Healthcare & Laboratory News

FDA Adjusts Valneva’s Chikungunya Vaccine Label, Lifts Pause In Older Adults

Fierce Pharma (8/7, Liu) reports that the FDA “has removed a pause in the use of Valneva’s chikungunya vaccine,” Ixchiq, for older adults and updated the label with stricter language. The FDA and CDC “recommended suspending administration of the shot...individuals age 60 and older back in May after post-marketing reports of some serious adverse events, including at least two deaths, in recipients of the vaccine who were between the ages of 62 and 89.” The vaccine is now recommended for those at “high risk” of exposure, with new warnings about serious adverse events, stating “that Ixchiq is ‘not advisable’ for most U.S. residents traveling abroad because the risk of exposure to chikungunya is low.”

Inhibiting Cellular Stress Response May Normalize Processes, Function In Patients With Rare ALS Type, Study Finds

ALS News Today (8/7, Levinson) reports a study found that “inhibiting a cellular stress response can normalize processes and function” in motor neurons for patients with “ALS related to the P56S mutation in the VAPB gene, a rare genetic abnormality.” According to the article, disrupting the mitochondrial-associated membrane (ER MAM) “can contribute to cellular stress and activate a cell’s integrated stress response (ISR). This is what the team saw in the motor neurons – sensitivity to stress was higher and adaptation to it was impaired in mutated cells relative to healthy ones. The ISR can initially be helpful by enabling a cell to adapt to a diverse stimuli and changes in gene activity. Over time, however, it may lead to cell damage.” Although the findings are specific to VAPB-associated ALS, they “may have broader applicability in ALS and suggest the importance of considering genetic makeup in clinical trials.” The study was published in EMBO Molecular Medicine.

Embedding Infectious Disease Screening In Inpatient SUD Programs Increases Completion Rates For HAV, HBV, LTBI Screenings, Study Finds

HCP Live (8/7, Brooks) reports a new study is “shedding light on the potential benefits of embedding infectious disease (ID) screening within inpatient substance use disorder (SUD) programs, highlighting increases in testing uptake and low-barrier delivery of preventive and therapeutic treatment.” Researchers observed that “ID screening was completed for 60.2% and 90.8% of patients in the usual care and intervention groups, respectively, with the greatest increases in HAV, HBV, and LTBI. The prevalence of any identified treatment or prevention needs significantly increased from 28.7% to 79.3% in the intervention group. Investigators noted HAV and HBV vaccinations increased from 0% to 58% and 71%, respectively.” Further analysis also “revealed screening for STIs increased significantly for gonorrhea, chlamydia, syphilis, and trichomonas in the intervention period.” The study was published in Open Forum Infectious Diseases.

Severe Manifestations Of Enterovirus D68 Uncommon In Infants, Young Children With Symptomatic, Community-Acquired Infection, Study Finds

Infectious Disease Advisor (8/6, Basilio) reports a study found that “severe manifestations of enterovirus D68 (EV-D68) in infants and young children appear to occur in only a minority of those with symptomatic, community-acquired infection.” Researchers observed that “incidence of EV-D68 infection for epidemiologic year was 0.78 per 100 child-weeks, while incidence of EV-D68 infection for the 2018 season was 1.64 per 100 child-weeks.” They noted that “from July to November 2018, at least 1 swab from 204 children was submitted, with 630 (23%) positive for rhinovirus/enterovirus. Of those, 59 (9%) were positive for EV-D68 infection.” In addition, “more than half (52%) of EV-D68 infections had a preceding viral detection within the prior 30 days.” The study was published in the Journal of the Pediatric Infectious Disease Society.

Study Affirms Safety Of COVID-19 mRNA Vaccine Targeting Omicron JN.1

HealthDay (8/6, Gotkine) reports a study found that “vaccination with the updated COVID-19 mRNA vaccine containing the severe acute respiratory syndrome coronavirus-2 Omicron JN.1 lineage was not associated with an increased risk for 29 adverse events.” The researchers observed “that during the 28-day risk period after receipt of a JN.1-containing mRNA vaccine, there were no significant increases in the rate of hospital contacts for any of 29 adverse events compared with reference period rates. The incidence rate ratios were 0.84, 0.92, and 1.12 for ischemic cardiac events, intracranial bleeding, and myocarditis, respectively.” The study was published in JAMA Network Open.

BeLPT Struggles To Distinguish CBD From Sarcoidosis In Patients With Granulomatous Lung Disease, Study Finds

Pulmonology Advisor (8/6, Stong) reports a study found that “the beryllium lymphocyte proliferation test (BeLPT) is highly specific for identifying chronic beryllium disease (CBD) in patients with granulomatous lung disease, but has poor sensitivity, especially in distinguishing CBD from sarcoidosis.” Study results indicate that when “differentiating between patients with confirmed CBD and sarcoidosis, the sensitivity and specificity, respectively, of a single test were 61.5% and 90.8%. Using a high threshold approach, where borderline results were counted as negative, the sensitivity and specificity were 52.7% and 91.6%, respectively; using a low threshold approach, where borderline results were counted as positive, the sensitivity and specificity were 67.1% and 83.2%, respectively; for split samples (with 2 parallel assays), the sensitivity and specificity were 76.0% and 80.4%, respectively.” The study was published in Chest.

Health Experts Criticize Administration’s Decision To Cut Research Funding For mRNA Projects

The Washington Post (8/6, Johnson, Weber) reports that the Administration’s “decision to terminate hundreds of millions of dollars to develop mRNA vaccines and treatments imperils the country’s ability to fight future pandemics and is built on false or misleading claims about the technology, public health experts said.” HHS Secretary Robert F. Kennedy Jr. “has criticized mRNA vaccines, arguing that they are ineffective at fighting upper respiratory infections and keeping up with the mutations of a virus.” Researchers fear the Administration’s “criticism of the mRNA technology would have a chilling effect on one of the most promising fields in medicine.” The Post interviewed six scientific and medical experts who “said Kennedy and HHS offered misleading assessments of mRNA technology as they announced the termination of research.”