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The FDA approved the first oral fecal microbiota productopens in a new tab or window for preventing recurrent Clostridioides difficile infections in adults, the agency announced on Wednesday. Developed as SER-109 and given the trade name of Vowst, the therapy is indicated for patients who have already received a course of antibiotics for recurrent C. difficile infections. SER-109 -- which involves four pills taken once a day for 3 consecutive days -- contains live bacteria from donor fecal matter, with the donors and stool screened for a slew of pathogens. Despite that, the agency still warns that the product carries the potential risk of transmitting infectious agents or food allergens. "Today's approval provides patients and healthcare providers a new way to help prevent recurrent C. difficile infection," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "The availability of a fecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening."

 

Approval was supported by the randomized ECOSPOR III trialopens in a new tab or window and an open-label studyopens in a new tab or window conducted in the U.S. and Canada. In ECOSPOR III, which involved 182 patients with recurrent infections but with symptoms under control following a course of antibiotics, patients assigned to SER-109 had significantly lower recurrence rates of C. difficile infection through 8 weeks compared with those assigned to placebo (12.4% vs 39.8%, P<0.001). Results were consistent across age groups and largely held up at 24 weeks, at 21.3% in the SER-109 group and 47.3% for the placebo group. C. difficile infections can cause a host of symptoms (diarrhea, abdominal pain, fever) and organ failure or death in severe cases. One of the most common healthcare-associated infections, these infections are linked with anywhere from 15,000 to 30,000 deaths each year. While standard treatment involves antibiotics, these can alter the microbiome and allow C. difficile to return, and few treatments exist for recurrent infections, which are more likely to affect immunocompromised individuals, people over 65, and those who are hospitalized or living in nursing homes. Recurrent C. difficile infection is a highly debilitating and life-threatening disease," said Carl Crawford, MD, of Weill Cornell Medical College in New York City, in a statementopens in a new tab or window from developer Seres Therapeutics, adding that antibiotics alone do not address the underlying cause of recurrent infections -- "dysbiosis of the gut microbiome."

 

FDA Press release (April 26, 2023):

https://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides 

Via Juan Lama

In what is believed to be the first published study of COVID-19 vaccine effectiveness in long-term care facilities such as nursing homes, a research team co-led by the Yale School of Public Health found a widely used vaccine is highly successful in preventing infections. Residents of such facilities, particularly those in skilled nursing facilities (SNFs), have experienced disproportionately high levels of COVID-19–related death and illness since the pandemic first arrived in the United States nearly a year ago.  Despite this, this group was not included in COVID-19 vaccine clinical trials and there is limited post-shot vaccine effectiveness data available for members of this population who are typically older, more frail, and have more underlying medical conditions than the general population. For the study, researchers were able to capitalize on the rapid vaccine rollout in Connecticut's nursing homes facilitated by the state Department of Public Health. Specifically, they examined the "real-world" effectiveness of the Pfizer-BioNTech vaccine among 463 residents in two nursing homes in Connecticut that were experiencing COVID-19 outbreaks. They found that the vaccine had an estimated effectiveness of 63% against SARS-CoV-2 infection among facility residents after the first dose. This is similar to estimated effectiveness for a single dose of COVID-19 vaccine in adults across a range of age groups in non-congregate settings and strongly suggests that a complete two-dose vaccination offers significant protection for medically frail and older adult residents of SNFs.

 

"This confirms what we had all hoped: This vaccine is highly effective in perhaps the most at-risk group and can potentially save many lives," said Sunil Parikh, an associate professor at the Yale School of Public Health and the study's senior author. "Vaccines work in this highly vulnerable population and their implementation should not be delayed." The findings were published March 15 as an "early release" in the Centers for Disease Control and Prevention's (CDC) Morbidity and Mortality Weekly Report. The study was a joint collaboration with state and federal partners—the Connecticut Department of Public Health and the CDC—and involved two Ph.D. students at YSPH, Jillian Armstrong and Hanna Ehrlich. "This is a great demonstration of the power of collaboration between applied public health at the local and federal levels and academic public health entities," said Parikh. Since the early days of the pandemic, Connecticut has partnered with Parikh and others at the Yale School of Public Health to conduct enhanced surveillance in all Connecticut nursing homes. This surveillance system enabled the rapid detection of outbreaks.

 

Research published in  MMWR (March 15, 2021):

http://dx.doi.org/10.15585/mmwr.mm7011e2 

Via Juan Lama