Professional Documents
Culture Documents
27 Widener LRev 165
27 Widener LRev 165
Citations:
Roseann B. Termini*
I. INTRODUCTION
Vaccines are far from a new phenomenon.' Over two centuries ago,
Edward Jenner was credited with inventing a vaccine to prevent smallpox.2
Other notable vaccines include Pertussis (1914), Diphtheria (1926), Tetanus
(1938), which were combined to make the DTP vaccine in 1948.3 The
licensing of the polio vaccine in 1955 was cause for celebration. 4 Fast
forward to early 2020, the dire necessity for a vaccine to combat COVID-19
became apparent as an unprecedented pandemic infiltrated the United
States.5 This article will provide a succinct overview of the global COVID-
* Roseann B. Termini, B.S. magna cum laude, M.Ed. Fellow, J.D., a food and drug law
attorney, is the author of Food and Drug Law: Federal Regulation of Drugs, Biologics,
Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco
Products, www.fortipublications.com. She teaches several Food and Drug Law courses at
Delaware Law School, Widener University School of Law. Ms. Termini dedicates this writing
to those who continue to go that extra mile at the Federal Food and Drug Administration,
National Institutes of Health, Centers for Disease Control, and other federal and state agencies,
as well as those who continue to work tirelessly on the front lines of this unprecedented
pandemic. She further dedicates this article to the memory of her parents, who instilled values
that fostered the determination to write about this topic, and her family and non-lawyer friends
for reading the many drafts to comport with plain language considering this complicated issue.
Finally, Ms. Termini thanks Ms. Jamie G. Judefind, Editor-in-Chief, Widener Law Review,
Maria Kontis, External Managing Editor and staff members.
Author contact: [email protected]
Paul A. Offit, Vaccine History: Developments by Year, CHILDREN'S HOSPITAL OF
PHILADELPHIA (Dec. 18, 2019), https://www.chop.edu/centers-programs/vaccine-education-
center/vaccine-history/developments-by-year. However, by the early 1970s, smallpox was
eliminated and therefore the smallpox vaccine was not recommended by the medical
community after 1972. Id In the 1980s, several other vaccines were recommended, including
a vaccine for Hepatitis B and for Haemophilus influenzae type b. Id Vaccines for the
adolescent population were recommended as well, and these include: Tdap (2005),
meningococcal conjugate (2005), HPV (2006 females and in 2009 for males), and
meningococcal serogroup B vaccine (2014). Id
2 Id; see Stefan Riedel, EdwardJenner and the History of Smallpox and Vaccination, 18
BAYLOR UNIV. MED. CTR. PROCEEDINGS, 21-25 (2005).
3 Offit, supra note 1.
41d
s See A Timeline of Covid-19 Developments, AJMC, https://www.ajmc.com/view/a-
timeline-of-covidi9-developments-in-2020 (last updated Jan. 1, 2021).
165
166 Widener Law Review [Vol. 27:165
6See Jacobson v. Massachusetts, 197 U.S. 11, 25 (1905). Police power is a legal term of
art used to describe the authority of a state to enact a public protection measure; see also What
is Police Power?, THE LAw DICTIONARY, https://thelawdictionay.org/police-power/ (last
visited Feb. 7, 2021). Author Note: Culture has vastly impacted COVID-19 in terms of the
individual right to either obtain the vaccine or to refuse the vaccine. For example, the deaths
(26) and cases (2,257 cases) in New Zealand are notably low as compared to the United States
with one-half a million deaths. Part of this is attributed to the proactive measures taken by the
government and part attributed to the manaakitanga culture based on the Maori people and in
fact is taught in New Zealand schools. See WHO Coronavirus(COVID-19) Dashboard:New
ZealandSituation, WHO, https://covidl9.who.int/region/wpro/country/nz (last visited Apr.
27, 2021); see also Matthew Milner & Richard Ngata, Opinion: The indigenouscustom behind
New Zealand's strong covid-19 response, THE WASHINGTON POST (Mar. 11, 2021)
https://www.washingtonpost.com/opinions/2021/03/11/new-zealand-covid-19-maori-
indigenous-manaakitanga/; infra note 14.
