The Hill's Headlines - May 18, 2025
NATIONAL Mexican navy ship crashes into Brooklyn Bridge leaving two people dead STATE WATCH 1 person killed in explosion outside Palm Springs fertility clinic; police say act was 'intentional' INTERNATIONAL Vice President Vance greets Pope Leo XIV in Vatican City TRANSPORTATION Over 300 flight delays reported at Philadelphia International Airport; ground stop lifted HEALTH FDA approves Novavax COVID-19 shot but with stricter new restrictions
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San Francisco Chronicle
43 minutes ago
- San Francisco Chronicle
Who's in charge? CDC's leadership 'crisis' apparent amid new COVID-19 vaccine guidance
WASHINGTON (AP) — There was a notable absence last week when U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced in a 58-second video that the government would no longer endorse the COVID-19 vaccine for healthy children or pregnant women. The director of the Centers for Disease Control and Prevention — the person who typically signs off on federal vaccine recommendations — was nowhere to be seen. The CDC, a $9.2 billion-a-year agency tasked with reviewing life-saving vaccines, monitoring diseases and watching for budding threats to Americans' health, is without a clear leader. 'I've been disappointed that we haven't had an aggressive director since — February, March, April, May — fighting for the resources that CDC needs,' said Dr. Robert Redfield, who served as CDC director under the first Trump administration and supported Kennedy's nomination as the nation's health secretary. $9.2 billion-a-year agency without leader as nomination awaits The leadership vacuum at a foremost federal public health agency has existed for months, after President Donald Trump suddenly withdrew his first pick for CDC director in March. A hearing for his new nominee — the agency's former acting director Susan Monarez — has not been scheduled because she has not submitted all the paperwork necessary to proceed, according to a spokesman for Sen. Bill Cassidy, R-La., who will oversee the nomination. HHS did not answer written questions about Monarez's nomination, her current role at the CDC or her salary. An employee directory lists Monarez, a longtime government employee, as a staffer for the NIH under the Advanced Research Projects Agency for Health. Instead, a lawyer and political appointee with no medical experience is 'carrying out some of the duties' of director at the agency that for seven decades has been led by someone with a medical degree. Matthew Buzzelli, who is also the chief of staff at the CDC, is 'surrounded by highly qualified medical professionals and advisors to help fulfill these duties as appropriate,' Andrew Nixon, an HHS spokesperson said in a statement. Adding to the confusion was an employee-wide email sent last week that thanked 'new acting directors who shave stepped up to the plate." The email, signed by Monarez, listed her as the acting director. It was was sent just days after Kennedy said at a Senate hearing that Monarez had been replaced by Buzzelli. The lack of a confirmed director will be a problem if a public health emergency such as the COVID-19 pandemic or a rapid uptick in measles cases hits, said Michael Osterholm, an epidemiologist at the University of Minnesota. 'CDC is a crisis, waiting for a crisis to happen,' said Osterholm. 'At this point, I couldn't tell you for the life of me who was going to pull what trigger in a crisis situation." An acting director rarely seen, and stalled decisions At CDC headquarters in Atlanta, employees say Monarez was rarely heard from between late January – when she was appointed acting director – and late March, when Trump nominated her. She also has not held any of the 'all hands' meetings that were customary under previous CDC chiefs, according to several staffers. One employee, who insisted on anonymity because they were not authorized to speak to the media and fears being fired if identified said Monarez has been almost invisible since her nomination, adding that her absence has been cited by other leaders as an excuse for delaying action. The situation already has led to confusion. In April, a 15-member CDC advisory panel of outside experts met to discuss vaccine policy. The panel makes recommendations to the CDC Director, who routinely signs off on them. But it was unclear during the meeting who would be reviewing the panel's recommendations, which included the expansion of RSV vaccinations for adults and a new combination shot as another option to protect teens against meningitis. HHS officials said the recommendations were going to Buzzelli, but then weeks passed with no decision. A month after the meeting ended, the CDC posted on a web site that Kennedy had signed off on recommendations for travelers against chikungunya, a viral disease transmitted to humans by mosquitos. But there continues to be no word about a decision about the other vaccine recommendations. The problem was accentuated again last week, when Kennedy rolled out