Should Kids Be Required to Get a COVID-19 Vaccine? An Ethics Perspective
As COVID-19 cases in Washington state and around the world continue to rise, there is increasing focus on when a vaccine will be available and to whom.
But are COVID-19 vaccines being developed safely? Who will get the vaccine first and why? Should children be required to get it? We asked Dr. Doug Opel, associate director of the Treuman Katz Center for Pediatric Bioethics, these questions and more. Read on to learn what he had to say.
How will the approval process for a COVID-19 vaccine differ from typical vaccines?
The standard path to vaccine licensing in the U.S. is the Food and Drug Administration’s (FDA) Biologics License Application (BLA) process. This is a rigorous process that requires comprehensive data on the vaccine's safety and efficacy, and several levels of review by federal advisory committees. The BLA process has an extraordinary track record of promoting clinician confidence and public trust in vaccines that are ultimately approved.
Due to the severity of the COVID-19 pandemic, the FDA commissioner has stated a willingness to use an Emergency Use Authorization (EUA) for a COVID-19 vaccine. An EUA does not require safety and efficacy data that is as comprehensive as the standard process. For instance, EUA guidelines for a COVID-19 vaccine require a median of two months of follow-up safety data. This is a shorter duration of safety data than required by the standard process. The intent with an EUA, though, is to strike a reasonable balance between making a vaccine available quickly and making sure it is safe and effective.
An EUA has only been used to make a vaccine available once – in 2005 to make the anthrax vaccine. Existing research suggests many people might be wary of a vaccine made available by an EUA. A recent study found most U.S. adults would not be willing to accept a COVID-19 vaccine made available through an EUA.
Children are currently being included in clinical trials for a COVID-19 vaccine. Is this ethical?
Typically, children are not included in clinical trials until phase 3 trials (in which the vaccine is given to thousands of people and tested for efficacy and safety) have been done in adults. This is justifiable in order to ensure we have strong and compelling safety data of the vaccine in adults before enrolling kids. Children are a vulnerable research population because they cannot provide consent, so it is important to minimize the risks to which they are exposed in research.
That said, to control this pandemic, kids will need to be vaccinated, so we need to start accumulating data on the safety and efficacy of a COVID-19 vaccine in children. Therefore, even though phase 3 trials in adults are not yet complete, enrollment of children can be justifiable, especially when done in a staged manner, such as by starting enrollment with teenagers and only including younger children and infants after some understanding of its side effects in teenagers.
“It would be a mistake to make a COVID-19 vaccine mandatory without sufficient safety data. Vaccine safety is fundamental to maintaining the public’s trust in vaccines and skirting this safety criterion could have far-reaching consequences.”
Who will get the vaccine first, and why?
Four criteria have been proposed to help determine who will get the vaccine first: those who are at high risk of getting infected; those who are at high risk of severe disease or death if they get infected; those who have societal function and other individuals’ lives and livelihoods depend on them directly; and those who are at high risk of transmitting infection to others.These criteria are based on foundational ethical principles, such as maximizing benefit. According to these criteria, high-risk healthcare workers and first responders will be prioritized first, along with individuals of all ages with underlying conditions that put them at significantly higher risk.
The Centers for Disease Control and Prevention (CDC) has suggested the vaccine is unlikely to be initially available to children. Is this fair?
The proportion of children who become infected with SARS-CoV-2 and who become severely ill is much smaller than in adults, so prioritizing others at higher risk of infection and severe disease is justifiable. Also, vaccine trials only began enrolling children recently, so it is important to take the time needed to accumulate the safety and efficacy data of the vaccine that will form the basis for any approval decisions for use of the vaccine in children.
Should a COVID-19 vaccine be mandated for children in schools?
It's too early to know. We don't know enough about the performance of any COVID-19 vaccine or the epidemiology of SARS-CoV-2 in children to make any firm judgments about whether a COVID-19 vaccine should be mandatory in children. There are a few criteria, though, that my colleagues and I recently argued should be used when it is time to make this decision:
- First and foremost, there must be evidence that a COVID-19 vaccine is safe for children with an acceptable level of risk.
- The burden of COVID-19 disease ought to be substantial in at least a subset of the population. This criterion has already been met.
- Vaccinating an infant, child or adolescent against this disease should reduce the risk of person-to-person transmission. At this time, the role of children in person-to-person transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is still poorly understood.
- The COVID-19 vaccine must be effective in protecting a child from the disease. It doesn’t need to be 100% effective, but its effectiveness should be comparable with other vaccines we currently require for children.
- The COVID-19 vaccine mandate should not be burdensome for a child or, more accurately, a child’s parent or guardian, to comply with. This means the vaccine must be widely available, easily accessible and affordable to all.
How does refusal to accept a COVID-19 vaccine compare to more general vaccine hesitancy?
I believe they are distinct. Hesitancy toward a COVID-19 vaccine is mostly rooted in the fact that these vaccines are still in development and have an unknown safety and efficacy profile. On the other hand, general vaccine hesitancy – being indecisive about a vaccine that has a known safety and efficacy profile, has been approved for use and has been administered to millions of people – is steeped in a complex sociocultural milieu of consumerism, pervasive misinformation and the rejection of objective, scientific evidence as truth.
However, there is overlap between vaccine hesitancy and a reluctance to accept a COVID-19 vaccine in terms of trust. Both require trust in the processes and systems that develop, approve and monitor the safety of vaccines, as well as the people and agencies who recommend and endorse vaccination.
Is it appropriate to compare the COVID-19 vaccine to the flu vaccine?
The analogy is understandable since COVID-19 has been portrayed by some in the media as like influenza. Though it is true that SARS-CoV-2, the virus that causes COVID-19, is a respiratory virus like influenza with the most common symptoms being cough and fever, there are many important differences. And these differences are really important to how we should decide whether we require the vaccine to prevent these two diseases.
For instance, SARS-CoV-2 appears to spread more efficiently than influenza. The number of others to whom an infected person would spread the disease if they were placed in a susceptible population (i.e., the reproduction number) is approximately 1 for the influenza virus. For SARS-CoV-2, the reproduction number is 2 to 2.5. We should focus on the specifics of each vaccine, each disease and how each vaccine is delivered to determine whether or not it should be mandated.
What can be done to increase confidence in a COVID-19 vaccine?
We need to restore trust among the public in vaccine development and approval processes. The politicization of these processes over the last year has badly damaged public trust. A good starting point would be a unified, proactive, highly visible communication structure within federal public health agencies to inform the public on a regular basis about the status of these processes.
Note
This article is based on the following articles Opel has recently published in JAMA Network Open and JAMA Pediatrics: Building Trust to Achieve Confidence in COVID-19 Vaccines and Should We Mandate a COVID-19 Vaccine for Children?