? Naming the coronavirus disease (COVID-19) and the virus that causes it, WHO,
https://www.wlho.int/emergencies/diseases/novel-coronavirus-2019/technical-
guidance/naming-the-coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it (last
visited Feb. 27, 2021); see also WHO COVID-19: Case Definitions, WHO (Dec. 12, 2020),
https://www.who.int/publications/i/item/WHO-2019-nCoV-Surveillance_Case_Definition-
2020. The World Health Organization (WHO) provided the official name for the "coronavirus
disease 2019" as follows: COVID-19 which is an abbreviation for: CO=Corona; VI=Virus;
D=Disease; 19=2019 year. About COVID-19, CTR. FOR DISEASE CONTROL (Sept. 1, 2020),
https://www.cdc.gov/coronavirus/2019-ncov/cdcresponse/about-COVD-19.html.
8 Coronaviruses, NAT'L INST. OF ALLERGY AND INFECTIOUS DISEASES,
https://www.niaid.nih.gov/diseases-conditions/coronaviruses (last visited Feb. 3, 2021); see
About COVID-19, supranote 7.
9 See About COVID-19, supra note 7; see also WHO Experts Visit Wuhan Lab at Center
of Virus Conspiracy Theory, BLOOMBERG NEwS (Feb. 2, 2021),
https://www.bloomberg.com/news/articles/2021-02-03/who-experts-visit-wuhan-lab-at-
center-of-virus-conspiracy-
theory?cmpid=BBD020321_CORONAVIRUS&utmmedium=email&utmsource=newslett
er&utmterm=210203&utm_campaign=coronavirus.
2021 ] The COVID-19 Modern Era Pandemic 167
Youth Epidemic, Menthol, Graphic Warnings and Corrective Statements and Cigarette
Labeling GraphicHealth Warnings, 17 IND. HEALTH L. REV. 107, 126 (2020); see Issue Brief
Reports of increases in opioid- and other drug-relatedoverdose and other concerns during
COVID pandemic, AM. MED. Soc'Y., https://www.ama-assn.org/system/files/2020-10/issue-
brief-increases-in-opioid-related-overdose.pdf (last updated Mar. 3, 2021); see generally
Roseann B. Termini & Rachel Malloy-Good, 50 Years Post ControlledSubstances Act: The
War on Drugs Rages on with Opioids at the Forefront, 46 OHIo N.U.L. REV. 1 (2020).
16 Different COVID-19 Vaccines, CDC, https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/different-vaccines.html (last updated Apr. 3, 2021). At the time of writing,
vaccines authorized under emergency use and recommended to prevent COVID-19: Pfizer-
BioNTech COVID-19 vaccine; Modema's COVID-19 vaccine. Id. The following are in Phase
3 Clinical Trials: AsiraZeneca's COVID-19 vaccine and Novavax's COVID-19 vaccine. Id.
Janssen COVID-19 vaccine was authorized February 27, 2021. Press Release, FDA, FDA
Issues Emergency Use Authorization for Third COVID-19 Vaccine (Feb. 27, 2021)
(https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-
authorization-third-covid-19-vaccine); FDA Commissioner Hahn: Lessons Learned From
COVID-19, ISPE (Nov. 30, 2020), https://ispe.org/pharmaceutical-engineering/ispeak/fda-
commissioner-hahn-lessons-learned-covid-19; Press Release, FDA, FDA Approves First
Treatment for COVID-19 (Oct. 22, 2020), https://www.fda.gov/news-events/press-
announcements/fda-approves-first-treatment-covid-19. Veklury (remdesivir) was the first
approved treatment for COVID-19 and this occurred on October 22, 2020. Id. This antiviral
drug is manufactured by Gilead for use in adult and pediatric patients 12 years of age and older
weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring
hospitalization; however, the World Health Organization (WHO) recommended against its
use; see WHO Recommends Against the Use of Remdesivir in COVID-19 Patients, WHO
(Nov. 20, 2020), https://www.who.int/news-room/feature-stories/detail/who-recommends-
against-the-use-of-remdesivir-in-covid-19-patients; Stephen Hahn, Commissioner, Food and
Drug Admin.: The COVID-19 Pandemic -Finding Solutions, Applying Lessons Learned
(Jun.1, 2020) (available at https://www.fda.gov/news-events/speeches-fda-officials/remarks-
commissioner-stephen-hahn-md-covid- 1 9-pandemic-finding-solutions-applying-lessons-
learned); Press Release, CDC, Coronavirus (COVID-19) Update: FDA Announces Advisory
Committee Meeting to Discuss Janssen Biotech Inc.'s COVID-19 Vaccine Candidate (Feb. 4,
2021), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-
update-fda-announces-advisory-committee-meeting-discuss-janssen-biotech-incs; see also
Press Release, FDA, Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal
Antibodies for Treatment of COVID, FDA (Nov. 21, 2020), https://www.fda.gov/news-
events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-
antibodies-treatment-covid-19.
