Tuesday, March 11, 2025

 

Meningococcal vaccine found to be safe and effective for infants in sub-Saharan Africa



Study led to new lifesaving vaccine recommendations for use of meningococcal pentavalent (five in one) vaccine for infants in Africa



University of Maryland School of Medicine






University of Maryland School of Medicine (UMSOM) researchers helped conduct an important new global health study that found a vaccine that protects against five strains of meningitis prevalent in sub-Saharan Africa is safe and effective for use in young children beginning at 9 months of age. This study provided evidence that formed the basis for the World Health Organization’s (WHO) decision last year to recommend the pentavalent Men5CV meningitis vaccine for infants ages 9 months and older.

Results of the study were published today in the journal Lancet.

In January 2024, the WHO recommended that all countries in the African meningitis belt introduce Men5CV into their routine immunization programs, providing a single-dose shot to infants and young children ages 9 to 18 months. Previous data supported use of this vaccine starting at age 1, but there was no data on whether the vaccine could be given as part of the routine vaccination schedule for infants or whether it should be given on a separate occasion, requiring an additional medical encounter. 

Receiving WHO approval could lead to a monumental shift in the burden of meningitis in susceptible parts of Africa. This critical clinical study provides reassuring evidence that this pentavalent vaccine can be safely and effectively given along with other routine immunizations, which makes it far easier to curtail invasive meningococcal disease and potentially save tens of thousands of lives,” said Wilbur Chen, MD, MS, the Frank M. Calia, MD Endowed Professor of Medicine at UMSOM’s Center for Vaccine Development and Global Health (CVD) and protocol chair for this study.

The African meningitis belt is a region of 26 countries in sub-Saharan Africa where the rate of incidence of meningitis is very high. It includes Mali, where this study was conducted, and extends from Senegal to Ethiopia. Death rates from meningitis can surpass 15 percent in this region due to lack of healthcare access to medical care. Long-term complications like brain damage or paralysis occur twice as frequently compared to more developed countries.  

Because of the rapid onset of invasive bacterial meningitis and difficulties in accessing care in the African meningitis belt, prevention by vaccination is the optimal way to reduce meningitis cases.

The primary cause of meningitis in the belt is Neisseria meningitidis. At present, the WHO has prequalified only one vaccine, Men5CV, that protects against the five most prevalent subtypes of N. meningitidis: serogroups A, C, W, X, and Y.

During six months of 2022, more than 1,300 children were enrolled in the study conducted in Mali and randomly assigned to receive a meningitis vaccine at either 9 months or 15 months of age. Infants randomized to the 9-month age group were then further randomized in a 2:1 ratio to receive a single dose of the investigational meningococcal vaccine Men5CV (brand name MenFive®, manufactured by Serum Institute of India Pvt. Ltd.) or a single dose of the comparator meningococcal vaccine (MenACWY-TT, Nimenrix), which protects against only 4 of the 5 serogroups. The results of the trial involving 9-month-old infants found Men5CV is proven to protect against meningococcal serogroups A, C, W, X, and Y.

“Demonstrating that this vaccine is safe and immunogenic in infants is a critical step in providing a broadly effective tool for preventing epidemics of severe illness and death in the swath of Africa known as the meningitis belt,” said Karen Kotloff, MD, Professor of Pediatrics at UMSOM who is also the Associate Director for Clinical Research and Principal Investigator of the Vaccine and Treatment Evaluation Unit (VTEU) at CVD. “Men5CV can be stored at room temperature for up to 12 weeks and is affordable for African countries.”

Researchers at the VTEU conducted the study in partnership with the Center for Vaccine Development-Mali (CVD-Mali). The VTEU at CVD is part of a national program known as the Infectious Diseases Clinical Research Consortium (IDCRC).  The IDCRC is funded by the National Institute of Allergy and Infectious Diseases to provide a ready resource for conducting clinical trials of vaccines and treatments for infectious diseases.

Milagritos Tapia, MD, Professor of Pediatrics at UMSOM, and Samba Sow, MD, MS, Director General of the CVD-Mali and Adjunct Professor of Medicine at the UMSOM were Co-Principal Investigators on the study.

The international global health organization PATH provided support for the study design and managed and funded the serology testing.

“The development of affordable, effective vaccines that are designed for use in Africa have been a game-changer for meningitis belt countries and are instrumental for global efforts to defeat meningitis by 2030,” said Bill Hausdorff, PhD, director of PATH’s meningitis vaccine development projects. “PATH is proud to have contributed to this essential study that helped lower the age limit for Men5CV and enable its inclusion in routine immunization programs—ensuring widespread protection from meningococcal disease is possible and epidemics become a thing of the past.”

