike anthrax, smallpox is a virus and cannot be effectively treated with antibiotics. However, the vaccinia virus vaccine given up to four days after exposure to the virus can provide protection or lessen the severity of smallpox.[157]

Is forced vaccination under Section 603 of the Model Act the correct policy for the federal government to adopt with regard to a smallpox vaccine? I suggest that this is a far closer case than that of anthrax and cannot be answered based on the disease alone, but rather also is dependent on the timing of the vaccination and the perceived emergency. On the one hand, unlike anthrax, smallpox cannot be successfully treated with antibiotics. However, as noted above, vaccination within a short period of exposure can be effective.

In a comparative evaluation of anthrax and smallpox under Section 603 of the Model Act, smallpox and anthrax share the uncertainty element regarding the chance of outbreak[158] as well adverse reactions from the vaccine. In the case of smallpox, adverse reactions include generalized vaccinia, eczema vaccinatum, progressive vaccinia, and postvaccinial encephalitis.[159] However, smallpox is distinguishable from anthrax due to its ease of transmissibility, its high mortality rate, and its established ability to ravage populations.[160]

While Section 603(a) does not distinguish between infectious diseases such as anthrax and contagious diseases such as smallpox, I suggest that the nature of the disease and its ability to spread will (or should) be a factor in the determination of a public health emergency. Furthermore, while the safety standard of Section 603(a)(2) is relatively low, only requiring the vaccine to not be reasonably likely to lead to serious harm to the affected individual, the high mortality rate combined with the lack of available treatment, aside from vaccination within four days of exposure, shifts the balance of factors towards the forced vaccination. However, the uncertainty about whether or not smallpox has been weaponized, should give the CDC pause before requiring a pre-emptive vaccination with agents having known and sometimes, severe side effects. I suggest that the Model Act, as applied to smallpox, can be rationalized as good policy only in the face of a known or imminent biological attack.

Would the adoption of Section 603 of the Model Act be a valid exercise of the police powers if adopted by, for example, Massachusetts? Because smallpox was the disease being vaccinated against in Jacobson, the legal precedence favors upholding another forced vaccination against smallpox in the face of a real threat. I suggest that the constitutionality of Section 603 as applied to smallpox would be upheld in the face of a true epidemic, as the court in Jacobson noted that smallpox was present in Cambridge and the disease was increasing.[161] While the case for forced vaccination without actual presence of the disease could be distinguished from Jacobson, the outcome of the constitutional question will likely turn on the context of the case, e.g., the court’s perception of the atmosphere of fear and the perceived likelihood of a biological attack.

An additional check on the government’s eagerness to impose mandatory smallpox vaccinations is the inadequacy of the current supply. However, a recent study released by the National Institute of Allergy and Infectious Diseases, supported diluting the current smallpox vaccine stockpile[162] to stretch the supply.[163] The study included 680 young adults with no history of smallpox vaccination, wherein 97% of all participants in the trial responded with a vaccine “take,” which suggested that the vaccine was effective.[164] While the study did not note a statistical difference in “take rate” between the diluted and undiluted stock, which is determined by the formation of a blister and subsequent scar at the injection site, the study did note a difference of adverse reactions between the two. “The undiluted vaccine caused greater inflammation at the site of the injection and more swollen glands, whereas the diluted vaccines more often caused satellite lesions.”[165] No analysis was directed towards the consequences in safety or effectiveness of the vaccine deduced from these differences in adverse reaction.

Evaluation of Childhood Vaccination Programs :

While mandatory vaccinations to defend against bioterrorism can only be discussed in the hypothetical, every state in the union requires children to be vaccinated against an increasingly large number of diseases before they can enter the public schools.[166] For example, Massachusetts requires, prior to Kindergarten, 3 doses of Hepatitis B, 5 doses of DtaP/DTP/DT/Td, 4 doses of Polio, 2 doses of Measles, 1 dose of mumps, 1 dose of rubella, and 1 dose of Varicella (chickenpox.).[167] In fact, according to the Jordan Report 2000,[168] vaccines are currently in development for roughly 100 different diseases. Among those diseases include Epstein-Barr virus, Groups A and B streptococcus, Human papillomavirus, and Herpes simplex virus types 1 and 2.[169]

As noted above, the National Childhood Vaccine Injury Act grew out of Congressional concern, that without relieving the manufacturers of liability, they would exit the vaccine market.[170] Mission accomplished. The vaccine market, including development of new vaccines, is alive and well.[171] However, this booming vaccine market has not come without costs. The Vaccine Adverse Events Reporting System, was set-up together with the National Childhood Vaccine Injury Act to require health care providers to report certain adverse events occurring after vaccination.[172] To date, upwards of 100,000 adverse events have been reported.[173] , [174] While there exists over $1 billion in the fund to compensate victims of vaccine injuries, there has also been a growing concern over the ability to recover for those injuries. In response to this concern, Congressmen Burton and Waxman, in February 2002, introduced legislation HR 3741 to improve recovery to victims. Changes include an increase length in statute of limitations, an increase in compensation from $250,000 to $300,000, and making compensation for lost wages more generous.[175]

Clearly childhood vaccines, like all vaccines, come with risks. Unlike the scenario presented above for smallpox or anthrax vaccinations, it is more difficult to trace the effects of a single vaccine on a child given that they often receive multiple shots in one visit to the pediatrician. However, the studies do suggest that vaccines can cause neurological complications,[176] and some scientists are suggesting that vaccines may be responsible for the increase rate in autoimmune diseases.[177] In addition to the concern of the vaccine itself, increasing concern has arisen regarding the adjuvants contained within the vaccines.[178]
In August 1998, the FDA announced a license for a vaccine against rotavirus.[179] In its press release, the FDA stated that approximately 80% of children develop symptoms of rotavirus before the age of five, and roughly 20-40 deaths in the U.S. annually were attributed to rotavirus.[180] The vaccine study included 7,000 infants, 2,000 who actually received the vaccine. The results indicated that the vaccine prevented at least half of all cases of rotavirus and at least 70% of the severe cases.[181]

