The federal agency says it will mandate randomized, controlled clinical trials for vaccination of younger, healthy individuals
It’s been a confusing past few weeks in terms of what the general public’s access to COVID-19 vaccinations will be like in the future.
Public health experts have been verbally jousting with the federal Department of Health and Human Services (HHS) about moves its health officials made recently regarding the vaccines. This could put clinical laboratories on the front lines to help determine whether COVID cases—particularly severe ones—eventually rise as a result.
Food and Drug Administration (FDA) commissioner Martin A. Makary, MD, MPH, and Vinay Prasad, MD, MPH, who leads the agency’s vaccine oversight, announced on May 20 that the agency will require randomized, controlled clinical trials before approving COVID vaccines for healthy individuals under age 65.
“While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe COVID-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,” Makary and Prasad wrote in NEJM.
Under the new framework, they noted, the agency expects that it will continue to approve vaccines for adults over 65 as well as younger people with health conditions that put them at high risk of severe outcomes from COVID-19.
The range of diseases is “vast, including obesity and even mental health conditions such as depression,” they wrote. “Estimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner.”
In their NEJM commentary, FDA commissioner Martin Makary, MD (left), and Vinay Prasad, MD (right), wrote, “Moving forward, the FDA will adopt the following COVID-19 vaccination regulatory framework: On the basis of immunogenicity—proof that a vaccine can generate antibody titers in people.” (Photo copyrights: Wikimedia Commons.)
Former CDC APIC Member Pushes Back
The announcement drew criticism from public health and medical experts.
“The FDA guidance presented in the NEJM was not released in the Federal Register, did not invite comment, and provided only a general outline for COVID-19 vaccine licensure,” wrote pediatrician and vaccinologist Kathryn M. Edwards, MD, in a commentary for STAT. Edwards is a former member of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), which makes vaccine recommendations to the agency.
On June 9, in an opinion piece for The Wall Street Journal, HHS Secretary Robert F. Kennedy Jr. announced that he’s removing all 17 current members of ACIP.
“The FDA mandate is to ensure safe and effective vaccines based on the clinical studies performed, but not to develop specific recommendations for their use,” Edwards added. “Providing recommendations on vaccine use for the civilian population is the mandate of the ACIP.”
Edwards contended that extensive data is already available on the safety and effectiveness of COVID-19 vaccines. She stated that “there is no precedent for mandating continued placebo-controlled randomized clinical trials for vaccines that have already been licensed.”
New Policy Announcement Raises Questions
The New York Times notes that many questions remain about the specifics of the new policy and how broadly the vaccines will be available.
A likely scenario, the paper reported, is that health insurers will play a role as “gatekeepers by demanding medical documentation of an underlying condition before agreeing to cover the cost.” Without insurance coverage, people would likely pay approximately $140 per shot out of pocket.
This stands in contrast to European countries, where outreach campaigns target specific populations based on public health recommendations. according to Forbes. However, “in virtually all instances, COVID-19 vaccines can be gotten free of charge across Europe regardless of health or age status,” the article notes.
In their NEJM commentary, Prasad and Makary noted that adoption of the annual COVID-19 booster shot is already low. The CDC reported that 23% of Americans 18 and older received vaccinations in the 2024-2025 season, up slightly from 21.6% in 2023-2024.
Kennedy Steps In
On May 27, Kennedy announced in a video on X that the CDC would remove the COVID-19 vaccine from the recommended immunization schedule for healthy children and healthy pregnant women. Previously, the CDC recommended the vaccine for everyone ages six months and older.
Kennedy was joined in the video by Makary and National Institutes of Health director Jay Bhattacharya MD, PhD.
However, CDC staffers were “blindsided” by the announcement, NPR reported, citing an agency official who requested anonymity.
“Hours after the post on X, CDC staffers received a directive from Secretary Kennedy—dated May 19, but sent May 27—rescinding the department’s 2022 acceptance of the CDC’s recommendations for the use of COVID shots in children and during pregnancy,” NPR reported.
It now appears that HHS has at least partially backtracked on Kennedy’s announcement.
The CDC’s immunization schedule now states that vaccination of healthy children should be a matter of “shared clinical decision-making” between the doctor and parent or patient.
“After confusing, mixed messages from leaders at HHS earlier this week, we are relieved to see today that the CDC updated its schedules for child and adolescent immunizations to allow families to maintain the choice to immunize their children against COVID in consultation with their doctor,” American Academy of Pediatrics president Susan Kressly said in a statement from the organization.
