FDA Finally Recommends COVID-19 Booster Shots for All Adults

After months of inconsistent messaging and a chaotic track record, will anybody trust it?

On Friday, the Food and Drug Administration (FDA) officially announced its recommendation for COVID-19 booster shots for all American adults. This is great news, as the U.S. faces not only the continued spread of the delta variant, but also potential outbreaks over the winter. Unfortunately, the agency's track record up to this point could seriously jeopardize the rollout.

The new guidelines recommend single-dose boosters of either the Pfizer or Moderna vaccines for any American adult who has received either two doses of the Pfizer or Moderna shots, or one dose of the Johnson & Johnson vaccine. As the FDA's announcement explains, "Prior to today's authorizations," single-dose vaccine boosters "[were only] authorized for administration to individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19 and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2."

What this news leaves out, however, is the fraught process in between. In August, President Joe Biden recommended authorizing boosters to all adults no later than September 20. The FDA acting commissioner and White House COVID-19 czar both endorsed the plan, but internally the FDA disagreed, feeling it was more important to prioritize shots for children under 13—despite the fact that it was already known by then that unvaccinated children were about as safe from COVID-19 as vaccinated adults. While Biden stuck to his original deadline, making the recommendation himself, the FDA waited two full months before authorizing booster shots for anyone but the most vulnerable.

Of course, in those two months, plenty of evidence emerged for the boosters' safety, effectiveness, and necessity. For example, Moderna first submitted data on the effectiveness of its vaccine as a third-dose booster on September 1. Two weeks later, on September 15, it released updated information on long-term effectiveness, demonstrating that while still highly effective long after receiving the two initial doses, "The increased risk of breakthrough infections…illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection."

By mid-October, Israel was seeing widespread success in containing outbreaks, in part based on authorizing Pfizer boosters for people ages 12 and up. Severe breakthrough cases have been increasingly rare and there has been no increase in rare yet serious side effects, like myocarditis, among teens and young adults.

And yet, the FDA's inconsistent messaging on the subject rarely matched the seriousness of the moment. Scott Gottlieb, a former FDA commissioner, told CBS's Face the Nation that "the confusing message around the boosters may end up being one of the biggest missed opportunities in this pandemic." Even in the initial authorization for vulnerable populations, when the Centers for Disease Control and Prevention (CDC) chose not to include those in high-risk occupations, the agency's director Rochelle Walensky simply overruled the recommendation and included them anyway. Regardless of whether her decision was correct, the shambolic way in which it was carried out undermines the message.

In recent days, the most straightforward and authoritative direction on boosters came not from the public health agencies, but from Ashish Jha, dean of Brown University's School of Public Health. Writing in The Atlantic, in an article candidly titled "You Should Get a Booster Now," Jha plainly conveys the reality of the current situation: While the Pfizer/Moderna vaccines generate high levels of immunity, their effectiveness wanes over time. The unvaccinated are still several times more likely to become infected, and to die, than the vaccinated. Breakthrough infections are still possible, and with large enough spread, the disease can still pose a threat to the vaccinated. Boosters are extremely effective and are the least onerous way to protect not only the vulnerable, but the greater public as well. Why the FDA was unable to convey those plain facts clearly and unambiguously up to this point boggles the mind.

By all accounts, it seems clear that most adults who were vaccinated at least six months ago should receive a booster as soon as possible. And yet, the FDA and CDC have done such a poor job up to now that it is unsurprising that they enjoy such low levels of trust among the public. To the extent that messaging about boosters can reach the general population, it will be in spite of our public health agencies, not because of them.