However, less than one year following the license of RotaShield,[182] researchers linked the vaccine to a rare but dangerous bowel obstruction called intussusception.[183] One study reports that a detailed analysis of vaccinated children concluded that RotaShield caused 1 case of intussuseption in every 4670 to 9474 infants vaccinated. These numbers amount to roughly 361 and 732 cases of vaccine-caused intussusception annually.[184] The CDC subsequently recommended that healthcare providers postpone the use of the vaccine, [185] and shortly thereafter, the manufacturer voluntarily withdrew the vaccine from the market.[186] This study, together with others, suggests that the risk benefit calculation for RotaShield may have been in error.[187]

In light of the number of significant risks inherent in any vaccine and the potential for human error, why do the CDC and FDA, continue to recommend more and more vaccines against often non-serious diseases to children? Do these recommendations make good public health policies? Would these vaccine requirements withstand a constitutional challenge under the principles of Jacobson? Two of the newer vaccines in the pre-kindergarten regime include Chickenpox (Varicella) and Hepatitis B. Forty-two states now require vaccination against Hepatitis B, and twenty-seven,[188] now twenty-eight states require vaccination against Chickenpox.[189] Evaluating these vaccines as currently recommended, I suggest that neither do these recommendations make good policy, nor could these requirements withstand a constitutional challenge.

Childhood Vaccination Against Chickenpox :

Roughly 4 million cases of chickenpox are reported each year, which are linked to about 100 deaths.[190] One hundred deaths are certainly more than the number reported with rotavirus, however, the majority of these deaths occur in identifiable high risk groups such as children with leukemia, persons receiving steroids, and adults.[191] While the vaccine against chickenpox has been declared safe, side effects include pain, redness, and swelling at the injection site with roughly 20% of patients; a localized rash in about 3%-5% of patients; and a generalized varicella-like rash in 3% to 5% of patients.[192] More serious adverse events have also been reported in temporal association with varicella vaccine. These adverse events include encephalitis, ataxia, erythema multiforme, Stevens-Johnson syndrome, pneumonia, thrombocytopenia, seizures, neuropathy, and death.[193]

With these numbers, why do the American Academy of Pediatrics (AAP) and the CDC recommend the vaccine to children as young as 12 months?[194] , [195] Does this make good policy? The AAP reports a number of studies supporting the universal vaccination of children against chickenpox using a cost benefit analysis. Each of the analyses concluded that, when direct medical and indirect societal costs were considered, a routine varicella immunization program for healthy young children was cost-beneficial.[196] However, I suggest that policy makers should be very hesitant to include “indirect societal costs” when setting policy that often results in mandatory medical treatment to individuals, especially when those individuals are children. Evaluating the risks and benefits to the individual child outlined above, it seems difficult to justify a federal policy that supports the vaccination of 12 month old children against chickenpox.[197]

While I advocate limiting the risk-benefit analysis to the individual, a look into the “indirect benefits” of a vaccine program may help to shed light onto the policy set by the CDC, FDA, and other federal agencies. In particular, parties that indirectly benefit from vaccine policy include the pharmaceutical industry, the manufacturer of the vaccine[198] and those parties associated with the manufacturer. According to a report by the House of Representatives Committee on Government Reform, these interests have too much influence over the committees that help make vaccine policies.[199] In particular, the report investigated the advisory committees that recommended the rotavirus vaccine.

According to the report, the committees were aware of potential problems including bowel obstructions, failure to thrive, and high fevers; yet the committee voted unanimously to approve the vaccine.[200] Why? This unanimous vote can be better understood in light of the additional findings uncovered in the investigation, including the following: members, including the chair, of the FDC and CDC advisory committees owned stock in the company making the vaccine; individuals on both committees own patents for vaccines under consideration; three of the five members on the FDA committee had conflicts of interest, which were waived; 7 of the 15 members of the FDA advisory committee were not present at the meeting; the CDC grants conflict-of-interest waivers to every member of the advisory committee a year at a time, allowing full participation in the discussions leading up to the vote; and the CDC’s advisory committee has no public members (e.g., parents), while the FDA has just one.[201] Under these circumstances, it is difficult to imagine a scenario where a vaccine would not be recommended. However, it does help to understand how vaccines like RotaShield and VARIVAX® , end up on the recommended list, even in the face of a risk-benefit balance to the individual that is neutral at best.

While these indirect beneficiaries have a clear voice in vaccine policymaking, the National Childhood Vaccine Injury Act, gives additional incentive for these parties to exert influence the over the advisory committees. Section 300aa-14 of the act allows any party to recommend a vaccine’s inclusion on the injury table. Therefore, the manufacturer not only receives the benefit of a guaranteed (or near guaranteed) market for its product, through the recommendations of the advisory committee, it also lays a foundation to protect itself from future products liability claims through influencing the vaccine’s inclusion on the Vaccine Injury Table.

Although the CDC and FDA have the authority to implement federal vaccine policy, it is the states that actually require these vaccinations. This state requirement is implemented using the public schools as a gatekeeper. For example, the majority of the states now require the chickenpox vaccine prior to entering kindergarten. Is this a valid exercise of a state’s police power under the principles of Jacobson? I suggest that it is not, but it is rather a law going beyond the necessity of the case and violating rights secured by the Constitution.[202] While requiring chickenpox vaccinations prior to entering school is clearly a convenient manner to reach large sections of the population, convenience does not equal necessity.[203] Furthermore, although chickenpox is highly contagious, a vaccination program against chickenpox can easily be distinguished from a vaccination program against smallpox by its far lower mortality rate, 0.0025% relative to 30%. Yet, these numbers do not complete the story because the mortality rate of chickenpox significantly decreases in cases of individuals six years old and younger, which is roughly the age of children required to be vaccinated against the disease. Unlike smallpox, chickenpox among children six and younger can hardly be described as “an epidemic of disease which threatens the safety of it members.”[204]

In addition to distinguishing the chickenpox requirement from Jacobson on grounds of the severity of the disease, the case can also be distinguished based on the severity of the punishment. In Jacobson, the court upheld $5 in monetary damages, whereas with the school entry requirements, failure to vaccinate a child can result in loss of access to the public schools. This sanction seems to stretch the limits of reasonableness, but instead goes beyond was is reasonably required for the safety of the public.[205]