PATH also previously supported development of the investigational vaccine through a 13-year collaboration with SIIPL, leading to its licensure and subsequent prequalification by WHO.

“This study underscores the importance of academic medicine partnerships with world class global health entities like PATH,” said Mark T. Gladwin, MD, who is the John Z. and Akiko K. Bowers Distinguished Professor and Dean of University of Maryland School of Medicine. “After widespread use of the MenAfrivac vaccine, meningococcal A disease has been virtually eliminated from the African meningitis belt, and now, with the Men5CV vaccine, we see the potential to end meningococcal disease epidemics caused by other predominant serogroups.” 

The IDCRC, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health, conducted this study. The research was supported by NIAID cooperative agreement UM1AI148689.

 AMERIKA

Socioeconomically disadvantaged people still underusing emergency department services in the wake of the COVID pandemic




University of California - Los Angeles Health Sciences





New research finds that socioeconomically disadvantaged groups may still be underusing emergency departments for potentially serious illnesses in the wake of the COVID pandemic, despite an overall rebound in emergency department use by 2022.

The UCLA-led study, published in the peer-reviewed journal Health Affairs, shows that most of the rebound was driven primarily by patients covered by commercial insurance or Medicare fee-for-service. When stratified by insurance type, the rebound was found to be significantly lower among patients covered by Medicaid or dual Medicare/Medicaid, who tend to be socioeconomically disadvantaged.

The findings surprised the researchers, who expected socioeconomically disadvantaged patients to utilize the ED more compared to patients with more resources. Instead, less well-resourced patients exhibited lower relative utilization for non-avoidable visits, which raises concern that these groups are forgoing potentially life-saving care. This represents a reversal in the pre-pandemic trend of Medicaid and dual-eligible patients exhibiting increasing emergency department utilization compared to other insured groups.

“Our findings highlight a mixed reality: while fewer potentially avoidable ED visits suggest more efficient healthcare use, the concerning trend is that Medicaid and dual-eligible patients—who are often socioeconomically disadvantaged—may be forgoing necessary high-acuity care,” said Dr. Richard Leuchter, assistant professor of medicine at the David Geffen School of Medicine at UCLA and the study’s lead author. “This disparity, exposed by the COVID-19 pandemic, underscores yet another vulnerability in the U.S. healthcare system.”

The researchers analyzed data for 15.6 million ED visits from public and private insurance companies using the Milliman MedInsight Emerging Experience Research Database from the 50 U.S. states and Washington D.C. They used what is called the difference-in-differences method, which accounts for changes in outcomes over time for different groups, to compare ED use between March 2020 and August 2022 with rates from the same months in 2018-19.

They found that potentially avoidable visits declined by 25% for all insured groups early in the pandemic compared to the pre-pandemic period.  Non-avoidable visits, which had declined by an overall 30%, rebounded to about 95 percent of expected rates by the end of the pandemic across all insured groups. But this rebound did not occur among Medicaid and dual-eligible patients, where utilization generally remained at 75% of expected rates by the end of the study period.

The researchers suspect that vulnerable groups may have been more likely to self-isolate early in the pandemic due to factors such as living in multi-generational households or fear of becoming infected with COVID, or later on prioritized work over seeking healthcare.

“To the best of our knowledge, this was the first nationwide study to report a persistent reversal in the pre-pandemic trend of increasing ED use by Medicaid and dual-eligible patients, which has important postpandemic policy implications,” the researchers write.

For instance, the findings should spur research into whether these trends persisted past the pandemic and examine how they may impact long-term health. In addition, the findings may have an effect on efforts to curb avoidable ED usage, such as having the unintended effect of reducing non-avoidable ED visits by Medicaid and dual-eligible patients.

There are limitations to the study. Among them, the analysis did not account for any changes in the patient mix in what was assumed to be a stable and homogenous patient cohort, nor did it account for individual patient characteristics, and it did not include uninsured patients or stratify ED visits by diagnosis.  In addition, Medicaid or dual-eligibility are imperfect substitutes for determining socioeconomic status.

Though the research suggests a welcome reduction of emergency department utilization for non-emergency treatment, “it also indicates the emergence of a disparity whereby socioeconomically disadvantaged groups may be underusing the ED for higher-acuity illness,” the researchers conclude.

Study co-authors are Sitaram Vangala, Chi-Hong Tseng, Julia Cave Arbanas, Cyrus Tabatabai-Yazdi, Dr. Catherine Sarkisian, Dr. John Mafi and Dr. Katherine Kahn of UCLA, Cheryl Damberg of RAND Corporation, and Melody Craff, Michael Hadfield and Dale Skinner of Milliman MedInsight.

