Even as coronavirus cases surge across the United States and the world, a slew of headlines in recent days paints an optimistic picture of where the COVID-19 pandemic is headed. Pharmaceutical companies say two vaccine candidates are about 95 percent effective in preventing the potentially deadly disease. The makers of one of those inoculations, Pfizer and BioNTech, have applied for government approval for their shots and have said they can begin shipping the vaccine within hours of winning it. After 250,000 deaths this year in the United States alone—not to mention 12 million cases and months of lockdowns and economic disruption—the companies’ pledge sounds just great.
Pharmaceutical companies have already set world records with the speed in which they have developed COVID-19 vaccine candidates and rolled out clinical trials, dramatically shortening a drug development and approval process that can take months or even years. Companies like Pfizer and BioNTech will pursue a regulatory shortcut to getting their vaccines to market: the Food and Drug Administration’s emergency use authorization process.
While an emergency use authorization may be the speediest way for public health officials to begin a vaccination campaign, it may not end up shaving that much time off of a more traditional route to government approval. Using a different expedited process, the FDA cleared a novel Ebola vaccine in just six months. Polls have shown that many Americans are wary of getting a COVID-19 vaccine. Other paths toward granting official approval to COVID-19 vaccines may get vaccines to the public almost as quickly as emergency use authorization can—while providing the public with greater reassurance that those vaccines are safe and effective.
A history of emergency use. The United States was the first country to develop an emergency use policy, but several others have followed suit, including South Korea and China. In the United States, the FDA is responsible for issuing such authorizations for medical countermeasures, including vaccines, therapeutic drugs, diagnostic tests, and other medical devices. For example, the federal government has previously granted emergency-use status for an anthrax vaccine, influenza antivirals, and diagnostic kits for Zika. The emergency use authorization policy—which originated as a tool for improving biodefense after letters laced with the anthrax were delivered to media and political figures in 2001—is now facing its greatest test.
Since the start of the COVID-19 pandemic, the FDA has issued more than 250 emergency use authorizations for antiviral drugs, diagnostic kits, ventilators, and other medical equipment. Now various stakeholders, the public, biomedical professionals, and politicians in the United States are interested in emergency use authorizations for COVID-19 vaccines.
The anthrax attacks, which killed five people and infected 17 others, convinced US officials that the country needed an efficient and well-resourced process for developing and acquiring medical countermeasures—drugs, vaccines, tests, protective gear, and devices—that could quickly be distributed to the public after a chemical, biological, radiological, or nuclear attack. In 2004, President George W. Bush signed the Project Bioshield Act to strengthen the ability of the federal government to protect the public against weapons of mass destruction.
The emergency use authorization was one of three main pillars of the act, which also included reforms to facilitate research and development of medical countermeasures and the establishment of a special fund to procure them.
Once an emergency has been declared, the FDA begins to review whether an emergency use authorization is appropriate. To be eligible for such an authorization, the medical countermeasure in question needs to meet four broad criteria: There needs to be a life-threatening situation, evidence that the countermeasure is effective, a risk-benefit analysis, and no better option to address the situation. The emergency use authorization is a careful policy that takes into account risks, benefits, and urgency.
From biodefense tool to pandemic fighter. Initially, the emergency use policy was exclusively aimed at the threat posed by weapons of mass destruction—that is, a chemical, biological, radiological, or nuclear weapon. In 2004, as the legal framework for emergency use authorization was established under Project Bioshield, the Department of Health and Human Services launched the City Readiness Initiative to ensure that major cities would be able to distribute antibiotics and other medical countermeasures to 100 percent of their populations within 48 hours. To meet the goal, the FDA issued an emergency use authorization for doxycycline, a broad-spectrum antibiotic, in emergency kits for eligible US Postal Service participants and their families.
The first and only vaccine approved for emergency use is an anthrax vaccine. It was not a novel and investigational vaccine, but one that had been licensed in 1970. Under the Department of Defense’s Anthrax Vaccine Immunization Program, a million military personnel have received shots since 1998. At one point, a US district court stopped the military’s vaccination program for several months because the vaccine hadn’t been approved to protect against inhaled anthrax, just against anthrax absorbed through the skin. But after the emergency use authorization process was developed and one was issued for off-label use to protect against inhalation anthrax, the court approved the resumption of the program, highlighting the legal protections an emergency use authorization offers.
