User:BD2412/Vaccine law resources/More vaccine issues

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Vaccine input

A century ago, infectious disease was the cause of death for more than half of all people. David S. Jones, Scott H. Podolsky, and Jeremy A. Greene, The Burden of Disease and the Changing Task of Medicine, New England Journal of Medicine, Vol. 366, No. ?, June 21, 2012, p. 2333-2338.

Vaccine issues

Right-to-try law, Vaccine trial, Biological Weapons Convention

Julia Belluz, "The global crackdown on parents who refuse vaccines for their kids has begun", Vox.com (August 6, 2017).

UK: Vegan mother forced by High Court to vaccinate her children

• Michigan mother jailed for refusing to vaccinate her son, BBC News (October 4, 2017)

• Vaccines Get New Scrutiny, U.S. News, Deborah Kotz, Dec. 11, 2008: "Many problems filed with VAERS have nothing to do with vaccinations; real adverse events often go unreported. A better monitoring system, the agency's Vaccine Safety Datalink, regularly scans 5.5 million anonymous health records provided by managed care organizations to see whether new vaccines are associated with a spike in certain conditions."

• Philippines Suspends Dengue Shots After Drug Firm’s Warning, Felipe Villamor, New York Times, December 1, 2017

• Biomarkers in the diagnosis of Alzheimer's disease: are we ready?

• Note: FERPA rights cease at death; HIPAA privacy rights and physician/patient privilege survive death

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Interestingly, however, not all countries struggle with immunization. Brazil, for instance, enjoys consistently high compliance with mandated vaccinations, and Japan reports high vaccination rates for popular vaccines without any government mandates. Significantly, as a result of prior high compliance rates, these countries have been relatively untouched by the recent outbreaks in vaccine-preventable diseases, such as measles. In today's interconnected world, it is increasingly important to maintain vaccination rates across borders and around the globe. This article reviews the approach taken by various countries in North America, South America, Europe, and East Asia to examine whether mandatory vaccination laws are successful and how concepts of individual liberties impact their effectiveness.

Opposition to vaccination has existed since at least the mid 1800s.

In the United States, advocacy against vaccinations is protected by the First Amendment. It has been argued, however, that a person who has been injured due to exposure to another person who was unvaccinated due to the influence of anti-vaccine advocacy would be able to pursue a civil lawsuit against that advocate. Noah Berlatsky, Fighting the Anti-Vax Movement With Lawsuits, The Atlantic (February 4, 2015).

In other countries, anti-vaccine advocacy can be prohibited and punished. The Australian government, for example, has denied entry visas to American anti-vaccine advocates on several occasions. Kent Heckenlively, US 'anti-vaxxer', denied Australian visa, BBC News (August 31, 2017)

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Lindzi Wessel, Four vaccine myths and where they came from, Science (April 27, 2017)

Religious Exemption: The Law – a Summary (Hastings articles on Vaccination)

"UK rations hepatitis B vaccine amid global shortage", BBC (August 8, 2017)

Carlos Gueverra, "Class Action Lawsuit Against HPV Vaccine Filed in Colombia", Medscape (August 8, 2017)

Brooke Singman, Senate passes 'right-to-try' bill by unanimous consent, Fox News (August 03, 2017)

Sequera VG, Bayas JM, Vaccination in the prison population. A review., Preventive Medicine and Epidemiology. Hospital Clínic de Barcelona.

• Anne Trafton, One vaccine injection could carry many doses MIT News Office (September 14, 2017)

MIT engineers have invented a new 3-D fabrication method that can generate a novel type of drug-carrying particle that could allow multiple doses of a drug or vaccine to be delivered over an extended time period with just one injection.

• James T. Matthews, Egg-Based Production of Influenza Vaccine: 30 Years of Commercial Experience, (December 3, 2008)

Regulatory agencies are also responsible for reviewing changes in product labeling, labeling for new products, and changes in packaging and product inserts for new virus strains. In the United States, monovalent bulk vaccine requires a regulatory review and lot release. Standardization laboratories are responsible for the calibration of potency reagents.

Figure 4 also shows some of the common constraints to the regulatory pathway, such as clinical studies that must be done with hundreds of healthy volunteers, both young people and elderly adults, to assess the safety of the vaccine and the strength of the HA titers expected from that particular formulation. Such studies are required in the EU, as are market authorization and releases by member states, before the vaccine can be delivered and the immunization campaign begun.

Because embryonated eggs are themselves potentially susceptible to avian influenza, flocks associated with vaccine production are under strict contract and must be completely housed, monitored by veterinarians, and raised under biosecurity regulations. With government support, Sanofi Pasteur has also established contingency flocks as a backup against avian influenza and other risks.

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Liability for infection

Criminal

• Prevalence and Public Health Implications of State Laws that Criminalize Potential HIV Exposure in the United States
• HIV-Specific Criminal Laws

Civil

• Christie D'Zurilla, Usher sued by fans who say he exposed them to herpes without warning, L.A. Times (Ausgust 7, 2017)
• Andreas Preuss, Charlie Sheen's ex-fiancée sues, alleges assault, battery, failure to disclose HIV, CNN (December 4, 2015)

Right to try

Right-to-try law

Right-to-try laws are U.S. state laws that were created to let terminally ill patients try experimental therapies (drugs, biologics, devices) that have completed Phase 1 testing but have not been approved by the Food and Drug Administration (FDA).

Specific vaccines

Administration of the smallpox vaccine ended in 1971, with the eradication of the disease.