In a June 1 interview with the CBS News program “Face the Nation,” Makary confirmed that the recommendation to vaccinate “should be with the patient and their doctor.”
However, he also criticized ACIP as a “kangaroo court where they just rubber stamp every single vaccine put in front of them.”
Findings could lead to clinical laboratory test that can both track the disease’s progress and differentiate it from other forms of dementia
Another research study is underway with hopes of developing a new clinical laboratory blood test to aid in the diagnoses of Alzheimer’s disease and help physicians determine the best course of treatment.
Researchers at the Washington University School of Medicine (WashU Medicine) in St. Louis and Lund University in Sweden have developed a test that focuses on the presence of a protein called MTBR-tau243, a potential biomarker for Alzheimer’s. This protein is correlated to the toxic accumulation of tau aggregates in the brain and the severity of the disease, according to a WashU new release.
Cognitive tests and brain imaging are also used to diagnose the condition. However, existing tests cannot establish how far the illness has progressed. Alzheimer’s therapies are most effective during early stages, so determining the disease’s progression could provide insights doctors need to devise the most effective treatment protocols.
Washington University’s new blood test that identifies MTBR-tau243 protein could lead to new biomarkers as well as identifying how far the disease has progressed.
“This blood test clearly identifies Alzheimer’s tau tangles [aka, neurofibrillary tangles], which is our best biomarker measure of Alzheimer’s symptoms and dementia,” said co-senior author Randall J. Bateman, MD, professor of neurology at WashU Medicine in the WashU news release.
“In clinical practice right now, we don’t have easy or accessible measures of Alzheimer’s tangles and dementia, and so a tangle blood test like this can provide a much better indication if the symptoms are due to Alzheimer’s and may also help doctors decide which treatments are best for their patients,” said co-senior author Randall J. Bateman, MD, professor of neurology at WashU Medicine in a news release. (Photo copyright: Washington University.)
Distinguishing between Alzheimer’s and Other Forms of Dementia
The WashU scientists tested the study participants in three main stages of Alzheimer’s disease:
Pre-symptomatic.
Early stage with mild cognitive impairment.
Late symptomatic where patients have been diagnosed with dementia.
The study included 108 volunteers from WashU Medicine’s Charles F. and Joanne Knight Alzheimer Disease Research Center and a subset of 55 people from the Swedish BioFINDER-2 study, which aims to discover key mechanisms in neurodegenerative disorders. The scientists validated their results in an independent dataset involving 739 other people in the BioFINDER-2 database. The patient information used for the study represented patients from all stages of the disease.
Alzheimer’s disease involves an accumulation of amyloid into plaques in the brain, which turn into tangles of tau proteins. When these tau tangles become detectable, cognitive symptoms begin to occur and exacerbate as the tangles spread. WashU’s new blood test can detect MTBR-tau243 levels in the brain with 92% accuracy. The researchers also found that MTBR-tau243 levels were significantly higher for patients in the mild cognitive stage of the disease and up to 200 times higher for patients in the late symptomatic stage.
“MTBR-tau243 is a chipped (off) piece of the protein in Alzheimer’s tau tangles,” Bateman told Medical News Today. “The blood test measures this piece of tau tangles in the blood as a measure of how many tangles are in the brain.”
The researchers also found that MTBR-tau243 levels were normal in patients with cognitive symptoms attributed to diseases other than Alzheimer’s, suggesting that the test can distinguish Alzheimer’s dementia from other forms of dementia.
“We’re about to enter the era of personalized medicine for Alzheimer’s disease,” said Kanta Horie, PhD, voluntary research associate professor of neurology at WashU Medicine, co-first and co-corresponding author of the study, in the WashU news release.
More Studies Needed
According to the Centers for Disease Control and Prevention (CDC), Alzheimer’s is the seventh leading causes of death in the US. It accounted for more than 120,000 deaths in 2022, the most recent year for available data. With the ebbing of COVID-19, which was ranked number four in 2022, Alzheimer’s is assumed to be higher in ranking for more recent years.
Washington University’s new blood test for Alzheimer’s may one day enable earlier detection of the disease, earlier intervention, and slowing of its advancement. However, more research and trials are needed into the theory behind this study.