Finally, conflicts of interest are not limited to the federal, policymaking level. Illinois, the state most recently requiring the chickenpox vaccine for entering kindergarteners, recently passed a bill in both the house and senate that provided that a person is ineligible to serve on the Illinois Immunization Advisory committee if the person or his spouse is an officer, employee, or agent of or has any ownership or other financial interest in a pharmaceutical company that manufactures vaccines.[206] The governor vetoed the bill, stating that it would severely limit the number of pediatric disease specialists and pediatric physicians in general who would be eligible to serve on the committee.[207] His statement was confirmed by one of the committee members at the July 12, 2001 meeting, where the member exclaimed, “No infectious disease specialist will be able to serve on this committee! We all take money from pharmaceutical companies.”[208] This sort of conflict of interest at least suggests that special interests are served with a vaccine policy that recommends increasing numbers of vaccines, under the guise of exerting a police power.[209] For this reason, along with the reasons outlined above, a challenge to required vaccination against chickenpox should be strictly scrutinized and should be ultimately struck down as exceeding the bounds of the Constitution.

Childhood vaccination against Hepatitis B :

The CDC currently recommends a vaccination series against Hepatitis B (HBV), with the first dose recommended before the age of two months. HBV is spread through having sex with an infected person without using a condom, sharing needles or "works" when "shooting" drugs, or through needlesticks or sharps exposures on the job.[210] The virus can also be passed from a mother to her newborn baby during delivery (perinatal transmission).[211] In 1996, the CDC reported 10,637 new cases of individuals infected with HBV, 279 of who were below the age of 14.[212] Short term, acute HBV infection usually goes away on its own; but long term, chronic HBV infection can lead to serious diseases such as cirrhosis and liver cancer.[213] Chronic infection occurs in 90% of infants infected at birth, 60% of children between the ages of 1-5, and 6% in all other populations.[214]

Two treatments are currently available for HBV, Alpha interferon and lamivudine.[215] Alpha interferon stops the growth of the virus in 30%-40% of patients, but requires injections and has significant unpleasant side effects.[216] Lamivudine can be taken orally, however, when treatment is discontinued, the virus continues to reproduce in 70% to 80% of people.[217] Two vaccines are available for HBV, RECOMBIVAX HB® (manufactured by Merck & Co.) and Energix-B® (manufactured by GlaxoSmithKline). Vaccine-associated side effects include pain at the injection site in 3%-29% of individuals and a temperature greater than 37.7 C in 1%-6% of individuals. Additionally, surveillance of adverse reactions has shown a possible association between Guillain-Barre syndrome (GBS) and receipt of the first dose of plasma-derived hepatitis B vaccine (54, CDC unpublished data).[218]

According to the CDC, preventing HBV transmission during early childhood is important because of the high likelihood of chronic HBV infection and chronic liver disease that occurs when children less than 5 years of age become infected.[219] While this is correct, the CDC also noted that only 279 of the new cases a year occur in individuals below the age of 14. They did not indicate the number of new infections to children below the age of two months, the age at which the first dose of HBV vaccine is recommended. However, these low numbers make sense in light of the manner in which the disease is transmitted. Does the high percentage of chronic infections under circumstanced in which the incidence of infection is so low justify the CDC’s vaccination policy? Based on the number of infected individuals alone, I suggest that the CDC does not even present a valid prima facie case for supporting such a vaccination program. Therefore, without even evaluating the tradeoffs between the symptoms of the disease and the risks associated with the vaccine, I suggest that the CDC’s current policy cannot be justified.

Is requiring an HBV vaccination series prior to entering kindergarten a valid exercise of a state’s police power under the principles articulated in Jacobson? The case for mandatory HBV vaccinations in six year olds (the typical age of kindergarteners) can be easily distinguished from the facts in Jacobson. While both smallpox and HBV are contagious, HBV is not transmitted through casual contacts as is smallpox, but rather requires behaviors such as sexual intercourse or IV drug use, that result in sharing of bodily fluids. While there are always exceptions to the rule, sexual intercourse and IV drug use are not typical behaviors of six year olds. These facts are borne out in the statistics which show only a very small minority of new HBV cases occurring in children under 14, only a portion of which occur in children the age of five or six. Furthermore, while the CDC justifies early vaccination based on the higher incidence of chronic HBV, 60% in HBV positive children between the ages of 1-5, that percentage drops to 6% for all other individuals. Incidentally, it would by the individuals having roughly a 6% likelihood of chronic HBV that the state law reaches.

In light of the very low number of kindergarteners at risk of chronic HBV infection, it is difficult to justify a vaccine administered to the entire population of kindergarteners that has any risk of adverse events. Yet, as with all vaccines, adverse events are also reported with the HBV series. In fact, The National Vaccine Information Center (NVIC), reports that the number of HBV vaccine-associated serious adverse event and death reports in American children under the age of 14 outnumber the reported cases of HBV disease in that age group.[220] If challenged, it would be very difficult to prove that vaccinating six year olds is necessary to protect the public against an epidemic of (HBV) disease, which threatens the safety of its members.[221] Even upon application of some of the softer language of Jacobson, stipulating that the mandate be reasonably required to protect the public health,[222] the state would be facing a difficult burden of proof based on the available statistics. While as in chickenpox, vaccinating children prior to entering school, would be a convenient way to reach broad section of the population, convenience is not sufficient. In order to justify such an intrusion into the personal liberties of an individual, the constitution requires that the law be necessary.

Suggestions for the road ahead:

I have evaluated four vaccination programs, two in the hypothetical, and two current requirements for children entering the public schools. Only one of those vaccines, smallpox, can be arguably necessary to protect the public health. Yet these programs are representative of the direction of public health policy and state vaccine requirements.

In order to respect the personal liberties guaranteed by the Bill of Rights, yet still protect the public health, I suggest that the focus of a risk benefit analysis of any public health care program needs to be shifted back to the individual and to the public. However, currently, there is no voice for the individual or for the diffuse public on the committees that setting vaccination policy.[223] The absence of this voice gives results similar to the current chickenpox policy, in light of the fact that a parent’s refusal to vaccinate his child against chicken pox does not create significant risk to others. Therefore one place to improve policy is to include laypersons, parent of young persons in particular, on vaccination committees.