* Emergency Use Authorization for Vaccines Explained, FDA (Nov. 20, 2020),
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-
vaccines-explained.
2021 ] The COVID-19 Modern Era Pandemic 169
s Claudia Wells, The Best Evidence for How to Overcome COVID Vaccine
Fears,
SCIENTIFIC AMERICAN (Jan. 7, 2021), https://www.scientificamerican.com/article/the-best-
evidence-for-how-to-overcome-covid-vaccine-fears 1/.
i9 Sophie Haigney, Long Shot, 9-12 NY TIMES MAGAZINE, Jan. 24, 2021, at 9 (detailing
the use of celebrities in 1956 when Elvis Presley received a vaccination against polio
backstage just prior to "The Ed Sullivan Show"); Kareem Abdul-Jabbar, A Reason to Jump
the Vaccine Line, NY TIMEs, Feb. 2, 2021, at A23; see Julie Wernau & Paul Overberg, Shot
Skeptics Impede Herd Immunity Goal, WALL ST. J., Feb. 4, 2021, at A7; see also Sulan
Pulliam, Betsy McKay & Kris Maher, Vaccine Skeptics Join Forces with Critics of Mask
Rules, WALL ST. J. (Feb. 3, 2021), https://www.wsj.com/articles/vaccine-skeptics-join-forces-
with-antimask-crowd-11612284890.
20 Jarrett Ramos Lewis JR, What Is Driving the Decline in People's Willingness to Take
the COVID-19 Vaccine in the United States?, JAMA HEALTH FORUM (Nov. 18, 2020),
https://jamanetwork.com/channels/health-forum/fullarticle/2773320 (explaining that
although concerns about biological agents would be used after the September 11 attacks, 35%
would not get the vaccine).
21 Sandra Knispel, The Politicizationof the CDC was Under Way Before Trump, UNIV. OF
ROCHESTER NEWSCENTER (Oct. 23, 2020), https://www.rochester.edu/newscenter/cdc-
politicization-health-risk-assessment-459152/.
22 See, e.g., id. Pew Research Center data revealed that 86% of Democrats and 69%
Republications indicated a willingness to get the vaccine; see Alec Tyson, Courtney Johnson
& Cary Funk, U.S. Public Now Divided Over Whether to get COVID-19 Vaccine, PEw RES.
CTR. (Sept. 17, 2020), https://www.pewresearch.org/science/2020/09/17/u-s-public-now-
divided-over-whether-to-get-covid-19-vaccine/ (discussing concerns of the safety and
efficacy along with the speed of approval process); see also Thom File & Abinash Mohanty,
Around Half of Unvaccinated American Indicate They Will "Definitely" Get COVID-19
Vaccine, CENSUS BUREAU, (Jan. 27, 2021),
https://www.census.gov/library/stories/2021 /01/around-half-of-unvaccinated-americans-
indicate-they-will-definitely-get-covid-19-vaccine.html.
2
Jacobson, 197 U.S. at 23-24.
170 Widener Law Review [Vol. 27:165
pursuant to section 319 of the Public Health Services Act, for the entire
United States to aid in the nation's health care community response to the
COVID-19 outbreak.24 Azar also issued a Declaration pursuant to the PREP
Act to provide liability immunity for activities related to medical
countermeasures against COVID-19.25 A PREP Act declaration is for the
purpose of providing immunity from liability, and is different from, and not
dependent on, other emergency declarations. 26 By way of illustration, the
Bioshield Act of 2004 exempts certain federal contractors from federal and
state tort liability.2 7
Further, the PREP Act authorizes the Countermeasures Injury
Compensation Program (CICP) for individuals, or estates of individuals,
injured as a direct consequence of the administration or use of the covered
countermeasure such as a COVID-19 vaccine. 28 The issuance of this
declaration was critical in terms of emergency use authorization under
29
Section 564(b) of the Federal Food, Drug, and Cosmetic Act. Declarations
are far from a recent phenomenon; there have been others over the years
pertaining to the Ebola virus in 2016 and the Zika virus in 2017.30 As set forth
above, the PREP Act declaration affords immunity from liability; however,
COVID-19 vaccines are covered countermeasure under the Countermeasures
24 Renewal of Determination That a Public Health Emergency Exists, supra note 11;
Secretary Azar Declares Public Health Emergency for United States for 2019 Novel
Coronavirus, U.S. DEP'T OF HEALTH AND HUM. SERV. (Jan. 31, 2020),
https://www.hhs.gov/about/news/2020/01/31/secretary-azar-declares-public-health-
emergency-us-2019-novel-coronavirus.html; Alex M. Azar II, Public Health Emergency;
Supplementary InformationU.S. DEP'T. OF HEALTH AND HUM. SERV. OFF. OF THE SECRETARY
(Mar. 10, 2020), https://www.phe.gov/Preparedness/legal/prepact/Pages/COVtD19.aspx; see
Pub. L. No. 109-148, § 2, 119 Stat. 2680, 2819-20; Declaration Under the Public Readiness
and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed.