This study received funding from NHLBI (Grant No. 1K38 HL164955-01) and NIA (Grants Nos. 5K24AG047899-05, P30AG021684-16, and 1K76AG064392-01A1).

 

Breast cancer death rates will rise in elderly EU patients but fall for all other ages



Experts predict death rates from all cancers for the EU and UK for 2025




European Society for Medical Oncology





Death rates from breast cancer will fall in 2025 in every age group in the EU and the UK apart from in EU patients aged 80 years and older. In these older patients, overall mortality rates from the disease are predicted to rise by nearly 10% in 2025.

However, in the UK, breast cancer death rates are expected to decrease by 7% in this age group, compared to rates observed between 2015-2019. In Spain, there is also a 4% decrease in patients aged 80 and over.

These findings are from a new study published in the leading cancer journal Annals of Oncology [1] today (Wednesday), which predicts death rates from cancer in the EU and UK for 2025.

Researchers led by Carlo La Vecchia (MD), Professor of Medical Statistics and Epidemiology at the University of Milan (Italy), suspect that the reason why death rates from breast cancer are increasing in older patients in the EU is because women aged 80 and older are not screened regularly for breast cancer and are less likely to receive the most up-to-date treatments.

Prof. La Vecchia said: “Elderly women are not covered by screening and probably are less favourably affected by the substantial advances in breast cancer management, including improvements in chemo- and hormone therapy, such as trastuzumab and related drugs, but also in radiotherapy and surgery.

“The increased prevalence of overweight and obesity over the last few decades in most of northern and central Europe has led to an increased risk of breast cancer. In the elderly, this has not been counter-balanced by improved diagnosis and management. This accounts for the increased mortality in people aged 80 and over.”

Younger women aged between 20 to 49 years are usually not screened regularly either, but the experts predict death rates will fall by about 7% in this age group in the EU and by almost 15% in the UK, compared to death rates seen between 2015-2019.

Prof. La Vecchia and colleagues predict that, compared to death rates in 2020, breast cancer rates overall will fall by 4% in the EU and by 6% in the UK in 2025. The age standardised mortality rate (ASMR) [2] in the EU will be 13.3 deaths per 100,000 of the female population (a total of 90,100 deaths) and 13.2 per 100,000 in the UK (a total of 11,400 deaths).

The rates vary by country and age group. In Germany, overall breast cancer death rates will fall by 14%, in the UK by 10%, in Poland by 9%, in France and Spain by 8%, and in Italy by 2%. Across all age groups, breast cancer death rates will fall by 7%-12% in the EU in different age groups, with the exception of women aged 80 and over where there will be an increase in the EU, apart from Spain.

“We estimate that between 1989 and 2025, 373,000 breast cancer deaths have been avoided in the EU and 197,000 in the UK. Most of these are due to improved management and therapy, but 25-30% are likely to be attributable to more widespread screening and early diagnosis,” said Prof. La Vecchia.

“Given that breast cancer is now a largely curable cancer that requires modern integrated approaches, it is essential that all diagnoses of breast cancer are referred to comprehensive cancer centres, which can offer the complete range of therapies that might be required.

“As indicated by the unfavourable trends in elderly women, control of overweight and obesity is a priority now, not only for cardiovascular diseases, but also for cancer, including breast cancer.”

All cancers:

The researchers analysed cancer death rates in the EU 27 Member States [3] as a whole and separately in the UK. They looked at the five most populous EU countries (France, Germany, Italy, Poland and Spain) and, individually, for stomach, intestines, pancreas, lung, breast, uterus (including cervix), ovary, prostate, bladder and leukaemias for men and women [4]. Prof. La Vecchia and his colleagues collected data on deaths from the World Health Organization and United Nations databases from 1970 to 2021 for most of the EU-27 and the UK. This is the fifteenth consecutive year the researchers have published these predictions, which have proved to be reliable over the years.

In the EU-27 countries, they predict there will be a 3.5% fall in the age standardised death rates for all cancers from 125 per 100,000 of the population in 2020 to 121 per 100,000 in 2025 for men, and a 1% fall from 80 to 79 per 100,000 among women. A total of approximately 1,280,000 people will die from the disease in the EU and 173,000 in the UK.

In the UK, the age standardised death rate for all cancers in men will fall by 10% from 112 to 101 per 100,000, and by 6% from 87.6 to 82 per 100,000 among women in 2025.

