Government Regulation

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: 1898

Britain Allows Exemptions

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Timeline Entry: 12/4/1894

New York City Regulates Antitoxin

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: 7/1/1902

The Biologics Control Act

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

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Timeline Entry: 1792

Stricter Regulations Passed for Inoculation

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

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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

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Timeline Entry: 1898

Britain Bans Arm-to-Arm Vaccine Transmission

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Timeline Entry: 1898

Regulation of Vaccine Supply Increases

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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