Vaccination policy

Vaccination policies aim to produce immunity to preventable diseases. Besides individual protection from getting ill, some vaccination policies also aim to provide the community as a whole with herd immunity. Herd immunity refers to the idea that the pathogen will have trouble spreading when a significant part of the population has immunity against it, reducing the effect an infectious disease has on society. This protects those unable to get the vaccine due to medical conditions, such as immune disorders.^[8] However, for herd immunity to be effective in a population, a majority of those who are vaccine-eligible must be vaccinated.^[9]

Vaccine-preventable diseases remain a common cause of childhood mortality with an estimated three million deaths each year.^[10] Each year, vaccination prevents between two and three million deaths worldwide, across all age groups, from diphtheria, tetanus, pertussis and measles.^[11]

With some vaccines, a goal of vaccination policies is to eradicate the disease – disappear it from Earth altogether. The World Health Organization (WHO) coordinated the effort to eradicate smallpox globally through vaccination, the last naturally occurring case of smallpox was in Somalia in 1977.^[12] Endemic measles, mumps and rubella have been eliminated through vaccination in Finland.^[13] On 14 October 2010, the UN Food and Agriculture Organization declared that rinderpest had been eradicated.^[14] The WHO is currently working to eradicate polio,^[15] which was eliminated in Africa in August 2020 and remained only in Pakistan and Afghanistan at the time.^[16]

The likely behavior of individuals when offered vaccines can be modeled economically using ideas from game theory.^[17] According to such models, individuals will attempt to minimize the risk of illness, and may seek vaccination for themselves or their children if they perceive a high threat of disease and a low risk to vaccination.^[18] However, if a vaccination program successfully reduces the disease threat, it may reduce the perceived risk of disease enough so that an individual's optimal strategy is to encourage everyone but their family to be vaccinated, or (more generally) to refuse vaccination once vaccination rates reach a certain level, even if this level is below that optimal for the community.^[19][20] For example, a 2003 study predicted that a bioterrorist attack using smallpox would result in conditions where voluntary vaccination would be unlikely to reach the optimum level for the U.S. as a whole,^[21] and a 2007 study predicted that severe influenza epidemics cannot be prevented by voluntary vaccination without offering certain incentives.^[22]

Governments often allow exemptions to mandatory vaccinations for religious or philosophical reasons, but decreased rates of vaccination may cause loss of herd immunity, substantially increasing risks even to vaccinated individuals.^[23] However, mandatory vaccination policies raise ethical issues regarding parental rights and informed consent.^[24]

Fractional dose vaccination is a strategy that trades societal benefit for individual vaccine efficacy,^[25] has proven to be effective in randomized trials in poverty diseases,^[26][27] and in epidemiologic models^[28] was thought to hold a significant potential for shortening the COVID-19 pandemic when vaccine supply is limited.^[25]

At various times, governments and other institutions have established policies requiring vaccination with the aim of reducing the risk of disease. An 1853 law required universal vaccination against smallpox in England and Wales, with fines levied against people who did not comply.^[29] These policies stirred resistance from a variety of groups, collectively called anti-vaccinationists, who objected on ethical, political, medical safety, religious, and other grounds.^[30] In the United States, the Supreme Court ruled in Jacobson v. Massachusetts (1905) that states have the authority to require vaccination against smallpox during a smallpox epidemic.^[31] All fifty U.S. states require that children be vaccinated to attend public school,^[32] although 47 states provide exemptions based on religious or philosophical beliefs.^[33] In the European Union, the 2021 case of Vavřička and Others v. the Czech Republic,^[34] decided by the European Court of Human Rights (ECtHR), held that the nation of the Czech Republic did not violate the European Convention on Human Rights by imposing a vaccination mandate on children in that country.^[35][36]

Forced vaccination (as opposed to fines or refusal of services) is rare, and typically happens only as an emergency measure during an outbreak. This has been reported in parts of China.^[37] Compulsory vaccinations greatly reduce infection rates for the diseases they protect against.^[29]

