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Contributed by Brian Dean Abramson
As both scientists and politicians have noted, the most effective way to mitigate the economic and societal effects of the coronavirus pandemic, and more importantly, to limit infection and death, will be the development and deployment of an effective vaccine. With that in mind, vaccine law is uniquely poised to chart the way out of this crisis.
The substantial impact of this disease has led the U.S. government to initiate extraordinary measures towards achieving this goal. It has at its disposal additional powers at the ready to dispel certain legal impediments to vaccine development as they arise, and to aggressively bring a developed vaccine to the point of administration to the population. This article discusses the legal issues involved in expediting vaccine development during a pandemic.
On March 19, 2020, the Food and Drug Administration announced that it “intends to use all of the regulatory flexibility granted to it by Congress to ensure the most efficient and timely development of vaccines” to fight Covid-19. Notably, none of the flexibility presently being exercised has required the passage of new legislation at the congressional level, or even rulemaking at the agency level. Rather, all of these measures are pursuant to existing laws and rules enacted in anticipation of exactly such a crisis as this one.
Between mid-March and mid-April 2020, the FDA issued progressively revised guidance for all parties engaged in “the conduct of clinical trials of medical products, including drugs, devices and biological products,” which will inevitably include Covid-19 drug and vaccine trials, with the guidance thus issued providing substantial flexibility for the conduct of all such trials.
Under normal circumstances, the development of a new vaccine takes several years. As with any new pharmaceutical product, this arises from multiple rounds of clinical trials, each of which can take more than a year to complete. In fact, the FDA specifically advised in its guidance that parties should consider delaying new drug trials “other than trials intended to evaluate investigational treatments or vaccines” for Covid-19.
Clinical trials begin with an animal model. Appropriate test animals are selected based on their having similar biological functionality to humans with respect to the affected organ or bodily function. The vaccine candidate is then tested on these animals to see if it provokes an immunological response in the animal comparable to that which is sought in humans, and to reveal any obvious or immediate side effects that would make the risks of the vaccine outweigh its benefits.
Once animal testing has been completed and evaluated, trials move to the first of three well-delineated phases of human testing, under the supervision of an FDA-approved Institutional Review Board. A small group, perhaps 40 to 50 people, are administered the vaccine and then carefully observed and examined over a lengthy period to make initial determinations about its effectiveness and its safety for use in humans. Typically, only once this has been completed, and all of the outcomes carefully examined, do trials move to a second larger phase with hundreds of test subjects, which is more heavily focused on determining effectiveness. Similarly, only once the second phase is completed and scrutinized does testing move to a very large final phase, with thousands of human subjects.
With respect to Covid-19, however, much of the traditional practice has been turned on its head. Researchers have effectively been given the go-ahead by the FDA to begin later clinical trial phases before the earlier phases are complete, with some adjustments to later phases to be made on the fly, based on continuing results from the earlier phases. The FDA has also initiated a Coronavirus Treatment Acceleration Program, under which pharmaceutical products relating to the treatment of Covid-19 will be moved ahead of any other products awaiting FDA review, and will be reviewed by the agency in the fastest possible manner. This program is aimed at therapies, but the same framework will be applicable to vaccines as they develop.
Because of the costs involved both in testing protocols and in ramping up of the production of any new pharmaceutical, it is also almost always the case that the manufacturer will not actually begin production until after all testing is completed and evaluated. Here again, however, the FDA has indicated support for companies to initiate mass manufacturing processes before the vaccines have been licensed for use.
It is important to note that when clinical trials are being conducted, researchers are looking for far more information than whether the vaccine is effective. They are also determining the ideal dosages—too little may be ineffective, too much may be harmful, or at least wasteful. The ideal schedule for administration must be determined, especially if it turns out that the vaccine is most effective when given in doses spread out over specific intervals. Even if immunity is successfully mediated by a vaccine, years of observation will be required to determine how long immunity lasts—it is presently unknown whether the coronavirus itself will mutate seasonally, such that vaccination will become an annual ritual like flu vaccination.
As is the case with many other vaccines, there will likely be multiple vaccines developed and deployed for Covid-19, with some being preferable to specific communities, such as pregnant mothers, those with immunological disorders, and the elderly. Vaccines attuned to different target populations may provide differing levels of robustness and periods of immunity.
The FDA has the authority to issue an Emergency Use Authorization allowing deployment of unapproved products including vaccines “intended for use in an actual or potential emergency.” 21 U.S.C. §360bbb-3(a)(1). The agency has already used this authority with respect to other products developed to deal with the Covid-19 crisis, most notably for diagnostic tests. The FDA is therefore likely to issue an EUA for an unapproved Covid-19 vaccine, for so long as the public health emergency persists.
Another aspect of the law that will bend towards the fast combination of vaccine research involves the primary intellectual property regime used to enforce ownership rights in vaccines, patent law. Under 28 U.S.C. §1498, the government has the right to infringe on a patent where public health is implicated, and need only pay a reasonable royalty for the use while remaining immune from access penalties, attorneys’ fees, and costs. Furthermore, the statute specifically designates agents of the government, which can include private corporations, as falling within the ambit of this protection.
Given the vast number of extant patents regulating inventions in the pharmaceutical industry, and with respect to vaccine development and functionality specifically, it is highly likely that a number of patents exist that read on aspects of any technology that is developed or used towards developing a Covid-19 vaccine. The government, by designating those entities that are working towards the creation of such a vaccine as its agents for this purpose, can apply this provision of the statute to them.