recommendations for the COVID-19 vaccine saying they were no longer recommended for healthy children or pregnant women, even though expectant mothers are considered a high-risk group if they contract the virus. Kennedy made the surprise announcement without input from the CDC advisory panel that has historically made recommendations on the nation's vaccine schedule. The CDC days later posted revised guidance that said healthy kids and pregnant women may get the shots. Nixon, the HHS spokesman, said CDC staff were consulted on the recommendations, but would not provide staffer's names or titles. He also did not provide the specific data or research that Kennedy reviewed to reach his conclusion on the new COVID-19 recommendations, just weeks after he said that he did not think 'people should be taking medical advice' from him. 'As Secretary Kennedy said, there is a clear lack of data to support the repeat booster strategy in children,' Nixon said in a statement. Research shows that pregnant women are at higher risk of severe illness, mechanical ventilation and death, when they contract COVID-19 infections. During the height of the pandemic, deaths of women during pregnancy or shortly after childbirth soared to their highest level in 50 years. Vaccinations also have been recommended for pregnant women because it passes immunity to newborns who are too young for vaccines and also vulnerable to infections. Nixon did not address a written question about recommendations for pregnant women. Kennedy's decision to bypass the the advisory panel and announce new COVID-19 recommendations on his own prompted a key CDC official who works with the committee – Dr. Lakshmi Panagiotakopoulos – to announce her resignation last Friday. 'My career in public health and vaccinology started with a deep-seated desire to help the most vulnerable members of our population, and that is not something I am able to continue doing in this role,' she wrote in an email seen by an Associated Press reporter. Signs are mounting that the CDC has been 'sidelined' from key decision-making under Kennedy's watch, said Dr. Anand Parekh, the chief medical adviser for The Bipartisan Policy Center. 'It's difficult to ascertain how we will reverse the chronic disease epidemic or be prepared for myriad public health emergencies without a strong CDC and visible, empowered director,' Parekh said. 'It's also worth noting that every community in the country is served by a local or state public health department that depends on the scientific expertise of the CDC and the leadership of the CDC director.'
Yahoo
an hour ago
- Yahoo
Blue states call on FDA to expand abortion pill access
Attorneys general of New York, California, New Jersey and Massachusetts are asking the Food and Drug Administration (FDA) to expand access to the abortion pill and remove some 'unnecessary' drug restrictions that have been in place for more than two decades. The joint petition, filed Thursday, comes days after FDA Commissioner Marty Makary committed to reviewing the abortion drug amid pressure from Department of Health and Human Services Secretary Robert F. Kennedy Jr. and some Republican lawmakers. The FDA first approved of the use of mifepristone and misoprostol for an abortion in 2000. Unlike surgical abortions, medication abortions do not need to take place in a clinical setting, and patients are able to take the pills at home. Most abortions in the U.S. are now medication abortions, according to data from the reproductive health and rights group Guttmacher Institute. In 2023, 63 percent of all abortions in the U.S. were medication abortions. The safety of mifepristone has come under increased scrutiny by some Republican lawmakers, citing a flawed study claiming the rate of adverse health events that occur among patients is far higher than previously reported. More than 100 scientific studies have been conducted looking at the safety and efficacy of mifepristone and misoprostol; all of them have found that the drugs are a safe way to terminate a pregnancy. 'Given Mifepristone's 25-year safety record, there is simply no scientific or medical reason to subject it to such extraordinary restrictions,' New York Attorney General Letitia James said. 'The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care.' Mifepristone's use is subject to a Risk Evaluation and Mitigation Strategy (REMS) program under the FDA. The attorneys general argue three requirements under the REMS program for the drug should be removed since they pose a burden to patients and health care systems. The first is related to prescriber certification. As part of the REMS program, health care providers who prescribe mifepristone are required to add their names to national and abortion provider lists, which the attorneys general say raise 'serious safety and legal concerns.' The second has to do with patient agreement forms. All patients who want mifepristone — even those using the drug to treat a miscarriage — are required to sign a document stating they are using the drug to end a pregnancy. The third requirement mentioned in the petition is connected to pharmacy certification. As part of mifepristone's REMS program, pharmacies that carry the drug are subject to tracking, shipping and reporting requirements, which the attorneys general argue may 'dissuade' some from carrying the drug. The FDA has yet to reply to a request for comment from The Hill about the petition. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