Common objections included the argument that governments should not infringe on individuals' freedom to make medical decisions for themselves or their children, or claims that proposed vaccinations were dangerous.^[30] Many modern vaccination policies allow exemptions for people with compromised immune systems, allergies to vaccination components, or strongly held objections.^[38]

In 1904, in the city of Rio de Janeiro, Brazil, following an urban renewal program that displaced many poor, a government program of mandatory smallpox vaccination triggered the Vaccine Revolt, several days of rioting with considerable property damage and a number of deaths.^[39]

Compulsory vaccination is a difficult policy issue, requiring authorities to balance public health with individual liberty:

Vaccination is unique among de facto mandatory requirements in the modern era, requiring individuals to accept the injection of medicine or medicinal agent into their bodies, and it has provoked a spirited opposition. This opposition began with the first vaccinations, has not ceased, and probably never will. From this realisation arises a difficult issue: how should the mainstream medical authorities approach the anti-vaccination movement? A passive reaction could be construed as endangering the health of society, whereas a heavy-handed approach can threaten the values of individual liberty and freedom of expression that we cherish.^[30]

An ethical dilemma may emerge when health care providers attempt to persuade vaccine-hesitant families towards receiving vaccinations as this persuasion may lead to violating their autonomy.^[9] Investigation of different types of vaccination policy finds strong evidence that standing orders and allowing healthcare workers without prescription authority (such as nurses) to administer vaccines in defined circumstances increase vaccination rates, and sufficient evidence that requiring vaccinations before attending child care and schools also does so.^[40] There is also evidence that mandatory vaccination policies for healthcare workers, for instance for influenza shots, increase uptake.^[41] One argument among public health professionals is that compulsory vaccination is necessary in severe circumstances, but that it should be approached carefully in order to avoid polarizing the population and decreasing trust in the long term.^[42]

Many countries (Canada, Germany, Japan, and the United States) have specific requirements for reporting vaccine-related adverse effects; others (Australia, France, and the United Kingdom) include vaccines under their general requirements for reporting injuries associated with medical treatments.^[43] A number of countries have both compulsory vaccination and national programs for the compensation of injuries alleged to have been caused by a vaccination.^[44]

In November 2021, during a COVID-19 outbreak, Austria banned unvaccinated individuals from leaving their home apart from going to work, buying essential supplies, or exercise, in an effort to reduce the spread of disease.^[45] During the fourth wave of the COVID-19 pandemic, with a low vaccination rate compared to the rest of Western Europe (79%), the Austrian government made vaccination mandatory.^[46][45]

Medical ethicist Arthur Caplan argues that children have a right to the best available medical care, including vaccines, regardless of parental opinions toward vaccines, saying, "Arguments about medical freedom and choice are at odds with the human and constitutional rights of children. When parents won't protect them, governments must."^[47][48] However, government entities, such as Child Protective Services, can intervene only when the parents directly harm their child via abuse or neglect, considering a child does not have the ability to give or take away consent. Although withholding medical care meets the criteria of abuse or neglect, refusing vaccinations does not, as the child is not being harmed directly.^[49]

To prevent the spread of disease by unvaccinated individuals, some schools and doctors' surgeries have prohibited unvaccinated children from being enrolled, even where not required by law.^[50][51] Doctors who refuse to treat unvaccinated children harm both the child and public health, and may be considered unethical when parents are unable to find another provider.^[52] Opinion on this is divided, with the largest professional association, the American Academy of Pediatrics, saying that exclusion of unvaccinated children may be an option under narrowly defined circumstances.^[53]

One historical example is the 1990–91 Philadelphia measles outbreak, which led to the deaths of nine children in an anti-vaccination faith healing community. Court orders were obtained to have infected children given life-saving medical treatment, against the wishes of their parents, and also for healthy children to be vaccinated without parental consent.^[54][55]

