As of the end of December, the FDA has granted emergency use approval to two coronavirus vaccines: those made by Pfizer-BioNTech and Moderna. Both require two shots, spaced weeks apart, and both appear to be extremely effective. By the end of 2020, all 50 states in the U.S. will receive tens of millions of doses, with states already administering the first set of shots. As we all wait for our turn to receive the vaccine, questions have arisen about risks, vaccine mandates, manufacturer liability and other topics. Here, Stanford Law’s Nora Freeman Engstrom and George Washington University Law School’s Peter H. Meyers discuss these and other questions:
Do these vaccines have any risks?
Current evidence suggests that both the Pfizer-BioNTech and Moderna vaccines are very safe. Still, even very safe vaccines sometimes have side effects, and the COVID-19 vaccines are no different. Thus far, out of the roughly 272,000 doses of Pfizer’s vaccine that have been administered, six cases of anaphylaxis have been reported in the U.S., while others have experienced less significant, transitory effects.
Knowing what you know about vaccines, will you be willing to get vaccinated?
Emphatically yes. Every action requires a risk-benefit tradeoff and here, in our view, the extraordinary benefits of these vaccines greatly outweigh the risks, which are miniscule. It’s not our turn in the queue yet, as health workers, essential workers, and the elderly are appropriately getting priority. But, when it is our turn, we will get vaccinated without hesitation and with tremendous gratitude for the trailblazing scientists who have created these vaccines.
Can the government or private business require that people get vaccinated?
Not at this time. The Federal Food and Drug Act states that, except for a narrow exception involving members of the military, vaccines approved for emergency use cannot be mandated.
That said, the government could theoretically mandate the receipt of vaccines later in 2021 after the vaccines receive normal approval by the FDA. In particular, an old 1905 U.S. Supreme Court case, Jacobson v. Massachusetts, acknowledges the state and federal government’s power to require adults and children to receive an approved vaccine. That case involved the smallpox vaccine in a period where smallpox was having a devastating effect on the state.
Yet, there are some exceptions to the sweep of this authority, some of which were recognized by Jacobson and some of which have evolved over time. In particular, it’s now established that the state must make an exception for persons who have weakened immune systems or would suffer a severe allergic or other serious reaction to the vaccine—what’s called the “medical exception.” States also exempt people whose religious beliefs oppose vaccinations—the “religious exception.” And the Americans with Disabilities Act (ADA) also requires that reasonable accommodations must be made for individuals with disabilities.
Once the coronavirus vaccines receive regular (as opposed to the current “emergency”) approval from the FDA, private businesses could also require their employees to be vaccinated, consistent with the medical and religious exceptions described above, the requirements of the ADA, and to the extent such a mandate is consistent with any union or other contractual obligations that apply.
So, it sounds like the government and private businesses have significant power to mandate that Americans get vaccinated. Will governments or private businesses exercise that power?
Notwithstanding the Jacobson opinion, American adults have generally not been subject to any vaccination requirement. Kids attending schools have been, though even that is subject to various medical and religious exclusions. Is the danger posed by COVID-19 sufficiently different that states and/or businesses will start to exercise their longstanding authority to compel the vaccination of adults? Quite possibly, but it’s hard to say, as such a move is apt to stir significant controversy.
What obstacles do you see as most daunting, in terms of a successful vaccination strategy?
Evidence suggests that the two vaccines that have been approved thus far are far safer, and offer far greater protection than many had dared hope. Yet, when it comes to having a successful vaccine strategy numerous challenges remain. Arguably the most daunting will be instilling public confidence.
Confidence is key, because, without public confidence in the vaccine’s safety and efficacy, not enough Americans will agree to be vaccinated. And if vaccine rates are not sufficiently high, herd immunity won’t be achieved, and the vaccine project will fail.
Currently, this confidence is shaky. According to a recent poll, 63% of Americans say they are willing to be immunized. That’s up sharply from September (when the comparable figure was 50%), but it’s still lower than we’d like.
How can health authorities shore up confidence in the vaccines?
Health authorities and policymakers have numerous tools at their disposal. Politicians from both sides of the aisle can show that they think the vaccine is safe by publicly getting it themselves—and, indeed, numerous politicians, including Vice President Pence, President Elect Biden, and Speaker Nancy Pelosi have already done just that. They can enlist healthcare workers in the effort. This too has taken place, as social media is abuzz with triumphant pictures of doctors, nurses, and aides getting inoculated. And, they can be transparent about the vaccines’ risks and benefits. This, too, is on display.
But while the steps taken thus far are salutary, in our view, they are insufficient. That’s because all vaccines—even safe and time-tested ones—have inevitable side effects for some people. Even the best vaccines, which save millions of lives, can sometimes leave a small number of seriously injured victims in their wake. Recognizing this, we believe that one plank of any comprehensive effort to bolster confidence must be to convince the public that if they are one of the unlucky few who are hurt by a coronavirus vaccine, they and their families will be treated fairly, protected, and provided for.
What’s the current process for those who are harmed by a coronavirus vaccine?
