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Government Regulation — History of Vaccines
 

Government Regulation

The development and growing use of smallpox vaccine in the early 1800s triggered the establishment of vaccination mandates, especially for children. Then, as the incidence of smallpox declined over time, some governments loosened requirements, while other mandates remained in place. At the same time, a variety of govermental agencies and regulations emerged to oversee the production and testing of vaccines.

The judicial branch of U.S. federal goverment has had a role as well in vaccination. A variety of court decisions have considered the validity of vaccination mandates and have attempted to address the conflict between individual rights and protection of the public’s health.

Below are a variety of events associated with the establishment of vaccination mandates and the role of government agencies in monitoring vaccine production and use.

Last update 29 Jan 2016

Timeline Entry: 1792 Stricter Regulations Passed for Inoculation

The Historical Medical Library of The College of Physicians of Philadelphia
Commonwealth of Virginia consolidation act for smallpox regulation
 
The Historical Medical Library of The College of Physicians of Philadelphia
Commonwealth of Virginia consolidation act for smallpox regulation
 
The Historical Medical Library of The College of Physicians of Philadelphia
Commonwealth of Virginia consolidation act for smallpox regulation
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The Commonwealth of Virginia passed an act to consolidate previously passed acts regulating smallpox inoculation into one. The new act included a penalty of $1,500 or six months’ imprisonment for anyone willfully spreading smallpox in a manner other than specified by the act.

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Timeline Entry: 1802 Vaccination Endorsed

Massachusetts became the first U.S. state to encourage the use of vaccination against smallpox. Dr. Waterhouse, the first doctor in Boston to obtain vaccine material, convinced the city’s Board of Health to sponsor a public test of vaccination. Nineteen volunteers were successfully vaccinated.

Initially, Waterhouse sought to retain a monopoly over smallpox vaccine in North America, refusing to provide vaccine material to other doctors without a fee or a portion of their profits. This monopoly led to efforts to obtain vaccine material from vaccination pustules on human patients, or via clothing carrying pus from vaccination pustules. In at least one such case, a pustule on the arm of a British sailor used to obtain such material was not, in fact, from vaccination, but from a full smallpox infection. Sixty-eight people died after material from the pustule was used to vaccinate patients in Marblehead, Massachusetts.

Eventually, other doctors began receiving genuine vaccine material from sources in England. After his initial monopoly was broken, Waterhouse shared his supplies without complaint.

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Timeline Entry: 1813 U.S. Vaccine Agency Established

The U.S. Congress authorized and James Madison signed "An Act to Encourage Vaccination," establishing a National Vaccine Agency. James Smith, a physician from Baltimore, was appointed the National Vaccine Agent. The U.S. Post Office was required to carry mail weighing up to 0.5 oz. for free if it contained smallpox vaccine material—an effort to advance Congress’s ruling to “preserve the genuine vaccine matter, and to furnish the same to any citizen of the United States.”

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Timeline Entry: 1840 Britain Bans Variolation

William Farr in The Lancet characterized Britain’s National Vaccine Act of this year as inadequate, with five London children per day still dying of smallpox. The Act did, however, offer free vaccination for infants (the first instance of free medical service in the country) and banned variolation, a move heralded by the medical profession.

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Timeline Entry: 1855 Vaccination Law Passes

Massachusetts passed the first U.S. law mandating vaccination for schoolchildren.

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Timeline Entry: 1874 German Vaccination Law

The Historical Medical Library of The College of Physicians of Philadelphia
Prussian army smallpox cases in the late 1800s. Blue represents illness; black represents deaths.
 
The Historical Medical Library of The College of Physicians of Philadelphia
French army smallpox cases in the late 1800s
 
The Historical Medical Library of The College of Physicians of Philadelphia
Austrian army smallpox cases in the late 1800s. Blue represents illness; black represents deaths.
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A compulsory smallpox vaccination and revaccination law went into in effect in Germany. Over the next decades, smallpox deaths there dropped rapidly.

“After the law of 1874 went into effect the annual mortality in Prussia fell so that between 1875 and 1886 the average yearly mortality per 100,000 of population was only 1.91. On the other hand, in Austria, where the lax vaccination and revaccination requirements remained unchanged, the mortality of smallpox during about the same period (1872-1884) increased, varying between 39.28 and 94.79 per 100,000 of population…. In 1897, there were but five deaths from this disease in the entire German Empire with a population of 54,000,000.”

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Timeline Entry: 12/4/1894 New York City Regulates Antitoxin

The Historical Medical Library of The College of Physicians of Philadelphia
The pseudomembrane of diphtheria may cover a wide area. It is formed from waste products and proteins.
 