Vaccination requirements for access to daycare and schools increase vaccine uptake in the United States and there is evidence that these requirements may decrease disease.^[56]: 661 However, the majority of studies of mandatory vaccination took place in the US and the cultural climate in United States is quite different from other industrialized nations.^[56]: 665 A study shows that many Europeans countries have whooping cough vaccination rates as high as those in the United States despite no mandates.^[57][58] Canada has a similar vaccination to the US despite 11 of its provinces and territories having no vaccine mandates, which may in part be due to vaccination programs taking place in school in Canada.^[56]: 664

In the United Kingdom, children are not vaccinated against chickenpox despite the availability of a vaccine since the 1990s. Modelling predicted that vaccinating children would increase the number of cases amongst adults due to the absence of natural boosting from exposure to chickenpox in day-to-day life. The Joint Committee on Vaccination and Immunisation were concerned that more pregnant women would become infected because immunity in the general population would decrease .^[59]: 10

Vaccination policy is typically proposed by national^[60][61] or supranational^[62] advisory committees on immunization, and in many cases, is regulated by the government.^[63]

Predictive vaccination strategy models^[64] play an important role in predicting effectiveness of vaccination strategies at population level. The may, e.g., compare the sequence of age groups to be vaccinated and study the outcome in terms of caseload, deaths, length of a pandemic,^[65] healthcare system load,^[66] and economic impact.^[67]

The promotion of high levels of vaccination produces the protective effect of herd immunity as well as positive externalities in society.^[68] Large scale vaccination is a public good, in that the benefits obtained by an individual from large scale vaccination are both non-rivalrous and non-excludable, and given these traits, individuals may avoid the costs of vaccination by "free-riding"^[68] off the benefits of others being vaccinated.^[68][69][70] The costs and benefits to individuals and society have been studied and critiqued in stable and changing population designs.^[71][72][73] Other surveys have indicated that free-riding incentives exist in individual decisions,^[74] and in a separate study that looked at parental vaccination choice, the study found that parents were less likely to vaccinate their children if their children's friends had already been vaccinated.^[75]

Trust in vaccines and in the health system is an important element of public health programs that aim to deliver life-saving vaccines. Trust in vaccination and health care is an important indicator of government work and the effectiveness of the social policy. The success in overcoming diseases and in vaccination depends on the level of trust in vaccines and health care. The lack of trust in vaccines and immunization programs can lead to vaccine refusal, risking disease outbreaks, and challenging immunization goals in high- and low-income settings. Today, the medical and scientific communities obviously face a big challenge where vaccines are concerned, namely enhancing the trust with which the general public regards the entire endeavor. Indeed, earning the public's trust in public health is a big challenge. Accurately, studying the trust in vaccines, and understanding the factors that affect the reduction of trust, allows authorities to build an effective vaccine campaign and communication strategies to fight the disease. Trust is a key parameter to work with before and while undertaking any vaccine campaigns. The state is responsible for providing smart communication, and to inform a population about diseases, vaccines, and the risks of both. The WHO recommends that states work long-term, to build population resilience against vaccine myths and scares, to develop a strong campaign that is well prepared to respond to any event that may erode trust, and respond immediately to any event which may erode trust in health authorities.^[76] A review of 34 studies into communication strategies to tackle untruths about vaccines has also suggested strategies that are helpful, such as communicating scientific consensus and using humour to dispel myths, and unhelpful, such as scare tactics. ^[77][78]

The first economic analysis of routine childhood immunizations in the United States took place in 2001, and reported cost savings over the lifetime of children born that year.^[79] Other analyses of the economic costs and potential benefits to individuals and society have since been evaluated.^[80][81] In 2014, the American Academy of Pediatrics published a decision analysis that evaluated direct costs, such as program costs, vaccine cost, administrative burden, negative vaccine-linked reactions, and transportation time lost to parents.^[81] The study focused on several communicable diseases, including diphtheria, tetanus, pertussis, measles, hepatitis A and B, and varicella (chickenpox), but did not include seasonal flu vaccines. Estimated costs and benefits were adjusted to 2009 dollars and projected over time at three percent interest.^[81] Of the theoretical group of 4,261,494 babies, beginning in 2009, who had followed a standard childhood immunization schedule under the Advisory Committee on Immunization Practices guidelines "will prevent ~42,000 early deaths and 20 million cases of disease, with net savings of $13.5 billion in direct costs and $68.8 billion in total societal costs, respectively."^[81] In the United States, and in other nations,^[82][83][84] there is an economic incentive and "global value" to invest in preventive vaccination programs, especially in children as a means to prevent early infant and childhood deaths.^[85] Socioeconomic disparities have been found to hinder reasonable access to vaccinations in the U.S., and it has also been found that even if such status is not a factor, "racial ethnic minority adults are less likely than whites to receive preventive care including vaccination".^[86][87]

