(WASHINGTON) — FDA’s Deputy Commissioner for Food Policy and Response, Frank Yiannas, has announced he is resigning from his post. His departure comes in the wake of last year’s infant formula shortage, throughout which Yiannas held a prominent leadership role.

The decision also comes amid the ongoing HHS-OIG audit into whether the FDA responded adequately to the mounting crisis, as ABC News was first to report — and whether the agency followed proper recall protocol once a deadly bacteria had been detected inside Abbott’s Michigan formula plant.

Additionally, the FDA is preparing to give an update later this month on steps it plans to take to strengthen its foods program, following an independent review that found it lacks leadership and mission clarity.

An FDA spokesperson tells ABC News that “by the end of February,” they will also offer additional updates on how they’re improving their organizational structure — including how Yiannas’ position responsibilities will be handled moving forward.

Yiannas had been in his role since December 2018. His resignation will be effective February 24, writing in a tweet he is “honored to have served the American public, alongside each and every one of you, over these past four years.”

Yiannas was among the senior officials who was involved in responding to the formula crisis and admitted to lawmakers in May 2022 that a string of internal failures and communication breakdowns at his agency contributed to how bad the situation had grown.

Lawmakers and the public alike repeatedly pushed for further clarity on why it took so long for federal regulators to respond to the mounting crisis.

Months before Abbott’s massive formula recall in February of last year, there had already been warnings about quality and safety concerns at the key facility.

There had been a whistleblower report alleging a “litany of violations” and safety issues at Abbott’s key plant sent to the FDA in October 2021 — however, as Yiannas said under oath before Congress in May 2021, he and other FDA leaders didn’t learn that report for months. The agency blamed their mailroom and called it an “isolated failure” that was “likely due to COVID-19 staffing issues.”

Yiannas said the complaint was not immediately escalated, and he didn’t see it until mid-February, roughly four months after it had been sent.

By that time, as ABC News has reported, reports of infants getting sick and hospitalized after consuming Abbott’s formula had already been emerging, including one who had already died — in addition to the quality and safety concerns flagged at their Sturgis facility.

However, Abbott maintains none of the bacterial strains found at their plant matched the samples genetically sequenced from the hospitalized infants, and that there is no conclusive evidence that its products contributed to the ultimate death of two infants.

“Why is it then, if you’re the deputy commissioner for food policy, you didn’t get the report?” Rep. Gary Palmer (R-AL) asked during the previous May hearing. “How is it that it got tied up in bureaucracy and it didn’t get to the person who arguably should be responsible for responding to it?”

“Yeah, I’m not sure why the report wasn’t shared with me and how it didn’t get escalated,” Yiannas said. “As you’ve heard the commissioner state, I know there’s going to be a review, and we’re going to try to get to the bottom of it.”

Yiannas’ boss, FDA Chief Robert Califf, acknowledged the response to the formula crisis had been “too slow,” and that “there were decisions that were suboptimal along the way.”

In his resignation letter, tendered to Califf on Wednesday, Yiannas does not own any responsibility for the agency’s missteps during the formula crisis — rather, he touts his achievements.

“In February 2022, as you rejoined the agency, I shared with you that I was considering leaving, expressing my concern that the decentralized structure of the foods program that you and I both inherited, significantly impaired FDA’s ability to operate as an integrated food team and protect the public,” Yiannas’ letter says.

“It was also in February of 2022 that I first learned of the infant formula incidents that had been reported to various parts of the FDA several months before, so I postponed this decision and dedicated myself and my staff to doing all we could to help tackle this crisis. With the Abbott facility now reopened, infant formula availability more prevalent, and – very importantly – the necessary monitoring, data systems, and insights now in place through the 21 Forward platform to help address the current and any future infant formula supply chain challenges, I believe the time is right for me to leave and vacate this position.”

In a statement to ABC News, the FDA thanked Yiannas for his “service and dedication.”

“The FDA can confirm Frank Yiannas has resigned from his position as deputy commissioner for Food Policy and Response effective February 24. The agency thanks Mr. Yiannas for his service and dedication to the FDA’s public health mission,” the agency said. “Mr. Yiannas has served as a valued member of the agency’s leadership team, spearheading important initiatives including the New Era of Smarter Food Safety to help create a safer and more digital, traceable food system for our country.”

ABC News’ Anne Flaherty contributed to this report.

