Children's Health Ireland

Appearing before a Senate committee seven months after taking the reins at the US Department of Health and Human Services (HHS), Secretary Robert F. Kennedy Jr. defended his aggressive restructuring of federal health agencies, most notably his recent decision to remove Centers for Disease and Prevention (CDC) Director Susan Monarez less than a month into her tenure. Kennedy faced intense questioning during Thursday's Senate Finance Committee hearing, with Democratic senators leading the criticism — though some Republicans also held his feet to the fire. 'Healthcare calamity' "The United States is in the midst of a healthcare calamity — the largest cuts to American healthcare in the history of our nation, and they are approaching like an avalanche," said Sen. Ron Wyden (D-OR), highlighting the dismissal of Monarez, and the resignations of several high-level CDC employees that followed suit, "after refusing to bow to Robert Kennedy's unceasing crusade against vaccines." In his opening remarks, Kennedy addressed the recent shakeups at the agency — which includes his firing of all 17 members of the CDC's Advisory Committee for Immunization Practices (ACIP) in June and replacing them with a hand-picked slate of eight new members. He said the changes were "absolutely necessary adjustments to restore the agency to its role as the world's gold standard public health agency, with the central mission of protecting Americans from infectious disease. CDC failed that responsibility miserably during COVID." Regarding the CDC director's ouster last week, Sen. Elizabeth Warren (D-MA) pointed out that Kennedy had described Monarez only a few weeks ago as having "unimpeachable" scientific credentials, and questioned how, "in a month, she became a liar?" Kennedy responded, "You should ask her [Monarez] what changed." Rubberstamping ACIP? In a Wall Street Journal commentary published Thursday, Monarez wrote that during an Aug. 25 meeting, Kennedy instructed her "to preapprove the recommendations of a vaccine advisory panel (ACIP) newly filled with people who have publicly expressed antivaccine rhetoric… It is imperative that the panel's recommendations aren't rubber-stamped but instead are rigorously and scientifically reviewed before being accepted or rejected." And ACIP may soon be welcoming even more new members who "hold unscientific views about the Covid-19 pandemic," according to a report from Inside Medicine that cited several agency insiders. The outlet, run by emergency medicine physician and public health expert Jeremy Faust, said Kennedy has selected seven new ACIP appointees: Hillary Blackburn, Joseph Fraiman, John Gaitanis, Evelyn Griffin, Kirk Milhoan, Raymond Pollak and Catherine Stein. Kennedy denied ever directing Monarez to simply endorse ACIP's decisions. The episode has nevertheless caused unease among lawmakers, including Republicans. With ACIP set to discuss childhood vaccine recommendations at its next meeting taking place on Sept. 18 and 19, Sen. John Barrasso (R-WY) said, "I've been hearing from many of my medical colleagues, people I've known from medical school, residency, and when I practised medicine in Wyoming, and there are real concerns that safe, proven vaccines like measles, like hepatitis B and others could be in jeopardy." Conflicting stances Meanwhile, Kennedy appeared to stumble when pressed on the apparent contradiction between his past denunciations of mRNA vaccines and his support for President Donald Trump to be awarded the Nobel Peace Prize — echoing Pfizer CEO Albert Bourla — for his role in launching Operation Warp Speed, the initiative that brought the first mRNA vaccines to market during the COVID-19 pandemic. When Kennedy responded that Trump "absolutely" deserves the prize, Sen. Bill Cassidy (R-LA) — whose support was instrumental in securing Kennedy's HHS nomination earlier this year — said, "But you just told Sen. Bennett (D-CO) that the COVID vaccine killed more people than COVID." Cassidy continued, "You also said that…as lead attorney for the Children's Health Defence, you engaged in multiple lawsuits attempting to restrict access to the COVID vaccine. Again, it surprises me that you think so highly of Operation Warp Speed when as an attorney, you attempted to restrict access." The senator further noted that HHS, apparently under Kennedy's direction, recently cancelled $500 million in contracts for mRNA vaccine projects. "It seems like an incredible waste of money," Cassidy said, "but it also seems like a commentary upon what the president was attempting…in Operation Warp Speed, which is to create a platform by which to create vaccines." Blockbuster drug shield? Kennedy was also asked by Sen. Catherine Cortez Masto (D-NV) about a "massive win" apparently handed to pharmaceutical companies with the recent passage of Trump's so-called Big Beautiful Bill that "shields billion-dollar drugs" like Merck & Co.'s Keytruda (pembrolizmab) from Medicare pricing negotiations. A report in WSJ last month highlighted two little-known provisions that industry had been lobbying to be included in the bill, which Trump signed into law in July. Keytruda, along with Bristol Myers Squibb's Opdivo (nivolumab) and Johnson & Johnson's Darzalex (daratumumab) "were widely expected to be selected for Part B negotiation in 2026 for 2028 implementation," Cortez Masto said, but "they are now, because of the actions of this administration, exempt from negotiation for at least several additional years, if not permanently." Citing Congressional Budget Office estimates, the WSJ report said that exempting or delaying these drugs from negotiations will cost Medicare at least $5 billion in missed savings over 10 years. Kennedy said, "It's part of the [most-favoured nation pricing] negotiations. I'm not sure of that provision in the [Big Beautiful Bill]."

