Covid-19 booster shot distribution must learn from vaccine roll-out mistakes

With news that Covid-19 booster shots are in Americans’ imminent future, the chaos and uncertainty of the initial vaccine rollout are making a reprise.

Whether boosters for everyone in the U.S. are necessary, justified, or ethical are important questions, but are different from the issue at hand.

President Biden’s decision — that everyone be equally eligible for a booster eight months after the initial shot — risks reproducing many of the flaws that plagued the first roll-out of the Covid-19 vaccines, such as failing to establish clear priorities and methods of distribution.

This approach pits those most in need, either because of health status or the type of work they do, against those who are better able to navigate the system. During the initial vaccine rollout, scheduling an appointment in many states required a level of tech-savvy that even digital natives struggled to navigate, shutting out many eligible individuals in need — generally those who were older, sicker, and poorer.

Before boosters were even recommended for the general population, some individuals had already taken matters into their own hands and procured doses however they could — lying about their prior doses, or claiming they were immunocompromised.

This is redolent of the failures of the first round of vaccinations in the U.S., in which those who were most able to manage the system got vaccines instead of those who most needed them.

To prevent the perpetuation of this inequity, which would further jeopardize the nation’s health, U.S. leaders must act quickly to acknowledge and then mitigate the flaws of the first rollout.

Here’s what went wrong before and what needs to happen now:

Create an evidence-based framework for distributing booster shots. During the initial vaccine rollout — between December 2020 and March 2021 — the federal government dumped vaccine doses at the doorsteps of all 50 states, the territories, and Indian Tribes. Under-resourced and ill-prepared health departments were left to develop systems for distributing vaccines to people facing very different risks of infection, as well as significantly different interest in getting vaccinated.

This patchwork, ad hoc approach meant that those who were most at risk of contracting the virus or developing severe outcomes were often not given priority for getting vaccinated. In Florida, for example, a blanket policy giving priority to all residents over age 65 meant that healthy seniors camped out on lawn chairs outside health departments so that they could resume their active social lives, while younger essential workers continued to risk their health to earn a living.

This time, the federal government should create a binding, evidence-based framework for booster distribution. That way, those who will benefit most from booster shots will be the first to get them.

Having national guidelines does not mean disregarding the reality that in a country as large and diverse as the United States there is no “one size fits all” solution. But it means that solutions crafted at the local level must still maintain priorities of fairness and inclusion, rather than blankly preferring people with local power and influence. It is well within the power of the federal government to establish criteria for distributing vaccines it is providing free of charge.

To determine criteria for prioritizing who gets booster shots when, the government could leverage the admittedly scanty U.S. data on Covid-19 deaths among those who were fully vaccinated, ideally supplemented by more robust international data. Relevant factors are likely to be pre-existing medical conditions, including immune conditions, old age, and date of initial vaccination. The resulting framework for vaccine distribution should be made binding by incorporating the conditions under which a booster dose can be administered into either the emergency use authorizations for the vaccines or, when fully approved, into their labels.

Community representatives should be part of the multidisciplinary cohort of public health professionals establishing these guidelines, and their input also should be used to strategize vaccine delivery methods – for example, home delivery for harder-to-reach populations, such as frail, older individuals.

Record vaccinations. All administered vaccines should be recorded using a secure and accessible national system for record-keeping modeled on those implemented by states like New York, Colorado, and California. While these records don’t necessarily need to be maintained at the federal level, each individual should have a unique individual identification number tied to vaccine status. Otherwise, those seeking to game the system, either by claiming a booster for which they are not entitled, or claiming to have had a booster, can do so by providing an easily counterfeited scrap of cardboard.

Ready access to vaccination records. Individuals must be able to access their own vaccination records, and this information must also be available for public health surveillance efforts. Not recording vaccination data, or keeping it in a patchwork of public and private proprietary networks will make it impossible to know if booster shots are effective. This is especially important given the likelihood that as the virus continues to mutate, more booster drives will be needed.

Address adverse effects. Public health officials now understand the common side effects associated with the vaccines, and have data to suggest that some individuals will experience similar (or lessened) side effects to a booster dose. Accordingly, the Centers for Disease Control and Prevention and the Food and Drug Administration should take a proactive approach, shaping expectations and developing an appropriate symptom control protocol for booster shots.

Myths and horror stories about adverse consequences to boosters inevitably will circulate. The CDC has a chance now to get ahead of these accounts, which have the potential to spur vaccine hesitancy or refusal.

The CDC and FDA should also offer workable advice on how to mitigate short-lived but very real post-vaccine reactions. It is not enough to dismiss concerns by stating that any discomfort or pain resulting from the vaccines is “better than getting Covid.” These agencies should also work to comprehensively track post-booster side effects.

Without transparent and proactive attempts to address concerns about side effects and potential adverse consequences, people in need of a booster may be afraid to get one — and the resulting publicity could further dissuade those currently eligible, but not yet vaccinated, as well as those soon-to-be eligible (or, more realistically, those in charge of the decision, such as parents and guardians).

But if the nation’s health agencies seize this opportunity to provide compassionate, honest, and forthright communication about vaccine concerns, it may promote vaccine uptake more generally; transparency about side effects may help to get first doses in the arms of those concerned during the initial rollout.

If done well, distributing booster shots across the country could work synergistically with the broader vaccination campaign. For example, community-based outreach for booster distribution could also be used as a tool to vaccinate harder-to-reach populations.

Likewise, requiring thorough record-keeping may pave the way for a more robust vaccine credentialing system.

The country has been through vaccine chaos once already, and what went wrong has become plainly apparent. Federal, state, and local public health officials need to take the reality of booster shots as an opportunity to learn from the mistakes of the initial vaccine roll-out and set the country on a path toward managing the spread of Covid-19.

Jennifer S. Bard is a professor of law at the University of Cincinnati College of Law and professor in the department of internal medicine at the University of Cincinnati College of Medicine. Chloe Reichel is the communications associate for the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and editor-in-chief of its Bill of Health blog.