National Library of Medicine
Treatment with diphtheria antitoxin, 1895, Pasteur Institute, New York City. Harper's Weekly, v. 39, p. 8.
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The New York City Board of Health told the Health Department to devise a plan to ensure the purity and potency of diphtheria antitoxins sold in the city. At this point, most of the antitoxin came from two suppliers in Germany.

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Timeline Entry: 1898 Regulation of Vaccine Supply Increases

The Historical Medical Library of The College of Physicians of Philadelphia
This invitation to an inspection of the vaccine farms of Dr. H. M. Alexander illustrates the emerging regulation of vaccine production. Page 1.
 
The Historical Medical Library of The College of Physicians of Philadelphia
This invitation to an inspection of the vaccine farms of Dr. H. M. Alexander illustrates the emerging regulation of vaccine production. Page 2.
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As smallpox rates declined, the apparent need for vaccination was less pressing, and the occasional adverse reactions to vaccination became more visible. At the same time, developments such as the addition of glycerin to vaccine lymph, the increasing regulation of pharmaceutical suppliers, and the advancements of microbiology led to the generally increasing safety of the vaccine supply.

A Pennsylvania commission reporting on inspections wrote:

This [Inspection of Vaccine Propagating Establishments] included a personal inspection of each plant…and a bacteriological examination of the points produced at each place. These points were purchased in open market. The matters investigated were location, size, number and construction of buildings, arrangements for cleanliness, character of animals, mode of operation and of taking of lymph, modes of preparation of virus, precautions taken in packing and bacteriological control. Fourteen of these establishments were visited and the inspectors were uniformly received with courtesy. Of these, four are located in this State. It is somewhat humiliating to find that three of these are not conducted with such regard to hygienic precautions or even to ordinary cleanliness, as to warrant the Board in expressing anything but condemnation of the establishments themselves and of the methods pursued therein. On the other hand it is gratifying to our State pride to be able to point to the fourth as admirable in all its appointments and conducted with the strictest observance of modern surgical asepsis. The establishment referred to is known as the Lancaster County Vaccine Farms, at Marietta, Dr. H. M. Alexander & Co., Proprietors."

H.M. Alexander & Company's facilities in Marietta, Pennsylvania, were eventually acquired by Wyeth Pharmaceuticals and played an important role in global smallpox eradication.

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Timeline Entry: 7/1/1902 The Biologics Control Act

National Library of Medicine
Future staff of NIH Division of Biologics Control
 
The Historical Medical Library of The College of Physicians of Philadelphia
Diphtheria antitoxin data
 
The Historical Medical Library of The College of Physicians of Philadelphia
Advertisement for Roux's diphtheria antitoxin, developed by the Pasteur Institute
 
The Historical Medical Library of The College of Physicians of Philadelphia
Alexander and Co.'s diphtheria antitoxin promised a guaranteed number of antitoxin units. No date.
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The U.S. Congress passed "An act to regulate the sale of viruses, serums, toxins, and analogous products," later referred to as the Biologics Control Act (even though "biologics" appears nowhere in the law). This was the first modern federal legislation to control the quality of drugs. This act emerged in part as a response to the 1901 St. Louis and Camden contamination events.

The Act created the Hygienic Laboratory of the U.S. Public Health Service to oversee manufacture of biological drugs. The Hygienic Laboratory eventually became the National Institutes of Health.

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Timeline Entry: 2/20/1905 U.S. Supreme Court Addresses Vaccination

The U.S. Supreme Court in the case of Jacobson v. Massachusetts upheld the constitutionality of mandatory smallpox vaccination programs to preserve the public health.

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Timeline Entry: 1922 School Vaccination Requirements

The Historical Medical Library of The College of Physicians of Philadelphia
Philadelphia Department of Public Health and Charities smallpox vaccination certificate
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By this time, many United States schools required smallpox vaccination before children could attend. Some students and their families, however, sought the help of the courts to avoid the requirement. One such case was considered by the U.S. Supreme Court, when Rosalyn Zucht, a student from San Antonio, Texas, was excluded from a public school for failure to present proof of vaccination.

The complaint alleged that the city ordinances requiring vaccination to attend public school violated the due process and equal protection clauses of the Fourteenth Amendment. The court dismissed the writ of error that brought the case to them, stating that the constitutional question presented was not substantial in character, and citing previous cases which had determined that a city ordinance was a law of the state—and that it was “within the police power of a state to provide for compulsory vaccination.”

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