Practice Academy Empower Your Success

 brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The 

provides a concise summary of one of the website's leading stories you may not have seen.

Last week, we reported on findings from a study published in 

that examined the association between sodium glucose cotransporter-2 inhibitor (SGLT2i) use and improved functional capacity and quality of life (QOL) among patients with heart failure (HF). 

Researchers conducted a systematic review and meta-analysis of the Medline, EMBASE, and Cochrane databases. They searched for relevant randomized clinical trials (RCTs) published until July 31, 2023, that focused only on nonpregnant patients aged 18 years and older with HF.

QOL was assessed using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12), which evaluates various aspects of QOL in patients with HF, including physical limitations, symptom frequency, QOL perception, and social limitations.

, 6MWD, KCCQ-12-total symptom score (TSS), KCCQ-12 clinical summary score (KCCQ-CSS), KCCQ-12 overall summary score (KCCQ-OSS), and the proportion of participants with small (≥5 points), moderate (≥10 points), or large (≥15 points) improvement in KCCQ-12 scores at the end of the study.

The analysis included 17 RCTs with 23 523 patients (mean age, 69 years), of whom 36% were women and 46% had type 2 diabetes. Results showed that SGLT2i therapy was associated with significantly higher performance on all 5 functional capacity and QOL end points evaluated, regardless of sex, diabetes status, or ejection fraction. 

"These findings suggest that SGLT2i therapies should be considered for improving functional capacity and QOL in addition to reducing the risk of hospitalization and mortality among patients with HF."

Articles

Your daily dose of the clinical news you may have missed.

SGLT2i Use and Improved QoL, Functional Capacity in Adults With HF: Daily Dose

In 2 new analyses of data from the pivotal phase 3 SELECT cardiovascular outcomes trial, the glucagon-like peptide-1 (GLP-1) mimetic semaglutide, demonstrated sustained clinically significant long term weight loss and improvements in anthropometric measures as well as cardiovascular benefits regardless of initial baseline body mass index (BMI) or the amount of weight lost in adults with overweight or obesity, preexisting cardiovascular disease, and without diabetes.

The findings from both analyses were presented at the European Congress on Obesity, May 12-15, in Venice, Italy.

The SELECT trial (October 2018 through June 2023) included 17 604 participants aged 45 years or older with preexisting CV disease and a BMI of 27 or more but with no history of type 2 diabetes.

 The geographically and ethnically/racially diverse population was drawn from 41 countries. SELECT participants were not enrolled in the study for the purpose of weight loss.

The cohort was randomly assigned to receive either subcutaneous semaglutide 2.4 mg or placebo. Mean follow up was approximately 40 months and the primary endpoint was a composite of major adverse CV events. Semaglutide was associated with a 20% relative reduction in risk of major adverse CV events (HR, 0.80; 95% CI, 0.72 to 0.90; 

 <. 001). Participants lost an average of 9.4% of bodyweight from baseline.

In the first prespecified analysis, simultaneously published in 

lead author Donna Ryan, MD, associate executive director for clinical research with the Pennington Biomedical Research Centre, New Orleans, Louisiana, and colleagues examined the effects of semaglutide on weight and on body mass index (BMI), waist circumference (WC), and waist-to-height ratio (WHtR) as surrogate markers for amount and location of body fat and evaluated semaglutide safety and tolerability, all by baseline BMI.

The weight loss trajectory for participants in the semaglutide group over 4 years showed decline continued to week 65 and was sustained through week 208 at which point the semaglutide group had lost 10.2% of baseline bodyweight vs 1.5% in the placebo group.

The average reduction of WC at week 208 among semaglutide-treated participants was 7.7 cm and 1.3 cm in the placebo group.

By week 104, 41.2% of the semaglutide cohort reached WC below sex- and race-specific WC cutoff points vs 18% of the placebo group. Ryan and colleagues reported too that average WHtR was reduced by 6.9% in those receiving semaglutide vs 1% receiving placebo.

Further, after 104 weeks, BMI category was improved for more than half (52.4%) of the semaglutide group compared to 15.7% of those receiving placebo. Moreover, the proportion of participants with obesity (BMI ≥30 kg/m

) at baseline fell from 71.0% to 43.3% in the semaglutide group versus 71.9% to 67.9% in the placebo group.

Adverse event rates were lower across all BMI categories vs placebo.

“This degree of weight loss in such a large and diverse population suggests that it may be possible to impact the public health burden of multiple obesity-related illnesses,” Ryan said.