Another area for improvement is to force the vaccine companies to create their own market for the vaccine. In other words, ban mandatory vaccination programs of diseases that are not true public health threats. This may include creating a more objective standard of the term “epidemic.”

Furthermore, get rid of the National Childhood Vaccine Injury Act, but instead give those individuals injured by vaccines an opportunity to seek compensation from the party who has financially benefited from the federal policies and state laws,.

Finally, instead of passing laws that exempt manufactures from the duty of providing information about their product, this information should be legally required. Individuals receiving medical treatment deserve to be informed about that treatment,[224] and where possible, they should be able to choose to decline that treatment. In the words of Thomas Jefferson, “I know of no safe depository of the ultimate powers of the society but the people themselves, and if we think them not enlightened enough to exercise control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education.”

[*] Catherine McCarty; Food and Drug Law in combination with Third Year Writing Requirement.

[1] Thomas Jefferson, in his chapter on religion in his 1781 "Notes on the State of Virginia."

[2] Amendment X (1791). The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.

[3] James Madison, The Federalist No. 45, 292-93.

[4] James G. Hodge, Jr. 12 J.L. Health 309, 317 (1998).

[5] Women’s Community Health Center of Beaumont, Inc. v. Texas Health Facilities Commission, 685 F.2d. 974, 980, n11, citing Willson v. The Black Bird Creek Marsh Co., 27 U.S. 245, 251 (1829); Huron Portland Cement Co. v. City of Detroit, 362 U.S. 440, 442 (1960); Sporhase v. Nebraska, 458 U.S. 941 (1982); Medtronic, Inc. v. Lohr, 116 S.Ct. 2240, 2245 (1996).

[6] Supra note 4, 311.

[7] Supra note 4, 326, citing 39 AM. JUR.2D Health §22 (1968).

[8] See Lawton v. Steele , 152 U.S. 133(1894); Jew Ho v. Williamson , 103 F. 10 (C.C.N.D. Cal. 1990).

[9] See, e.g., Chy Lung v. Freeman, 92 U.S. 275, 280 (1875).


[11] Supra note 4, 312.

[12] Pub. L. No. 57-244, 32 Stat. 728 (1902).

[13] Pub. L. No. 59-384, 34 Stat. 768 (1906) (Codified at 21 U.S.C. §§ 1015 (1934) (repealed in 1938 by 21 U.S.C. §392(a) (1988)).

[14] Pub. L. No. 75-717, 52 Stat. 1040 (1938), as amended at 21 U.S.C. §§ 301 et. Seq.

[15] 42 U.S.C. 201 (1944).

[16] Supra note 3, citing JAMES A. TOEY, PUBLIC HEALTH LAW 37 (1926).

[17] Merriam Webster’s Collegiate Dictionary On-line edition. http://www.m-w.com/cgi-bin/dictionary .

[18] WILLIAM E. PAUL, FUNDAMENTAL IMMUNOLOGY, p. 1309 (3d ed., 1993). A brief history of vaccination.

[19] Historical Overview of Vaccines (Prim. Care 2001, Dec; 28(4):685-95, 685.

[20] Supra note 18 at 1309. As Voltaire recorded in 1733, in order to avoid disruption of the trade in young, beautiful maidens from Circassia to the seraglios of the Turkish Sultan and the Persian Sophy when epidemics of smallpox erupted, the Circassians inoculated in the bodies of their children ‘a pustule taken from the most regular and at the same time most favorable sort of smallpox that could be procured.’

[21] Supra note 19 at 686; See also Barbara Loe Fisher, Smallpox and Forced Vaccination: What Every American Needs to Know, The Vaccine Reaction, Published by the National Vaccine Information Center, (Winter 2002). (Many individuals were unknowingly infected with syphilis, tuberculosis and hepatitis because the biological matter from the smallpox lesions was taken from persons also suffering from those diseases. http://www.vaccinationnews.com/DailyNews/December2001/SmallpoxNVICReport.htm (Last visited April 14, 2002.)

[22] Supra note 19 at 687.

[23] Supra note 4 at 687.

[24] The Ethics of Vaccine Usage in Society: Lessons from the Past, Bazin H Endeavor 2001 Sep; 25(3):104-8, 104.

[25] Supra note 19 at 687.

[26] Supra note 24 at 104.

[27] Supra note 18 at 1310.

[28] See note 19 at 690; and See note 2 at 1310 (e.g., Salmon and Theobald Smith’s demonstration that heat-killed cultures of chicken cholera bacilli could protect pigeons against disease, Roux and Yersin’s showing that administration of a bacterium free filtrate of a culture of diptheria bacillus would induce a protective response involving the formation of antibodies that ‘neutralized’ the activity of the bacterial toxin.).

[29] World Health Organization. Office of Health Communications and Public Relations. Vaccines Can Save up to 12 Million Lives Yearly: Many New Vaccines Could be Deployed Soon. [Press Release] Press 3, January 10, 1988.

[30] CDC. Recommended Childhood immunization schedule—United States, 2002.

[31] See note 24 at page 107.

[32] Shots, or not? Medical establishment asserts need for vaccines as more parents raise questions. The Seattle Times, February 5, 2002, Tuesday Fourth Edition. Virtually all mainstream health agencies and organizations say that recommended immunizations are not only safe, but essential to the health of nearly everyone. However, the trend with parents to ask more questions and seek exemptions from required immunizations. The parents concerns are fueled by a reported British study linking the MMR vaccine to autism together with a variety of websites, such as the National Vaccine Information Center, with anti-vaccination information.

[33] The Big Question: Do Vaccinations Actually Help or Hurt Children? American Morning with Paula Zahn, CNN, Monday February 25, 2002. Discussion of a report by the Institute of Medicine studying whether the numerous immunizations received before the age of two increase the risk of contracting type one Diabetes or various infections, such as pneumonia, meningitis, and asthma. While the report sponsored by the Institute of Medicine did not concluded that the childhood vaccinations increases the risk of type one Diabetes, pneumonia, or meningitis. The representative from the National Vaccine Information Center still questioned whether vaccines could be ruled out as contributing to the doubling of asthma in the last 20 years, the doubling of learning disabilities and Attention Deficit Disorder, the tripling of Diabetes, and the increase in autism by 600 percent.