There is an economic incentive to establish vaccination programs for older adults as the general population is aging due to increasing life expectancy and decreasing birth rates.^[88] Vaccinations can reduce the issues linked with both polypharmacy and antibiotic-resistant bacteria in the older demographic with comorbidities by preventing infectious diseases and decreasing the necessity of polypharmacy and antibiotics.^[89][90] One 2016 study done in Western Europe found that the estimated cost of vaccinating one person over a lifetime against 10–17 potentially debilitating pathogens would be €443–3,395 (equivalent to €544–4,172 in 2023).^[91] Another study found that if 75% of adults over 65 were vaccinated against seasonal influenza, 3.2–3.8 million cases and 35,000–52,000 influenza-related deaths could be avoided, and €438–558 million saved annually, solely on the European continent.^[92]

In 2006, the World Health Organization and UNICEF created the Global Immunization Vision and Strategy (GIVS). This organization created a ten-year strategy with four main goals:^[93]

• to immunize more people against more diseases
• to introduce a range of newly available vaccines and technologies
• to integrate other critical health interventions with immunization
• to manage vaccination programmes within the context of global interdependence

The Global Vaccination Action Plan was created by the World Health Organization and endorsed by the World Health Assembly in 2012. The plan, which is set from 2011 to 2020, is intended to "strengthen routine immunization to meet vaccination coverage targets; accelerate control of vaccine-preventable diseases with polio eradication as the first milestone; introduce new and improved vaccines and spur research and development for the next generation of vaccines and technologies."^[94]

In December 2018, Argentina enacted a new vaccine policy requiring all persons who are medically able, both adults and children, to be vaccinated against specified diseases. Proof of vaccination is required to attend any level of school, file for a marriage license, and request any kind of government ID, including a passport or driver's license. The law requires the government to pay for all aspects of vaccinations and deems vaccination to be a national emergency; vaccines are exempt from internal and customs taxes.^{[134][135][95][96]}

In an effort to boost vaccination rates in Australia, the Australian Government decided, starting on 1 January 2016, certain benefits (such as the universal "Family Allowance" welfare payments for parents of children) would no longer be available for conscientious objectors of vaccination. Those with medical grounds for not vaccinating continue to receive such benefits.^[137] The policy is supported by a majority of Australian parents as well as the Australian Medical Association (AMA) and Early Childhood Australia. In 2014, about 97 percent of children under seven were vaccinated, although the number of conscientious objectors to vaccination had increased by 24,000 to 39,000 in the previous decade.^[138]

The government began the Immunise Australia Program to increase national immunization rates.^[139] They fund a number of different vaccinations for certain groups of people. The intent is to encourage the most at-risk populations to get vaccinated.^[140] The government maintains an immunization schedule.^[141]

In most states and territories, children can consent to vaccinations if they are judged Gillick competent; normally, this applies to children aged 15 or older.^[142] In South Australia, the Consent to Medical Treatment and Palliative Care Act 1995 allows children 16 and older to consent to medical treatment.^[143] Additionally, children under this age can be immunized if judged capable of informed consent.^[143] In New South Wales, children can consent to medical treatment at the age of 14.^[143]

When several COVID-19 vaccines were nearing completion in November 2020, Australian Prime Minister Scott Morrison announced that all international travelers who fly to Australia without proof of a COVID-19 vaccination would be required to quarantine at their own expense.^[144]

It is also lawful for workplaces in Australia to mandate vaccines. The legality of this was upheld in the Fair Work Commission case Kimber v Sapphire Coast Community Aged Care Ltd in 2021.^[145]

