Emergency Use Authorization for Covid-19 Vaccines: Lessons from the Past

by Dorit Reiss, PhD LLB, Art Caplan, PhD, and Working Group on Vaccine Ethics and Policy

The question whether the FDA will give an Emergency Use Authorization (EUA) to a COVID-19 vaccine is currently being widely discussed.  The emphasis in the discussions is on whether political intervention will lead to an EUA with no good basis in evidence. What is not as clear but is crucially important is what past emergency uses of vaccines can teach us about how to use an EUA for a vaccine today. 

Four historical events can help us think about COVID-19 vaccines EUA. In 2005, a particularly bad outbreak of anthrax in livestockand an FBI Director  Robert Mueller created the Weapons of Mass Destruction Directorate. Secretary of Health and Human Services, Tommy G. Thompson, issued the only official vaccine EUA ever used in the United States.  He allowed emergency use for the Anthrax Vaccine Absorbed (AVA) against inhalation anthrax. https://www.federalregister.gov/documents/2005/02/02/05-2027/determination-and-declaration-regarding-emergency-use-of-anthrax-vaccine-adsorbed-for-prevention-of At that point, the AVA vaccine had been approved by the FDA, after review and with its advisory panel’s recommendation, since 1985.  But it had not been used against inhalation anthrax, and litigation quickly followed around approving it for that use. DoD was concerned that not being able to provide the vaccine until the process ended would undermine military readiness. It requested an EUA, and it was granted, on condition that DoD inform members of the option to refuse the vaccine and that no steps would be taken against members who refused. https://wwwnc.cdc.gov/eid/article/13/7/06-1188_article Despite the controversy it is important to note that this was not a vaccine without significant data, and the basis for the approval was the Department of Defense’s conclusion that there was a “heightened risk” of an anthrax attack against military personnel.

In 2009, the U.S. faced the H1N1 pandemic. Although an EUA for a vaccine was not issued, it such a move was discussed; and a study done at the time suggested there would be considerable hesitation around taking an unapproved vaccine issued under an EUA. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2998968/

In 2014, FDA officials allowed the use of a meningococcal B vaccine that was, at the time, already licensed in Europe and Australia in response to a meningococcal outbreak in several U.S. colleges that killed at least one student. https://www.nbcnews.com/health/emergency-meningitis-vaccine-will-be-imported-halt-ivy-league-outbreak-2D11603651 Access to the vaccine was allowed, not through an EUA but as breakthrough therapy. https://www.fda.gov/media/90982/download The vaccine was also at late stages of application in the U.S., and there was clearly data that had served as the basis of licensing it in Europe and Australia and subsequent experience with the vaccine in those countries. 

Finally, although not in the U.S., an Ebola vaccine was used on an emergency basis for at risk people – at risk healthcare workers, adults and children – during an Ebola outbreak in 2014-2016 in West Africa, using investigational expanded access protocols, alongside clinical trials.https://pubmed.ncbi.nlm.nih.gov/28890191/ This was justified by the severity and high risks of the disease. The outbreak was the largest Ebola outbreak known, and ended with over 28,000 cases and over 11,000 deaths; Ebola has high mortality. https://www.cdc.gov/vhf/ebola/history/2014-2016-outbreak/index.html

What can we learn from these examples? In the three cases in which emergency use of vaccine was allowed, authorities were facing a high risk situation in a limited target population, with dangerous diseases. Anthrax, meningococcal infection and Ebola all carry high risks of deaths and/or complications. In all these cases, the emergency use was limited in scope to a specific population for which there was good reason to think the risks were especially high. In two of these cases (meningococcal and anthrax) there was already substantial safety and efficacy data about the vaccine in question, allowing assessment of risks v. benefits. For the third, Ebola, the risks of the disease were extraordinarily high and trials continued. In the only case in which a universal vaccine EUA was considered were there indications were that the vaccine would not be accepted. It’s important to note that an H1N1 vaccine EUA was not issued.

These lessons should inform us as to when it is appropriate for companies to ask—and officials to grant—a CoOVID-19 vaccine EUA. First, it is not usually an appropriate tool for general use, as a way to shortcut or accelerate approval. Second, an EUA might be an appropriate tool in a specific high-risk emergency—for example, an outbreak among a vulnerable population, a prison or a nursing home – if enough data is already available to reasonably assess the vaccines’ risks and benefits.

An EUA is an emergency tool. It should be limited to emergency circumstances for particular populations where there are clear indications that the benefits outweigh the risks. It ought not serve as a means to accelerate approval of vaccines for the general population.