This blog post is an excerpt and summary of, Ensuring Uptake of Vaccines Against SARS-CoV-2, published in The New England Journal of Medicine, June 26, 2020. Permission to summarize has been given by Ross D. Silverman, J.D., M.P.H.
As coronavirus continues to exact a heavy toll, development of a Covid-19 vaccine appears the most promising means of restoring normalcy to civil life. But bringing a vaccine to market is only half the challenge; also critical is ensuring a high enough vaccination rate to achieve herd immunity. Concerningly, a recent poll found that only 49% of Americans planned to get vaccinated against SARS-CoV-2.
One option for increasing vaccine uptake is to require it. Mandatory vaccination has proven effective in ensuring high childhood immunization rates in many high-income countries.
Although a Covid-19 vaccine remains months to years away, developing a policy strategy to ensure uptake takes time. Below is a framework that states can apply now to help ensure uptake of the vaccine when it becomes available — including consideration of when a mandate might become appropriate.
Six substantive criteria should be met before a state imposes a COVID-19 vaccine mandate.
Covid-19 is not adequately controlled in the state and is an ongoing threat. If testing, contact tracing, isolation and quarantine are not preventing new cases, hospitalizations, or deaths, then further measures should be taken. By the time a Covid-19 vaccine is available, more will be known about herd immunity, the consequences of relaxing social-distancing, and the feasibility of scaling up test-and-trace strategies; there should be a reasonable indication as to whether further measures are needed.
The Advisory Committee on Immunization Practices (ACIP) has recommended vaccination for the groups for which a mandate is being considered. Current available evidence suggests that the elderly, health professionals working in high-risk situations or with high-risk patients, and persons with certain underlying medical conditions may be high-priority groups for the ACIP’s consideration, along with other workers with frequent, close, on-the-job contacts and persons living in high-density settings such as prisons and dormitories. When a vaccine nears approval, the ACIP should review the updated evidence and develop recommendations. Only recommended groups should be considered for a vaccination mandate, though health officials can encourage voluntary uptake for others.
The supply of the vaccine is sufficient to cover the population groups for which a mandate is being considered. Initially, global demand for SARS-CoV-2 vaccines will outstrip supply. New York State’s unsuccessful attempt to mandate H1N1 influenza vaccination for health care workers demonstrates that imposing requirements before adequate supply has been secured needlessly provokes controversy and alienates people who have already made sacrifices to fight an epidemic.
Available evidence about the safety and effectiveness of the vaccine has been transparently communicated. Particularly given the possibility that the evidence underlying FDA approval of SARS-CoV-2 vaccines may be more modest than usual, policymakers and the public will need to understand the limits of what is known. Public trust has already been compromised by federal officials’ endorsement of hydroxychloroquine as a Covid-19 treatment without evidentiary support; the same must not occur for vaccines.
The state has created infrastructure to provide access to vaccination without financial or logistic barriers, compensation to workers who have adverse effects from a required vaccine, and real-time surveillance of vaccine side effects. Lessons from past vaccination campaigns suggest that a generous compensation program for people who have serious vaccine side effects should be a centerpiece of these efforts. States will also have to create distribution systems to provide SARS-CoV-2 vaccine to high-priority groups with near-zero financial and logistic barriers — for example, bringing free vaccines to points of care, pharmacies, and work sites. It is equally critical to have a safety-assessment plan in place before vaccines are widely distributed to enable health officials to evaluate safety evidence in real time.
In a time-limited evaluation, voluntary uptake of the vaccine among high-priority groups has fallen short of the level required to prevent epidemic spread. Vaccination mandates should be imposed only after a time-limited trial of voluntary vaccine provision has proved unsuccessful. Principles of public health ethics support trying less burdensome policies before moving to more burdensome ones whenever possible. In this case, the costs of a failed voluntary scheme are sufficiently high that the attempt should be limited to a matter of weeks.
If the proposed trigger criteria were met, what might a vaccination mandate look like?
Because the constitutional power to protect public health rests primarily with states, each state will need to adopt its own legislation. Proposed legislation should be supported by attestations from the state health officer, the ACIP, or another expert committee that all trigger criteria have been met.
The need to build public trust requires that state officials implement vaccination policy through a transparent and inclusive process, working closely with stakeholder groups such as local health officers, health professional and hospital associations, representatives of high-risk population groups, and groups concerned about vaccine safety.
As with social distancing orders, we can expect that the advent of SARS-CoV-2 vaccines will spark intense clashes of feeling about what people owe to one another in the fight against the pandemic. In contrast to earlier phases of the pandemic, though, we currently have some time on our side. Careful deliberation now about state vaccination policy can help ensure that we have a strategy when the breakthrough comes.