Austrian vaccine recommendations are developed by the National Vaccination Board (German: Nationales Impfgremium), which is part of the Federal Ministry of Social Affairs, Health, Care and Consumer Protection.^[146]

Children aged 14 and older can be vaccinated without parental consent.^[147]

Vaccinating children has been mandatory in Brazil since 1975, when the federal government instituted the National Immunization Program.^[148] The compulsory character was written into law in 1990, in the Statute of Children and Adolescents (Art. 14, Para. 1).^[149] Parents in Brazil who don't take their children to be vaccinated run the risk of being fined or charged with negligence.^[150]

Vaccination in Canada is voluntary.^[112] While vaccination is generally required to attend school in Ontario and New Brunswick, there are exemptions given to those who are opposed.^[112]

Under the mature minor doctrine, minors capable of granting informed consent can be vaccinated without parental approval.

China has passed the World Health Organization's (WHO) regulatory vaccine assessments, demonstrating that they adhere to international standards.^[155] The Chinese government's Expanded Program on Immunization (EPI) was created in 1978 and provides certain obligatory vaccines, named Category 1 vaccines, for free to all children up to 14 years of age. Initially, the vaccines consisted of Bacillus Calmette-Guérin (BCG) vaccine, oral polio vaccine (OPV), measles vaccine (MV) and diphtheria, tetanus and pertussis (DPT vaccine).^[156] By 2007, the vaccine list was expanded to include hepatitis A, hepatitis B, Japanese encephalitis, A + C meningococcal polysaccharide, mumps, Rubella, hemorrhagic fever, anthrax, and leptospirosis.^[157] Category 2 vaccines, such as the rabies vaccine, are private-sector, non-obligatory vaccines that are not included in neither EPI nor the government health insurance.^[158] Due to the privatized nature of Category 2 vaccines, these vaccinations are associated with low coverage rates.^[159]

Both the Changsheng Bio-Technology Co Ltd and the Wuhan Institute of Biological Products have been fined for selling ineffective vaccines.^[160][161] In December 2018, China enacted new laws imposing strict controls over the production and inspection of aspects of vaccine production from research, development, and testing through production and distribution.^[162][163]

In November 2021, Costa Rica added COVID-19 to the list of infectious diseases required to be vaccinated against. The vaccine is mandatory for children between the ages of 5 and 18.^[164]

In France, the High Council of Public Health is in charge of proposing vaccine recommendations to the Minister of Health. Each year, immunization recommendations for both the general population and specific groups are published by the Institute of Epidemiology and Surveillance.^{[france 1]} Since some hospitals are granted additional freedoms, there are two key people responsible for vaccine policy within hospitals: the Operational physician (OP), and the Head of the hospital infection and prevention committee (HIPC).^{[france 1]} Mandatory immunization policies on BCG, diphtheria, tetanus, and poliomyelitis began in the 1950s and policies on Hepatitis B began in 1991. Recommended but not mandatory suggestions on influenza, pertussis, varicella, and measles began in 2000, 2004, 2004, and 2005, respectively.^{[france 1]} According to the 2013 INPES Peretti-Watel health barometer, between 2005 and 2010, the percentage of French people between 18 and 75 years old in favor of vaccination dropped from 90% to 60%.^{[citation needed]}

Since 2009, France has recommended meningococcus C vaccination for infants 1–2 years old, with a catch up dosage up to 25 years later. French insurance companies have reimbursed this vaccine since January 2010, at which point coverage levels were 32.3% for children 1–2 years and 21.3% for teenagers 14–16 years old.^[169] In 2012, the French government and the Institut de veille sanitaire launched a 5-year national program to improve vaccination policy. The program simplified guidelines, facilitated access to vaccination, and invested in vaccine research.^[170] In 2014, fueled by rare health-related scandals, mistrust of vaccines became a common topic in the French public debate on health.^[171] According to a French radio station, as of 2014, three to five percent of kids in France were not given the mandatory vaccines.^[171] Some families may avoid requirements by finding a doctor willing to forge a vaccination certificate, a solution which numerous French forums confirm. However, the French State considers "vaccine refusal" a form of child abuse.^[171] In some instances, parental vaccine refusals may result in criminal trials. France's 2010 creation of the Question Prioritaire Constitutionelle (QPC) allows lower courts to refer constitutional questions to the highest court in the relevant hierarchy.^{[france 2]} Therefore, criminal trials based on vaccine refusals may be referred to the Cour de Cassation, which will then certify whether the case meets certain criteria.^{[france 2]}