[34] Jacobson v. Massachusetts , 25 S.Ct. 358, 358-366 (1905).

[35] Id. at 359.

[36] Id. at 361.

[37] PETER BARTON HUTT & RICHARD MERRIALL, FOOD AND DRUG LAW, CASES & MATERIALS, p. 660 (2d ed. 1991). A discussion of the historical and statutory background of biologics and blood products.

[38] Supra note 34 at 362.

[39] Zucht v. King , 260 U.S. 174 (1922).

[40] See, e.g., Employment Div., Dept. of Human Resources v. Smith , 485 U.S. 660 (1988); Robinson v. California , 370 U.S. 660 (1962); Bates v. City of Little Rock , 361 U.S. 516 (1960); Falbo v. United States , 320 U.S. 549 (1944).

[41] 2 Stat. 806 (1813).

[42] H.R.Rep. No. 48, 17th Cong., 1st Sess. (1822), H.R. Rep. No. 93, 17th Cong., 1st Sess. (1822).

[43] Pub. L. No. 57-244, 32 Stat. 728 (1902).

[44] Pub. L. No. 59-384, 34 Stat. 768 (1906) (codified at 21 U.S.C. §§ 1-15 (1934) (repealed in 1938 by 21 U.S.C. § 392(a) (1988)).

[45] Pub. L. No. 75-717, 52 Stat. 1040 (1938), as amended at 21 U.S.C. §§ 301 et.seq. [referred to as FDCA].

[46] Ch. 288, 37 Stat. 309 (1912) (codified at 42 U.S.C. §§ 201 et seq. (1988)).

[47] See 42 U.S.C. § 262(i) “Biological product” defined. A virus, therapeutic serum, toxin, antitoxin, vaccine, blood...., applicable to the prevention, treatment or cure of a disease or condition of human beings. Note the statute was amended in 1970 to explicitly include vaccines. Pub. L. No. 91-515 §291, 84 Stat. 1297, 1308 (1970).

[48] 42 U.S.C. § 262(a).

[49] 42 U.S.C. § 262(a)(2)(B)(i)(I).

[50] 42 U.S.C. § 262(a)(2)(B)(i)(II).

[51] 42 U.S.C. §262(b).

[52] 42 U.S.C. 262(c).

[53] 42 U.S.C. §262(d).

[54] Wade, Division of Biologics Standards: In the matter of J. Anthony Morris, 175 Science 861 (1972); Wade, Division of Biologics Standards: Scientific Management Questioned, 175 Science 966 (1972); Wade, Division of Biologics Standards: The Boat That Never Rocked, 175 Science 1225 (1972); Wade, Division of Biologics Standards: Agency Contravenes Its Own Regulations, 176 Science 34 (1972). (Publicizing the controversy within the NIH over biologics, in particular conflicts of interests and ineffective vaccines.)

[55] 37 Fed. Reg. 12865 (June 29, 1972).

[56] 21 CFR 601.25.

[57] Id.

[58] Id.

[59] See e.g., 65 FR 31003 (May 15, 2000).

[60] 21 C.F.R. pts. 610.

[61] 42 U.S.C. §§ 300aa1-5.

[62] 42 U.S.C. § 300aa-1.

[63] 42 U.S.C. §300aa-5(a) Two of the most influential committees that influence this policy include the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the CDC’s Advisory Committee on Immunization Practices (ACIP).

[64] 42 U.S.C. § 300aa-5(b).

[65] See e.g, Combination Vaccines for Childhood Immunization MMWR 48(RR01);1-15 (May 14, 1999); Standards for Pediatric Immunization Practices MMWR 42(RR-5);001 (April 23, 1993).

[66] 42 U.S.C. §§ 300aa-10 to –33 (1989); Important federal purpose of National Childhood Vaccine Injury Act is to free manufacturers from specter of large, uncertain tort liability, and thereby keep vaccine prices fairly low and keep manufacturers in market. Schafer v. American Cyanamid Co., C.A.1 (Mass.) 1994, 20 F.3d 1 .

[67] 42 U.S.C. § 300aa-22(b)(1) (1989).

[68] Restatement (Second) of Torts § 402A (1965).

[69] Restatement (Second) of Torts § 402A, comment k.

[70] Sanzo, Vaccines and the Law, 19 Pepp. L. Rev. 29 (1991).

[71] See e.g., Ethicon, Inc. v. Parten , 520 S.W.2d. 527 (Tex. Civ. App. 1975).

[72] Davis v. Wyeth Laboratories, Inc ., 399 F.2d. 121, 131 (9th Cir. 1968).

[73] Reyes v. Wyeth Laboratories , 498 F.2d. 1264 (5th Cir. 1974).

[74] Id.

[75] Givens v. Lederle, 556 F.2d. 1341 (5th Cir. 1977).

[76] Id. at 1345.

[77] Id.

[78] Supra note 70.

[79] Id.

[80] Id. at 42.

[81] 42 U.S.C. §§ 300aa-10 to –33 (1989).

[82] 42 U.S.C. § 300aa –22.

[83] Id. (A manufacturer will not be liable if it has complied with the requirements of the Federal Food, Drug and Cosmetic Act and Section 351 of the Public Health Service Act.)

[84] 42 U.S.C. §300aa –23; Purpose of National Vaccine Injury Compensation Program is to ensure availability of childhood vaccines and to provide fair and simple compensation to those injured by such vaccines, and not to provide coverage of any vaccine- injured persons, including adults injured by nonchildhood vaccines. Charette v. Secretary of Dept. of Health and Human Services, Fed.Cl.1995, 33 Fed.Cl. 488 .

[85] 42 U.S.C. §300aa –14.

[86] Id.

[87] Id.

[88] Id.

[89] 42 U.S.C. §300aa-13.

[90] 42 U.S.C. §300aa-21(a).

[91] Hepatitis B Vaccine Safety Hearing, Opening Statement, Chairman John L. Mica; Subcommittee on Criminal Justice, Drug Policy and Human Resources Committee on Government Reform. (May 18, 1999). http://www.house.gov/reform/cj/hearings/99.5.18/mica.htm .

[92] World Health Organization. Office of Health Communications and Public Relations. [Press Release] Press 3, January 10, 1998.

