Strengthening trust in public health, especially around big changes to vaccine policy, requires transparency, including letting the American people know what data you're using to make them.
Newly announced rules that limit the use of COVID vaccines suggest that Health and Human Services Secretary Robert F. Kennedy Jr. and federal public health agencies are moving in the opposite direction.
Federal dictate via op-ed without adequate consultation
We support a fresh look at COVID-19 vaccine and vaccination policies, informed by the experience of the past 5 years and the evolving science and epidemiology. We viewed the upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on May 22 as an opportunity to begin that discussion, with the interested public looking on. (VRBPAC, and independent panel of experts advises the US Food and Drug Administration (FDA) on vaccines and other medical products.)
But yesterday—before the planned VRBPAC meeting of advising experts—the FDA's Center for Biologics Evaluation and Research Director Vinay Prasad, MD, MPH, and Commissioner Marty Makary, MD, MPH, announced new rules for COVID vaccine use via an opinion piece in the New England Journal of Medicine. Without the benefits of their committee's expertise and public discussion, the op-ed dictates that shots will be reserved for people over 65, or for those in a risk-category for severe illness.
Processes can always be improved, and the process for approving vaccines and recommending their use should be routinely reexamined. But processes are in place for a reason.
We support a fresh look at COVID-19 vaccine and vaccination policies, informed by the experience of the past 5 years and the evolving science and epidemiology.
The FDA typically uses a "notice and comment rule-making" process for publishing new guidance and policies that are developed by the agency, with input from FDA scientists. This involves developing and publishing a proposed rule in the Federal Register with ample time to allow for public comment, and then issuing a final rule based on the feedback received.
A public, deliberate process lets the people who are affected weigh in, and the opportunity to examine that feedback typically leads to better rules and better outcomes—for patients, clinicians and manufacturers. In addition, bringing proposed changes to the federal advisory committee charged with providing this kind of advice is an opportunity for all to hear the discussion and debate in a public forum.
The op-ed proclamations occurred in the absence of public comment, and it remains unclear whether or how broadly FDA scientists and outside experts have been consulted.
Clear message about FDA's interest in public input
Instead, the cart appears to have passed the horse by a furlong. Rather than following a process that seeks input from all parties, Prasad and Makary moved the goalposts on their own. This directive coming out days before the VRBPAC meeting on COVID vaccines sends a message about the FDA's interest in public input. It may have the effect of limiting people's access to potentially lifesaving vaccines without the opportunity to provide feedback.
It is true that COVID-19 is far less dangerous to most people today than it was even a few years ago. Yet it remains a notable health threat for many: people over 65, the youngest Americans, pregnant women, the immunocompromised, and people with underlying medical conditions.
The hospitalization rate for kids 4 years and under during the most recent respiratory virus season was roughly the same for COVID-19 as it was for flu, even though it was a mild season for COVID.
The hospitalization rate for kids 4 years and under during the most recent respiratory virus season was roughly the same for COVID-19 as it was for flu.
The closed-door decision-making process on display here is troubling if it is an example of how federal public health decisions will be made moving forward—by a select few and in private. The announced changes also set up an obvious conflict with Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), which typically makes recommendations about vaccine use.
Raft of unanswered questions
We're left with a series of important questions. The sooner they can be adequately answered, the better:
- Is there an off-label use?
- Can ACIP advise on a spectrum of off-label use worthy of consideration—such as living with an immunocompromised loved one or someone who is pregnant or being a home healthcare worker? In their YouTube appearance yesterday to discuss the new COVID vaccine rules, Makary and Prasad indicated that we don't have data showing a protective effect for healthy people, but real-world data indicate that COVID vaccination curbs the likelihood of infection and severe disease, and reduces the chances of developing long COVID, so we do have evidence.
- Will a healthy child who has never been vaccinated against COVID-19 be able to access the primary series?
- What real-time surveillance will be done so that, if indications predict a bad COVID season, we can scale up? Will there be enough vaccine if that is the case? Was any modeling done to predict the impact of these new rules on access to COVID vaccines and on production plans if the season turns out to be a severe one?
- What are the legal implications of the rule, given the new process that has been implemented to create it?
- In the context of the FDA now making implementation rules, what is ACIP's role?
- How does the FDA plan to meet a timeline for a randomized controlled trial that will have results within the same season that can be implemented in real time?
We support the reevaluation of COVID-19 vaccine use. Indeed, it has been a constant process since their deployment—for federal agencies and VRBPAC and ACIP. But decisions to change policies will be best made when more voices are heard and more experiences are weighed.
Rulemaking by op-ed lacks transparency. It increases the likelihood that mistakes will be made—mistakes that could be avoided by listening to independent experts who are appointed to advise the government and to those who will be most affected.
Vaccine Integrity Project Viewpoints are authored by project staff and advisers. They are intended to address timely issues regarding vaccines with straight talk and clarity by presenting facts to counter falsehoods.