We have protected those hurt by vaccines consistently and unwaveringly since 1986, when Congress created the Vaccine Injury Compensation Program (“VICP”), a Program that protects vaccine makers from liability and which has transparently considered and evaluated some 22,000 claims for the regular childhood vaccines and the annual flu vaccine for children and adults. Under the Program, which is paid for by a $.75 excise tax on each vaccine dose administered, every person who can show she was injured by a covered vaccine, is entitled to compensation for medical expenses, lost income, and up to $250,000 for pain and suffering. Unlike in the tort system, she need not show that the doctor erred in the vaccine’s administration or preparation, that the vaccine was accompanied by an inadequate warning, or that the vaccine itself was defectively manufactured or designed. As such, the VICP is intended to provide adequate, though abridged, compensation to all individuals injured by covered vaccines via “less adversarial, expeditious, and informal proceeding[s].”
Yet, when considering compensation for the inevitable victims of the coronavirus vaccine, the Trump Administration has decided against following this familiar, well-charted path. Rather than routing these vaccine injury claims to the VICP, the Administration has, instead, decided to consign COVID vaccine claims to a novel, and largely untested, program, ominously titled the Countermeasures Injury Compensation Program (“CICP”).
What’s the CICP?
Created by Congress in 2005, the CICP arose out of concern that we were facing a potential H1N1 avian flu pandemic, as well as worries regarding potential bioterrorism threats from anthrax and other toxins. The CICP encouraged private industry to create “countermeasures” to such threats, including by developing new vaccines. To help spur this innovation, among other sweeteners, the CICP gave companies a powerful liability shield to protect them from future claims arising from injuries caused by the countermeasures they developed. In particular, the CICP shields all manufacturers, distributors and dispensers of covered vaccines from liability unless they engage in “willful misconduct”—and any individual claiming an injury from a covered vaccine must file a petition for compensation not in the tort system, and not with the VICP, but instead with the U.S. Department of Health and Human Services.
How is the CICP different than the VICP?
The CICP is different than the VICP in many respects—and, worryingly, along every one of the dimensions where the two programs diverge, the CICP is less fair to the petitioner (the vaccine-injured person).
Consider transparency. At the conclusion of VICP proceedings, special masters issue written decisions so that the public—and independent researchers—can know which injuries have been found to be caused by which vaccines and which not. By contrast, the CICP is a place where all claims for compensation are decided by agency officials in secret, without the opportunity for injured individuals to speak to or interact with decision-makers. Furthermore, in the CICP, all opinions are unpublished, so that the public (and researchers) never know which adverse events the CICP found were related to the vaccine and which were not.
Or, consider another important procedural safeguard: the right to an appeal an adverse ruling to a court. The VICP features meaningful judicial review to ventilate issues and correct errors. As noted above, a petitioner first adjudicates her claim before a special master in the U.S. Court of Claims. Then, if she is unhappy with the special master’s determination, the frustrated petitioner can appeal the determination to a judge of the U.S. Court of Claims, then to the U.S. Court of Appeals for the Federal Circuit, and even, possibly, to the U.S. Supreme Court. By contrast, in the CICP, all decisions to grant or deny compensation are unappealable to any judge.
The story regarding legal representation is similar. In the VICP, injured individuals are typically represented by attorneys and have the assistance of expert witnesses, both paid for by the program. The CICP offers neither. Injured individuals are supposed to navigate the program on their own.
Next, the VICP’s damage awards boast at least a modicum of generosity: In recent years, roughly three-quarters of VICP petitioners have received compensation. Here, again, the CICP comes up short. One of us has filed a Freedom of Information Act request to try to see how the CICP has worked thus far. (Such a request was necessary, as the CICP refuses to publish even summary statistics.) That request revealed that more than 90% of claims filed in the CICP for prior vaccine injuries have been rejected.
For successful petitioners, paths also diverge. As noted above, the VICP offers compensation for medical expenses, lost income, and up to $250,000 for pain and suffering. Compensation within the CICP is comparatively limited. Payments for medical expenses are authorized, but no compensation is allowed for pain and suffering, and only partial, prorated compensation is allowed for lost income.
Given the CICP’s shortcomings, what do you think should be done?
We certainly hope that COVID-19 vaccine injuries are few and far between. But, we are fooling ourselves if we think that there won’t be any injuries. And when those inevitable injuries take place, the victims need to be treated fairly by the U.S. government. It’s not right to ask—or compel—people to be vaccinated for the greater good and then to deprive them of fair treatment if they are one of the unlucky few hurt in the process. Toward that end, we believe that COVID-19 vaccine injury claims must be moved out of black hole that is the CICP and into the VICP—a program that, as explained above, is far from perfect but much fairer.
An even better option also exists. Congress could adopt a compensation program for COVID-19 vaccine injury modeled on the highly successful program Congress passed in 2001 after the September 11th terrorist attacks. That program—the 9/11 Victim Compensation Fund—successfully adjudicated some 7,408 claims filed on behalf of those injured or killed, and it paid out over $7 billion quickly and equitably, and with transparency and generosity. Bipartisan action to enact such a program here, when we are in the grips of yet another national disaster, would no-doubt help to inspire necessary confidence in the vaccine project. The CICP—with its tight-fist and stacked deck—never will.
Peter H. Meyers is a Professor of Law Emeritus at The George Washington University Law School where he directed the Vaccine Injury Litigation Clinic. He can be reached at Peter@law.gwu.edu.