Administrative approval of vaccines during emergencies
I. Overview: Emergency Use Authorization (EUA)
During public health emergencies, the U.S. Food and Drug Administration (FDA) has authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to authorize the Emergency Use Authorization (EUA) of medical products, including vaccines.
The EUA provision, codified under 21 U.S.C. § 360bbb-3, allows the FDA to:
Approve use of unapproved medical products
Approve unapproved uses of approved products
Expedite availability of drugs, diagnostics, or vaccines when no adequate alternatives exist
Conditions for EUA:
A declared emergency (by the HHS Secretary)
Evidence that the product may be effective
Known and potential benefits outweigh risks
No adequate, approved, and available alternatives
This administrative mechanism was widely used during the COVID-19 pandemic to authorize vaccines from Pfizer-BioNTech, Moderna, and Johnson & Johnson prior to full FDA approval.
II. Regulatory Framework
Public Health Service Act (PHSA), 42 U.S.C. § 247d
Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301 et seq.
Administrative Procedure Act (APA), 5 U.S.C. §§ 551 et seq.
National Emergencies Act (50 U.S.C. §§ 1601 et seq.)
These statutes provide the legal authority for the government to issue EUAs and regulate vaccine distribution during emergencies.
III. Key Case Law on Administrative Vaccine Approval During Emergencies
1. Doe v. Rumsfeld, 297 F. Supp. 2d 119 (D.D.C. 2003)
Facts: U.S. military personnel challenged the Department of Defense's (DoD) mandatory anthrax vaccine program, arguing it was unlawful because the vaccine had not received proper FDA approval for the use imposed.
Holding: The court ruled that administrative agencies cannot mandate use of unapproved drugs or vaccines without informed consent, unless the President waives that right. The anthrax vaccine was not approved for inhalation anthrax at the time.
Significance: This case clarified that administrative agencies must follow strict procedures when approving or mandating vaccines under emergency conditions and cannot override informed consent absent presidential authorization.
2. Doe #1 v. Rumsfeld, 341 F. Supp. 2d 1 (D.D.C. 2004)
Facts: A continuation of the anthrax vaccine litigation. The court issued a preliminary injunction stopping mandatory anthrax vaccinations because the EUA process had not been followed properly.
Holding: The court held that even in emergencies, proper regulatory procedures must be followed for vaccine authorization, including issuance of an EUA with full disclosure and informed consent requirements.
Significance: Reinforced the importance of procedural safeguards, even during emergencies, and affirmed the role of judicial oversight in checking agency actions.
3. Bridges v. Houston Methodist Hospital, 543 F. Supp. 3d 525 (S.D. Tex. 2021)
Facts: Hospital employees challenged their employer's mandate requiring COVID-19 vaccination under an EUA, arguing it violated federal law and Nuremberg Code principles.
Holding: The court dismissed the case, ruling that private employers can mandate EUA vaccines and that the EUA law only limits government action, not private mandates.
Significance: Although this case did not challenge the FDA's administrative approval directly, it affirmed that EUA-approved vaccines are legally valid for use and can form the basis of mandates, even without full approval.
4. Klaassen v. Trustees of Indiana University, 549 F. Supp. 3d 836 (N.D. Ind. 2021), aff’d, 7th Cir. (2021), cert. denied
Facts: Students sued Indiana University, arguing that mandatory COVID-19 vaccination (while the vaccines were under EUA) violated their constitutional rights.
Holding: The court upheld the university’s mandate, relying on Jacobson v. Massachusetts (1905) (which upheld vaccine mandates), and found no constitutional violation from requiring EUA vaccines with medical/religious exemptions.
Significance: Confirmed that administrative approval via EUA meets legal standards to support mandates during emergencies, especially when exceptions are allowed.
5. Children’s Health Defense, Inc. v. FDA, 573 F. Supp. 3d 122 (D. Md. 2021)
Facts: A nonprofit group sued to stop the use of COVID-19 vaccines authorized under EUA, arguing that the FDA failed to meet EUA standards.
Holding: The court rejected the claims, finding that the FDA had followed the law in granting EUAs and that plaintiffs lacked standing and failed to show legal injury.
Significance: Upheld the FDA’s discretion and scientific judgment in issuing EUAs during emergencies, affirming courts' deference to agency expertise in public health crises.
6. Jacobson v. Massachusetts, 197 U.S. 11 (1905)
Facts: A seminal case where the Supreme Court upheld a Massachusetts law requiring smallpox vaccination.
Holding: The Court ruled that states may enact reasonable regulations to protect public health, including mandatory vaccination, even over individual liberty claims.
Significance: While not about administrative approval, Jacobson remains foundational in vaccine law and has been cited in virtually every modern case involving emergency vaccine use or mandates.
IV. Judicial Deference to Agencies in Emergencies
Courts generally apply the Chevron deference or Skidmore deference doctrines when reviewing agency actions:
Chevron Deference: Courts defer to an agency’s interpretation of an ambiguous statute if it is reasonable.
Skidmore Deference: Courts may give weight to agency decisions based on their persuasive power.
In the context of vaccine EUAs, courts have typically deferred to the FDA’s expertise, especially when the agency has provided robust scientific evidence and followed proper procedure.
V. Procedural Safeguards in EUA Approval
Despite the speed and flexibility of EUAs, there are procedural and legal requirements that ensure safety and transparency:
Scientific review by FDA advisory committees
Requirement for informed consent or notification of EUA status
Post-marketing surveillance and reporting (VAERS)
Periodic re-evaluation and revocation if criteria are no longer met
VI. Summary Table of Key Cases
| Case | Year | Issue | Holding | Significance |
|---|---|---|---|---|
| Doe v. Rumsfeld | 2003 | Military vaccine mandate | Informed consent required for unapproved use | Limits on agency power without EUA or waiver |
| Doe #1 v. Rumsfeld | 2004 | Anthrax vaccine mandate | Injunction issued for improper procedure | EUA must be properly followed |
| Bridges v. Houston Methodist | 2021 | Employer vaccine mandate | EUA vaccines can be required by private entities | Validity of EUA vaccines affirmed |
| Klaassen v. Indiana University | 2021 | Student vaccine mandate | Mandate upheld under Jacobson | EUA approval sufficient during emergencies |
| Children’s Health Defense v. FDA | 2021 | Challenge to EUA for COVID-19 vaccines | FDA followed proper process | Court defers to agency scientific judgment |
| Jacobson v. Massachusetts | 1905 | Vaccine mandate | Upheld state power to require vaccines | Legal foundation for public health mandates |
VII. Conclusion
The administrative approval of vaccines during emergencies, especially under the Emergency Use Authorization (EUA) framework, is legally robust and subject to judicial review. Courts have consistently upheld the FDA’s authority to issue EUAs and have deferred to the agency’s expertise when challenged, provided proper procedures are followed.
Key takeaways:
EUA is a powerful administrative tool, but subject to legal safeguards.
Courts require proper process but do not second-guess scientific decisions absent clear violations.
Informed consent or notification is critical when vaccines are used under EUA.
Mandates based on EUA vaccines have generally been upheld when exemptions are available.
This body of case law reinforces the legal legitimacy of emergency vaccine approvals while maintaining checks on administrative overreach.
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