“The initial study needs to be replicated in larger and more diverse populations to confirm its accuracy and reliability across different demographics, ethnicities, and stages of the disease,” Manisha Parulekar, MD, director of the Division of Geriatrics at Hackensack University Medical Center, told Medical News Today. “This includes testing individuals with other neurological conditions to ensure specificity. Clear and standardized protocols for blood collection, processing, and analysis must be established to ensure consistent and reproducible results across different laboratories and healthcare settings.”
Findings may lead to new clinical laboratory testing and treatments for Parkinson’s patients
Gut bacteria have repeatedly been proven to perform critical roles in the development of certain diseases. And many clinical laboratory tests use human microbiota as biomarkers.
Now, researchers at Nagoya University Graduate School of Medicine in Japan have discovered a link between microbes in the gut and the brain. The connection may play a part in the development of Parkinson’s disease, according to a Nagoya University news release.
The researchers found that a reduction in the genes responsible for synthesizing riboflavin (vitamin B2) and biotin (vitamin B7) may increase the likelihood of developing Parkinson’s.
They also determined that the lack of these genes may lessen the integrity of the intestinal barrier that prevents toxins from entering the bloodstream causing the inflammation often seen in Parkinson’s patients.
“Supplementation therapy targeting riboflavin and biotin holds promise as a potential therapeutic avenue for alleviating Parkinson’s symptoms and slowing disease progression,” said lead researcher Hiroshi Nishiwaki, PhD, Division of Neurogenetics, Center for Neurological Diseases and Cancer, Nagoya University Graduate School of Medicine, in a news release. (Photo copyright: Nagoya University.)
Key Deficiencies in Parkinson’s Patients
According to the Parkinson’s Foundation, nearly one million people in the US are living with Parkinson’s and that number is expected to increase to 1.2 million by the year 2030. Approximately 90,000 new cases of Parkinson’s are diagnosed in the US each year, and more than 10 million people are living with the disease worldwide.
To perform their research, the Nagoya University team analyzed stool samples from 94 Parkinson’s patients from Japan, the US, Germany, China, and Taiwan. They also included 73 relatively healthy controls from Japan. They then used shotgun sequencing (a laboratory technique for determining the DNA sequence of an organism’s genome) to gain a better understanding of the microbial community and genetic makeup of each sample.
The scientists discovered a decrease in B2 and B7 vitamins in patients diagnosed with Parkinson’s. B vitamins promote the production and functions of short-chain fatty acids (SCFA) and polyamines.
“Supplementation of riboflavin and/or biotin is likely to be beneficial in a subset of Parkinson’s disease patients, in which gut dysbiosis plays pivotal roles,” the authors wrote in NPJ-Parkinson’s Disease.
The examination of fecal metabolites in Parkinson’s patients revealed a reduction in both components.
“Deficiencies in polyamines and SCFAs could lead to thinning of the intestinal mucus layer, increasing intestinal permeability, both of which have been observed in Parkinson’s,” said Hiroshi Nishiwaki, PhD, a professor at Nagoya University Graduate School of Medicine and a lead researcher for the study, in the news release.
“This higher permeability exposes nerves to toxins, contributing to abnormal aggregation of alpha-synuclein, activating the immune cells in the brain, and leading to long-term inflammation,” he added.
The team surmises that the weakened protective layer in the gut exposes the intestinal nervous system to more of the toxins people experience in everyday life, such as chemicals, pesticides, and herbicides. These types of toxins lead to the overproduction of alpha-synuclein fibrils. These molecules are aggregates of the α-synuclein protein that form into long, thread-like structures which are primarily found in the brains of individuals with neurodegenerative diseases like Parkinson’s.
Alpha-synuclein fibrils amass in dopamine-producing cells in the brain and increase the type of inflammation that leads to the debilitating motor skills and dementia symptoms of Parkinson’s.
Precision Medicine Analysis Suggested
Due to their research, the team proposes that high doses of vitamin B may help reduce the damage of toxins on the gut microbiome, help protect against neurodegenerative diseases like Parkinson’s, and aid in the creation of personalized therapy plans for patients.
“We could perform gut microbiota analysis on patients or conduct fecal metabolite analysis,” Nishiwaki noted. “Using these findings, we could identify individuals with specific deficiencies and administer oral riboflavin and biotin supplements to those with decreased levels, potentially creating an effective treatment.”
The results of the Nagoya University study illustrate the importance of a healthy gut microbiome in the prevention of disease. Altering the bacterial level in the gut may enable doctors to stave off the progression of neurodegenerative illnesses like Parkinson’s disease.
