FDA fast-tracks Staph aureus vaccine

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Swiss biotech company LimmaTech Biologics AG announced late last week that the US Food and Drug Administration (FDA) has granted Fast Track authorization to the company's Staphylococcus aureus vaccine candidate.

The multivalent toxoid vaccine, LBT-SA7, contains weakened forms of multiple S aureus toxins, and is designed to prevent skin and soft-tissue infections (SSTIs) caused by the pathogen. SSTIs account for roughly 90% of all S aureus infections and can vary from superficial wound infections to more severe, virulent infections, especially when caused by methicillin-resistant S aureus.

"Staphylococcus aureus infections are a major cause of global mortality and morbidity, with traditional antibiotic treatments becoming increasingly ineffective due to rising antibiotic resistance," LimmaTech CEO Franz Werner-Haas said in a company press release. "Despite this urgent medical need, no vaccine is currently available to prevent the consequences of an S. aureus infection."

The FDA's Fast Track designation expedites the review process for products that have the potential to treat or prevent serious conditions and address unmet medical needs.

The company says the safety and immunogenicity of LBT-SA7 will be tested in a phase 1 clinical trial in the United States involving 130 participants aged 18 to 50 years, with initial results reported in the second half of 2025.

Study ties early phenotype-desirable antibiotics to better outcomes for bloodstream infections

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Bacteria in bloodstream
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Receipt of early phenotype-desirable antimicrobial therapy (PDAT) was associated with favorable 30-day clinical outcomes in patients hospitalized with Enterobacterales bloodstream infections, researchers reported today JAMA Network Open.

In a retrospective cohort study that analyzed data on adult patients with at least one blood culture isolate positive for Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, or Proteus mirabilis, researchers from PINC AI Applied Sciences, bioMerieux, and the University of Maryland compared clinical outcomes in patients who received early versus delayed PDAT, which is defined as the receipt of a beta-lactam antibiotic with the narrowest spectrum of activity to effectively treat the patient's phenotype. While PDAT is considered crucial for antimicrobial stewardship, the impact of timing of clinical outcomes is not well understood.

A total of 8,193 patients (mean age, 69; 58.1% female) from 252 hospitals were included in the study, and 5,033 (61.4%) received early PDAT (within 0 to 2 days of blood culture collection). The main outcome was desirability of outcome ranking (DOOR), with 1 being the most desirable outcome and 5 the least.

More desirable outcomes with early PDAT

After adjusting for comorbidities and severity of illness, patients receiving early PDAT were 20% less likely to be readmitted within 30 days compared with those receiving delayed PDAT (odds ratio, 0.80; 95% confidence interval [CI], 0.69 to 0.92; ). A higher percentage of patients receiving early PDAT had a DOOR of 1 compared with patients receiving delayed PDAT (56.3% vs 52.2%). Those receiving early PDAT had a 52.5% probability (95% CI, 51.3% to 53.7%) of a more desirable outcome than those receiving delayed PDAT, a finding that persisted in the adjusted analysis (probability, 52.0%; 95% CI, 50.9% to 53.2%).

The study also found that patients who received delayed PDAT were more likely to be still hospitalized or discharged someplace other than home and have longer hospital stays and higher healthcare costs compared with those who received early PDAT.

"Starting early PDAT may be important not only for antimicrobial stewardship but also for improving the clinical outcome of affected patients," the study authors concluded.

Belgium becomes 8th non-African country to confirm clade 1b mpox case

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mpox virus
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For the first time, Belgium has confirmed a case of clade 1b mpox case, becoming the eighth country outside of Africa to report the infection, the European Centre for Disease Prevention and Control (ECDC) said in its latest weekly communicable disease threat report.

Belgium reported the case on December 18 in an adult traveler returning from an African country where the clade 1b virus circulates. The patient, who had sexual contact with a person with mpox-like symptoms, isolated on their own before diagnosis. No high-risk contacts in Belgium have been identified, and the risk to the public in the country remains low, according to the ECDC.

Clade 1b cases have also been reported in Canada, Germany, India, Sweden, Thailand, the United Kingdom, and the United States.

Mpox outbreaks in Africa near 70,000 cases

Africa has been dealing with complex mpox outbreaks, which were nearing the 70,000-case mark last week from 20 countries since the first of the year. The cases are caused by different clades of the mpox virus and follow different transmission patterns, with regional variations seen in some countries such as the Democratic Republic of the Congo, the main hot spot.

Quick takes: WHO vaccine advisers say to stick with JN.1 lineage, respiratory viruses found in some DRC remote-outbreak samples

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  • The World Health Organization (WHO) today announced that its Technical Advisory Group on COVID-19 Vaccine Composition recently met to review the latest SARS-CoV-2 genetic developments, along with immune responses to infection and vaccination, and recommends that countries stick with monovalent (one-strain) COVID vaccines targeting the JN.1 lineage. The group initially recommended JN.1 lineage vaccines in April, and several manufacturers have updated their formulations to cover JN.1 or KP.2. The group emphasized that variant timing and antigenic characteristics are hard to predict. “There are JN.1-derived variants such as LP.8.1, NP.1 and LF.7.2 that are currently in low proportions, but which have mutations that may give them more immune escape than XEC,” the group said. "These will continue to be monitored and/or characterized."
  • Ongoing analysis of lab samples collected following an illness outbreak in the Democratic Republic of the Congo (DRC) has found influenza in 28% of samples, a government spokesman said in a December 20 TV broadcast following a council of ministers meeting, Xinha reported. Reading from the meeting minutes, the spokesman, citing the public health minister, said some patients had flulike symptoms and that the outbreak occurred during flu season. Along with flu, some samples yielded human rhinovirus and SARS-CoV-2. Initial test results suggested a severe form of malaria with malnutrition as a factor. Follow-up testing is still under way, including on samples from a man who died from hemorrhagic fever symptoms. The outbreak is occurring in Kwango province’s Panzi health district, a remote region in southwestern DRC, located about 425 miles from Kinshasa. 

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