[93] WILLIAM E. PAUL, FUNDAMENTAL IMMUNOLOGY, p. 1311 (3d ed., 1993).

[94] Joel Warner, The Sky is Falling: An analysis of the Swine Flu Affair of 1976. http://www.haverford.edu/biology/edwards/disease/viral_essays/warnervirus.htm .

[95] Id.

[96] Supra note 70 at 42.

[97] 42 U.S.C. §247 (1976).

[98] See Supra note 94.

[99] See Supra note 94. GBS is a rare paralytic disease, similar to polio, which causes the onset of polyneuritis, or tingling and weakness of the extremities and then some extent of paralysis. While most recover in the following months, there is a 5% fatality rate (mostly due to secondary respiratory disease or pneumonia), and 10% remain paralyzed to some extent.”

[100] Id.

[101] See Supra note 70. The government trade, removing potential products liability suit, to induce reluctant manufacturers to produce the vaccine.

[102] See Supra note 70, 94.

[103] See Supra note 94.

[104] Barbara Loe Fisher, Smallpox and Forced Vaccination: What Every American Needs to Know. Published by the National Vaccine information Center. http://www.vaccinationnews.com/DailyNews?December2001/SmallpoxNVICReport.htm

[105] The Model State Emergency Health Powers Act. (December 21, 2001). A draft for discussion prepared by: The Center for Law and the Public’s Health at Georgetown and Johns Hopkins Universities for the Center for Disease Control and Prevention.

[106] See Supra note 94.

[107] See Supra note 94.

[108] Silverstein, Arther M. Pure Politics and Impure Science: The Swine Flu Affair. Baltimore and London: The John Hopkins University Press, 1981.

[109] MMWR 50(42); 909-919, October 26, 2001. Update: Investigation of Bioterroism-Related Anthrax and Interim Guidelines for Exposure Management and Antimicrobial Therapy, October 2001. (As of October 24, investigations have identified 11 confirmed and 4 suspected cases of anthrax in the District of Columbia, Florida, New Jersey, New York City, Maryland, Pennsylvania, and Virginia.)

[110] Friday April 19, 2002, New York Times News Service. Senate Passes Bill to Increase Boarder Security, by Robert Pear. (By a unanimous vote, the Senate passed a bill Thursday to increase the security of that nation’s borders, to improve enforcement of immigration laws and to restrict the admission of visitors from countries that support terrorism.)

[111] Testimony before the Committee on Appropriations, Subcommittee on Labor, Health and Homan Services, Eduacation and Related Agencies, United States Senate. Released October 23, 2001. http://www.hhs.gov/asl/testify/t011023a.html . (Last viewed, April 19, 2002.)

[112] CDC Recommends, MMWR Vol 49, No RR04;1 , April 21, 2000 Biological and Chemical Terrorism: Strategic Plan for Preparedness and Response – Recommendations of the CDC Stratecgic Planning Workgroup. (The report sets a framework to enhance public health infrastructure, outlining five key focus areas to provide foundations for local, state, and federal planning efforts. These five focus areas are Preparedness and Prevention, Detection and Surveillance, Diagnosis and Characterization of Biological and Chemical Agents, and Response, and Communication.)

[113] HHS News, HHS Accelerates Bioterroism Research, New Programs Expedite Ideas from Concerned Scientists, released December 6, 2001. http://www.hhs.gov/news/press/2001pres/20011206a.html (Last visited April 17, 2002).

[114] The “Category A” diseases defined by the CDC are anthrax, botulism, plague, smallpox, tularemia, and viral hemorrhagic fevers.

[115] The Model State Emergency Health Powers Act, A Draft for Discussion Prepared by: The Center for Law and the Public’s Health at Georgetown and Johns Hopkins Universities For the Centers for Disease Control and Prevention [CDC] To Assist: National Governors Association [NGA], National Conference of State Legislatures [NCSL], Association of State and Territorial Health Officials [ASTHO], and National Association of County and City Health Officials [NACCHO]. Hereinafter, “Model Act.” http://publichealthlaw.net/MSEHPA/MSEHPA2.pdf (Last visited April 20, 2002)

[116] Id. at Section 603(a)(1).

[117] Id. at section 603(a)(2).

[118] Id. at Section 603(a)(3).

[119] Center for Civilian Biodefense Strategies; Anthrax. http://www.hopkins-biodefense.org/pages/agents/agentanthrax.html (Last visited April 20, 2002.)

[120] Id.

[121] CDC Public Health and Emergency Preparedness and Response, Facts about Anthrax. http://www.bt.cdc.gov/DocumentsApp/FactSheet/Anthrax/about.asp (Last visited April 20, 2002.)

[122] Id.

[123] CDC Division of Bacterial and Mycotic Diseases; Disease Information, Anthrax. http://www.cdc.gov/ncidod/dbmd/diseaseinfo/anthrax_g.htm (Last visited April 22, 2002.)

[124] Id.

[125] Supra note 120.

[126] Supra note 122.

[127] Supra note 120.

[128] MMWR 50(42);909-919. (October 26, 2001) Update: Investigation of Bioterroism-Prelated Anthrax and Interim Guidelines for Exposure Management and Antimicrobial Therapy, October 2001. (Supra Note 105)

[129] Information about Anthrax, “The Vaccine.” The Official DOD Website for the Anthrax Vaccine Immunization Program. http://www.anthrax.osd.mil/Site_Files/vaccine_info.htm (Last visited April 20, 2002)

[130] U.S. v. Washington, 54 M.J. 936 . (Along with upholding the bad-conduct discharge, the court also upheld the prosecution’s objection to prevent the defense from litigating the safety and effectiveness of the anthrax vaccine. Additionally, the court did not require that the appellant receive counseling regarding the safety and efficacy of the vaccination for the order to be lawful.)

[131] Supra note 128.

[132] CDC Public Health Emergency Preparedness and Response, FAQ’s about Anthrax. http://www.bt.cdc.gov/DocumentsApp/FAQAnthrax.asp#topic9 (Last visited April 19, 2002).

[133] Welcome to CiproUsa.com, Important Safety Considerations. http://www.ciprousa.com/ (Last visited April 20, 2002.)

