The FDA is the Arbiter of Vaccine Safety

INTRODUCTION

The many vaccines that protect us from disease today are more than merely clever ideas in which someone invested; they are each the product of a long series of scientific steps designed to keep us safe.[1]  To maximize that safety, the majority of these steps are regulated and overseen by the Food and Drug Administration (FDA) which follows the drugs through their lifecycle – even into the market after approval.[2]  FDA oversight helps ensure but does not guarantee that vaccines are absolutely safe.[3]  Emergency Use Authorization (EUA) authority provides the flexibility needed to respond quickly to public health emergencies, while still maintaining safety oversight.[4]  

Vaccine safety is balanced with the public need for a degree of heard immunity.[5]  In an attempt to strike this balance, Congress created a simplified process for collecting compensation for injury or death caused by vaccines.[6]  Those affected by vaccine safety issues can also sue in civil court, but only after exhausting the simplified process.[7]  In general, vaccine manufactures are at the highest liability risk for flaws in the safety of their products when the companies fail to satisfy FDA manufacturing and labeling requirements.[8]  But under the simplified process, manufacturer liability is limited and pre-specified.[9]

LEGAL AND REGULATORY FRAMEWORK OF OVERSIGHT

The FDA regulates vaccines as biological products (“biologics”).[10]  In 1902, the United States passed the Biologics Control Act – its first law to ensure vaccine safety.[11]  But the FDA itself did not come into existence until 1927.[12]  The FDA’s original name was the Food, Drug, and Insecticide Administration, and the Agriculture Appropriation Act shortened the name to its current form in 1930.[13]  The FDA did not take over regulation of biologics from the NIH until 1972.[14]  By then, the Drug Amendments of 1962 had already established the requirement for drugs in general to be approved only when approval is supported by “substantial evidence” of their efficacy.[15]  And by 1998, the FDA had matured its guidance and regulation of vaccines into its present-day state of rigorous control and supervision, including ensuring valid scientific and clinical evidence of efficacy.[16]  The FDA’s oversight does not merely address the research side of vaccine availability, though; it also regulates among other things manufacturing, handling, labeling, and adverse event reporting after the product hits the market.[17]  

Especially pertinent to current events, the FDA may also authorize emergency use of medical countermeasures such as vaccines to further safeguard public health in extreme circumstances such as a pandemic, even though the product may not have completed the normal approval process.[18]  The FDA’s Emergency Use Authorization (“EUA”) guidance aids in interpretation of the Pandemic and All–Hazards Preparedness Reauthorization Act of 2013, that describes broad FDA discretion for EUA issuance.[19]  In general, the primary factors considered for such an authorization attempt to balance the conflicting demands of the associated public health emergency and the availability of product safety data.[20]  As an example, the FDA first issued an EUA for the Pfizer BioNTech COVID-19 Vaccine on December 11, 2020.[21]  This authorization came only after extensive testing to ensure the product is safe and effective.[22]  

However, the FDA may actually authorize an EUA with much less evidence – if it believes the situation warrants such action.[23]  In fact, one key point adds flexibility and risk to the FDA’s EUA approval criteria – an EUA can be based merely upon evidence of (possible) effectiveness.[24]  Moreover, with an EUA, the FDA only asks for two months of follow-up data after full vaccination, compared to the six months normally required for FDA vaccine approvals.[25]

Should the safety of a vaccine prove inadequate, the National Vaccine Injury Compensation Program (“NVICP”) is a simplified, prescriptive program that allows plaintiffs to file in the United States Court of Federal Claims, with the Secretary of Health and Human Services named as the respondent.[26]  The NVICP limits discovery in such cases.[27]  And, it places limitations on awards for pain, suffering, and death to provide further manufacturer protection.[28]  The NVICP also disallows punitive or exemplary damages.[29]  However, if petitioner is not satisfied with results, she may still file a civil action.[30]

LEGAL EFFECT OF AN EUA IS AN OPEN QUESTION

Federal courts have only begun to test the legal weight of an EUA for (vaccines) in one case series prior to the onset of the COVID-19 pandemic – Doe v. Rumsfeld.[31]  The case concerned an anthrax vaccination, and was an attempt to prevent the military from administering an approved vaccine for unapproved use to military personnel against their will.[32]  The case began following the October 27, 2004 injunction of the military from using the vaccine for inhalational exposure without either consent, or a Presidential waiver.[33]  The military sought to add the new FDA EUA path to enable vaccine use on troops.[34]  The court permitted the modification to the injunction with the stipulation that even with an EUA, the vaccine still must only be administered on a volunteer basis.[35]  This proviso might be construed as questioning the safety of such a vaccine, but the FDA itself effectively nullified Doe’s impact on the legal landscape by issuing a new final order that classified the vaccine as safe “regardless of the route of exposure,” thereby dissolving the injunction.[36]  

