Late last week, three US congressional representatives sent a scathing letter to Food and Drug Administration (FDA) Commissioner Martin Makary, MD, MPH, condemning an agency email that contained “inaccuracies, misinformation, and unsupported claims regarding the agency’s regulation of vaccines, and asserting an unproven link between COVID-19 vaccines and pediatric deaths.”

The letter authors were Frank Pallone Jr. (D-NJ), Energy and Commerce Committee ranking member, and ranking members of the Health Subcommittee (Diana DeGette [D-CO]) and the Oversight and Investigations Subcommittee (Yvette D. Clarke [D-NY]).

The missive described “a troubling trend under your [Makary’s] leadership—of the agency making policy announcements with zero transparency regarding its decision-making process, zero public access to the ‘evidence’ it is relying on, and zero opportunity for the public to provide input.”

Lack of data supporting changes, claims

Specifically, the letter centered on an internal memo that FDA Center for Biologics Evaluation and Research Director Vinay Prasad, MD, MPH, sent to agency staff on proposed changes to vaccine regulations and an unproven link between COVID-19 vaccine and 10 child deaths.

Pallone and colleagues pointed out that the purported research findings Prasad cited weren’t published in a peer-reviewed journal and that Prasad’s claim about COVID-19 vaccine deaths wasn’t grounded in evidence.

Please provide the exact statutory and regulatory citations and explain how those authorities permit FDA to forego formal rulemaking, public comment, and processes outline in statute.

“In fact, Dr. Prasad concedes as much in the next sentence, by saying the relation of these deaths to vaccination is only ‘possible,’” they wrote. “Meanwhile, you [Makary] and Dr. Prasad have treated the fact that 183 children died of COVID-19 in the United States from 2020 to 2022 as, in effect, irrelevant.”

Prasad’s email also proposed changes to vaccine regulations such as more stringent requirements for authorizing vaccines for pregnant women and an altered seasonal flu vaccine approval process.

The authors ended the letter with demands for data supporting these assertions and proposed changes: “Please provide the exact statutory and regulatory citations and explain how those authorities permit FDA to forego formal rulemaking, public comment, and processes outline in statute.”

Gastrointestinal colonization with carbapenem-resistant Enterobacterales (CRE) is “alarmingly prevalent” worldwide, with significant variations across regions, researchers reported today in the American Journal of Infection Control.

In a systematic review and meta-analysis, Chinese researchers analyzed 89 studies that reported the prevalence of CRE colonization in 116,473 participants. CRE colonization of the gastrointestinal tract is important to monitor, the study authors note, because carriage of the multidrug-resistant bacteria frequently precedes invasive disease, particularly in critically ill hospital patients, and can persist for months and serve as a reservoir for hospital-based CRE outbreaks. But few studies have provided a “comprehensive synthesis” that integrates findings across populations, regions, and screening methods.

“By providing a global synthesis of CRE epidemiology, this review aims to inform infection control policies and prioritize surveillance strategies in both high- and low-resource settings,” the authors wrote.

14% pooled CRE colonization rate

Pooled CRE colonization prevalence across the 89 studies was 14%, with a peak of 33% in 2017, and a low of 8% in 2023. Among the countries included in the studies, Vietnam had the highest CRE colonization prevalence (43%), followed by Iran (39%), India (24%), Egypt (14%), and China (12%). The United States (5%) and Ethiopia (5%) had the lowest rates. Klebsiella pneumoniae (52.8%) and Escherichia coli (44.9%) were the most common organisms, and NDM (45.6%) and OXA-type (36.3%) were the predominant carbapenemase genes.

Subgroup analyses showed that children (18%) and newborns (15%) had similar CRE colonization prevalence rates as adults (13%), and that hospital-based (18%) and universal screening (20%) yielded higher prevalence than community-based (3%) and targeted/systematic sampling (3% to 15%). 

The authors note the 14% prevalence estimate is substantially higher than reported in previous reviews that were focused on specific settings or pathogens, but mirrors the timeline of CRE emergence and spread that’s been documented by public health authorities.

“These findings highlight the urgent need for standardized surveillance, particularly in high-risk environments, and support targeted infection control strategies to limit CRE spread,” the authors wrote. “Enhanced molecular monitoring and further research into colonization dynamics and clinical outcomes are essential to inform public health responses.”

Georgia officials have expanded the state’s chronic wasting disease (CWD) management area with the discovery of the first infected deer in Atkinson County, in the southeast part of the state.

Late last week, the Georgia Department of Natural Resources (DNR) Wildlife Resources Division announced the case in a deer harvested for disease monitoring in Atkinson County, near the Berrien County line, roughly 14 miles from the nearest CWD-positive location. The results have been sent to the National Veterinary Services Laboratories for confirmation.

A fatal neurodegenerative disease of cervids such as deer, elk, and moose, CWD was first found in Georgia in January 2025 in a hunter-harvested deer near the Lanier/Berrien county line. In response, the DNR set up a CWD management area, which includes all counties abutting a five-mile radius around each positive location. 

In addition to Atkinson, Berrien, and Lanier counties, the management area also includes Lowndes County. Since January 2025, 398 samples have been submitted from the management area, yielding nine positive samples.

“We applaud hunters and private landowners for their efforts so far this season with submitting samples and staying vigilant for signs of the disease,” DNR Commissioner Walter Rabon, MPA, said in the news release.

More testing and drop-off sites

DNR staff are adding more testing and drop-off sites in Atkinson County and will continue working with landowners and hunters to determine the CWD geographic extent and prevalence, including harvesting another five to 10 deer around the detection.

• LaGrange County, Indiana, is once again the site of several major commercial poultry outbreaks of avian flu, according to recent updates from the US Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS). LaGrange has eight detections affecting more than 100,000 birds, many of whom were exposed on commercial duck farms. In Elkhart County, Indiana, 15,000 birds were affected in two commercial duck meat facilities. APHIS also noted detections in Florida, Nevada, Vermont, and Washington. Avian flu has been detected among 97 flocks in the past 30 days, including 40 commercial flocks and 57 backyard flocks, affecting 1.08 million birds in total.
• Mexico has seen 92 human cases of myiasis caused by New World screwworm as of November 28, according to new data from the National Epidemiological Surveillance System (SINAVE). Cases have been detected in five states, including Oaxaca, Yucatán, Campeche, Tabasco, and Chiapas. Chiapas has had 79 reported cases, 10 of whom are still hospitalized. There have been five deaths in infected patients this year, one in Campeche and four in Chiapas.
• US flu activity is on the rise, according to the latest FluView published late last week by the Centers for Disease Control and Prevention (CDC). Clinical labs are presenting a 7.1% positivity rate (up from 5% the previous week), and 2.9% of visits to a health care provider in the prior week were for respiratory illnesses (up from 2.5%). “The largest increases [were] reported among children and young adults and in the northeastern and mountain west areas of the country,” the CDC said. “Influenza A(H3N2) viruses are the most frequently reported influenza viruses so far this season.”