Researchers tracked “excess deaths” among adults aged 25 to 44 years and found disparate causes to blame
Studies conducted at the University of Minnesota and Boston University found that mortality rates among young adults have risen substantially since 2010 due to a variety of factors, pointing to a possible “mortality crisis” as they get older.
The researchers used data from the Centers for Disease Control and Prevention (CDC) and US Census Bureau to analyze nearly 3.4 million deaths in the US between 1999 and 2023 among adults aged 25 to 44 years, according to a Boston University press release.
They then used mortality data from 1999 through 2010 to project expected death rates for the later years and compared those projections to the actual post-2010 mortality rate to calculate the number of “excess deaths,” defined as “those [deaths] above what had been projected for a given period.”
“What we didn’t expect is how many different causes of death have really grown for these early adults,” said study lead author Elizabeth Wrigley-Field, PhD, of the University of Minnesota, in a U of M pressrelease. “It’s drug and alcohol deaths, but it’s also car collisions, it’s circulatory and metabolic diseases—causes that are very different from each other. That tells us this isn’t one simple problem to fix, but something broader.”
From that perspective, clinical laboratories could be part of the solution in tracking down these early conditions and steering young patients towards healthier outcomes.
“The rise in opiate deaths has been devastating for Americans in early and middle adulthood,” said sociologist Elizabeth Wrigley-Field, PhD, of the University of Minnesota in a press release. (Photo copyright: University of Minnesota.)
One-Two Punch
In 2019, excess mortality amounted to 41.7 deaths per 100,000 population, nearly 35% higher than expected, the researchers wrote. Then, in 2021 during the pandemic, excess mortality from all causes was nearly three times higher: 116.2 deaths per 100,000 population. In 2023, excess mortality decreased, but only to 79.1 deaths per 100,000 population.
“As a result, early adult mortality was 70.0% higher in 2023 than it would have been had pre-2011 trends continued,” the researchers wrote in Jama Network Open.
Speaking with Healio, Wrigley-Field described a “one-two punch that these age groups have seen: first, rising mortality since 2010; then the pandemic, only partially recovered from.”
Five causes accounted for nearly 75% of the excess deaths in 2023, the researchers found:
Drug poisoning, such as opiate overdoses (31.8%)
Residual natural causes (16%)
Transport-related deaths, such as motor vehicle accidents (14.1%)
Alcohol-related deaths (8.5%)
Homicide (8.2%)
The researchers also found that cardiometabolic conditions accounted for 9.2% of excess deaths. These include metabolic, circulatory and endocrine, and nutritional conditions, they noted.
Study co-author Andrew Stokes, PhD, of Boston University characterized the latter as a red flag, according to the Boston University press release. “Usually, it takes a lifetime to manifest cardiovascular disease and related mortality,” he said.
“Our findings underscore the urgent need for comprehensive policies to address the structural factors driving worsening health among recent generations of young adults,” he said in the U of M press release. “Solutions may include expanding access to nutritious foods, strengthening social services, and increasing regulation of industries that affect public health.”
Policy Measures
In their paper, the researchers suggested that policymakers should pay more attention to underlying causes such as opioid use, alcohol consumption, and traffic safety, as well as “ongoing consequences of the COVID-19 pandemic—which may be expressed in causes of death related to long-term consequences of infection, medical disruption, and social dislocation—and to deleterious health trends that predated it.”
“Individuals might not necessarily be able to reverse those factors, or their consequences, on their own, but public health collectively has been very successful at improving health through policies like tobacco regulation, to name one example,” Wrigley-Field told Healio.
She added that “the cardiometabolic causes of death stand out because these are really a bellwether of population health. These causes tend to be very responsive to the fundamentals of healthy living: healthy food, exercise, sleep, limited exposure to tobacco and air pollution, and limited experience of excessive stress.”
Young adults have also been dealing with the “expansion of industries that affect public health—processed foods and beverages, prescription drugs and OxyContin, alcohol, combined with this creeping effect of the obesity epidemic,” Stokes said.
He added: “These are the ages, 25 to 44, in which behaviors become entrenched and life course risks start to develop. And if we’re seeing this excess mortality in this generation now, it’s also an indication of what may happen to population health as a whole in decades ahead as this generation ages.”
This information can inform physicians and laboratorians about what diagnostic tests to consider for young people showing symptoms, even if their ages traditionally don’t indicate a chronic condition.