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(WASHINGTON) — A panel of public health experts for the Food and Drug Administration convened for an all-day meeting on Thursday to discuss whether the U.S. is ready to start treating COVID boosters like an annual flu vaccine, a move that would normalize COVID shots as permanent public health upkeep.

Creating a yearly COVID shot schedule would mean updating the shot once a year and hoping that it matches whichever variant is circulating that upcoming winter season, similar to how the flu shot schedule works. No longer would public health agencies and vaccine companies attempt to reactively update the COVID vaccine when variants come on the scene.

It would also eliminate the two-shot primary series for most unvaccinated people, in favor of a mainstreamed program.

“This is a consequential meeting to determine if we’ve reached a point in the pandemic that allows for simplifying the use of current COVID-19 vaccines,” Dr. David Kaslow, director of the FDA’s Office of Vaccines Research and Review, told the group of advisors on Thursday.

Dr. Peter Marks, the FDA’s vaccine chief, said the virus has evolved so rapidly that the FDA has constantly needed to revise its approach. Now, he said, it was time to determine if they could do that on a schedule rather than at the whim of the virus’ evolutions.

“We’re now in a reasonable place to reflect on the development of the COVID-19 vaccines to date to see if we can simplify the approach to vaccination in order to facilitate the process of optimally vaccinating and protecting the entire population moving forward,” Marks said.

The goal, FDA officials said, would be to deliver simpler messaging in the hope of reaching more Americans.

The way it stands now, people get different numbers of vaccines depending on their age and prior vaccination status. For example, unvaccinated people get their initial series in two shots, a few weeks apart, while vaccinated people have been encouraged to get a booster every few months, depending on how old they are.

The plan proposed by the FDA is to recommend every American get a single shot every year, with a few exceptions.

It’s based on the idea that the vast majority of Americans already have some immunity in their system, either because they’ve been exposed to COVID itself or gotten vaccinated.

“Presumably, at this point in the pandemic, most of the general U.S. population have been sufficiently exposed to spike protein, either to infection, vaccination or both, such that a single dose of a COVID-19 vaccine would induce or restore vaccine effectiveness,” Kaslow said.

But older, high-risk and immunocompromised Americans could still be recommended to get two shots a year, as could young children when they reach the age eligible for vaccinations.

“It could be that more than one dose is needed for high-risk older adults, persons with compromised immunity and young children who have not yet been completely immunized. At this time, those risk based adjustments remain to be determined,” Kaslow said.

Responding to the proposal, some experts on the panel emphasized that people who haven’t had COVID or been vaccinated might still need to get two shots to shore up their immunity.

But the members were broadly supportive of the move to simplify the COVID vaccine schedule.

“I certainly support this approach. Simpler is better,” said Dr. Mark Sawyer, a professor of clinical pediatrics at the University of California, San Diego and a member of the FDA’s panel.

“I think this is definitely the way to go as soon as we can figure out how to do it,” he said.

More data is necessary to decide exactly who will be protected enough by one dose, experts said.

“My general feeling from the committee is that we need more data to figure out exactly who should get the two-dose schedule, who should get the one,” said Dr. Stanley Perlman, an infectious disease expert with the University of Iowa and a member of the panel.

“So all that kind of information will help determine this immunization schedule, but in general principle, the committee was supportive of going forward with this,” Perlman said.

The FDA will likely not make any concrete decisions until later in February, after a panel of experts at the Centers for Disease Control and Prevention has a similar public discussion on the newly-proposed schedule.

And just which variants the updated booster would target for next season won’t be decided until this summer, likely in early June, for distribution sometime in the fall.

Of course, the reality is that a small percentage of Americans have opted to get the current booster — around 16%, despite recent CDC research showing that it can cut risk of symptomatic infection by around half. And because less and less people have opted for a booster shot each time one has been recommended, the appetite could be lower by next fall.

But Marks, the FDA’s vaccine chief, was optimistic that aligning the COVID vaccine on a yearly schedule with the flu shot could encourage more people to make it a routine.

“If we can see the influenza vaccine and the COVID-19 vaccines occurring at the same visit, it facilitates a vaccination program that may lead to more people getting vaccinated and being protected, and reducing the amount of disease we see,” Marks said.

“So I think that overall, this seems like a reasonable way to go.”

ABC News’ Nicole Wetsman and Youri Benadjaoud contributed to this report.

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