The second prespecified analysis, led by Prof John Deanfield, director of the National Institute for Cardiovascular Outcomes Research, studied the relationship between time to first serious CV event and baseline weight,   weight lost, WC, and WHtR after early treatment. At 20 weeks, when participants had reached full dose semaglutide, Deanfield and team reported comparable rates of serious CV events among semaglutide participants with weight loss of 5% or more, 5% or less, or even weight gain (HR, 0.67; 95% CI, 0.52-0.87 vs HR, 0.85; 95% CI, 0.72-1.00). Rates were also comparable, across baseline anthropometric subgroups, according to the study.

"In this CV outcomes trial of semaglutide in patients with overweight or obesity but without diabetes, a reduction in MACE [major adverse cardiovascular events] was achieved regardless of the level of baseline adiposity. The magnitude of this treatment effect with semaglutide was also independent of the extent of achieved weight loss," Deanfield et al wrote. "This suggests alternative mechanisms of improved cardiovascular outcome beyond reduction in adiposity, which may benefit many patients on top of current guideline-directed care," the researchers concluded.

1. Ryan, DH, Lingvay I, Deanfield  J, et al. Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial. 

(2024). DOI - 10.1038/s41591-024-02996-7,  

https://www.nature.com/articles/s41591-024-02996-7

2. Deanfield J, Lingvay I, Kahn SK. Relevance of body weight and weight change on cardiovascular benefit with semaglutide: a prespecified analysis of the SELECT trial. Abstract presented at: European Congress on Obesity; May 12-15, 2024; Venice, Italy. GC4.351. Accessed May 14, 2024. https://karger.com/ofa/article-pdf/17/Suppl.%201/7/4225727/000538577.pdf

3. Lincoff AM, Brwon-Frandsen K, Colhoun HM, et al for the SELECT Trial Investigators. Semaglutide and cardiovascular outcomes in obesity without diabetes.

 2023;389(24):2221-2232. doi:10.1056/NEJMoa230756

Analyses of the SELECT trial found mean weight loss of 10.2% sustained for 4 years and comparable CV benefit with weight loss greater or less than 5%, or even weight gain. 


Semaglutide Supports Long-Term Weight Loss, Reduces CV Risk Across BMI Subgroups

Patient Care Online Digital Edition May 2024

. The digital edition is available monthly and offer a selection of the website's top ranked news and features, as measured by 

This month's issue focuses on cardiovascular disease and technology, including findings from a study on the efficacy and safety of a novel web app for over-the-counter statin medication, details on the first FDA-cleared AI-based algorithm to detect heart failure during routine examinations, and details on a remotely delivered-lipid lowering program found to help patients reach target LDL-C levels. 

Find details on a novel web tool found to help patients determine their eligibility for OTC statin use, FDA clearance of the first AI-based algorithm to detect HF during routine exams, and more.

May Issue of Patient Care Online Digital Edition is Now Live

 (CRC) significantly rose over a 22-year period in US adults aged less than 45 years, with the “most striking” increase of 333% observed in those aged 15 to 19 years, according to new data.

Findings will be presented during Digestive Disease Week 2024, being held May 18-21, 2024, in Washington, DC.

“This data reveals some very concerning trends, particularly in our younger population who do not typically come to mind when considering CRC screening for patients,” presenting author Islam Mohamed, internal medicine resident at the University of Missouri-Kansas City, said in a DDW press release.

Although CRC has historically been more prevalent among older adults, recent trends showing rising incidence among younger individuals, particularly those aged less than 45 years, have 

 including the American Cancer Society and the US Preventive Services Task Force to lower the recommended age to initiate CRC screening from 50 to 45 years.

To examine the incidence of CRC in younger adults, Mohamed and colleagues used data from the US Centers for Disease Control and Prevention WONDER database from 1999 to 2020. Individuals were grouped into 5 age groups: 10 to 14 years, 15 to 19 years, 20 to 24 years, 25 to 29 years, 30 to 34 years, and 40 to 44 years. Mohammed and colleagues reported incidence rates per 100 000 population and calculated percentage increase by comparing 1999 rates with 2020 rates, according to the study.