Lockdowns imposed during the COVID-19 pandemic had an impact on the gut microbiome development of babies born during these periods according to new research. Our gut microbiome, an ecosystem of microbes that live in our digestive tract, plays an essential role in human health. The study reveals significant differences in the microbiome development of babies born during lockdown periods when compared to pre-pandemic babies. Lockdowns imposed during the COVID-19 pandemic had an impact on the gut microbiome development of babies born during these periods according to new research from RCSI University of Medicine and Health Sciences, Children's Health Ireland and APC Microbiome Ireland (APC), a world leading SFI Research Centre, based in University College Cork. Our gut microbiome, an ecosystem of microbes that live in our digestive tract, plays an essential role in human health. The study published in Allergy is the first to specifically explore the gut health of newborns in the pandemic. It revealed significant differences in the microbiome development of babies born during lockdown periods when compared to pre-pandemic babies. Babies born during lockdown also had lower than expected rates of allergic conditions, such as food allergies. The findings highlighted gut health benefits for 'pandemic babies' arising from the unique environment of lockdown including lower rates of infection and consequent antibiotic use, and increased duration of breastfeeding. The newborns were found to have more of the beneficial microbes acquired after birth from their mothers. These maternal microbes could be playing a protective role against allergic diseases. Professor Jonathan Hourihane, Head of the Department of Paediatrics at RCSI, Consultant Paediatrician at Children's Health Ireland Temple Street, who is joint senior author of the study, commented on the research's implications: "This study offers a new perspective on the impact of social isolation in early life on the gut microbiome. Notably, the lower allergy rates among newborns during the lockdown could highlight the impact of lifestyle and environmental factors, such as frequent antibiotic use, on the rise of allergic diseases. "We hope to re-examine these children when they are 5 years old to see if there are longer term impacts of these interesting changes in early gut microbiome." Professor Liam O'Mahony, Principal Investigator at APC Microbiome Ireland and Professor of Immunology, at University College Cork is joint senior author. He added: "While we all start life sterile, communities of beneficial microbes that inhabit our gut develop over the first years of life. We took the opportunity to study microbiome development in infants raised during the early COVID-19 era when strict social distancing restrictions were in place, as the complexity of early life exposures was reduced and this facilitated a more accurate identification of the key early life exposures. Prior to this study it has been difficult to fully determine the relative contribution of these multiple environmental exposures and dietary factors on early life microbiome development. "One fascinating outcome is that due to reduced human exposures and protection from infection, only 17% of infants required an antibiotic by one year of age, which correlated with higher levels of beneficial bacteria such as bifidobacteria. The study has provided a rich repository of data, which we will continue to analyse and investigate in the future." The researchers from RCSI, CHI and APC Microbiome Ireland analysed fecal samples from 351 babies born in the first three months of the pandemic, comparing these with pre-pandemic cohorts. The former were part of the CORAL (Impact of CoronaVirus Pandemic on Allergic and Autoimmune Dysregulation in Infants Born During Lockdown) project. Online questionnaires were used to collect information on diet, home environment and health. Stool samples were collected at 6,12 and 24 months and allergy testing was performed at 12 and 24 months. 'Association between Gut Microbiota Development and Allergy in Infants Born during Pandemic-Related Social Distancing Restrictions' was carried out in collaboration with University College Cork, University of Helsinki, University of Colorado, Karolinska Institute Stockholm, Children's Health Ireland, Rotunda Hospital and The Coombe Hospital. The CORAL study was supported by the Temple Street Hospital Foundation in Dublin, Ireland and the Clemens von Pirquet Foundation in Geneva, Switzerland.