As summer gives way to fall, the Biden administration is turning its focus to the next phase of the COVID-19 pandemic: the rollout of booster shots. In August, President Joe Biden announced that boosters would be available to the general population by Sept. 20.

But the plan — which some have criticized as premature and confusing — is creating tumult within the Food and Drug Administration (FDA). Critics argue the White House is impinging on the agency’s independent review and decision-making process on the science, which is typically approved before policy is implemented.

This week, the FDA said that two of its leading vaccine officials would be leaving, reportedly due to their exasperation over the rollout of the booster shot policy sans regulatory approval. Marion Gruber, director of the Office of Vaccines Research & Review, and Philip Krause, the office’s deputy director, will both be leaving in the fall.

Public health experts have criticized agencies before, like the Centers for Disease Control and Prevention (CDC) for providing misleading and confusing messaging on COVID-19. Now, the disjointed booster shot plan appears to add another layer of confusion to the federal government’s COVID-19 response.

While the administration has insisted that it’s important to begin administering booster shots as soon as possible to prevent weakened immunity among vaccinated people, especially the immunocompromised, other public health experts argue the decision is premature.

The CDC’s Advisory Committee on Immunization Practices (ACIP), for one, noted earlier this week that evidence on boosters’ effectiveness is as yet unclear, which is one reason the committee would consider prioritizing long-term care facility residents over the general population. Among other eligible Americans, ACIP has argued, initial vaccination would still protect against severe disease and hospitalization, even as immunity wanes.

Yet Jeff Zients, who heads the White House Coronavirus Response, noted on Tuesday that the Biden administration’s decision to roll out booster shots by Sept. 20 “was made by and announced by the nation’s leading public health officials.”

“Having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot,” Zients said, noting that the administration had “also been very clear throughout that this is pending FDA conducting an independent evaluation and CDC’s panel of outside experts issuing a booster dose recommendation.”

Indeed, the FDA has decided to convene that meeting with its panel of outside experts on Sept. 17, only a few days before the deadline provided by the administration for public introduction of the shots.

Pending the FDA’s approval, state health officials are waiting for more clarity on the matter. Meanwhile, efforts are underway to prepare for an expected rollout from an infrastructure standpoint. 

At a press conference held by the Association of State and Territorial Health Officials Wednesday, state health officials discussed current plans for the booster shot intro.

In Mississippi, as in many states, administration of booster shots has already begun among the immunocompromised. Dr. Thomas Dobbs, an officer with the state’s health department, noted that officials are currently working on developing an effective infrastructure for the rollout, with a focus on localized pop-up clinics.

“We’ve transitioned from the drive-thru model to the normal modes-of-care model, augmented by county health departments doing self-appointments in every county in the state of Mississippi,” Dobbs reported. “We’ve recruited hundreds of clinics that are able to do vaccination on-site, which will be huge. We’ve built up a personalized infrastructure that will be more local and easier to access than the normal healthcare routes.”

Both Dobbs and Dr. Anne Zink, his counterpart for Alaska, said they hope that the experience from the initial vaccination deployment has taught states all they need to know to get shots in arms a third time.

“States and communities have gotten good at pivoting, and we’re ready to roll out a booster shot when it’s available,” Zink said. “We have more vaccine sites than the initial rollout, and we have more vaccines. So that will help the rollout be more streamlined.”

Whatever the FDA decides on third shots, some public health experts argue the primary focus should still be on initial immunization.

“Although there’s a focus on boosters, there’s a primary focus on regular vaccination,” said Dr. Nirav Shah, director of Maine’s Center for Disease Control and Prevention. “You can’t get a booster until you get the first shots. So that’s the primary focus.

“We are waiting to see what the ultimate direction from ACIP and the FDA is in respect to boosters,” Shah added. “I can’t speculate on where we might go or what messaging challenges we might have based on what will happen in the future. We’re focused on the planning and the architecture that’s needed to get boosters out – whether it’s distributed models or a focus on centralized models.”