Investigators observed “notable shifts” in the incidence of CRC across all age groups during the study period. They found CRC incidence rose by

Although participants aged 40 to 44 years had the lowest percentage increase of 45% compared to the other age groups, they experienced the highest incidence rate, peaking at 21.2 per 100 000 individuals in 2020. The next highest incidence rate in 2020 was 11.7/100 000 individuals among those aged 35 to 39 years, followed by 6.5/100 000 among those aged 30 to 34 years, 3.2/100 000 among those aged 25 to 29 years, 2/100 000 among those aged 20 to 24 years, 1.3/100 000 among those aged 15 to 19 years, and 0.6/100 000 among those aged 10 to 14 years.

The results underscore a need for further investigation into the factors driving these concerning trends, emphasizing the importance of early screening and preventive measures, especially among younger age groups,” Mohamed et al concluded.

Mohamed will present the study abstract “Evolving trends in colorectal cancer incidence among young patients under 45: a 22-year analysis of the Centers for Disease Control and Prevention Wonder Database” on Monday, May 20, at 12:30 pm ET, during the session titled “Epidemiology of Gastrointestinal Disorders.”

Mohamed I, Abosheaishaa H, Salem A, et al. Evolving trends in colorectal cancer incidence among young patients under 45: a 22-year analysis of the Centers for Disease Control and Prevention WONDER database. Presented at: Digestive Disease Week; May 18-21, 2024; Washington DC.

Alarming increases in CRC incidence among younger adults. News release. American Gastroenterological Association. May 10, 2024. Accessed May 14, 2024. 

https://news.ddw.org/news/alarming-increases-in-crc-incidence-among-younger-adults/

DDW 24. Among patients aged 15 to 19 years, the incidence of CRC rose 333% over a 22-year period, researchers reported.

Colorectal Cancer Rates Significantly Rising among Younger Adults and Teens, According to New Research

The FDA has granted Breakthrough Device Designation for Teal Health’s Teal Wand, a novel at-home self-collect cervical cancer screening device. Breakthrough was awarded following review of Teal Health’s positive midpoint clinical trial data. This will also grant priority status once Teal Health submits their final study data for FDA review.

According to Teal Health, the Teal Wand is a proprietary device designed to enable people to easily, comfortably, and confidently collect their own vaginal sample for cervical cancer screening from their home or health clinic, without the need for an invasive exam.

"I am so grateful to the amazing team at Teal, our hardworking PIs and sites, the supportive participants in our study, and the FDA for recognizing the importance of Teal's solution to help close the women's cervical cancer screening gap in the US. The speed of our study shows that if you design for and engage with women to advance women's health, you'll be met with resounding enthusiasm from this group that has been overlooked and under researched for far too long. This study and Breakthrough designation is an important moment for women's health," Kara Egan, CEO and co-founder of Teal Health said in a press release.

The Teal wand was initially tested in a 215-person study. It received positive feedback, with 97% of women saying it was easy or very easy to use, 94% saying they would choose self-collect over the current standard of care with a clinician collecting, and 87% saying they would be more likely to get screened if the Teal Wand were an option.

Teal Health followed this initial study with a nationwide clinical trial titled SELF-CERV (

 It is in progress at a number of leading health organizations including Johns Hopkins, Yale University, University of Colorado, University of Wisconsin, and Washington University. With over 600 participants representing different races/ethnicities, socioeconomic status, and sexual and gender orientation, the study was designed to validate the performance of the Teal Wand and compare results against a clinician collected sample with a speculum and brush.

"The Teal Wand and self-collection really resonated with our patients and they were excited to be a part of the SELF-CERV trial. We saw upwards of an 80% enrollment rate, which more than met our expectations. I am honored to have been part of the efforts to advance cervical cancer screening and create more options for patients to get the care they need," Lead SELF-CERV enroller, Clair Kaplan, MSN/APRN, MHS, MT(ASCP), director of clinical research and principal investigator at Planned Parenthood of Southern New England said in the press release.

The study is months ahead of schedule after it received an overwhelming response from women and people with a cervix.

"FDA's recognition of the Teal Wand as a Breakthrough device acknowledges the important public health benefit that self-collection for cervical cancer screening can have on those who are rarely screened or who do not participate in clinician-based screening for cervical cancer. The clinical performance of the Teal Wand shows promise that an at-home self-collection device is possible in the near term and Teal looks forward to working closely with FDA to expedite this option to eligible women and people with a cervix," Trena Depel, vice president of clinical and regulatory at Teal Health concluded.

