Federal judge blocks RFK Jr.'s vaccine overhaul

A federal judge on Monday blocked HHS from imp implementing recent vaccine policy changes, reversing all decisions made by panelists on CDC's ACIP. The judge argued that vaccine policy was unlawfully altered and that ACIP was improperly reconstituted.

In June of last year, HHS Secretary Robert F. Kennedy Jr. fired all 17 members of ACIP and replaced them with eight new appointees, although one member later stepped down. Several of the appointed members had previously expressed skepticism about vaccines and their safety. Last September, Kennedy appointed five additional members to the committee, bringing the total number up to 12.

Under Kennedy, HHS has overhauled the childhood vaccine schedule, reducing the number of shots routinely recommended to children, including for flu, hepatitis A, rotavirus, and meningococcal disease, and recommended delaying when most babies receive a vaccine against hepatitis B.

In his ruling, Judge Brian E. Murphy of the U.S. District Court for the District of Massachusetts said that Kennedy's reconstitution of ACIP and changes made to the childhood vaccine schedule were likely illegal, arguing those policy changes violated the Administrative Procedure Act, which determines how agencies consider and implement policy changes.

Murphy also noted that ACIP has historically made decisions through careful review of scientific evidence, "a method scientific in nature and codified into law through procedural requirements," he wrote. However, he added "unfortunately, the government has disregarded those methods and thereby undermined the integrity of its actions."

"This is all to say that there is a method to how these decisions historically have been made — a method scientific in nature and codified into law through procedural requirements. Unfortunately, the Government has disregarded those methods and thereby undermined the integrity of its actions," Murphy wrote. "First, the Government bypassed ACIP to change the immunization schedules, which is both a technical, procedural failure itself and a strong indication of something more fundamentally problematic: an abandonment of the technical knowledge and expertise embodied by that committee."

Murphy ruled in a lawsuit brought by several medical groups, including the American Academy of Pediatrics, the American College of Physicians, and the Infectious Diseases Society of America.

The pause on HHS' actions is temporary as the ruling is expected to be appealed. Andrew Nixon, a spokesperson for HHS, said the department "looks forward to this judge's decision being overturned just like his other attempts to keep the Trump administration from governing."

(Mandavilli, New York Times, 3/16; Sun/Roubein, Washington Post, 3/16; Oza, et al., STAT, 3/16; Sagonowsky/Kansteiner, Fierce Healthcare, 3/16)

White House chief of staff Susie Wiles has breast cancer

Susie Wiles, the White House chief of staff for President Donald Trump, said on Monday that she has been diagnosed with breast cancer, noting the disease was caught in its early stages.

Wiles said she will remain in her job and isn't planning on taking leave. She will start a course of treatment soon that will last several weeks in the Washington, D.C. area.

"Nearly one in eight women in the United States will face this diagnosis," she said in a statement. "Every day, these women continue to raise their families, go to work, and serve their communities with strength and determination. I now join their ranks."

Wiles said she told President Trump about the diagnosis after she learned of it last week.

"I am grateful to have an outstanding team of doctors who detected the cancer early and are guiding my care, and I am encouraged by a strong prognosis," Wiles said. "I am also deeply thankful for the support and encouragement of President Trump as I undergo treatment and continue serving in my current role."

In a post on Truth Social, President Trump described Wiles as "one of the strongest people I know" and said her prognosis is "excellent."

"During the treatment period, she will be spending virtually full time at the White House, which makes me, as President, very happy!" Trump said in the post. "She will soon be better than ever!"

(Binkley, Associated Press, 3/16; Haberman, New York Times, 3/16)

Makary also acknowledged that these are "nuanced topics … Sometimes you need an antibiotic."

"I watched lives saved right in front of my eyes within hours because of antibiotics in the hospital," Makary said, though he continued to stress the "profound effect" of the microbiome on a person's health.

Handy said there's "nothing conclusive at this point to say a child who has a 5- or 10-day course of antibiotics is definitely going to be more obese than their peers later in life."

"Effects that will happen 5, 10, 20 years later are really only relevant if they survive the infection, and there are many infections right now that can be deadly for children," she added.

(Firth, MedPage Today, 3/16)

Confidential report calls for overhaul of how COVID-19 vaccine harms are tracked and treated

A federal work group is calling for an overhaul of how the medical establishment treats and tracks injuries related to COVID-19 vaccines, according to a confidential report obtained by the New York Times.

The report was drafted for ACIP and proposes the creation of a diagnostic category specifically for COVID-19 vaccine injuries, new diagnostic guidelines, and a network of research centers in order to study the long-term harms from COVID-19 vaccines and from the illness itself.

The report cites two polls, one of them called "Killer Jab?" which was a survey conducted by polling firm Rasmussen Reports of 1,110 American adults in which respondents were asked "Do you know someone personally who died from side effects of the COVID-19 vaccine?" Roughly 25% of respondents said they did in the poll.

Billions of people around the world have received COVID-19 vaccines and most studies have not found widespread reports of deaths or severe side effects related to the shots. In June of last year, when HHS Secretary Robert F. Kennedy Jr. overhauled ACIP, CDC told the new panel members that its databases had found no increased risk of death following COVID-19 vaccination.

Sean O'Leary, head of the pediatric infectious disease committee for the American Academy of Pediatrics, said the work group's report misrepresented the body of work already available on the side effects of COVID-19 vaccines.

O'Leary added that the report cherry-picks studies of poor quality that support its thesis and omits those that don't. "It is straight out of the anti-vaccine handbook," he said.

(Mandavilli/Stolberg, New York Times, 3/15)