However, due to the increasing numbers of elderly people in the population, the actual number of deaths from cancer will rise from 671,963 in 2020 to 709,400 men in the EU in 2025, and from 537,866 to 570,500 women. In the UK, the number of deaths will rise from 91,239 to 92,200 men and from 80,378 to 81,100 women.

Death rates from most cancers are predicted to fall this year in the EU, with the exception of pancreatic cancer: up 2% in men and 3% in women. In women, lung cancer is also predicted to rise by nearly 4%, and bladder cancer will rise by nearly 2%.

In the UK, the only death rates predicted to rise are those for bowel cancer in women and in the uterus (both by less than 1%). Death rates from all other cancers are falling in both sexes.

Prof. Eva Negri from the University of Bologna (Italy), co-leader of the research, said: “Smoking remains by far the major recognised cause of pancreatic cancer, accounting for 20 to 35% of cases in various populations and age groups, according to their different smoking habits. Diabetes, being overweight and developing the metabolic syndrome account for around 5% of pancreatic cancers in Europe. This is becoming more and more important following the increasing prevalence of obesity, but control and avoidance of smoking remains the top priority for pancreatic cancer control.”

Over 37 years between 1988 and 2025, the researchers calculated the number of cancer deaths avoided, assuming that rates remained constant at the 1988 rates. They estimate that a total of 6.8 million deaths from all cancers have been avoided in the EU (4,700,000 in men and 2,100,000 in women), and a total of 1,500,000 in the UK (1 million in men and 500,000 in women).

Lung cancer will kill the greatest absolute number of men in both the EU and the UK (151,000 and 16,700 respectively), and among women in the UK (15,500). In the EU, breast cancer will kill the greatest number of EU women, but the predicted death rate from lung cancer is now slightly higher than breast cancer in these women and is increasing (up 3.8%), whereas it is falling for breast cancer (down 3.6%).

Prof. La Vecchia concluded: “Trends in cancer mortality continue to be favourable across Europe. However, there are a few negative indications. These include deaths from bowel cancer in people younger than 50, which have started to increase in the UK and several central and northern Europe countries, mainly due to increased prevalence of overweight and obesity in the young who are not covered by colorectal cancer screening.

“In addition, death rates from pancreatic cancer are not decreasing in the EU, and it is now the fourth cause of cancer death in Europe after lung, colorectal and breast cancer. Death rates from lung cancer are starting to level off but not yet to decrease in EU women. The trends in pancreatic and female lung cancer underline the urgency of implementing stricter tobacco control across Europe.”

(ends)

Notes:

[1] “European cancer mortality predictions for the year 2025 with focus on breast cancer”, by C. Santucci et al. Annals of Oncology, doi: 10.1016/j.annonc.2025.01.014

[2] Age-standardised rates per 100,000 of the population reflect the annual probability of dying adjusted to reflect the age distribution of a population.

[3] At the time of this analysis, the EU had 27 member states, with the UK leaving in 2020. Cyprus was excluded from the analysis because there were not enough long-term data available, which is needed to predict trends, especially in small countries. All other countries had data going back to at least 1970.

[4] The paper contains individual tables of cancer death rates for each of the six countries.

 

 

Researchers forecast shaking damage from crustal earthquake scenarios in Mexico City





Seismological Society of America





A recent swarm of small shallow earthquakes in Mexico City in 2019 and 2023 caused surprisingly strong ground shaking, prompting researchers to wonder how shaking from a moderate sized earthquake might impact buildings across the city.

In the Bulletin of the Seismological Society of America, Miguel Jaimes and Gerardo Suárez at Universidad Nacional Autónoma de México describe potential damage forecasts from ground shaking scenarios for moderate earthquakes in three regions of the Mexico City basin.

The three locations of the modeled earthquakes were based on recent seismic events: a 2023 earthquake in La Magdalena Contreras, the 2018 San Juan de Aragón earthquake, and the 1995 Milpa Alta and 1985 Juchitepec earthquakes.

Their model earthquakes, up to magnitude 5.5, produced ground shaking that led to different amounts of damaged buildings, with the extent of the damage depending on the region’s underlying geology, Jaimes and Suárez concluded.

For instance, their study found that ground shaking from a moderate earthquake in the Juan de Aragón lake zone would damage 15% of one- to two-story buildings, due to the area’s soft and supersaturated lakebed sediments.

By contrast, shaking from an earthquake in the La Magdalena transition zone between the lake zone and the city’s hill area would damage 13% of these buildings, while shaking from an earthquake in the Milpa Alta highlands to the southeast of the city would damage 5% of one- to two-story buildings.

