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.”

Health officials in South Carolina late last week reported eight new measles cases and exposures at four new schools.

In a December 5 update, the South Carolina Department of Public Health (DPH) said seven of the new cases are household members of known measles cases, while the eighth is still being investigated. DPH notified potentially exposed students, faculty, and staff at the four schools on December 1. There are currently 281 individuals in quarantine and two in isolation.

The new measles cases bring South Carolina’s total this year to 87 cases, 84 of which are related to the outbreak in the Upstate region. Of the 87 case-patients, 77 are unvaccinated, three are partially vaccinated, and two have unknown status.

“We remind people that measles is highly contagious and can cause serious illness resulting in hospitalizations and complications,” DPH said in its update. “Vaccination continues to be the best way to prevent measles and stop this outbreak.”

New case in Colorado

Also on December 5, the Colorado Department of Public Health and Environment (CDPHE) confirmed a measles case in a resident of Montezuma County. Department officials said the unvaccinated child had no known connection to recent exposures in Colorado and has not traveled outside the state.

“The lack of a clear source of infection suggests that unidentified measles cases may be occurring in or traveling through the Cortez area,” CDPHE said in a press release.

As of December 2, 1,828 confirmed measles cases have been reported in the United States, according to the latest update from the Centers for Disease Control and Prevention.

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.”

• 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.”