FDA requires Guillain-Barre label warnings for 2 RSV vaccines

News brief

The US Food and Drug Administration (FDA) announced yesterday that it has required and approved labeling changes for two respiratory syncytial virus (RSV) vaccines owing to the risk of Guillain-Barre syndrome, a rare neurologic disorder.

older man vaccination — *Drazen Zigic / iStock*

The new labeling warnings apply to Pfizer's Abrysvo vaccine and GSK's Arexvy vaccine. For both vaccines, which are used by adults, the required labeling change will reflect that postmarketing observational studies suggest an increased risk of GBS during the 42 days following vaccination.

GBS is a rare disease in which the body's immune system damages nerve cells, resulting in muscle weakness and sometimes paralysis.

Vaccines approved in 2023

Arexvy was approved in May 2023 for use in adults ages 60 and older, and the FDA subsequently approved an expanded indication for adults ages 50 to 59 years old who are at increased risk for lower respiratory tract disease caused by RSV.

The FDA approved Abrysvo a few weeks later for people ages 60 and older and later approved indications for adults ages 18 to 59 years old who are at increased risk of RSV infection and for pregnant women in their final 4 weeks of gestation to help protect infants from RSV.

CEPI announces award to advance needle-free vaccine delivery technology

News brief

Lisa Schnirring

The Coalition for Epidemic Preparedness and Innovations (CEPI) today announced a $3.7 million award to Atlanta-based Micron Biomedical to continue the development of a small dissolvable "button" to deliver needle-free vaccines.

vaccine research — *CDC / James Gathany*

In a statement, CEPI said the technology could help address critical vaccine access challenges. It said the financial support will help researchers to study the company's microarray technology in combination with a vaccine technology platform developed by CastleVax, which is designed to be quickly adapted to novel viral threats.

Vaccine button thermostable, could be self-administered

Micron Biomedical's button-like device can be applied to the skin and, when pushed, can deliver the vaccine painlessly. It doesn't require refrigeration and can be self-administered. The vaccine delivery system has shown promising findings in clinical trials of vaccines against seasonal flu and measles.

The next phase of research will use COVID-19 as a target pathogen to assess how well the button performs when compared to intramuscular or nasal versions of the vaccine.

Raafat Fahim, PhD, CEPI's acting executive director of vaccine manufacturing and supply chain, said, "By combining their innovation with a rapid response vaccine platform, we are developing a technology that could be a gamechanger through protecting populations against epidemic or pandemic threats even in the most remote regions. This project adds one of the most advanced vaccine patch developers to the CEPI portfolio, as well as CastleVax's new rapid response platform."

We are developing a technology that could be a gamechanger through protecting populations against epidemic or pandemic threats even in the most remote regions.

Stewardship intervention tied to cuts in unneeded antibiotics for bronchitis, viral respiratory infections

News brief

Chris Dall, MA

Urgent care clinic — KaraGrubis / iStock

An antibiotic stewardship intervention implemented at urgent care centers (UCCs) in 18 states was associated with significant reductions in inappropriate prescribing for bronchitis and viral upper respiratory tract infections (URTIs) among clinicians who were actively engaged in the intervention, researchers reported today in Infection Control & Hospital Epidemiology.

The intervention, implemented at 49 UCCs across 27 different networks, included signing an antibiotic stewardship commitment statement and selecting from five different intervention options during three plan-do-study-act cycles. Intervention options included patient education handouts and engagement materials, clinician education, treatment guidelines, and signage social media materials.

To evaluate the impact of the intervention, researchers from George Washington University compared the percentage of inappropriate prescribing for bronchitis and viral URTIs during a 3-month baseline period and 9-month intervention period, stratified by clinician engagement and diagnosis. Active engagement was defined as attendance at a minimum of four of nine monthly webinars during the 9-month intervention period, active participation implementation of the selected interventions, and participation in feedback and evaluation.

Significant reductions among engaged clinicians

Overall, among 15,385 encounters, antibiotic prescribing decreased from 18% during the baseline period to 13.6% by the final 2 months of the intervention.

When stratified by clinician engagement, the intervention was associated with a 48% relative decrease in inappropriate antibiotic prescribing for bronchitis (adjusted odds [aOR], 0.52; 95% confidence interval [CI], 0.33 to 0.83) and a 33% relative decrease for viral URTIs (aOR, 0.67; 95% CI, 0.55 to 0.82) among actively engaged clinicians compared to baseline. The intervention did not result in significant changes for clinicians not actively engaged.

The findings are noteworthy given the high rates of inappropriate prescribing reported at UCCs. Most previous studies of stewardship interventions have been conducted within single networks.

"This study highlights the importance of direct clinician engagement with stewardship efforts and provides a broadly applicable approach to antibiotic stewardship implementation in UCCs," the study authors wrote.