1. Teal Health completes clinical trial at record speed and receives FDA  Breakthrough Designation for its at-home cervical cancer screening device, the Teal Wand. News release. Teal Health. May 8, 2024. Accessed May 8, 2024. 

https://www.prnewswire.com/news-releases/teal-health-completes-clinical-trial-at-record-speed-and-receives-fda-breakthrough-designation-for-its-at-home-cervical-cancer-screening-device-the-teal-wand-302138565.html

 
2. Teal Health partners with leading health organizations in a nationwide clinical trial for their self-collect device for cervical cancer screening, the Teal Wand. Press release. Teal Health. January 9, 2024. Accessed May 8, 2024. 

https://www.prnewswire.com/news-releases/teal-health-partners-with-leading-health-organizations-in-a-nationwide-clinical-trial-for-their-self-collect-device-for-cervical-cancer-screening-the-teal-wand-302029073.html

Teal Health Granted Breakthrough Device Designation for Self-Collect Cervical Cancer Screening Device

we reported on the US Food and Drug Administration (FDA) approval of ColoSense, a noninvasive multitarget stool RNA (mt-sRNA) colorectal cancer (CRC) screening test for use in adults aged 45 years or older considered at average risk for developing CRC.

ColoSense is the first noninvasive CRC screening test to give a dynamic view of disease activity via RNA biomarkers. 

The approval is based on data from the pivotal CRC-PREVENT trial, a phase 3, blinded, prospective, cross-sectional study of 8920 individuals identified using social media platforms and enrolled between June 2021 and June 2022. Participants were aged 45 years and older and represented diverse racial, ethnic, and socioeconomic backgrounds. Unlike traditional centralized clinical trials where participants are usually already engaged in a health care screening program, ColoSense investigators used a novel decentralized enrollment strategy that resulted in a cohort in which 64% had never been screened for CRC and more than two-thirds (68%) of whom did not have a colonoscopy screening scheduled at the time of study enrollment.

The study found that ColoSense sensitivity for detecting CRC was 94% and for detecting advanced adenomas, when the disease is most preventable, was 46%. The test’s specificity for no lesions on colonoscopy was 88%. Importantly the test maintained high performance in adults aged 45 to 49 years (sensitivity for CRC, 100% and for advanced adenoma 45%), a population for whom screening is now recommended.

FDA Approves Novel Noninvasive Multitarget Stool RNA CRC Screening Test: Daily Dose

Approximately half of sexually transmitted infections (STIs) are reported among patients aged 15 to 24 years, making it vital to understand their impact on this population.

 In this article, we discuss outcomes in young patients, general STI trends, and human papillomavirus (HPV) vaccination coverage.

Recently, Jill S. Blumenthal, MD, associate professor of medicine at UC San Diego Health, outlined STI trends among adolescents and young adults. These patients are undergoing hormonal changes that increase the risk of STIs. Many of these patients also have a lack of STI knowledge compared with adults.

Overall, STI prevalence has increased in the US.

 Cheruba Prabakar, MD, FACOG, of Alta Bates Summit Medical Center, noted that an STI has been reported in approximately 1 in 5 US patients, with gonorrhea, chlamydia, and trichomoniasis commonly reported.

While a prevalent cause behind the rise in STI cases has not been identified, Prabakar theorized increased education among the public and providers, alongside improved testing mechanisms, has led to fewer cases going unnoticed. However, young adults may not know how to discuss STIs with their provider, creating an additional barrier to STI testing.

Guidelines have been implemented to improve rates of STI testing.

 These include strict reporting requirements for diseases such as gonorrhea, chlamydia, and HIV, as well as recommendations that all patients aged under 25 years receive gonorrhea and chlamydia testing.

Even with these guidelines, providers may not always consider obtaining information about STIs among their pediatric patients compared to adults.

 Their patients may be unsure if their insurance will cover STI care without parental consent and may want to avoid disclosing their STI status to their parents.

Adolescents and young adults aged 15 to 24 years face a high risk of contracting sexually transmitted infections (STIs), with hormonal changes and lack of knowledge contributing to this vulnerability.

The prevalence of STIs, including gonorrhea, chlamydia, and trichomoniasis, has risen in the US, affecting approximately 1 in 5 patients. Improved education and testing mechanisms may contribute to identifying more cases, although barriers such as discomfort discussing STIs with healthcare providers hinder testing, especially among young adults.

Strict reporting requirements and testing recommendations aim to improve STI detection rates, particularly among young patients. However, factors such as insurance coverage and concerns about confidentiality may deter individuals from seeking testing, highlighting the need for increased accessibility and awareness.