[134] Center for Civilian Biodefense Strategies, Anthrax http://www.hopkins-biodefense.org/pages/agents/agentanthrax.html (Last visited April 20, 2002.) The protein-based human anthrax vaccine used by military personnel, in monkey studies was completely effective at 8 and 38 weeks, but dropped to 88% effectiveness by 100 weeks. See also Supra note 122 (Annual boosters are required for prolonged protection.)

[135] MMWR 50(42);909-919. (October 26, 2001) The current treatment protocol for adults includes initial therapy with intravenous ciprofloxacin (400 mg every 12 hrs) or intravenous doxycycline (100 mg every 12 hrs) followed by oral antimicrobial therapy when clinically appropriate. Treatment is continued for 60 days.

[136] See e.g., supra at notes 49, 50, 51 and 56.

[137] Supra note 81.

[138] Supra note 94.

[139] The Constitution is applied to the states through the 14th Amendment. (No state shall make or enforce any law abridging the privileges or immunities of citizens of the United States, nor deprive any person of life, liberty, or property without due process of law, nor deny any person within its jurisdiction the equal protection of the laws.

[140] See e.g., Gibbons v. Ogden , 9 Wheat 1, 203, 6 L. ed. 23, 71.

[141] Supra note 34.

[142] Id. at 362.

[143] Id. at 360. (Citing Gibbons v. Ogden , 9 Wheat 1, 203, 6 L. ed. 23, 71; Hannibal & St. J. R. Co. v. Husen, 95 U.S. 465, 470. 24 :/ ed/ 527. 530; Boston Beer Co. v. Massachusetts , 97 U.S. 25, 24 L. ed. 516, 520, 6 Sup. Ct. Rep. 252; Lawson v. Steele , 152, U.S. 133, 38 L. ed. 385, 14 Sup. Ct. Rep. 499.)

[144] Id. at 362.

[145] Id. at 363.

[146] CDC Smallpox Homepage; Disease of the past and protection for the future. http://www.cdc.gov/nip/smallpox/default.htm (Last visited April 21, 2002.)

[147] Id.

[148] Supra note 21. Barbara Loe Fisher, Smallpox and Forced Vaccination: What Every American Needs to Know

[149] HHS Awards $428 Million contract to produce smallpox vaccine. Acambis/Baxter will produce 155 million doses by end of 2002. HHS News Wednesday, November 28, 2001. http://www.hhs.gov/news/press/20011128.html (Last visited April 21, 2002.)

[150] Henderson DA, Inglesby TV et al. sJAMA 1999; 281: 2127-37. Smallpox as a biological weapon. (Consensus Statements of the Working Group on Civilian Biodefense).

[151] Id.

[152] World Health Organization. 2001. Smallpox; Weekly Epidemiological Record 76.

[153] Supra note 147.

[154] Supra note 147.

[155] Supra note 147.

[156] Medline plus Health Information, A service of the National Library of Medicine. Smallpox. The mortality rate of smallpox refers to the more serious form of the disease, Variola major. The less serious form of smallpox, Variola minor, has a mortality rate of less than 1%. http://www.nlm.nih.gov/medlineplus/ency/article/001356.htm (Last visited April 26, 2002.)

[157] Supra note 147.

[158] Smallpox Vaccination Policy – The Need for Dialogue. Fauci N Engl J Med 2002;10.1056/NEJMe020026. http://content.nejm.org/cgi/reprint/NEJMe020026v1.pdf (Last visited April 21, 2002.)

[159] Id.

[160] Id.

[161] Supra note 34, 362.

[162] See Isselbacher KJ, Braunwald E et al, eds. HARRISON’S PRINCIPLES OF INTERNAL MEDICINE. 13th ed. (1994), “Vaccinia virus never underwent controlled trials to establish safety and efficacy before licensing. Nevertheless, the vaccine was highly effective, despite considerable adverse effects.

[163] NIAID Study Results Support Diluting Smallpox Vaccine Stockpile to Stretch Supply. NIAID NEWS, Office of Communications and Public Health, Released Thursday March 28, 2002. http://www.niaid.nih.gov/newroom/releases/smallpox.htm .

[164] Id.

[165] Id. This comment was followed by another statement that, “Many clinicians may not realize that smallpox vaccination causes an acute illness in adults who’ve never received the vaccine before.” Roughly one third of the volunteers had adverse reactions significant enough to cause a change in their daily activities.

[166] 2002 Immunization Requirements by State, K-12, Sabin Vaccine Institute. http://www.sabin.org/map.htm (Last viewed April 24, 2002.)

[167] Massachusetts Department of Public Health, Immunization Requirements for Entry in the 2002 School and College Year.

[168] The Jordan Report 2000, Accelerated Development of Vaccines. Released by the National Institute for Allergy and Infectious Diseases. http://www.niaid.nih.gov/publications/jordan/ (Last visited April 25, 2002.)

[169] Id. at Appendix A.

[170] Supra at note 80.

[171] 37 CAWLR 321, Michael E. Horwin, Ensuring Safe, Effective and Necessary Vaccines for Children. (Spring 2001). See FN 249, citing Bruce Goldman, Why Vaccines are Hot. Large pharmaceutical companies now view vaccines as a great opportunity for growth.

[172] The Vaccine Adverse Event Reporting System Data. Guide to Interpreting Case Report Information Obtained from the Vaccine Adverse Event Reporting System (VAERS). The VARES reporting system has a significant limitation to keep in mind when interpreting the data; because it is a passive system, it is subject to underreporting. http://www.vaers.org/info.htm (Last visited April 25, 2002.)

[173] VAERS Public Data. http://www.vaers.org/data.htm (Last visited April 25, 2002.)

[174] See David A. Kessler, Introducitn MedWatch: A New Approach to Prepoerting Medication and Device Adverse Effects and Product Problems, 269 JAMA 2765 (June 2, 1993). Kessler, former FDA commissioner, writes that “only a fraction” of serious events are reported to the FDA.

[175] HR 3741 1H, National Vaccine Injury Compensation Program Improvement Act of 2002 (Introduced in the House). http://thomas.loc.gov/cgi-bin/query (Last visited April 25, 2002.)