Hospitals in 38 states confirmed patient infections of the dangerous, drug-resistant fungus
Rapidly spreading Candida auris fungus is once again showing up in hospitals throughout the United States, with multiple cases confirmed in Georgia and Florida. Hospital laboratories and pathology departments are encouraged to take advantage of CDC resources to help in the diagnosis of this deadly pathogen.
Candida auris (C. auris) spreads between patients in hospital settings, is resistant to anti-fungal medications, and can cause severe illness, according to the Centers for Disease Control and Prevention (CDC). Tracking data from CDC’s National Notifiable Diseases Surveillance System found 4,514 new clinical cases of C. auris in the US in 2023.
“The number of clinical cases has continued to increase since the first US case was reported in 2016,” said the CDC of past outbreaks of C. auris. “Based on information from a limited number of patients, 30–60% of people with C. auris infections have died. However, many of these people had other serious illnesses that also increased their risk of death.” The fungus has been spreading at a high rate from 2016-2023 with several cases cropping up recently in Georgia.
According to representatives from the Georgia Department of Public Health, “the state has seen over 1,300 cases as of the end of February,” WJCL reported.
The Hill reports a significant recent increase in the spread of the fungus in all but 12 states. Though the number of cases in each state remains small, the overall percentage of increased cases is large and growing.
And a study conducted at Jackson Health System in Miami, Fla., and published in the American Journal of Infection Control, found that “The volumes of clinical cultures with C. auris have rapidly increased, accompanied by an expansion in the sources of infection.”
“If you get infected with this pathogen that’s resistant to any treatment, there’s no treatment we can give you to help combat it. You’re all on your own,” Melissa Nolan, PhD, associate professor of epidemiology and biostatistics at the Arnold School of Public Health, University of South Carolina, told Nexstar. (Photo copyright: University of South Carolina.)
CDC Recommendations
The deadly fungus was first detected in 2016 in US hospitals, and the number of cases in hospital patients has grown every year based on CDC data from 2023. Invasive medical procedures can provide a gateway for C. auris to infect patients, and the immunosuppressed nature of these patients can lead to further complications.
Invasive procedures that could expose a patient to C. auris include the placing of breathing and feeding tubes, and the insertion of vein or urinary catheters.
“We’ve had four people at one time on and off over the past few months, and in years past, it was unusual to have one or even two people with Candida auris in our hospital,” Timothy Connelly, MD, told WJCL about the spread of the fungus at Memorial Health in Savannah, Ga.
Cases have also rapidly increased in Miami according to the Jackson Health System study. The researchers found that, “The volumes of clinical cultures increased every year and infection sources expanded.”
The CDC considers C. auris “an urgent antimicrobial resistance threat” based on the severe risk an infected patient can face. “The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control,” said Meghan Lyman, MD, in a CDC news release.
Fungal Infection is Difficult to Treat and Diagnose
C. auris has been shown to be resistant to antifungal medications, making it an acute threat to ill patients. And since it tends to infect already sick patients, it can be difficult to detect because symptoms of infection can be generic, such as fever or chills.
The fungus is also adept at surviving on hospital surfaces.
“It’s really good at just being, generally speaking, in the environment,” Melissa Nolan, PhD, associate professor of epidemiology and biostatistics at the Arnold School of Public Health, University of South Carolina, told Nexstar. “So, if you have it on a patient’s bed for example, on the railing, and you go to wipe everything down, if in whatever way maybe a couple of pathogens didn’t get cleared, then they’re becoming resistant. And so over time, they can kind of grow and populate in that hospital environment.”
CDC Resources to Help Identify C. auris
C. auris also can be misidentified with other candida species fungi. The CDC recommends identification using a diagnostic device “based on matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF).” The CDC also recommends using supplemental MALDI-TOF databases and molecular methods to help distinguish C. auris from other candida.
Prompt clinical laboratory diagnosis is extremely important to stem outbreaks as they become more frequent in hospital settings. The CDC offers resources for hospital pathology departments to aid in screening and detection.
“I think we need to do a better job of predicting,” Nolan told Nexstar. “Moving forward [we need] more funding to support quality surveillance of these potential infectious strains so that we can know in advance, and we can do a better job of stopping disease spread before it becomes a problem.”
According to the CDC, the fungus typically spreads in hospital settings and is not known to affect healthy people.