Trichomoniasis, a prevalent nonviral STI, lacks adequate testing methods and reporting requirements, leading to underdiagnosis. Symptoms such as vaginal discharge may go unnoticed, emphasizing the importance of increased awareness and testing to prevent discomfort and potential complications.

Human papillomavirus (HPV) vaccination is crucial in preventing various outcomes, including cancers and genital warts. While vaccination rates have improved, disparities exist based on factors such as gender, socioeconomic status, and geographic location. Efforts to enhance education and access to vaccinations can help protect adolescents and young adults from HPV-related diseases.

These issues, alongside transportation barriers, may prevent young patients from receiving STI testing. Additionally, young adults may be experimenting with multiple or new sexual partners and may not always discuss STIs, further increasing their risk.

Another common STI, trichomoniasis, currently does not have adequate testing.

 There are no reporting requirements, leading many patients and providers to be unaware about the condition, especially since STIs are often asymptomatic. Increased awareness about testing and symptoms such as vaginal discharge is necessary to increase testing rates.

Trichomoniasis is a parasitic infection and the most common nonviral STI in the US. The condition can lead to significant discomfort because of symptoms such as irritation, discharge, painful sex, and cervical bleeding.

These symptoms, alongside increased odds of infection with other STIs, indicate a need for adequate treatment. According to Prabakar, it is not difficult to detect and treat trichomoniasis when testing for the condition.

Of STIs, HPV is the most common, making vaccination vital to prevent infections and related outcomes such as precancerous lesions, genital warts, and cervical, vulvar, anal, vaginal, penile, and oropharyngeal cancers.

 HPV vaccination is recommended in patients aged 11 to 12 years, and may be started as early as age 9 years.

Recently the Centers for Disease Control and Prevention (CDC) provided a report about HPV vaccination rates among patients aged 9 to 17 years. Data was collected from the 2022 National Health Interview Survey.

According to the data, 38.6% of children aged 9 to 17 years had received at least 1 HPV vaccination dose in 2022. An increase in the rate of vaccination was observed based on age, at 7.3% in those aged 9 to 10 years, 30.9% in those aged 11 to 12 years, 48.8% in those aged 13 to 14 years, and 56.9% in those aged 15 to 17 years.

An increased rate was observed among female pediatric patients compared to male patients, at 42.9% and 34.6%, respectively. The odds were also increased in non-Hispanic White children compared to Hispanic children, at 39.9% and 34.4%, respectively.

Health insurance coverage was linked to increased rates of HPV vaccination. The rate of HPV vaccination was 41.5% among children with private health insurance vs 37% for children with Medicaid coverage, 30.2% for children with other government coverage, and 20.7% for children without insurance.

When evaluating vaccination based on parental education, a rate of 31.1% was reported for children of parents with high school level or less education, vs 42.1% for children of parents with bachelor’s degree or higher education. For family income, a rate of 29.9% was reported for an income under 100% of the federal poverty level vs 45.7% for an income of 400% or more of the federal poverty level.

Urbanization level also impacted HPV vaccination, with a rate of 39.4% among children living in large central metropolitan areas vs 41.1% for large fringe metropolitan areas, 39.4% for small and medium metropolitan areas, and 30% for nonmetropolitan areas.

The CDC recommends pediatric patients receive a 2-dose vaccine regimen against HPV, administered within 6 to 12 months when aged 11 to 12 years. However, further steps must also be taken to protect adolescents and young adults from STIs.

Blumenthal discussed how stigma is an additional risk factor for STIs among pediatric patients.

 Patients’ emotional, mental, and physical health may all be impacted by the stigma surrounding the STI, making it seem like a significant issue when they are infected even when the disease is easily treatable.

According to Blumenthal, many young patients are concerned about herpes. However, the disease is very common, and while it is not curable, it can be managed, and transmission can be reduced.

Additionally, improved education may improve STI awareness, with Prabakar wishing to see a broader campaign for STI education among young patients and providers.

 While HIV and HPV have received significant attention in the past, gonorrhea, chlamydia, and trichomoniasis need further education.

Education can be provided in school, college, and the office. Patients should be taught about the long-term consequences of STIs, as this will increase general awareness and the ease of testing.

One of the most important aspects of STI care is for young patients to feel comfortable talking about STIs with their doctor as another part of their health and well-being, as discussed by Blumenthal.