Though other EUAs have been issued, their ability to hold up to legal scrutiny and challenge has not been tested.[37]  To date, the FDA has issued EUAs for two COVID-19 vaccines.[38]  Though the legal impact of those EUAs has yet to be tested, the FDA has also issued multiple other EUAs.[39]  Many of these have also been related to COVID-19, as well.[40]  Not including renewals and terminations: nine of these EUAs were related to two flu viruses and three were related to anthrax.[41]  The FDA has also issued fourteen EUAs for Zika, one for Entovirus, ten for Ebola, and two for the MERS coronavirus – a different virus than involved in the current COVID-19 pandemic.[42]  The lack of court cases testing the EUA framework is somewhat counterbalanced by the success of the National Childhood Vaccine Injury Act of 1986 (“NCVIA”), as tested in Bruesewitz v. Wyeth in 2011.[43]

Bruesewitz held that vaccine manufacturers are shielded from design-defect tort liability for injury or death resulting from unavoidable, adverse side effects of administration of a vaccine.[44]  The plaintiffs’ child Hannah had become disabled after receiving a diphtheria, tetanus, and pertussis (DTP) vaccine.[45]  The parents filed a vaccine injury petition, but were rebuffed in the Court of Federal Claims.[46]  The Court of Federal Claims held that the fact that the NCVIA specifically addresses defective manufacture and inadequate warnings without mention of design defects suggests a legislative intent for the NCVIA to pre-empt design-defect claims against vaccine manufacturers in cases of this sort.[47]

CONCLUSION

FDA oversight works in conjunction with scientific processes to manage vaccine safety and the associated laws provide an abbreviated mechanism for redress when the safety regime fails.[48]  Emergency Use Authorizations provide a mechanism to accelerate access to vaccines in a public health emergency.[49]  The legal efficacy of EUAs remains untested, with just one case making its way to federal court, and only to then be rendered moot by an FDA final order.[50]  However, manufacturers do enjoy some immunity from design defect claims through the NCVIA.[51]

FOOTNOTES

[1] Vaccine Development – 101, FDA (Dec. 14, 2020), https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101 [https://web.archive.org/web/20201230212707/https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101] (laying out the typical lifecycle of vaccine approval in a series of dropdowns).

[2] Id. 

[3] Id.  (“Like any drug, vaccines have benefits and risks , and even when highly effective, no vaccine is 100 percent effective in preventing disease or 100 percent safe in all individuals.”). 

[4] Emergency Use Authorization for Vaccines Explained, FDA (Nov. 20, 2020), https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained[https://web.archive.org/web/20210109221935/https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained].

[5] Bruesewitz v. Wyeth, 562 U.S. 223, 228 (2011) (“[Depression in vaccination rates] was a source of concern to public health officials, since vaccines are effective in preventing outbreaks of disease only if a large percentage of the population is vaccinated.”). 

[6] Id. at 228 (explaining that because vaccines can result in individual injury, and to minimize the impact of this risk on the overall public health promoted by vaccine use, the National Childhood Vaccine Injury Act of 1986 established the National Childhood Vaccine Injury Program, which provides for quick adjudication based on a table listing compensable side effects and their timing).  See also Establishment of program, 42 U.S.C. § 300aa–10 (1986).  A table lists the types of harm the program may compensate for, and the timeframe during which the harm must be evident and allows for compensation to be paid based on a petition substantiated with medical evidence, rather than requiring the claimant to file suit.  Determination of eligibility and compensation, 42 U.S.C. § 300aa–13 (1986).  See also Vaccine Injury Table, 42 U.S.C. § 300aa–14 (2016).

[7] 42 U.S.C. § 300aa–21 (1986).  See also 42 U.S.C. § 300aa–11 (2016). 

[8] Bruesewitz, 562 U.S. at 237 (explaining that manufacturers who fail to comply with the vaccine’s license stipulations for manufacturing and labeling could lose the regulatory-compliance defense). 

[9] 42 U.S.C. §§ 300aa-14 – 300aa-16. 

[10] 21 C.F.R. § 600.3(h) (2020).

[11] Milestones in U.S. Food and Drug Law History, FDA (Jan. 1, 2018), https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/milestones-us-food-and-drug-law-history [https://web.archive.org/web/20201118000335/https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/milestones-us-food-and-drug-law-history].

[12] Id.  

[13] § 3807. A brief history of the Food and Drug Administration, West’s Federal Administrative Practice (July 2020), https://1.next.westlaw.com (search for "Food, Drug, and Insecticide Administration" including quotes; in the “Documents related to your search” section, click “§ 3807.A brief history of the Food and Drug Administration”). 

[14] Milestones in U.S. Food and Drug Law History, supra note [11].  

[15] Drug Amendments of 1962, 76 Stat. 781 (1962). 