In March 2020, American biopharmaceutical company AbbVie Inc., announced that it would cease enforcement of its patents for an antiviral medication thought to help in the treatment of Covid-19. This announcement, however, may not have been entirely altruistic, as it came in the wake of a compulsory licensing decree by the Israeli government.
Additionally, another section of the patent law, 35 U.S.C. §203, gives the government “march-in rights” to use patented technology derived from a patent for which the government has invested funds in the development of that technology. Historically, the U.S. government has substantially invested in developing vaccines for coronaviruses. Therefore, it is highly likely that many of the patents that would stand in the way of a given developer deploying a Covid-19 vaccine are those toward which the government has previously dedicated some level of funding, thereby establishing these march-in rights.
Once a working Covid-19 vaccine has been developed, the U.S. will enter a phase wherein existing case law precedent is uniquely suited to the present crisis. More than 120 years ago, in fact, the U.S. struggled through a crisis of similar proportions, with the regular occurrence of smallpox epidemics. Whereas Covid-19 appears to kill a substantially higher number of those who contract it than the flu, the measles, and many other diseases against which people are vaccinated—smallpox would kill as many as one out of six people. Even among those who were vaccinated for smallpox, the death rate was substantially higher than that of many lesser diseases today.
In the midst of this pattern of disease and death, vaccination mandates were liberally enacted, and a case regarding one of these wound its way up to the U.S. Supreme Court: Jacobson v. Massachusetts, 197 U.S. 11 (1905). In that case, the Court held that a state could legally mandate the vaccination of all citizens for smallpox, no matter the objections of the individual citizens, no matter even if they had a particular basis for believing that they would have a negative reaction to the vaccine itself. The court specifically upheld the ability of the state to impose criminal penalties on adults who refuse vaccinations.
There is some question as to whether Jacobson retains its full power in the modern age, where every state and federal vaccine mandate provides a medical exemption for those who are physically unable to receive vaccinations. However, perhaps an even more significant Supreme Court case was decided in 1922, Zucht v. King, 260 U.S. 174 (1922). In that brief opinion the Court held that the school district of San Antonio, Texas, could exclude from the schools—both public and private—any student who had not been vaccinated. Although it is unlikely that criminal penalties will be imposed on persons who merely refuse to receive a Covid-19 vaccination, the precedents of the Supreme Court not only give the states this power, but also the power to exclude from virtually every aspect of public life those who are unvaccinated, and to penalize those who seek to violate these exclusions.
One of the first acts taken by the current administration in addressing this crisis was to invoke a little-used law, the Public Readiness and Emergency Preparedness Act, or PREP Act. On Jan. 31, 2020, Secretary of Health and Human Services Alex Azar declared a public health emergency in the U.S. Then, on Feb. 4, 2020, Azar issued a Notice of Declaration under the PREP Act for medical countermeasures against Covid-19. This declaration specifically covers any vaccine, used to prevent or mitigate Covid-19.
The PREP Act immunizes vaccine manufacturers, distributors, and administrators from liability for any harm caused by the vaccine and their efforts to administer it, absent willful misconduct. 42 U.S.C. §247d-6d.(a)(2)(B). This immunity from suit encompasses those to whom the vaccine is administered without proper consent. In Parker v. St. Lawrence County Pub. Health Dep't, 102 A.D.3d 140, 144 (N.Y. App. Div. 2012), the court examined an instance where the H1N1 influenza vaccine was administered to a kindergarten child without parental consent during a declared public health emergency. The court found that the immunization provisions of the act extend “to qualified persons who administer a covered countermeasure to an individual without consent.”
Although this does not specifically authorize forced vaccinations (a practice that has been disfavored in the U.S. for over a century), it does allow those who are unconscious due to illness, or unable to consent to lack of mental capacity, or who are very young children, to be vaccinated without their express consent or that of their legal guardians. This greatly expands the opportunity for the swift vaccination of the largest possible portion of the entire population at the earliest possible opportunity, and the full reopening of economic and public life that this would engender. As of April 2020, the PREP Act was authorized through Oct. 1, 2024, although it is within the power of the Secretary of HHS to extend this invocation for as long as the emergency demands.
Efforts to develop a vaccine began almost immediately after the outbreak was announced, with dozens of candidate vaccines being formulated using technologies new and old. Nevertheless, despite the breadth of this effort, and the panoply of tools for speeding the process of invention, it must be cautioned that the fast development of a vaccine is not guaranteed. Of all vaccine candidates to begin Phase I clinical trials, 84% never make it any farther than that. Often they either fail or have unacceptable side effects, although it is also sometimes the case that development is halted because the crisis has ended without need for a vaccine, or a competitor was able to secure the market first, or because one manufacturer has several trials going at once, and chooses one most promising line of inquiry to pursue.
If a vaccine is indeed developed in the 18 to 24-month window envisioned by experts, it will mean that for at least one vaccine candidate, everything will have gone as well as it can for every step along the way to final manufacture for public use. It will remain unknown, at the time of deployment, if this vaccine mediates immunity lasting longer than the time taken to bring it to the market, nor will it be known what other effects it might have over a longer period of time. Every tool in the arsenal of the law will be used to hurry this process along, but no law can force a working vaccine into existence.
See Vaccine, Vaccination, and Immunization Law, for a more detailed discussion of vaccine law issues.