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May 3, 2021 (SENT VIA EMAIL AND FEDEX)
To: President Vincent E. Price
Duke University 207 Allen Building
Box 90001 Durham, NC 27708-0001
c/o Cici Stevens, Staff Assistant [email protected]
Re: Duke University’s COVID-19 Vaccine Mandate (1662 words)
Dear President Price:
Numerous students attending Duke University (“Duke”) have reached out regarding Duke’s COVID-19 vaccine mandate. We understand that Duke’s students were advised on April 9, 2021 that
“we plan to require all new and returning Duke students to present proof of vaccination to Student Health before they can enroll for the Fall 2021 semester.”
As I am sure you are aware, the COVID-19 vaccines are presently authorized under emergency use authorization (“EUA”).
It is a violation of federal law to mandate receipt of a product that is only available pursuant to an EUA. Duke cannot lawfully require students to receive a COVID-19 vaccine that is being distributed under an EUA.
Emergency Use Authorization of COVID-19 Vaccines
In December 2020, the FDA granted EUA for two COVID-19 vaccines, one sold by Moderna and the other by Pfizer. Both are based on an RNA technology never before used in a licensed vaccine. In February 2021, the FDA granted EUA for a third COVID-19 vaccine sold by Janssen.
This is a novel viral vector vaccine platform. The clinical trials that the FDA will rely upon to decide whether to license these vaccines are underway, but they are far from complete.
The EUA applications for these experimental vaccines were based on data which supports that these products may reduce certain symptoms of COVID-19 for some individuals, but the FDA’s EUA authorizations made clear that there is no evidence the COVID-19 vaccines can prevent recipients from becoming infected with and transmitting the virus.1
As the FDA explains, at the time of the EUA approval, the data was “not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 [i.e., the virus that causes COVID-19] from person to person.”2 In fact, the FDA Briefing Documents for the COVID-19 vaccines supporting the grant of an EUA list the following as still unknown:
- “[e]ffectiveness in certain populations at high-risk of severe COVID-19,”
- “[e]ffectiveness in individuals previously infected with SARS-CoV-2,”
- “effectiveness against asymptomatic infection,”
- “effectiveness against long-term effect of COVID-19 disease,”
- “effectiveness against mortality,” and
- “effectiveness against transmission of SARS-CoV-2.”3
The FDA Briefing Documents also make clear much is unknown about the safety of these products, including,
- “[a]dverse reactions that are very uncommon,”
- adverse reactions “that require longer follow-up to be detected,” and
- whether the vaccines will cause “[v]accine-enhanced disease.”4
As a result, the authorization letters for both COVID-19 vaccines expressly provide that the vaccines are each “an investigational vaccine not licensed for any indication” and require that “[a]ll promotional material relating to the COVID-19 Vaccine clearly and conspicuously … state that this product has not been approved or licensed by the FDA, but has been authorized for emergency use by FDA.”5
Reflecting that these vaccines have not yet been demonstrated to be safe and effective, use of one of them was recently paused by the CDC and FDA due to serious reactions that have proven fatal in some cases.6
This exemplifies why the authorization letters for the COVID-19 vaccines, in accordance with federal law, expressly provide that these vaccines cannot be required and must remain optional.
Federal Law Prohibits Mandating Products Granted EUA
The same section that authorizes the FDA to grant an EUA [Section 564 of the Federal Food, Drug, and Cosmetic Act (the “Act”), codified at 21 U.S.C. 360bbb-3], requires that the public have “the option to accept or refuse administration of the product.” 21 U.S.C. 360bbb-3(e).
It even provides that the Secretary of HHS is to “ensure that individuals to whom the product is administered are informed” of “the option to accept or refuse administration of the product.” (Id.)
The FDA and CDC’s guidance and regulations reflect the statutory prohibition from mandating that an individual receive a product that has only been granted EUA.
For example, the FDA guidance entitled Emergency Use Authorization of Medical Products and Related Authorities provides that: For an unapproved product [such as the COVID-19 vaccines], the statute [21 U.S.C. 360bbb-3] requires that FDA ensure that recipients are informed … [t]hat they have the option to accept or refuse the EUA product…7
Similarly, when responding to an inquiry regarding whether the COVID-19 vaccines can be required, the Executive Secretary of the CDC’s Advisory Committee on Immunization Practices (“ACIP”), Dr. Amada Cohn, publicly stated that “under an EUA, vaccines are not allowed to be mandatory.“
Therefore, early in the vaccination phase individuals will have to be consented and cannot be mandated to be vaccinated.”8
Dr. Cohn then reaffirmed to the FDA’s Vaccine and Related Biological Products Advisory Committee that no organization, public or private, can mandate the COVID-19 vaccines:
Organizations, such as hospitals, with licensed products do have capability of asking their workers to get the vaccine. But in the setting of an EUA, patients and individuals will have the right to refuse the vaccine.9
The EUAs for the COVID-19 Vaccines Repeats this Prohibition
The EUA letters for Pfizer, Moderna, and Janssen provide that each COVID-19 Vaccine is authorized for emergency use with the following product specific information required to be made available to the vaccination providers and recipients, respectively (referred to as ‘authorized labeling’):
- Fact Sheet for Health Care Providers Administering Vaccine … [and]
- Fact Sheet for Recipients and Caregivers.10 These fact sheets each provide that the receipt of the vaccine must be optional.
