It is probably safe to say that many people who never previously took interest in US Food and Drug Administration (FDA) regulatory processes have been learning a lot about them this past year by paying close attention to the development, review, and roll-out of Covid-19 vaccines.

Tens of thousands of individuals in the US enrolled in Covid-19 vaccine trials. More parents are interested in enrolling their children in pediatric trials than slots available. Announcements of FDA committee meetings to review Covid-19 vaccine data make national news. Whether because one is eager to get vaccinated as quickly as possible, or remains hesitant, people are keenly aware of the timelines for FDA review, authorization, and approval for Covid-19 vaccines.

One thing that many people might have only learned about for the first time because of Covid-19 is the practice of “off-label use” in medicine. Off-label use refers to administering an FDA-approved product outside of the population, indication, or at a different dosing, than that for which it was approved. It turns out off-label use is quite common in healthcare.

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So, in August of this year, when the Pfizer Covid-19 vaccine was slated to become “fully approved” by the FDA for people ages 16 and up (as opposed to authorized for emergency use as it had been since December 2020), discussions started popping up about whether the vaccine could be used off-label in kids who were still awaiting vaccine authorization.

Are off-label vaccines common practice?

I am an ethicist at a Children’s Hospital and a parent of a child under 5 – as well as a PEWS faculty affiliate. I find the topic of off-label vaccination against Covid-19 both professionally and personally compelling. I was struck by how little clarity there was around off-label use of Covid-19 vaccines. Plenty of doctors expressed comfort with prescribing medications off-label and suggested that administering Covid vaccines should be no different. But others worried they would face legal liabilities, while some claimed that vaccines are never used off-label. What was right?

To figure this out, I embarked on a research project with legal philosopher Shannon Fyfe. We found that off-label use is a common practice, rooted in established ethical and legal precedent. In theory, off-label Covid-19 vaccination should be ethically permissible. Like any other ethically engaged off-label use, it should not expose providers to increased liabilities.

However, Covid-19 vaccines are different. Not because they are vaccines, but because the CDC has taken the unusual move of writing into its Covid-19 vaccine provider agreement a prohibition against administering Covid-19 vaccines to individuals outside the ages for which they have been authorized or approved.  

As we say in the resulting paper published in the Hastings Center Report: “off-label vaccination during an outbreak or pandemic is not intended as a public health tool, but it is a medical strategy to confer protection to individual patients after weighing the risks and benefits.”

Off-label vaccines in kids

For at least some kids – especially those at high-risk for severe Covid-19 – the anticipated benefits of off-label vaccination might outweigh the risks. In these cases, off-label vaccination ought to be something that parents and pediatricians can make a shared decision about. But the CDC Covid-19 vaccine provider agreement effectively keeps them from doing so.

Recent news about Pfizer’s clinical trials in children under 5 illustrates opportunities – and challenges – for off-label vaccination. Trials in children between 2-5 years of age did not reveal new safety concerns, but also did not produce the immune response necessary to move toward FDA review of the vaccine for this age group. Further trials, and more time, are needed before authorization of Covid-19 vaccines for the youngest kids.

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If it were an option, off-label vaccination could afford an opportunity for higher risk kids to receive at least some antibody protection against Covid-19 prior to trial completion and vaccine authorization for their age group. But the trial results also raise uncertainty about whether these anticipated benefits would be as great as expected.

Public Understanding of Off-Label Use

Because our paper was responding to questions parents and pediatricians alike were asking about Covid-19 vaccines, we felt it was important to connect our research to wider audiences than those who read academic bioethics journals. We ran a blog post in the Hastings Center Bioethics Forum, and an explainer on off-label use and Covid-19 vaccines in The Conversation that was picked up by at least 20 news outlets.

Broader understanding about off-label use is important to public trust in healthcare practices far beyond Covid-19. And the departure from ethical and legal norms for off-label use of Covid-19 vaccines for kids remains especially relevant as kids under 5 await vaccine access while the pandemic wears on, and new “variants of concern” emerge.

Read the full essay in the Hastings Center Report here or check out the shorter pieces in the Hastings Center Bioethics Forum or The Conversation here and here.

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