“We were somewhat surprised that the geographic effect was very dependent on the type of geotechnical region the earthquake occurred,” said Suárez. “The potential damage is very different for earthquakes in the transition zone between the old lakebed and the highlands, than in the case of an earthquake in the lake region.”

Mexico City is no stranger to seismic events, feeling the effects of both shallow crustal earthquakes and deeper subduction earthquakes.

“The large ground accelerations shown by the recent small earthquakes in the city had not been recorded before because the instrumentation was very sparse. Improved seismic instruments, in both numbers and quality, installed in recent years have increased our capacity to record these local microearthquakes and their resulting accelerations,” said Suárez.

Peak ground accelerations from the microearthquakes were larger than those recorded during the devastating 19 September 1985 magnitude 8.1 and the 19 September 2017 magnitude 7.1 earthquakes.

“The recent microearthquakes recorded in Mexico City have awakened the interest of what effect an earthquake of moderate magnitude would have,” Suárez noted. “This is what we set out to investigate in the paper.”

Jaimes and Suárez estimated ground motion intensity measurements for the three earthquake scenarios, based on ground motion models from similar tectonic regions, along with data to capture the effects of local geology and a record of each region’s building stock.

While some taller buildings were also impacted, one- to two-story buildings received the most damage from local earthquake shaking from local earthquakes in the three scenarios.

“The reason is that the high frequency content of the seismic waves of local earthquakes coincides with the frequency of vibration of these structures,” Suárez explained. “It is similar to swinging a child on a swing following the period – or rhythm – of the swing.”

Suárez said “the lesson is clear” that urban planners, earthquake engineers and others “must consider that seismic risk of Mexico City stems not only from the large and frequent subduction earthquakes, but also from local crustal sources that, although rare, may cause substantial damage.”

 

How satisfied are you with your mattress? New research survey aims to find out



Mass General Brigham researchers developed and tested the Boston Mattress Satisfaction Questionnaire (BMSQ), a new tool to rigorously assess mattress satisfaction and characteristics.



Brigham and Women's Hospital




Sleep quality is a crucial aspect of health, yet while adults spend around a third of their lives sleeping, there is surprisingly little research on mattresses. Mass General Brigham researchers developed and tested the Boston Mattress Satisfaction Questionnaire (BMSQ), a new tool to rigorously assess mattress satisfaction and characteristics.

They administered the BMSQ to a representative sample of over 1,000 adults in the United States, finding that the tool is internally consistent and viable for assessing mattress satisfaction and may be helpful for customers, researchers and industry professionals. Results are published in Frontiers in Sleep.

“A mattress provides the foundation for a good night’s sleep, and sleeping on a comfortable surface is one of our key behavioral recommendations for improving sleep quality, but there is a dearth of research on mattresses in the scientific literature,” said lead author Rebecca Robbins, PhD, of the Division of Sleep and Circadian Disorders at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system.

The BMSQ was developed collaboratively by sleep scientists, clinicians, and mattress industry professionals to assess mattress satisfaction and characteristics. Satisfaction included comfort, firmness, temperature, and an overall rating on a scale of 1-10, with 10 being the most satisfied. Mattress characteristics explored included type, size, age, and experience of pain after waking. 

“We found that most people reported being somewhat satisfied with their current mattresses, with an average mattress satisfaction score of 6.9 out of 10,” said Robbins. “We also found the most common type of mattress was an all-spring mattress (34.9%), followed by an all-foam mattress (29.9%) and hybrid (springs combined with another component, such as a feather or foam topper, 28.4%), and mattresses comprised of air-filled chambers (5.0%).”

“Adults most commonly reported owning their mattress for 0-3 years (39.8%), but a substantial number of individuals reported owning their mattress for 10 or more years (17.0%). We found that compared to all-spring mattresses, sleeping on all-foam, hybrid or air-filled chamber mattress was associated with higher mattress satisfaction. Also, we found that the presence of a bed partner was associated with improved mattress satisfaction.” 

Authorship: In addition to Robbins, Mass General Brigham authors Matthew D. Weaver, Laura K. Barger, Stuart F. Quan, and Charles A. Czeisler.

Disclosures: Drs. Quan and Czeisler have served as consultants for the Bryte Foundation. Robbins reports personal fees from Savoir Beds Ltd.

Funding: This paper was supported by a gift from the Bryte Foundation.

Paper cited: Robbins, R, et al. “Developing a tool to assess mattress satisfaction: The Boston Mattress Satisfaction Questionnaire (BMSQ)” Frontiers in Sleep, DOI: 10.3389/frsle.2025.1509420

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