Reg. 15198; cf. 42 U.S.C. § 247(d).
25 The Secretary issued the Declaration pursuant to section 319F-3 of the Public Health
Service Act (42 U.S.C. § 247d-6d) to provide liability immunity for activities related to
medical countermeasures against COVID-19 public health emergencies. See 42 U.S.C. §
247d-6d; Renewal of DeterminationThat A Public Health Emergency Exists, supra note 11;
see also Public Health Emergency; Supplementary Information,supra note 24.
26 Pub. L. No. 109-48, § 2, 119 Stat. 2680, 2818.
27 BioShield Act of 2004, Pub. L. No. 108-276, § 2, 118 Stat. 835, 839 (2004).
28 42 U.S.C. § 247d-6e(b)l) (2005). Yet, in some situations the compensation provided
may be insufficient. See Bruesewitz v. Wyeth, Inc., 562 U.S. 223, 226 (2011) (deciding
whether 42 U.S.C. § 300aa-22(b)(1) of the National Childhood Vaccine Injury Act provided
total immunity to vaccine manufacturers from tort actions by those injured and seeking
compensation for injuries allegedly arising from defectively designed vaccines).
29 21 U.S.C. § 360bbb-3(a)(1) (2004).
s Notice of Amendment to the December 3, 2014, Declaration under the Public Readiness
and Emergency Preparedness Act for Ebola Virus Disease Vaccines, 81 Fed. Reg. 89471,
(Dec. 12, 2016); see Declaration Under the Public Readiness and Emergency Preparedness
Act for Zika Virus Vaccines, 82 Fed. Reg. 10365 (Feb. 10, 2017).
2021 ] The COVID-19 Modern Era Pandemic 17 1
Over 100 years ago, in the early 1900s, the United States Supreme Court
was faced with the issue of "police power," or the power of state government
to protect public health balanced against the Constitution's protection of
personal liberty. 33 In the United States Supreme Court case of Jacobson v
Massachusetts, the Court upheld the Cambridge Massachusetts Board of
Health's (Board) authority to require vaccination of healthy adults against
the smallpox epidemic which could compromise the community 34 The
plaintiff, Henning Jacobson, an adult, had refused the vaccination for
smallpox and was fined $5.00.35 The Revised Laws of the Commonwealth,
e. 75, § 137, provided that:
Subsequently, the Board of Health for the city of Cambridge adopted the
following regulation on February 27, 1902:
Unlike today, where chronic diseases account for most deaths, at that time,
infectious diseases were the leading cause of death and states administered
39
public health initiatives. 38 The FDA did not even exist at that time. Yet
today, globalization has essentially required immunizations from infectious
diseases. COVID-19 is an example of a pandemic, perhaps reminiscent of
earlier time periods in history, and today Jacobson is still relied on for the
right of a state to protect the public. 40 Jacobson clarified that "the authority
of the state to enact this statute is to be referred to what is commonly called
the police power-a power which the state did not surrender when becoming
4
a member of the Union under the Constitution." ' As a corollary to the
COVID-19 pandemic, Jacobson set forth solid grounding regarding police
42
power in terms of public protection.