 This will allow doctors to discuss potential sexual activity with their patients and provide appropriate testing as part of routine health care.

Blumenthal also noted that there are many vaccinations for STI preventions, and being able to discuss these vaccinations and their effects can help young patients. For example, alongside HPV prevention, the HPV vaccine can protect patients from certain cancers and warts, which can more easily be discussed with younger patients than STIs.

“Doctors and other providers have a responsibility to make sure that they’re discussing sex with their patients,” Blumenthal said. “Being what we call ‘sex positive’ can really help patients feel comfortable…talking about sex.”

This article originally appeared on our partner site 

Krewson C. Understanding the impact of STIs on young adults. 

https://www.contemporaryobgyn.net/view/understanding-the-impact-of-stis-on-young-adults

Krewson C. Trends in STI prevalence and testing guidelines. 

April 11, 2024. Accessed May 3, 2024. https://www.contemporaryobgyn.net/view/trends-in-sti-prevalence-and-testing-guidelines

Human papillomavirus vaccination coverage in children ages 9–17 years: United States, 2022. Centers for Disease Control and Prevention. February 2024. Accessed May 3, 2024. 

https://www.cdc.gov/nchs/products/databriefs/db495.htm

Details on educational gaps, vaccination rates, and the importance of an open dialogue between patients and clinicians, here.

STIs in Adolescents and Young Adults: Trends, Management, More

The US Food and Drug Administration (FDA) will not complete its review of the Biologics License Application (BLA) for Moderna’s investigational mRNA-1345 vaccine by the previously communicated Prescription Drug User Fee Act date of May 12, 2024, according to a 

 officials, the FDA cited administrative constraints for the reason behind the delay of the review for Moderna’s investigational respiratory syncytial virus (RSV) 

. The agency did indicate that it expects to conclude the review of the BLA by the end of May 2024. The FDA also did not inform the manufacturer of any issues related to vaccine safety, efficacy, or quality that would prevent the approval of mRNA-1345.

Moderna noted in the press statement that they still anticipate that the US CDC Advisory Committee on Immunization Practices (ACIP) will include mRNA-1345 on the agenda of its June 26-28 meeting. "Moderna is very grateful to the FDA for their continued efforts and diligence," Stephen Hoge, MD, President of Moderna, said in the release. "We look forward to helping the agency complete the review of our application, and to the June ACIP meeting."

For the approval, the FDA will be reviewing findings from ConquerRSV, a randomized, double-blind, placebo-controlled trial that included 35 541 adults aged 60 years and older conducted across 22 countries. The dual primary efficacy endpoints were based on 2 definitions of RSV lower respiratory tract disease (RSV-LRTD)—RSV-LRTD with 2 or more symptoms and RSV-LRTD with 3 or more symptoms of disease. Participants were randomly assigned to receive a single dose of the investigational vaccine or placebo.

Based on analyses conducted when at least half of the anticipated cases of RSV-LRTD had occurred, vaccine efficacy was 83.7% against the disease with at least 2 signs or symptoms and 82.4% effective against RSV-LRTD with at least 3 signs or symptoms.2 Conquer-RSV investigators reported vaccine efficacy against RSV-associated acute respiratory disease of 68.4%.2 The phase 3 trial, published in the 

 in December 2023, also found equal protection against RSV subtypes A and B.

Local and systemic adverse reactions were more common among participants in the active vaccine group compared to the placebo group, although most were transient and mild to moderate in severity. In both groups, 2.8% of participants experienced severe adverse events.

Moderna announces update on investigational RSV vaccine. News release. Moderna. May 10, 2024. Accessed on May 10, 2024. 

https://investors.modernatx.com/news/news-details/2024/Moderna-Announces-Update-on-Investigational-RSV-Vaccine/default.aspx

Wilson E, Goswami J, Gaqui AG, et al, for the ConquerRSV Study. Efficacy and safety of an mRNA-based RSV PreF Vaccine in older adults. 

. 2023;389:2233-2244. doi:10.1056/NEJMoa2307079

While Moderna expects mRNA-1345 to be approved later this month, the company  cites FDA administrative constraints as reason for delay.

Moderna Will Have to Wait for FDA Approval of Investigational RSV Vaccine

Key Messages and Strategies: Managing and Following Up Patients Receiving Teplizumab

Videos

Optimizing the Teplizumab Infusion Process: The Vital Role of Key Contacts and Champions