(See:Vaccine)
Early Examples in the History of Vaccination
Edward Jenner, a country doctor living in Berkeley (Gloucestershire), England, in 1796 is said to have performed the world’s first vaccination.[1] He had heard the tales that dairymaids were protected from smallpox after having suffered from cowpox. Jenner concluded that cowpox not only protected against smallpox, but also could be transmitted from one person to another as a deliberate mechanism of protection. In May 1796, Edward Jenner found a young dairymaid, Sarah Nelms, who had fresh cowpox lesions on her hands and arms. On May 14, 1796, using matter from Nelms' lesions, he inoculated an 8-year-old boy, James Phipps. The boy developed mild fever and discomfort as a result of the inoculation. Nine days after the procedure he felt cold and had lost his appetite, but on the next day he was reportedly much better. In July 1796, Jenner inoculated the boy again, this time with matter from a fresh smallpox lesion. No disease developed, and Jenner concluded that protection was complete.[2]
Until French chemist Louis Pasteur developed a rabies vaccine in 1885, vaccines included only cowpox inoculation for smallpox. Although, what Pasteur actually produced was a rabies antitoxin that functioned as a post-infection antidote due to long incubation period of the rabies germ, he expanded the term beyond its Latin association with cows and cowpox to include all inoculating agents.[3] Is it said that we have Pasteur to thank for today’s definition of vaccine as a “suspension of live (usually attenuated) or inactivated microorganisms (e.g., bacteria or viruses) or fractions thereof administered to induce immunity and prevent infectious disease or its sequelae.” [4]
In 1798, the United States created the Marine Health Service, the nation’s first public health agency. This agency provided hospital care for merchant seamen and protected port cities against diseases such as smallpox, cholera, and yellow fever. In 1893, city and state public health departments began mass production of diphtheria anti-toxin, following its introduction in European laboratories. On April 5, 1902, following the death of 22 children from contaminated vaccinations, the government passed the Biologics Control Act to ensure purity of biological treatments. In 1927, the Bacille Calmette-Guerin (BCG) vaccine was first used in newborns, representing the only vaccine against tuberculosis. President John F. Kennedy signed the Vaccination Assistance Act into law in 1962, which allowed the CDC to support mass immunization campaigns and to initiate maintenance programs. Following this act, in 1963, the Federal Immunization Grant Program was established. This grant provided funds to purchase vaccines and to support basic functions of an immunization program. In 1964, the Immunization Practices Advisory Committee (ACIP) was formed to review the recommended childhood immunization schedule, and two years later, in 1966, the CDC announced the first national measles eradication campaign.
Jumping forward to 1986, the National Childhood Vaccine Injury Act was enacted by Congress. This helped the Department of Health and Human Services establish the Vaccine Adverse Event Reporting System (VAERS), to accept all reports of suspected adverse events, in all age groups, after the administration of any U.S.- licensed vaccine. Later in 1988, the National Vaccine Injury Compensation Program (NVICP) was established to provide compensation following a vaccine-related adverse event that resulted in injury or death. NVICP was intended to serve as an alternative to civil litigation.