The Fact Sheets for Healthcare Providers for the three COVID-19 vaccines state that: “The recipient or their caregiver has the option to accept or refuse [the] COVID-19 Vaccine.”11
Similarly, the Fact Sheets for Recipients and Caregivers for each COVID-19 vaccine state on the first page: “It is your choice to receive the [] COVID-19 Vaccine.”12
The Fact Sheet for Recipients and Caregivers for each of the COVID-19 vaccines also set forth in sequence the information required to be provided to recipients of the vaccine pursuant to section 564 of the Act, including “the option to accept or refuse administration of the product” and “the consequences, if any, of refusing administration of the product.” 21 U.S.C. § 360bbb-3(e)(1)(A)(ii).
All of the COVID-19 vaccine fact sheets provide the required information in sequence, including telling potential recipients: “It is your choice to receive or not receive the [] COVID-19 Vaccine,” and that if “you decide to not receive it, it will not change your standard of medical care.”13
Duke’s Vaccine Mandate Violates the Act, the EUA, Public Policy and the Nuremberg Code
By implementing its vaccine mandate, Duke is deliberately taking away each student’s statutorily guaranteed right to decide whether to accept or refuse administration of the COVID-19 vaccines.
The university is doing so openly, without any regard for the personal and autonomous right of each student to choose whether they want to receive an unapproved and unlicensed medical product.
Duke is effectively forcing each student to choose between facing expulsion from Duke or receiving an experimental medical treatment to which they do not consent.
The right to informed medical consent is considered a fundamental, overriding principle of medical ethics and international law, first laid down by United States government jurists in the Nuremberg Code.
See e.g., The Nuremberg Code (1947), 313 BMJ 1448 (1996) (“The voluntary consent of the human subject is absolutely essential. This means that the person…[is] able to exercise free power of choice, without the intervention of any element of…coercion.”);14 see also UNESCO Universal Declaration on Bioethics and Human Rights, Article 6(1).15
Public policy further demands that uncoerced consent is required.
Congress made this plain in the Act by assuring that individuals can make their own medical decisions when it comes to EUA products, even during times of emergency.
The only exception Congress granted for allowing an EUA to be mandated is a Presidential order requiring members of the armed forces to receive the product.16
The clear policy choice made at the highest levels of government to protect the individual’s right to choose is further supported by the fact that whether COVID-19 vaccines are actually safe and effective is not yet known and will not be known until, at the earliest, the Phase III clinical trials are completed.
The FDA-approved study protocols for the COVID-19 vaccines’ timelines for collecting safety and efficacy data from trial participants is approximately two years.
(Moderna’s calls for 759 days of data collection, Pfizer’s 742 days, and Janssen’s 24 months.) When these companies submitted applications for an EUA, they had only accumulated data from study participants for a median of 6 to 8 weeks, i.e., less than 10% of the full study period.
Additional Considerations
As explained above, these vaccines have not been proven to prevent infection or transmission. Therefore, requiring that students receive these vaccines to prevent infection is unscientific.
It is also nonsensical to not require faculty and staff, some of whom may have a risk of severe COVID-19, while requiring healthy, young students to receive this experimental product.
To the extent the university’s policy permits faculty, staff, and other individuals on campus to choose or refuse vaccination, but does not allow that same choice for students, this may raise equal protection issues.
Additionally, Duke is failing to take into consideration that a significant portion of its student population is likely to have had SARS-CoV-2 and fully recovered. Putting aside the immunity conferred by having been previously infected, there have been concerns raised by medical professionals that vaccinating those recently infected can lead to serious injury or death by causing antigen specific tissue inflammation in any tissues harboring viral antigens.17
The university should consider whether it might be liable for any damages, poor health outcomes, and loss of life due to mandatory COVID-19 vaccination policies forced upon its students.
While manufacturers and vaccine administrators are protected by the PREP Act, Duke is not.
For all of the foregoing reasons, we respectfully request that Duke give serious consideration to the issues raised herein and withdraw its COVID-19 vaccine mandate forthwith since requiring an unlicensed and unapproved product violates federal law, international laws, civil and individual rights, and public policy.
Very truly yours,
Aaron Siri, Esq.
Elizabeth A. Brehm, Esq.
Jessica Wallace, Esq.
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