FDA limits use of Johnson & Johnson COVID vaccine

The U.S. Food and Drug Administration (FDA) has limited the authorized use of Johnson & Johnson’s Janssen COVID-19 vaccine to certain individuals due to risk of thrombotic events. The vaccine may still be used in people over the age of 18 who have experienced a reaction after an mRNA COVID vaccine, people who have concerns over mRNA vaccine use and would otherwise not receive a vaccine, and people with limited access to mRNA vaccines.

The Janssen vaccine was authorized for emergency use on February 27, 2021, but vaccine administration was paused in April of that year to investigate six reported cases of thrombosis with thrombocytopenia syndrome (TSS). The pause was lifted 10 days later following a safety evaluation. There have been a total of 15 cases of TSS reported following administration of the Janssen COVID vaccine, including those original six. After reviewing reported cases, the FDA determined that the risk of thrombosis following the vaccine warranted limiting the authorized use. However, the administration notes that the known benefits of the vaccine for prevention of COVID infection still outweigh the risks for people over the age of 18 for whom other vaccines are inaccessible or clinically inappropriate.

Study suggests psychological risk factors increase hospitalization risk after COVID diagnosis

A National Institutes of Health (NIH)-funded study suggests that people who reported that they felt worried, depressed, or lonely had a greater chance of hospitalization after a COVID-19 diagnosis than those who did not report similar feelings. The study, recently published in Psychological Medicine (Psychol Med May 2022), surveyed more than 3,600 people who tested positive for COVID between April 2020 and April 2021. Those who reported chronic depression before the pandemic were 72% more likely to be hospitalized after their COVID diagnosis; those who reported being very worried about COVID were 79% more likely to be hospitalized; and those who reported persistent feelings of loneliness were 81% more likely to be hospitalized.

The study authors note that their findings suggest psychological risk factors may increase risk of hospitalization after COVID diagnosis as much as physical risk factors and called for additional research to determine if treatment to reduce psychological distress, in addition to standard treatment, might reduce the severity of COVID-19.

Early Alzheimer’s test granted FDA approval

The FDA has permitted marketing for the first in vitro diagnostic tool for early detection of Alzheimer’s disease. The Lumipulse G β-Amyloid Ratio test is intended for use in adults 55 years of age and older who are being evaluated for Alzheimer’s disease or other causes of cognitive impairment. The Lumipulse test measures concentrations of amyloid proteins in cerebral spinal fluid, and a clinical study determined test results are consistent with amyloid PET scan results: 97% of participants with positive Lumipulse results had presence of amyloid plaques on PET scan results, and 84% of participants with negative Lumipulse results also had negative PET results.

According to the NIH, more than 6 million Americans may have dementia caused by Alzheimer’s disease. Early and accurate diagnosis is important for planning and early treatment options. Prior to the authorization, PET scans were used to detect amyloid plaques to determine Alzheimer’s diagnosis; this new option could provide a reliable, radiation-free test to determine if a patient’s cognitive decline is due to Alzheimer’s.

FDA clears Abbott test to simultaneously detect four STIs

Abbott has announced FDA clearance for its Alinity ™ m STI assay. Using a swab or urine sample, the test can simultaneously detect four bacteria that cause sexually transmitted infections: Chlamydia trachomatis, Neisseria gonorrhoae, Trichomonas vaginalis, and Mycoplasma genitalium. The test has been cleared to analyze samples collected in a health care setting, and Abbot plans to bring the test into the home setting for increased convenience and discretion.

The announcement comes at a time of increasing STI rates, likely exacerbated by the pause in testing and treatment during the COVID-19 pandemic. According to the Centers for Disease Control and Prevention (CDC), 20% of the U.S. population has an STI, and every year for the past six years, the CDC has reported that cases of chlamydia, gonorrhea, and syphilis reached an all-time high.

NIH launches trial to evaluate vaccine for Epstein-Barr virus

The National Institute of Allergy and Infectious Diseases, part of the NIH, has launched a phase 1 study to evaluate an experimental vaccine for Epstein-Barr virus (EBV), which causes mononucleosis and is associated with certain cancers and autoimmune diseases. The study will be conducted at the NIH Clinical Center in Bethesda, Maryland, and will enroll 40 healthy volunteers from 18 to 29 years of age, half of whom have had prior EBV infection and half of whom have not. Participants will be given a series of three injections of the vaccine to determine safety and immune response. The trial is expected to last four years and is one of only two studies to test an EBV vaccine in more than a decade.

New evidence shows psilocybin therapy may improve outcomes in anorexia

Compass Pathways has announced early evidence that its psilocybin therapy may improve outcomes in people with anorexia nervosa. In a small study of 10 participants – each of whom received a single dose of the company’s proprietary psilocybin formulation COMP360 – 40% experienced significant reductions in eating disorder psychopathology. Participants also reported reductions in concerns about body shape, though there were no reported change in weight concerns. Nine of the 10 subjects found the experience to be therapeutic, and there were no adverse events reported. Psilocybin has previously been shown to help patients with anxiety and obsessive compulsive disorder; this small study suggests the therapy could have future indications for eating disorders.


FDA clears MONARCH® robotic surgery platform for urology procedures

Johnson & Johnson’s Auris Health has announced FDA 510(k) clearance for use of its MONARCH endoscopic robotic platform for endourological procedures, allowing the system to be used in kidney stone removal. Physicians will be able to use the platform to snake an endoscope into the kidney to break up and remove kidney stones, while an attached camera provides a real-time view of the procedure. Auris plans to launch a large clinical study of the system’s endourological applications later this year. The MONARCH system was previously cleared in 2018 for bronchoscopy procedures; this new clearance makes it the first and only robotic platform for use in both bronchoscopy and urology.