an hour ago
- Yahoo
US COVID vaccine recommendations sow confusion among doctors, insurers
By Julie Steenhuysen and Amina Niasse CHICAGO (Reuters) -Health Secretary Robert F. Kennedy Jr.'s intervention in COVID-19 vaccine recommendations without input from a key U.S. CDC advisory panel has sown confusion among physicians and insurers over who should get the shots and whether they will be covered, experts told Reuters. Kennedy, a long-time vaccine skeptic, in a video posted on social media last week said the government was dropping its recommendation that healthy children and pregnant women should receive COVID shots. Days later, the Centers for Disease Control and Prevention updated its recommended childhood vaccine schedule online to show the shots could be given to healthy children when parents and doctors agree they are needed. It removed its recommendation that pregnant women should receive the shot. The moves sidestepped the normal process in which a panel of outside experts to the CDC - the Advisory Committee on Immunization Practices - reviews data in a public meeting and votes on vaccine recommendations. The ACIP recommendations are sent to the CDC director for approval and incorporated in the agency's vaccine schedule, which helps determine insurance coverage under the Affordable Care Act. "The surprise announcement has created uncertainty for payers and providers about whether the video posting constitutes an official policy change," said Sarah Moselle, a principal at health consultancy Avalere. Insurers will wait to make coverage decisions until after ACIP makes a recommendation at its upcoming meeting scheduled for June 25-27, according to Robert Popovian, founder of healthcare consultancy Conquest Advisors. The Department of Health and Human Services overseen by Kennedy said the move was within its legal and regulatory authority and reflects the agency's move toward clinical-guided decision making, a department spokesperson said. HHS will continue to rely on the work of expert panels, including ACIP, he said, noting that the committee will be meeting this month. The meeting agenda will be released in accordance with prior practice. Determinations on coverage are up to insurance providers, the spokesperson said. The CDC has previously recommended the COVID shot for everyone aged 6 months and older. 'AWAITING CLARITY' "This whole thing is so murky," said an ACIP member who spoke on condition of anonymity. "It's very unclear whose decision is final." Infectious Diseases Society of America President Dr. Tina Tan said the conflicting COVID vaccine guidance could cause "significant confusion among medical professionals and the public." Dr. Matthew Zahn, an Orange County, California, public health official at OC Health Care Agency who serves as a liaison to the CDC's advisory panel, said: "We're all awaiting clarity." "It's going to be important to understand how these vaccines are insured," Zahn said. "Specifically, if ultimately there is a recommendation for high-risk populations to be vaccinated, how that is interpreted by insurance companies and thus, how providers can recommend it." Zahn expects CDC to clarify its guidance in the weeks ahead, though he could not comment on whether that will be at the ACIP meeting. On Tuesday, Reuters reported that pediatric infectious disease expert Dr. Lakshmi Panagiotakopoulos, a CDC official who helped oversee the expert panel on COVID vaccines, told colleagues she was leaving her post as she was "no longer able to help the most vulnerable members" of the U.S. population. The American College of Obstetricians and Gynecologists raised concerns on May 27 that the HHS decision not to recommend COVID vaccines during pregnancy would make it harder for pregnant women to get the shot "despite the clear and definitive evidence demonstrating its benefit." The Affordable Care Act generally requires insurers to cover vaccines that are listed on ACIP's vaccine schedule, according to the CDC's website. Narrowing coverage without knowing what ACIP recommends could put insurers at risk, Popovian said. "It's a liability," he said, adding that insurers need clarity on what they will be required to cover. A source familiar with plans for the meeting said the panel is expected to consider and vote on COVID-19 vaccines for the upcoming autumn and winter season, adding that the panel had been leaning toward narrowing its recommendations. The advisory panel has yet to receive an agenda for the upcoming meeting, the source said, and it is unclear whether Kennedy would override any deviation from his announced policy.
