Healthcare & Laboratory News

Moderna Files For FDA Review Of Updated COVID-19 Vaccine

Reuters (5/23, Santhosh) reported Moderna said Friday that it had “filed a marketing application for the review of its updated COVID-19 vaccine” with the FDA. Branded as Spikevax, Moderna said the submission for the new vaccine “is based on guidance from the FDA, which advised that the shots should be updated to target strains that are a part of JN.1 lineage, with a preference for the LP.8.1 variant.” Government data indicate the LP.8.1 strain “accounts for about 70% of total cases in the U.S.” Moderna expects to “launch the updated vaccine by mid-August,” but COVID-19 vaccine manufacturers are “seeing greater regulatory scrutiny and facing tighter requirements for their shots that could increase their expenses.”

Remdesivir Shows Significant Survival Benefit Among Patients Hospitalized For SARS-CoV-2, Review Finds

Infectious Disease Advisor (5/23, Basilio) reported a systematic review and meta-analysis found that “clinical trial data and real-world evidence suggest remdesivir significantly improves survival and reduces rehospitalization risk among inpatients with SARS-CoV-2 across all disease severity levels.” Researchers analyzed a total of 122 unique studies “of randomized controlled trials (RCTs) and real-world studies published from January 2019 through December 2023 to summarize the effectiveness of remdesivir among inpatients with COVID-19.” The analysis “showed a significant overall survival benefit among inpatients with COVID-19 who received remdesivir, highlighting the need to ensure COVID-19 treatment recommendations remain aligned with evolving evidence.” The review was published in Clinical Infectious Diseases.

Vaccine, Therapeutic Clinical Trials For Prevention Of Highly Pathogenic Avian Influenza A/H5N1 Virus In Pediatric Populations Should Be Prioritized, Study Suggests

Infectious Disease Advisor (5/23, Basilio) reported a study found that “vaccine and therapeutic clinical trials for the prevention of highly pathogenic avian influenza A/H5N1 in pediatric populations should be prioritized as the virus evolves due to the high risk for severe infection in this group.” Although the risk for “avian influenza A/H5N1 virus infection is low in humans, infants and children typically show high rates of symptomatic influenza infection, particularly during pandemics.” Moreover, there is no FDA-approved “avian influenza vaccine for pediatric patients in the national vaccine stockpile.” Researchers concluded, “One of the greatest challenges in preventing HPAI [highly pathogenic avian influenza] A/H5N1 infection in the pediatric population will inevitably be in implementation.” Therefore, “it is critical that pediatric clinical trials of A/H5N1 vaccine candidates are adapted and prioritized.” The study was published in The Journal of the Pediatric Infectious Diseases Society.

CDC Confirms COVID-19 Variant NB.1.8.1 Has Been Detected In US

CBS News (5/26, Moniuszko, Brown Chau) reports the CDC has confirmed that “cases of the new COVID-19 variant NB.1.8.1, linked to a large surge in China, have been detected in multiple locations across the United States.” A CDC spokesperson said last week, “CDC is aware of reported cases of COVID-19 NB.1.8.1 in China and is in regular contact with international partners.” The spokesperson also “said that, so far, too few U.S. sequences have been reported of NB.1.8.1 to be included in the agency’s variant estimates dashboard.”

Hand Hygiene Intervention With Patient Participation Increases Healthcare Worker Compliance, Study Finds

Healio (5/23, Stulpin) reported a study presented at the SHEA Spring meeting found that “a hand hygiene intervention, which encouraged patients and visitors to the participating units to perform audits” of healthcare workers (HCWs), successfully improved compliance. In the pilot program, “a poster with program information and a QR code linked to the audit form was placed in each room and/or handed to patients and visitors. Patients were instructed to scan the QR code to access the audit form which included three questions regarding which location they were at, if the HCWs performed hand hygiene and if the patient/visitor would be comfortable asking staff to perform hand hygiene.” Patient observation audits indicated that “the HCW hand hygiene compliance rate averaged 92% in the inpatient units across 5 months.” In the outpatient units, “the average HCW hand hygiene compliance rate was also 92%.”

FDA Advisory Committee Split On Updates To COVID-19 Vaccines

The AP (5/22, Perrone, Neergaard) reports the FDA’s advisory panel was split Thursday “on whether drugmakers need to update their COVID-19 vaccines for next season.” The Vaccines and Related Biological Products Advisory Committee consists of outside experts who “have met annually since the launch of the first COVID-19 vaccines to discuss tweaking their recipes to stay ahead of the virus.” Some panelists “voiced support for a switch to a newer coronavirus subtype named LP.8.1,” the current dominant subtype. Other panelists “noted that subtype is such a close relative that last year’s shots seem to offer cross-protection, at least for now but with no guarantee there wouldn’t be a different version circulating by the time a vaccination campaign ramps up” later this year.

Exposure To Ambient Air Pollutants, Particularly Nitrogen Oxides, Associated With Metabolomic Changes In Postmenopausal Women That May Contribute To BMD Loss, Study Finds

Rheumatology Advisor (5/22, Khaja) reports a study found that “long-term exposure to ambient air pollutants, particularly nitrogen oxides, may alter circulating metabolite levels and contribute to bone mineral density (BMD) loss among postmenopausal women.” Researchers observed that exposure to nitrogen oxide (NO) and nitrogen dioxide (NO₂), but not particulate matter 10 μm or less (PM₁₀), “was significantly associated with changes in multiple metabolites, including C38:4 phosphatidylethanolamine (PE), taurine, inosine, and cytidine monophosphate.” In addition, “exposure to NO at the 3-year average timepoint was negatively associated with C38:4 PE levels, which in turn showed a positive association with lumbar spine BMD. Results of mediation analyses suggested that C38:4 PE may account for approximately 31% of the relationship between NO exposure and lumbar spine BMD loss.” The study was published in the Journal of Bone and Mineral Research.

Vitamin D Supplements May Slow Shrinking Of DNA Telomeres, Study Suggests

The Washington Post (5/22, Chesler) reports a study suggests that “people who have a higher vitamin D intake may be slowing down a biological process linked to aging.” In the study, researchers observed “telomeres – the protective caps of DNA code at the ends of chromosomes – which tend to shorten as we age.” However, they found that vitamin D supplements “may slow that shrinking process.” They believe “vitamin D supplementation’s benefit is related to tamping down inflammation.” With that said, researchers “emphasized that it is not a cure-all” because “there are many chronic diseases that do not seem to be reduced by vitamin D supplementation.” The study was published in the American Journal of Clinical Nutrition.

Older Patients With Cognitive Symptoms More Severe Than Their Biological Alzheimer’s Stage Often Have Additional Pathologies, Study Finds

MedPage Today (5/22, George) reports a study found that “older adults whose cognitive symptoms were more severe than their biological Alzheimer’s disease stage often had additional pathologies.” Researchers observed that patients “with more advanced clinical impairment compared with their biomarker-based Alzheimer’s stage often were positive for alpha-synuclein pathology or had higher neurofilament light (NfL) levels, a TAR DNA-binding protein 43 (TDP-43) imaging signature, or more cerebral small vessel disease than a reference group.” They said the findings are in line with neuropathology studies “showing that the presence of multiple pathologies is the norm rather than the exception with advanced age and neurodegenerative disease.” The study was published in JAMA Neurology.