Common law

Consent

In the early case of O'Brien v. Cunard S.S. Co., [O'Brien v. Cunard S.S. Co., 154 Mass. 272 (Mass. 1891).] a ship's passenger sued the ship owner for assault, asserting that she was vaccinated against her will, and had suffered ulceration and blistering as a result. The court found that it was unlikely that she did not consent to the injection, as proof of vaccination would be required for her to disembark at her destination.

Refusal to prescribe/provide?

Could an individual who opposes vaccination on religious or philosophical grounds refuse to prescribe or fill a prescription for a vaccination? The Supreme Court has noted that the right to freely exercise one's religion "does not relieve an individual of the obligation to comply with a 'valid and neutral law of general applicability on the ground that the law proscribes (or prescribes) conduct that his religion prescribes (or proscribes).'" Employment Div., Dep't of Human Res. of Or. v. Smith, 494 U.S. 872, 879, 110 S.Ct. 1595, 108 L.Ed.2d 876 (1990) (quoting United States v. Lee, 455 U.S. 252, 263 n. 3, 102 S.Ct. 1051, 71 L.Ed.2d 127 (1982) (Stevens, J., concurring in judgment)).

The Court noted that such a presumption would have wide-ranging and injurious effects on our society, as exemptions could be mandated from "compulsory military service, ... payment of taxes, ... health and safety regulation such as manslaughter and child neglect laws, compulsory vaccination laws, drug laws, and traffic laws, [and] social welfare legislation such as minimum wage laws, child labor laws, animal cruelty laws, environmental protection laws, and laws providing for equality of opportunity." Id. at 889, 110 S.Ct. 1595 (citations omitted).

As a weapon

In one of the most infamous acts in the history of the United States, British troops gave smallpox infested "gifts" to Native Americans.

During the French and Indian War, Jeffery Amherst, 1st Baron Amherst, Britain's commander in chief in North America authorized the use of smallpox to wipe out their Native American enemy. In his writings to Colonel Henry Bouquet about the situation in western Pennsylvania, Amherst suggested that the spread of disease would be beneficial in achieving their aims. Colonel Bouquet confirmed his intentions to do so.

"Out of our regard to them we gave them two Blankets and an Handkerchief out of the Small Pox Hospital. I hope it will have the desired effect." William Trent, William Trent's Journal at Fort Pitt

This event is well known for the documented instances of biological warfare. British officers, including the top British commanding generals, ordered, sanctioned, paid for and conducted the use of smallpox against the Native Americans. As described by one historian, "there is no doubt that British military authorities approved of attempts to spread smallpox among the enemy", and "it was deliberate British policy to infect the indians with smallpox".

The use of biological weapons is prohibited under customary international humanitarian law, as well as a variety of international treaties. The use of biological agents in armed conflict is a war crime.

Testing in Africa

There are presently HIV/AIDS vaccine trials being conducted in four African countries namely Uganda, Kenya, Tanzania and South Africa [8]. Proof-of-concept of vaccine induced protection from malaria infection and disease has recently been demonstrated in African children and several candidate malaria vaccines are in early clinical trials [9]. In Africa, malaria vaccine clinical trials are ongoing in Mozambique, Tanzania, Gabon, Ghana, Kenya, the Gambia, Burkina Faso and Mali (Ibid.). While a TB vaccine, Bacillus Calmette-Guérin (BCG), is available, it provides approximately 80% protection against TB meningitis and miliary TB in infancy and in young children but provides only variable protection against lung disease, at all ages, creating an urgent need for new candidate vaccines [10]. In Africa, TB vaccine trials are being conducted in South Africa and the Gambia (Ibid.), with site development taking place in Kenya, Uganda, Mozambique and Tanzania.

Correspondence Convergent ethical issues in HIV/AIDS, tuberculosis and malaria vaccine trials in Africa: Report from the WHO/UNAIDS African AIDS Vaccine Programme's Ethics, Law and Human Rights Collaborating Centre consultation, 10-11 February 2009, Durban, South Africa. Available at http://psychology.ukzn.ac.za/Libraries/publications/12.sflb.ashx

Emanuel EJ, Wendler D, Killen J, Grady C: What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis 2004, 189:930-937.

Malaria

• Simon Draper: Progress in Malaria Vaccine Research

VAERS

• FDA Vaccine Adverse Events

General Information

VAERS Overview

FDA's VAERS overview page

Vaccine Adverse Event Reporting System Brochure (PDF - 376KB)

Published by HHS, FDA and CDC

Report a Vaccine Adverse Event

Department of Health and Human Services

Vaccine Adverse Event Reporting System (VAERS) Questions and Answers

FDA's Questions and Answers

Vaccine Adverse Event Reporting System (VAERS) Database Information

Basic information about data collection

Información en español acerca del Sistema para Reportar Reacciones Adversas a las Vacunas (VAERS) (PDF - 2.3MB)

Understanding the Vaccine Adverse Event Reporting System (VAERS) (PDF - 868KB)

Regulatory Submissions in Electronic Format for Biologic Products

• FDA, GUIDANCE FOR INDUSTRY: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)

• CDC The Vaccine Adverse Event Reporting System (VAERS)

• 21 CFR 600.80 - Postmarketing reporting of adverse experiences

• Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)
• Parents' Questions About Vaccines: Answered

Reimbursement

• Vaccine and Vaccine Administration Payments Under Medicare Part D
• Reimbursement for Vaccines and Vaccine Administration Under Medicare Part D