In May 2015, France updated its vaccination policies on diphtheria, tetanus, acellular pertussis, polio, Haemophilus influenzae b infections, and hepatitis B for premature infants. As of 2015, while failure to vaccinate is not necessarily illegal, a parent's right to refuse to vaccinate his or her child is technically a constitutional matter. Additionally, children in France cannot enter schools without proof of vaccination against diphtheria, tetanus, and polio.^[172] French Health Minister, Marisol Touraine, finds vaccinations "absolutely fundamental to avoid disease," and has pushed to have trained pharmacists and doctors administer vaccinations.^[172] Most recently, the Prime Minister's 2015–2017 roadmap for the "multi-annual social inclusion and anti-poverty plan" includes free vaccinations in certain public facilities.^[173] Vaccinations within the immunization schedule are given for free at immunization services within the public sector. When given in private medical practices they are reimbursed at 65%.

In Germany, the Standing Committee on Vaccination (STIKO) is the federal commission responsible for recommending an immunization schedule. The Robert Koch Institute in Berlin (RKI) compiles data of immunization status upon the entry of children at school, and measures vaccine coverage of Germany at a national level.^[174] Founded in 1972, the STIKO is composed of 12–18 volunteers, appointed members by the Federal Ministry for Health for 3-year terms.^[175] Members include experts from many scientific disciplines and public health fields and professionals with extensive experience on vaccination.^[176] The independent advisory group meets biannually to address issues pertaining to preventable infectious diseases.^[177] Although the STIKO makes recommendations, immunization in Germany is voluntary and there are no official government recommendations. German Federal States typically follow the Standing Vaccination Committee's recommendations minimally, although each state can make recommendations for their geographic jurisdiction that extends beyond the recommended list.^[174] In addition to the proposed immunization schedule for children and adults, the STIKO recommends vaccinations for occupational groups, police, travelers, and other at risk groups.^[174]

Vaccinations recommendations that are issued must be in accordance with the Protection Against Infection Act (Infektionsschutzgesetz), which regulates the prevention of infectious diseases in humans.^[178] If a vaccination is recommended because of occupational risks, it must adhere to the Occupational Safety and Health Act involving Biological Agents.^[179] Criteria for the recommendation include disease burden, efficacy and effectiveness, safety, feasibility of program implementation, cost-effectiveness evaluation, clinical trial results, and equity in access to the vaccine.^[176] In the event of vaccination-related injuries, federal states are responsible for monetary compensation.^[179] Germany's central government does not finance childhood immunizations, so 90% of vaccines are administered in a private physician's office and paid for through insurance. The other 10% of vaccines are provided by the states in public health clinics, schools, or day care centers by local immunization programs.^[174] Physician responsibilities concerning immunization include beginning infancy vaccination, administering booster vaccinations, maintaining medical and vaccination history, and giving information and recommendations concerning vaccines.^[179]

Children aged 15 and over can legally consent to being vaccinated, even if their parents expressly object, provided the child gives the impression of being mature, informed, and capable of understanding the risks and benefits of their decision.^[180][181]

Beginning in March 2020, Germany made the measles vaccine compulsory for all children attending school or day care, as well persons employed at schools, day cares, and medical or community facilities.^[182]

As of January 2022, COVID-19-vaccination is mandatory for staff and students of secondary and tertiary education, employees in all arms of government, health workers, security personnel, and commercial drivers.^[117]

In the Republic of Ireland, childhood vaccination (up to age 16) requires the consent of the parents. The Department of Health strongly recommend vaccinations.^[183]