User:BD2412/Vaccine law resources/2023-c

WHO, Vaccination requirements and recommendations for international travellers; and malaria situation per country – 2022 edition (19 November 2022), https://www.who.int/publications/m/item/vaccination-requirements-and-recommendations-for-international-travellers-and-malaria-situation-per-country-2022-edition

WHO, Vaccines and immunization, https://www.who.int/health-topics/vaccines-and-immunization#tab=tab_1

Italy 2022

Alessandro Sindoni, Valentina Baccolini, Giovanna Adamo, Azzurra Massimi, Giuseppe Migliara, Corrado De Vito, Carolina Marzuillo, and Paolo Villari, Effect of the mandatory vaccination law on measles and rubella incidence and vaccination coverage in Italy (2013-2019), Hum Vaccin Immunother. 2022; 18(1): 1950505, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8920156/.
- From 2013 to 2015, vaccination coverage decreased for the first dose of measles (90.4% to 85.3%) and rubella vaccine (90.3% to 85.2%), but then it increased significantly, reinforced by the Italian Decree Law, reaching 94.4% in 2019. The trend for the second dose showed a decrease from 2013 to 2016 (84.1% to 82.2% for measles and 83.7% to 82.0% for rubella), but then increased significantly and reached 90.2% in 2019 for measles and 90.0% for rubella. The mandatory vaccination law has resulted in a significant increase in vaccination coverage for measles and rubella in Italy, and demonstrates encouraging progress toward the 95% target and the restriction of measles transmission.
- "Two doses of measles and rubella vaccine is the standard for all National Immunization Programs".
- In 2017, a large epidemic measles outbreak occurred in Italy, mostly attributable to the decreasing uptake of measles vaccination, which caused large pockets of measles-susceptible individuals. As a result, in line with France and Germany, a mandatory vaccination strategy was considered, and a new National Vaccine Plan for the years 2017–2019 was approved.11 This was followed by the National Law 119/2017, which expanded the number of mandatory vaccinations from four to ten (against polio, tetanus, diphtheria, pertussis, measles, mumps, rubella, chickenpox, hepatitis B and Haemophilus influenzae type b) and introduced administrative penalties for those parents or individuals who were hesitant about or refused vaccination.12,13 According to this Law, all children under 16 years are required to exhibit proof of mandatory vaccinations including measles and rubella, prior to be admitted to state schools.

Plotkin 2018

Marion F. Gruber and Valerie B. Marshall, Regulation and Testing of Vaccines, Plotkin's Vaccines. 2018 : 1547–1565.e2, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7152379/

21st Century Cures Act and NVICP

HRSA, About the National Vaccine Injury Compensation Program, https://www.hrsa.gov/vaccine-compensation/about

The 21st Century Cures Act (Public Law 114-255) (PDF), enacted on December 13, 2016, made several amendments to the National Childhood Vaccine Injury Act of 1986.

Expand the VICP’s coverage to include new categories of vaccines that previously were not covered by the VICP: vaccines recommended by the CDC for routine administration to pregnant women (but not for routine administration in children) and subject to a federal excise tax. See Section 3093(c)(1) of P.L. 114-255.
Make clear that vaccine-injury claims may be filed both with respect to injuries alleged to have been sustained by women receiving covered vaccines during pregnancy and with respect to injuries alleged to have been sustained by live-born children who were in utero at the time those women were administered such vaccines. See Section 3093(c)(2), (3) of P.L. 114-255.

Dismissal policies for vaccine refusal (by patients) among US physicians

Tamara B. Garcia and Sean T. O’Leary, Dismissal policies for vaccine refusal among US physicians: a literature review, Hum Vaccin Immunother. 2020; 16(5): 1189–1193, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7227633/.

"In the United States, the practice of dismissing families for vaccine refusal appears to be increasing as a strategy for dealing with vaccine refusal".
Retaining unvaccinated patients in a practice is associated with some legal risk as well. Pediatricians have been sued by third parties who contracted a vaccine-preventable disease from the physician’s patient if the physician failed to inform the patient how to avoid spreading the disease.18 Pediatricians have also been sued for failing to fully inform families about all of the consequences of a vaccine-preventable disease and for failing to offer the vaccine at a later visit. The average payment claim for malpractice lawsuits in pediatrics is greater than $500,000 which could exceed the maximum coverage of some malpractice policies, placing the pediatrician at personal financial risk.19
- 18. Bellamy, Jann, A pox on your bank account: failure to vaccinate and its legal consequences. Science-Based Medicine; 2010. https://sciencebasedmedicine.org/a-pox-on-your-bank-account-failure-to-vaccinate-and-its-legal-consequences/.
  - "[T]he duty of the physician treating a patient with a communicable disease is to prevent the spread of the disease, not for the benefit of the patient, whose health has already been compromised, but for the benefit of those third parties ‘within the foreseeable orbit of risk of harm.’" Troxel v. A.I. DuPont Institute, 450 Pa.Super. 71, 675 A.2d 314 (Pa. Super. 1996).
- 19. DeVille K, Goldberg D, Hassler G. Malpractice risk according to physician specialty. N Engl J Med. 2011;365:1939 & 1940.
In 2005, the AAP recommended that “pediatricians should avoid discharging patients from their practice solely because a parent refuses to immunize his or her child.”32 ... In 2016, the AAP changed its policy, stating that “a pediatrician may consider dismissal of families who refuse vaccination as an acceptable option” while acknowledging that the decision to dismiss should not be made without contemplating and respecting the beliefs of the family in question.33
- 32. Diekema DS. American academy of pediatrics committee on B. Responding to parental refusals of immunization of children. Pediatrics. 2005;115(5):1428–31. doi: 10.1542/peds.2005-0316.
- 33. Edwards KM, Hackell JM. Countering vaccine hesitancy. Pediatrics. 2016;138(3):e20162146–e20162146. doi: 10.1542/peds.2016-2146.