Later, the Vaccines for Children Program was established after passage of the Omnibus Budget Reconciliation Act of 1993. This act made vaccinations affordable for those in a lower socio-economic-status. The National Immunization Program (NIP) was created to establish to provide federal leadership and services to all local and state public health departments involved in immunization activities.[5]
In an attempt to eliminate the risk of vaccine-preventable disease outbreaks, several governments and other institutions have instituted policies requiring vaccination for all people. In the United States, the Supreme Court ruled in the 1905 case 'Jacobson v. Commonwealth of Massachusetts' that the state could require individuals to be vaccinated for the common good. The Court disagreed that mandatory vaccination “contravened” on individual rights. The petitioner argued “a compulsory vaccination law is unreasonable, arbitrary and oppressive, and, therefore, hostile to the inherent right of every freeman to care for his own body… the execution of such a law against one who objects to vaccination, no matter for what reason, is nothing short of an assault upon his person.”[6] The Court noted "the liberty secured by the Constitution of the United States to every person within its jurisdiction does not import an absolute right in each person, to be, at all times and in all circumstances, wholly free from restraint", however, the Court did acknowledge limits to the State’s power.”[6][6]
Today, every state and the District of Columbia require children entering school to meet state immunization requirements.[7] By and large, the Supreme Court, and most lower courts, have upheld such laws, granting considerable deference to the use of the states’ police power to require immunizations to protect the public health. Still, some courts have held that a state’s right to require vaccinations is not absolute, resulting in liberal interpretations of waiver exemptions.[8]
Contemporary United States vaccination policies require that all children receive common vaccinations against communicable diseases as a condition for school attendance.[7] In most instances, state school vaccination laws expressly apply to both public schools and private schools with identical immunization and exemption provisions. By 2014, the Centers for Disease Control recommended that children receive 69 doses of 16 vaccines by 18 years of age.[9] California, West Virginia, Minnesota and Mississippi only allow medical exemptions to school vaccination requirements, while Louisiana permits both medical and personal exemptions. Among the 45 remaining states, 30 accept medical and religious exemptions while 15 states allow medical, personal, and religious exemptions.[10][11] Additional state vaccination laws require specific vaccinations for university/college students, healthcare workers, and patients confined to certain facilities.[7] Resources for public health practitioners and legal counsel pertaining to state vaccination laws are provided by The Public Health Law Program.[7]
During the 2015-2016 school year, the CDC reported the median vaccination coverage for kindergarteners in the 50 states and the District of Columbia was greater than 94% for MMR (measles, mumps, rubella), DTaP (diptheria, tetanus, acellular pertussis), and varicella vaccines. MMR immunization was increased in 32 states compared to 2014-2015 estimates, which may be, in part, due to the 2015 measles outbreaks. The national median exemption rate was 1.9%, up slightly from 1.7% for the 2014-2015 school year. Among 23 states with data available, as many as 5.4% of kindergarteners did not have documentation of vaccination and received either provisional enrollment or were a granted a grace period.[12] Vaccination rates among kindergarteners nearly reached the vaccination coverage target of 95% set by Healthy People 2020.
Anti-vaccination movements have added to the discussion revolving around the implications of vaccinations. Religious, ethical, and personal reasons have contributed to the opposing end of vaccination efforts. As a result of anti-vaccination movements, a majority of the narratives focus on the ethical concerns revolving around an individuals freedom to choose not to vaccinate and a government having control over these choices. Many of these concerns are supported by both scientific and social commentary. Because of these movements and beliefs, creation of vaccination policies are impeded by social backlash and concerns directed toward the practice of vaccines. (see: Vaccine Controversies)
HPV Controversy:
Concerns over the HPV vaccine have been embedded in narratives between parents beliefs surrounding the implications of this vaccination. The concern for parents accepting the HPV vaccine is that this type of vaccination would encourage sexual practice and promiscuity among young females.[14][23] A study conducted in 2006 found that parents who were educated about the implications of HPV were more likely to accept vaccination practices in their children in comparison to those who had no prior knowledge.[23]
United States:
Public Health Law Research, an independent US based organization, reported in 2009 that there is insufficient evidence to assess the effectiveness of requiring vaccinations as a condition for specified jobs as a means of reducing the incidence of specific diseases among particularly vulnerable populations; that there is sufficient evidence supporting the effectiveness of requiring vaccinations as a condition for attending child care facilities and schools; and that there is strong evidence supporting the effectiveness of standing orders, which allow healthcare workers without prescription authority to administer vaccine as a public health intervention aimed at increasing vaccination rates. In order for adult immunization efforts to increase, the value of preventing these diseases, in both human and economic terms, must be recognized. Results from this analysis provide an estimate of the cost attributable to four major adult Vaccination Preventable Diseases, and highlights the importance of addressing adult vaccination uptake. Sensitivity analyses suggested that as the U.S. population ages over the next decade and beyond, without increased prevention efforts, these costs will dramatically increase.[24] Previous studies have suggested that system-wide changes, especially the implementation of standing orders for vaccination, assigning non-physician personnel vaccination responsibilities, and in-person clinician recommendation have the greatest impact on increasing uptake.[25] Implementing these types of interventions in sub-populations most at risk for developing adult VPDs and at greatest risk for not being vaccinated will likely yield the greatest benefit. Results from this model make it evident that a fundamental shift in the culture within which vaccines (and indeed preventive care as a whole) are provided to adults is required, and this analysis should provide a stimulus for policy makers to undertake this ambitious goal. Failure to do so, however, based on this model and previous reports, will continue to cost the United States billions of dollars each year.[26]
The year 2011 marked 16 outbreaks with 107 confirmed cases of measles in the United States. The economic burden on local and state public health institutions ranged from about $2.7 to $5.3 million. Outbreaks of vaccine-preventable diseases cost the United States millions of dollars in unneeded expenditures. Loss of “herd immunity”, or indirect protection of acquired immunity, remain a public health concern.[27]
(see: Vaccine Controversy, Vaccine injury)
Several government agencies oversee vaccination in the United States. The Advisory Committee on Immunization Practices (ACIP), established under Section 222 of the Public Health Service Act (42 U.S.C. § 2l7a), comprises medical and public health experts who develop recommendations on the use of vaccines in the civilian population of the United States. The recommendations stand as public health guidance for safe use of vaccines and related biological products.[28]
The Centers for Disease Control and Prevention (CDC) has compiled a list of vaccines and their possible side effects.[29] Allegations of vaccine injuries in recent decades have appeared in litigation in the U.S.. Some families have won substantial awards from sympathetic juries, even though most public health officials have said that the claims of injuries were unfounded.[30] In response, several vaccine makers stopped production, which the U.S. government believed could be a threat to public health, so laws were passed to shield makers from liabilities stemming from vaccine injury claims.[31]
Injuries resulting from vaccination are closely tracked through the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance program administered jointly by the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC). Several organizations contribute databases with information about health outcomes and vaccine-associated injuries to the Vaccine Safety Datalink and the National Vaccine Injury Compensation Program (VICP) of 1988, provides an avenue for individual who have suffered an injury from vaccination to receive compensation.[32]
The World Health Organization (WHO) estimates that vaccination against diphtheria, tetanus, pertussis (whooping cough) and measles averts 2-3 million deaths per year (in all age groups). In 2015, 116 million (86%) of infants were fully immunized against diphtheria, tetanus and pertussis (DTP3), with 126 countries reaching coverage levels of at least 90%, a level often considered sufficient to achieve herd immunity.[33]
Global immunization rates remained steady in 2015 for Haemophilus influenza (64% global coverage), hepatitis B (39% global coverage), measles (85% of children receiving at least 1 dose of the vaccine), pneumococcal diseases (37% global coverage), polio (86% global coverage), rotaviruses (23% global coverage), and rubella (46% global coverage). Vaccines directed against human papilloma virus (the leading cause of cervical cancer) and yellow fever (a viral infection caused by infected mosquitos) were introduced in 66 and 35 countries, respectively, by the end of 2015.[26]
Despite consistent trends in global vaccination rates, as well as an uptick in the use of new and underutilized vaccines, 2015 WHO estimates show that 19.4 million infants worldwide remain unvaccinated and up to 1.5 million children die each year from vaccine-preventable diseases. In 2013, 29% of deaths of children under five years old could have been prevented through vaccination.[26]
As they continue their efforts to increase vaccine coverage, in 2015 the Strategic Advisory Group of Experts on immunization (SAGE) identified priority areas to promote vaccination practices worldwide that include developing strong health systems and enlisting community involvement to provide access to affordable vaccines in all places at all times, especially for populations who are marginalized and displaced. SAGE independently assesses progress toward goals established in the Global Vaccine Action Plan 2011-2020 (GVAP), which set out to “strengthen routine vaccination 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 vaccine and technologies.”[34] In an effort reach these goals, GVAP strives to integrate immunization with other health services, such as postnatal care for mothers and children.
In April 2016, the WHO sponsored World Immunization Week where representative from more than 180 countries participated in training workshops, round-table discussions, and vaccination campaigns to increase awareness about immunizations, using the slogan “Close the Immunization Gap.” The WHO continue their efforts to improve access, affordability and delivery of immunizations to everyone and everywhere in the world.[35]