The United States Supreme Court recognized in Jacobson that "a
community has the right to protect itself against an epidemic of disease which
threatens the safety of its members."4 3 This case has been followed during
the COVID-19 pandemic, illustrated by the Tennessee Attorney General's
Office's citation to Jacobson in upholding the constitutionality of facemask
mandates." Following Jacobson, the question is whether the mandate is
arbitrary or unreasonable. 45 "[T] he Constitution does not recognize an
absolute and uncontrollable liberty."46 Succinctly stated, even though Mr.
Jacobson was a healthy adult he could not refuse vaccination because of the
epidemic society faced.47
Fast forward to the COVID-19 pandemic and undoubtedly religion could
undermine police power of a state to mandate restrictions during this
pandemic. In a recent United States Supreme Court Order, the application for
37
Jacobson, 197 U.S. at 12-13.
38 See Achievements in Public Health, 1900-1999: Control of Infectious Diseases, CDC
(Jul. 30, 1999), https://www.cdc.gov/mmwr/preview/mmwrhtml/mm4829a1.htm (stating that
pneumonia, tuberculosis, and diarrhea and enteritis were the leading causes of deaths in 1900).
39
Pure Food and Drugs Act of 1906, Pub. L. No. 59-384, Chap. 3915, 34 Stat. 768 (1906)
(explaining that the 1906 Pure Food and Drugs Act officially established the FDA); see The
Pure Food and Drug Act, U.S. HousE OF REPS., https://history.house.gov/Historical-
Highlights/1901-1950/Pure-Food-and-Drug-Act/ (Last accessed Feb. 4, 2021).
40 See, e.g., Jacobson, 197 U.S. at 19, 28.
a Id at 24-25.
42 Id at 12-13.
43
d at 27.
4" Constitutionality of Governmental Mandate to Wear Face Coverings, No. 20-14, 2020
WL 4375355 (Tenn. Op. Atty. Gen. July 24, 2020).
as Jacobson, 197 U.S. at 27, 38.
46 West Coast Hotel Co. v. Parrish, 300 U.S. 379, 391 (1937).
a7 See Jacobson, 197 U.S. at 13, 33-34, 39.
2021 ] The COVID-19 Modern Era Pandemic 173
48
South Bay United Pentecostal Church et al. v. Newsom et al., 141 S. Ct. 716, 717 (2021),
(Roberts, C. J., concurring) (stating that if the writ of certiorari was denied than the order
would automatically terminate, however, if the writ of certiorari was granted the order would
terminate when the Court entered judgment).
49 Id
s° Id. at 716 (citing South Bay United Pentecostal Church et al. v. Newsom et al., 140 S.
Ct. 1613, 1614 (2020) (Roberts, C.J., concurring)).
s' South Bay UnitedPentecostalChurch et al., 141 S.Ct. at 717 (Roberts, C. J., concurring)
(mentioning his concern that the state offered little guidance specifically tailored to places of
worship, evidenced by their "zero" tolerance policy).
z Id. (Barrett, J., concurring).
s South Bay UnitedPentecostalChurch et al., 141 S.Ct. at 723 (Kagan, J., dissenting).
s4 Industry Guidance to Reduce Risk, CALIF. Gov. (last updated Feb. 24, 2021),
https://covidl 9.ca.gov/industry-guidance/.
174 Widener Law Review [Vol. 27:165
V. FINAL COMMENTARY
Keeping the above quote from Page in the forefront, the question becomes
will Jacobson survive? 59 The answer for the current pandemic should be in
the affirmative with the caveat that a court must still balance the interests of
the state to protect the public and the interests of an individual. Perhaps
Jacobson 60 is viewed as a roadblock to individual liberty and, admittedly,
the strides in medicine are noteworthy; however, the United States' COVID-
19 pandemic remains unprecedented. Therefore, this article concludes with
the words of Justice Harlan which still ring true today despite marked inroads
to medical achievements:
s What You Should Know About COVID-19 and the ADA, the RehabilitationAct, and
Other EEO Laws, EEOC (Dec. 16, 2020), https://www.eeoc.gov/wysk/what-you-should-
know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws (explaining that if an
individual refuses a vaccine due to a disability and or strongly held religious belief, the
employer must made reasonable accommodation such as working remotely).
56
See Jacobson, 197 U.S. at 24-25.
s Page v. Cuomo, 478 F. Supp. 3d 355, 359 (N.D.N.Y. 2020).
58Page, 478 F. Supp. 3d at 371.
59
!d.
60
Jacobson, 197 U.S. at 11.
2021 ] The COVID-19 Modern Era Pandemic 175