A vaccine for the coronavirus is coming. The vaccine will almost certainly be authorized on an emergency basis, and not through the usual approval process at the Food and Drug Administration. That authorization will be subject to some nonzero level of political influence. It is not a question of whether these things will happen, but rather when. It is time to stop yelling about this possibility and start planning for it. Covid-19 has already ravaged the economy and will soon have killed more than 200,000 Americans. How can we make sure that the upcoming authorization of a vaccine is a positive for public health?
Walid Gellad (@walidgellad) is a physician and policy researcher at the University of Pittsburgh, where he directs the Center for Pharmaceutical Policy and Prescribing.
Some of the yelling serves a purpose. By highlighting the legitimate concerns about authorizing a vaccine based on limited data, it helped push vaccine makers to announce this week that they would not ask for authorization without first demonstrating safety and efficacy through phase III clinical trials. But there is a downside too. The yelling has taken on a political fervor, mired in the nasty politics of 2020. It is a disservice to public health to start the messaging around our first Covid vaccine by feeding into an atmosphere of mistrust. This will only make it harder to realize the benefits when that vaccine arrives.
Public health leaders would be wise to shift their focus to what is clearly coming—or, at a minimum, to spend less time criticizing the very idea of an emergency authorization of a vaccine and more time in a careful discussion of how to make sure the process works as intended.
First, we need to continue to push for full transparency of the data on safety and efficacy before a vaccine is authorized. The public is demanding this, and the politics of the moment require it. The FDA has scheduled an advisory committee meeting for October 22 to discuss Covid vaccines, although the official meeting announcement states that no specific vaccine authorization will be discussed. If that remains the case, then the data on safety and efficacy for whichever vaccine ends up being authorized may not be discussed publicly beforehand, despite the FDA’s earlier assurances. In the current climate, this would be an especially bad idea. Members of the public, and public health experts, should have an opportunity to review the data before authorization is given. Typically, the FDA provides a very short lead time, posting advisory committee meeting materials and the list of participants two days prior to a meeting. In this case, the FDA should consider an earlier release with full transparency about which key stakeholders will be represented on the committee.
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Second, we need more discussion about how to give the public a clear and consistent message about the vaccine while acknowledging uncertainty. It should be very clear, for example, that an authorization for the vaccine does not mean that anyone will be forced to get vaccinated, nor does it suggest that the public will have access to the vaccine right away. If a vaccine is authorized for emergency use on November 1, people won’t be lining up on the streets to get the vaccine on November 2. This distinction between the date of authorization and the date on which the public will start receiving the vaccine has so far been lost in the discussion, and it should be made very clear to set reasonable expectations. So should the fact that the first vaccine to be authorized could be targeted towards high-risk individuals, with no access whatsoever for the general public, or that multiple vaccines could be authorized at the same time.
Other communication issues also need attention. How will we counter social media misinformation and foreign interference once a vaccine is available? This misinformation campaign will take advantage of any disagreement among experts to sow confusion and uncertainty about the vaccine. Public health leaders need to think carefully about what they say about a vaccine right now, and how it could end up feeding into this environment. We need a plan for explaining any newfound or potential side effects of the vaccine after it has been rolled out. How can we responsibly discuss the first adverse event that may be related to the vaccine without its devolving into politicized “I told you so” complaints or becoming additional fodder for misinformation campaigns? Initial stories of ill effects from hydroxychloroquine were poorly vetted by public health experts and led to disproportionate concerns about the treatment. These, in turn, produced even more confusion and misinformation. If we overreact in a similar fashion to early anecdotes about a new vaccine, the consequences would be much worse.
Third, we need more discussion about how to distribute the vaccine, once it has been authorized for emergency use. The Centers for Disease Control and Prevention has started this conversation, to its credit, by communicating with states about the need to prepare for a rollout by November. The National Academy of Medicine issued a preliminary framework for how to prioritize vaccine distribution. But all the yelling about the appropriateness of an emergency authorization has distracted us from these vital details. How will we deal with the equity issues that will inevitably arise? The National Academy of Medicine report briefly touched on this topic, but there will be major decisions to make that deserve more public discussion. For example, some may call to prioritize racial minorities for the vaccine because they have faced the brunt of coronavirus; on the other hand, that same policy would leave those groups facing the brunt of any unanticipated side effects. Whether a vaccine is authorized in October, December, or January, there will be no long-term safety data and not enough data to know for sure if rare side effects may occur. This is the reality. We need to grapple with it.
There are, of course, other issues that also need discussion. Do we have the best systems in place for measuring and monitoring side effects once the vaccine is authorized? How should we communicate to the public the special liability protections given to pharmaceutical companies when their vaccines receive emergency authorizations? How do we ensure cost, geography, and insurance are not barriers to immunization?
The vaccine is coming, very likely through an emergency authorization, with or without political pressure. We need our public health opinion leaders to start guiding the conversation about what happens next.
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