[16] Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products, FDA (May, 1998), https://www.fda.gov/media/71655/download [https://web.archive.org/web/20200917020031/https://www.fda.gov/media/71655/download].  In 2019, the FDA announced the availability of an updated (draft) of this guidance, but the standards of effectiveness remain the same.  Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability, https://www.federalregister.gov/documents/2019/12/20/2019-27524/demonstrating-substantial-evidence-of-effectiveness-for-human-drug-and-biological-products-draft [https://web.archive.org/web/20201023221813/https://www.federalregister.gov/documents/2019/12/20/2019-27524/demonstrating-substantial-evidence-of-effectiveness-for-human-drug-and-biological-products-draft].

[17] 21 C.F.R. § 600 (2020). 

[18] Emergency Use Authorization of Medical Products and Related Authorities, FDA 1 (Jan., 2017), https://www.fda.gov/media/97321/download [https://web.archive.org/web/20201225173153/https://www.fda.gov/media/97321/download].

[19] Id. 

[20] Id. at 13. 

[21] Emergency Use Authorization, FDA (Jan. 8, 2021), https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs [https://web.archive.org/web/20210109153625/https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization].

[22] Id. at 2. 

[23] 21 U.S.C. § 360bbb-3(e)(1).

[24] COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations, GAO 11 (Nov., 2020), https://www.gao.gov/assets/720/710691.pdf [https://web.archive.org/web/20201221230943/https://www.gao.gov/assets/720/710691.pdf], (“One of these criteria—evidence that the product may be effective—requires less certainty of effectiveness than is required to approve therapeutics or license vaccines.”). 

[25] Id. at 21. 

[26] 42 U.S.C. § 300aa–12. 

[27] 42 U.S.C. § 300aa–12(d)(3)(B).

[28] 42 U.S.C. 300aa–15. 

[29] Id.

[30] 42 U.S.C. 300aa–21. 

[31] Doe v. Rumsfeld, No. 03-707, 2005 U.S. Dist. LEXIS 5573, (EGS), at *1 (D.D.C. Apr. 6, 2005).  See also, Doe v. Rumsfeld, 297 F. Supp. 2d 119 (D.D.C. 2003); Doe v. Rumsfeld, 341 F. Supp. 2d 1 (D.D.C. 2004).

[32] Doe v. Rumsfeld, No. 03-707, 2005 U.S. Dist. LEXIS 5573, (EGS), at *1 (D.D.C. Apr. 6, 2005) (describing the unapproved use as vaccination against inhalational anthrax).

[33] Id.

[34] Id.

[35] Id.

[36] Rempfer v. Sharfstein, 583 F.3d 860, 864 (D.C. Cir. 2009). 

[37] Searches for “Emergency Use Authorization” in both Lexis and Westlaw, and searches for references to the related code (21 USC § 360bbb-3) result in only a smattering of cases.  None of these cases other than the Doe supra note [32] series in any way test the ability of an EUA to provide access to vaccines, nor an EUA’s ability to shield a manufacturer from liability resulting from harm caused by a vaccine the EUA authorized.  But see Parker v. St. Lawrence County Public Health Dept., 102 A.D.3d 140 (Nov. 21, 2012) (holding that the Public Readiness and Emergency Preparedness Act provides immunity from liability and preempts state law in that context). 

[38] Vaccine EUA Questions and Answers for Stakeholders, FDA (Dec. 21, 2020), https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/vaccine-eua-questions-and-answers-stakeholders [https://web.archive.org/web/20210117203324/https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/vaccine-eua-questions-and-answers-stakeholders].

[39] Emergency Use Authorization (EUA), DHHS: Public Health Emergency (N.D.), https://www.phe.gov/emergency/news/healthactions/Lists/EUA/AllItems.aspx [https://web.archive.org/web/20201031172336/https://www.phe.gov/emergency/news/healthactions/Lists/EUA/AllItems.aspx]. See also, Emergency Use Authorization--Archived Information, FDA: MCM Legal, Regulatory and Policy Framework (Dec. 4, 2020), https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information [https://web.archive.org/web/20210116033635/https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information].

[40] Emergency Use Authorization, FDA (Jan. 8, 2021), https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covid19euas [https://web.archive.org/web/20210109153625/https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization].

[41] Id.

[42] Id.  See also, Emergency Use Authorizations for Medical Devices, FDA (Jul. 29, 2020), https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations-medical-devices [https://web.archive.org/web/20210102180554/https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations-medical-devices].

[43] Bruesewitz v. Wyeth, 562 U.S. 223 (2011). 

[44] Id. at 230. 

[45] Id.

[46] Id.

[47] Id. at 238 (“[T]he lack of guidance for design defects combined with the extensive guidance for the two grounds of liability specifically mentioned in the Act strongly suggests that design defects were not mentioned because they are not a basis for liability.”). 

[48] Vaccine Development – 101, supra note 1.

[49] Emergency Use Authorization for Vaccines Explained, supra note 4.

[50] Rempfer v. Sharfstein, 583 F.3d 860, 864 (D.C. Cir. 2009).

[51] Bruesewitz, 562 U.S. at 238.