White House names new acting CDC director

On Thursday, the White House named deputy HHS secretary Jim O'Neill as acting CDC director following the ousting of former director Susan Monarez.

Last week, Monarez was fired as CDC director after she refused to resign amid pressure from HHS Secretary Robert F. Kennedy Jr. and other officials to implement vaccine policy changes. Meanwhile, several top CDC officials resigned from the agency, citing lost funding, the political climate, and a broader attack on public health.

According to the Washington Post, O'Neill previously served as a senior health official during President George W. Bush's administration before leaving to become a Silicon Valley investor and entrepreneur. He was confirmed as deputy HHS secretary in June.

Tevi Troy, who served as deputy HHS secretary during the George W. Bush administration, called O'Neill a tested health official. "He believes that CDC should focus on its core mission of combating dangerous communicable diseases, and I trust he will bring that perspective to his new role," Troy said.

However, some physicians and Democratic lawmakers were critical of O'Neill's appointment as acting CDC director.

"Has America run out of actual health practitioners with demonstrated experience improving public health outcomes?" asked Atul Gawande, a physician who helped oversee global health strategy during the Biden administration.

For his part, Kennedy has praised O'Neill, saying that his prior experience in Silicon Valley and the federal government made him "ideally suited" to turn HHS into a "technological innovation powerhouse."

(Anthes, New York Times, 8/29; Diamond, Washington Post, 8/28)

FDA limits approval for new COVID-19 vaccines to higher-risk individuals

Last week, FDA approved new COVID-19 vaccines from Pfizer, Moderna, and Novavax. However, the approval was limited to certain high-risk groups.

"FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+)," HHS Secretary Robert F. Kennedy Jr. wrote in a post on X. "These vaccines are available for all patients who choose them after consulting with their doctors."

According to the Washington Post, Trump administration officials previously described those at higher risk as either being age 65 and older or having an underlying condition that could increase the risk of severe disease. In an article published in the New England Journal of Medicine, top FDA officials listed several COVID-19 risk factors, including asthma, smoking, physical inactivity, and obesity.

FDA also rescinded the emergency use authorizations for COVID-19 vaccines, a decision made to end vaccine mandates, Kennedy explained. "The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded," Kennedy said.

According to public health experts and industry, the narrowed approval for COVID-19 vaccines add new uncertainty about who will be able to access the shots, whether insurance will cover the vaccines, and whether people will be able to get vaccinated at their local pharmacies.

"For people who are not in the categories of high risk or over 65, I think there's no certainty they will get the shot," said Dorit Reiss, a professor at the University of California College of the Law, San Francisco. "It's not clear that the doctor would be willing to push to recommend it."

In response to the new approval, AHIP spokesperson Tina Stow said that the organization is "working closely with our members to review [the] FDA announcement and will be monitoring the forthcoming meetings and recommendations from [the Advisory Committee on Immunization Practices] ACIP and CDC on considerations around coverage."

Separately, Aetna said it plans to continue covering COVID-19 vaccines for its fully insured plans but noted that self-insured employers can make their own coverage decisions about the vaccines.

Some pharmacy chains have also shifted their COVID-19 vaccine policies in response to the new narrowed approval.

In 13 states, including New York, Florida, and Pennsylvania, CVS Health said it would only administer COVID-19 vaccines if patients have a prescription from an authorized provider. In three states, Massachusetts, New Mexico, and Nevada, patients will not be able to get a COVID-19 vaccine from CVS without ACIP approval, even if they have a prescription. 

HHS eliminates program aimed at supporting diversity in the biomedical workforce

Last month, HHS announced plans to eliminate the Minority Biomedical Research Support Program, an NIH grant program that provided support for biomedical students from marginalized backgrounds. The program helped fund undergraduates' lab salaries, mentorship from senior investigators, and more.

In a document posted to the Federal Register, HHS Secretary Robert F. Kennedy Jr. said the program failed to comply with the Trump administration's executive orders restricting federal agencies from supporting diversity, equity, and inclusion-related initiatives.

According to experts, the termination of the program could close off scientific careers for students who wouldn't otherwise be able to access research opportunities.

"Cutting of these programs means that an entire generation of students will end up being lost to science," said Rochelle Newman, a psychologist at the University of Maryland who received a grant from the program. "Those are students who, as scientists, would be creating the discoveries that will enhance health and our way of life in the future."

Separately, Fatima Stanford, an obesity medicine physician-scientist at Mass General Brigham, said the termination could leave early-career researchers who relied on mentorships supported by the program without a support structure to help them navigate the academic world.

"Individuals that may have had sustained mentorship or sustained support are really left in a boat without a paddle," Stanford said. "Who do they go to at this point? Do they change careers? What if they're in the middle of a grant application?"

"Not having programs like this program — particularly as a Black woman physician-scientist — will make it such that there are fewer investigators that come from these backgrounds," Stanford added. "I'm concerned about what the future looks like."

(Paulus, STAT, 8/25)

HHS pushes medical schools, residency programs to add more nutrition education

HHS recently announced plans requiring medical schools and residency programs to immediately implement "comprehensive nutrition education" in six areas:

• Pre-medical standards
• Medical school curricula
• Medical licensing exams
• Residency requirements
• Board certification
• Continuing education

Affected organizations, which presumably include medical schools, residency programs, and continuing medical education organizations, have until Sept. 10 to submit "written plans detailing the scope, timeline, standards alignment, measurable milestones, and accountability measures of their nutrition education commitments," HHS said.

"Medical schools talk about nutrition but fail to teach it," said HHS Secretary Robert F. Kennedy Jr. in the news release. "We demand immediate, measurable reforms to embed nutrition education across every stage of medical training, hold institutions accountable for progress, and equip every future physician with the tools to prevent disease — not just treat it."

Responses to the decision were mixed, with the Association of American Medical Colleges (AAMC) defending current nutrition education efforts and the American Medical Association (AMA) praising the decision to add more nutrition education.

"Medical schools understand the critical role that nutrition plays in preventing, managing, and treating chronic health conditions, and incorporate significant nutrition education across their required curricula," said Alison Whelan, AAMC's chief academic officer. "Through integrated education experiences, future physicians learn how to recognize the impact of diet on health and to apply evidence-based nutritional strategies in patient care."

"The importance of nutrition in medical education is increasingly clear, and we support expanded, evidence-based instruction to better equip physicians to prevent and manage chronic disease and improve patient outcomes," said David Aizuss, chair of AMA's board of trustees.

(Frieden, MedPage Today, 8/27)