[176] See e.g., Dr. Wakefield’s Latest: MMR and AutismDr. Wakefield has long been an advocate regarding MMR’s causal relationship to autism. http://www.mercola.com/1999/sep/12/mmr_and_autism.htm (Last visited April 28, 2002.)

[177] Autoimmunity: Vaccines alter risk of many autoimmune diseases. (Summary of some of the literature supporting a connection of vaccines with the increased incidence of autoimmune diseases.) http://www.vaccines.net/autoimmu.htm (Last visited April 28, 2002.)

[178] See e.g., Viera Scheibner; Adverse Effects Of Adjuvants In Vaccines. The literature suggests come vaccine adverse events are related to adjuvants contained in those vaccines such as Mercury and Aluminum. http://www.whale.to/vaccine/adjuvants.html (Last visited April 28, 2002.)

[179] HHS News, released August 31, 1998. New Oral Rotavirus Vaccine Helps Prevent Severe Childhood Diarrhea and Vomiting.

[180] Id.

[181] Id. (The trials were conducted in the U.S. as well as abroad.)

[182] Rotashield is the trade name for the rotavirus vaccine and was licensed to Wyeth Ayerst Laboratories.

[183] Jon Cohen, Science, Vol 293, pp. 1576-77 (August 31, 2001). Intussesception can usually be corrected with a barium enema, but it sometimes requires surgery and, if left untreated, can be fatal. No intussesception related deaths were contributed to RotaShield.

[184] Murphy, N Engl J Med 2001; 344:564-572, Feb. 22, 2001. Intessusception Among Infants Given an Oral Rotavirus Vaccine.

[185] MMWR 48(43);1007, November 5, 1999, Withdrawal of Rotavirus Vaccine Recommendation.

[186] Wyeth Lederle Vaccines withdrew the vaccine in October, 1999.

[187] Supra note 184.

[188] Supra note 165.

[189] Chicago Tribune, April 11, 2002. Chickenpox Shot is Added to the list of Required Vaccines. (Illinois was the most recent state to mandate chickenpox vaccine prior to entering kindergarten. The requirement officially takes effect July 1, 2002.)

[190] CDC National Immunization Program, Varicella Disease (Chickenpox). http://www.cdc.gov/nip/diseases/varicella/faqs-gen-disease.htm (Last visited April 27, 2002.) This is equivalent to a roughly 0.0025% chance of death.

[191] See Kristine M. Severyn, R.Ph., Ph. D. ACTIVISM Chickenpox vaccine: Does everyone need it? http://www.all.org/acitivsm.pox01.htm (Last visited April 26, 2002.) (For example, while adults comprise only 2% of chickenpox cases, they are responsible for 47.5% of deaths from chickenpox.)

[192] See Pediatrics Vol. 105, Number 1, Jan. 2001, pp. 136-141. Policy Statement, Varicella Vaccine Update. (RE9941) http://www.aap.org/policy/re9941.html (Last visited April 27, 2002.)

[193] Id.

[194] American Academy of Pediatrics, Committee on Infectious Diseases. Recommendations for the use of live attenuated varicella vaccine. Pediatrics. 1995;95:791-796.

[195] Centers for Disease Control and Prevention. Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 1996;45(RR-11):1-36.

[196] Supra note 193. Citing Lieu TA, Cochi SL, Black SB, et al. Cost-effectiveness of a routine varicella vaccination program for US children. JAMA. 1994; 271:375-381; Huse DM, Meissner HC, Lacey MJ, Oster G. Childhood vaccination against chickenpox: an analysis of benefits and costs. J Pediatr. 1994;124:869-874; and Beutels P, Clara R, Tormans G, Van Doorslaer E, Van Damme P. Costs and benefits of routine varicella vaccination in German children. J Infect Dis. 1996;174(suppl 3):S335-S341.

[197] Due to the current shortage of the vaccine, the CDC has set out interim guidelines, which suggest vaccinating the child at age 18-24 months. See. CDC. Prevention of varicella: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1996;45(No. RR11). CDC. Prevention of varicella: update recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1999;48(No.RR6).

[198] The chickenpox vaccine was licensed in 1995 and is manufactured by Merck & Co. under the trade name VARIVAX® .

[199] United States House of Representatives Committee on Government Reform, “FACA: Conflicts of Interest and Vaccine Development: Preserving the Integrity of the Process.” (Thursday, June 15, 2000) Opening Statement by Chairman Dan Burton.

[200] Id.

[201] Id.

[202] Supra note 34 at 362.

[203] Supra note 34 at 362.

[204] Supra note 34 at 362.

[205] Supra note 34 at 362.

[206] See Phyllis Schlafly, Follow the money on vaccines. September 5, 2001. Senate Bill 1304.http://www.vaccinationnews.com/DailyNews/September2001/FollowTheMoneyOnVax.htm (Last visited April 27, 2002.)

[207] Id.

[208] Id.

[209] Supra note 34 at 362.

[210] U.S. Centers for Disease Control and Prevention (2001). Viral hepatitis B fact sheet. http://www.cdc.gov/ncidod/diseases/hepatitis/b/fact.htm (Last visited April 27, 2002.)

[211] See WebMd Health, Hepatitis B. http://my.webmd.com/encyclopedia/article/2949.375 (Last visited April 27, 2002.)

[212] Subcommittee on Criminal Justice, Drug Policy and Human Resources Committee on Government Reform. Hepatitis B Vaccine Safety Hearing, Opening Statement by Chairman John L. Mica (May 18, 1999) http://www.house.gov/reform/cj/hearings/99.5.18/mica.htm (Last visited April 10, 2002.)

[213] Supra note 212.

[214] Supra note 211.

[215] Supra note 212.

[216] Supra note 212.

[217] Supra note 212.

[218] CDC; Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 40(RR-13);1-19 (November 22, 1991).

[219] Id.

[220] National Vaccine Information Center Press Release; Hepatitis B Vaccine Reaction Reports Outnumber Reported Disease Cases In Children According To Vaccine Safety Group. http://www.909shot.com/PressReleases/prhepb012799.htm (Last visited April 27, 2002.)

[221] Supra note 34 at 362.

[222] Supra note 34 at 362.

[223] Supra note 199.

[224] See e.g., Cobbs v. Grant P.2d 1 .