FDA - Bovine Derived Materials Used in Vaccine Manufacturing

FDA, Bovine Derived Materials Used in Vaccine Manufacturing Questions and Answers, 03/23/2018, https://www.fda.gov/vaccines-blood-biologics/bovine-derived-materials-used-vaccine-manufacturing-questions-and-answers
- "Cow components are often used simply because cows are very large animals, commonly used for food, and thus much material is available. Animal-derived products used in vaccine manufacture can include amino acids, glycerol, detergents, gelatin, enzymes and blood. Cow milk is a source of amino acids, and sugars such as galactose. Cow tallow derivatives used in vaccine manufacture include glycerol. Gelatin and some amino acids come from cow bones. Cow skeletal muscle is used to prepare broths used in certain complex media."
- Measures to avoid Bovine Spongiform Encephalopathy (BSE)

Sincerely Held or Suddenly Held

Mark E. Wojcik, Sincerely Held or Suddenly Held Religious Exemptions to Vaccination?, ABA Human Rights Magazine Vol. 47, No. 3/4 (July 5, 2022) https://www.americanbar.org/groups/crsj/publications/human_rights_magazine_home/intersection-of-lgbtq-rights-and-religious-freedom/sincerely-held-or-suddenly-held/

"Most religions and religious groups today do not object to medical vaccinations. To the contrary, most fully support vaccinations".
- Vatican’s Pontifical Academy for Life has stated that “COVID-19 exists, and the only way to return to normal is to get vaccinated.” Pope Francis himself supports vaccinations against COVID-19, stating that getting jabbed is “an act of love.”
- Per Vanderbilt University, "other Christian denominations that have no theological opposition to vaccines include Amish, Anglican, Baptist, Eastern Orthodox, Jehovah’s Witnesses, Mennonites, Mormon, Pentecostal Christians, Quakers, Seventh-day Adventist, and Unitarian-Universalist".
- Vaccination is widely accepted in countries that are predominantly Buddhist. Hinduism and Islam have no prohibitions against vaccination. Judaism supports vaccinations to protect life and health. And the National Spiritual Assembly of the Bahá’is of the United States urges followers to “adhere scrupulously to public health guidelines that have been established in their state” including “protocols for . . . vaccination.”
"State and local governments appear to be particularly ill-suited to adjudicate the sincerity of claims that religious beliefs or practices prohibit compliance with a mandate to be vaccinated against COVID-19".
- Measures proposed:
  - Require written submission of exemption claim
  - Consequences for "deliberately making a false statement"
  - Require acknowledgment of risk assumed
  - Require express reasoning for exemption
  - Require disclosure of whether the person would accept treatment for the disease
  - Require disclosure of whether the person also objects to testing/mask-wearing
  - Provide a date of adoption of beliefs and, if recent, a narrative of coming to them
  - "The claim should state whether the religious belief or practice against vaccination is held universally and uniformly within that person’s religion"
  - Disclose other vaccinations and reasons why those were permitted
  - "To support the claim for a religious exemption, a religious or spiritual leader should certify the religious or spiritual basis of the claim and that the claimant is a member of that faith group" (but this seems to run afoul of equal protection concerns)

Lancet: Beneficial non-specific effects

VOLUME 23, ISSUE 1, E34-E42, JANUARY 2023 Beneficial non-specific effects of live vaccines against COVID-19 and other unrelated infections Prof Peter Aaby, DMSc Prof Mihai G Netea, MD PhD Prof Christine S Benn, DMSc Published:August 26, 2022DOI:https://doi.org/10.1016/S1473-3099(22)00498-4

User:BD2412/Vaccine law resources/2023-c

Italy 2022

Plotkin 2018

21st Century Cures Act and NVICP

Dismissal policies for vaccine refusal (by patients) among US physicians

FDA - Bovine Derived Materials Used in Vaccine Manufacturing

Sincerely Held or Suddenly Held

Lancet: Beneficial non-specific effects

Vaccines on Horizon to Prevent Fentanyl and Heroin Overdoses

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