In 2006, the Pandemic and All-Hazard Preparedness Act expanded the scope of the emergency use authorization to public health threats whether they were deliberate, accidental, or natural. In 2013, the scope of the emergency use authorization was explicitly expanded to cover emerging infectious diseases.
Based on the broader scope afforded by this legislation, the FDA granted emergency-use status to peramivir, an unapproved antiviral drug, so it could be distributed during the global H1N1 pandemic in 2009. Emergency use authorization was also conferred on diagnostic kits to detect emerging infectious diseases such as MERS, H7N9 influenza, Ebola, and Zika. Prior to the COVID-19 pandemic, 33 of these diagnostic kits had been granted emergency-use status—most since 2013.
Emergency use and COVID-19. On January 31, Health Secretary Alex M. Azar declared the COVID-19 pandemic to be a public health emergency. By early September, 203 diagnostic kits, 35 molecular-based laboratory-developed tests, 20 personal protective equipment products, 26 ventilators, and five drugs and biological products had been granted emergency use authorizations to help combat the pandemic.
Many people expect the FDA to grant emergency use authorizations for COVID-19 vaccines. Companies have already announced promising results during Phase 3 clinical trials. The Pfizer and BioNTech partnership and Moderna have each announced that their vaccines are about 95 percent effective at preventing COVID-19 infections, results that far overshoot the 50-percent efficacy threshold the FDA has set for issuing an emergency use authorization.
Emergency use authorization could allow a vaccine to bring the COVID-19 pandemic under control relatively quickly.
But there are also significant disadvantages to using the emergency use authorization as the legal basis for approving a COVID-19 vaccine for widespread use. Most such authorizations issued for drug and biological products (a category which doesn’t include medical devices such as diagnostic kits and ventilators) have involved post-exposure prophylaxis or treatments. But vaccines have quite different medical purposes compared to treatments for someone exposed to anthrax or to nerve agents. With vaccination, healthy people take a risk to prevent the possibility of future sickness. “Therapeutics are given to people who are sick, maybe even in life-threatening situations,” FDA Commissioner Stephen Hahn said in October. “Vaccines are given to people who are, in general, healthy but may be at risk for life-threatening complications.”
If a COVID-19 vaccine receives an emergency use authorization, it will be the first time the FDA has used the process for a novel vaccine.
The emergency use authorization is not the best way of seeking fast COVID-19 vaccine approval. The FDA has already developed various programs to expedite drug development and review. These programs are: fast track, breakthrough therapy, accelerated approval, and priority review. Each has its own advantages that COVID-19 vaccine developers can adopt and apply. For example, the fast-track pathway has rolling review process that allows a drug company to submit completed sections of its applications for review, rather than waiting until every section is completed. The priority review is a drug approval program that has the goal of approving a drug within six months. A new Ebola vaccine was approved by the priority review process in less than six months.
Given the speed of these programs, they may not unduly lengthen the timeline for new COVID-19 vaccine development. And an official government seal of approval may help alleviate concerns many people have about vaccination.
According to the polling firm Gallup, the percentage of Americans willing to be vaccinated has risen up from 50 percent in early fall to 58 percent in October, before the most recent spate of positive headlines about vaccine studies. That still leaves many people unwilling to get the vaccine, potentially limiting how effective it will be in crushing the pandemic. Another poll by the health news organization STAT in October also showed that 58 percent of people would get a vaccine as soon as it’s available. Both organizations noted a dip in the late summer or early fall when news coverage focused on how an inoculation might be rushed out.
In March, Azar published a declaration under the 2005 Public Readiness and Emergency Preparedness Act to provide liability immunity for activities related to medical and security countermeasures against the pandemic. Under the 2005 law, liability protection covers manufacturers and others who participate in a vaccination campaign. Drugs, devices, or vaccines approved by the FDA or authorized for emergency use are subject to the law’s liability protections.
Some patients may consider it too risky to take a novel vaccine that has such strong liability protections. An officially approved vaccine could go a long way toward alleviating people’s concerns.
The emergency use authorization is certainly an appropriate platform for authorizing a vaccine for off-label uses–post-exposure prophylaxis, or pediatrics use, for instance, as well as for authorizing drugs to treat people already ill with COVID-19. While scientific scrutiny of the vaccine development process in the United States ensures that we can be confident that the vaccine candidates—including those that may receive an emergency use authorization—have been rigorously tested for safety and efficacy, the emergency-use process is being stretched too far. Approving new COVID-19 vaccines through one of the four FDA official fast-tracked program can provide speedy access to a vaccine and can help bolster the public’s confidence in it.
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