Investigational gonorrhea vaccine receives FDA Fast Track designation

News brief

British drugmaker GSK announced today that it has received Fast Track designation from the US Food and Drug Administration (FDA) for its investigational gonorrhea vaccine.

The designation means that the NgG vaccine, which is in an ongoing phase 2 trial, will receive expedited review by FDA officials. The phase 2 trial began in November 2022 and will include 750 participants in eight countries, with the aim of assessing the efficacy of the vaccine in healthy adults ages 18 to 50 who are considered at risk of Neisseria gonorrhoeae infection.

The FDA's Fast Track program aims to hasten the development and review of new drugs and vaccines for serious conditions with unmet medical needs. In addition to being the second most common sexually transmitted infection worldwide, gonorrhea is now resistant to most antibiotics and is considered an urgent unmet medical need by global health officials.

Gonorrhoea is a major concern for sexual and reproductive health around the globe.

"With a high and growing incidence, gonorrhoea is a major concern for sexual and reproductive health around the globe," Phil Dormitzer, MD, PhD, GSK's head of global vaccines R&D, said in a company press release. "This designation recognises the potential for a vaccine that could help protect millions of people across the world against the serious health consequences of infection with a bacterium that is considered a 'high priority' pathogen by the World Health Organisation."

Canada releases 5-year plan to address antimicrobial resistance

News brief

Two lab researchersThe Canadian government last week released a roadmap to guide the country's efforts to address antimicrobial resistance (AMR) over the next 5 years.

Developed in collaboration with federal, provincial, and territorial partners and Indigenous groups and guided by One Health principles, the Pan-Canadian Action Plan on AMR lays out 10 priority actions to guide the country's efforts across five pillars—research and innovation, surveillance, stewardship, infection prevention and control, and leadership. The plan is designed to encourage jurisdictions, sectors, and stakeholders across the country to identify how and where they can best contribute to collective efforts to address AMR.

The priority actions include:

  • Improving access to new and existing antibiotics, diagnostics, and antibiotic alternatives
  • Expanding the scientific knowledge base and tools to inform effective AMR interventions
  • Expanding sources, coverage, and integration of AMR and antibiotic use surveillance across One Health sectors
  • Developing, implementing, and promoting guidelines and standards for appropriate antibiotic use in human and animal medicine
  • Establishing baselines and targets for national, provincial, and territorial levels of AMR and antibiotic use

The plan also calls for educational efforts to raise public awareness of AMR and inappropriate antibiotic use, effective implementation of infection prevention measures, and development of enhanced biosecurity and food safety protocols across the agricultural and agri-food sectors.

The Public Health Agency of Canada says it will work with jurisdictional partners and other stakeholders to develop and implement an approach to monitor and report on progress.

We call on all relevant One Health partners to join us.

"While governments have a responsibility to address AMR, contributions from many partners across several sectors are required to achieve our goal," the plan states. "We call on all relevant One Health partners to join us and work together to improve the appropriate use of antimicrobials and reduce the spread of AMR."

Tropical diseases not linked to long COVID, but rate of prolonged symptoms high in Amazon Basin

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Aedes mosquito

A cohort study in the Amazon Basin suggests long-COVID symptoms—reported in almost two thirds of COVID-19 patients—may be more likely in people who reported COVID reinfections over a 1-year period, but not in those with a history of tropical diseases, including dengue, malaria, and Zika. The study was published yesterday in The American Journal of Tropical Medicine and Hygiene.

The study was based on 12 months of follow-up of 1,371 patients with confined COVID-19 in Rio Branco, Acre, a municipality in the Brazilian Amazon Basin. Participants were followed up via telephone shortly after COVID-19 diagnosis and 12 months after. All participants reported a first infection from March 17 to August 26, 2020.

The average age of participants was 39.7 pears, and 50.7% were female. The average number of symptoms reported in the acute phase of infection with COVID was nine, and 32 (2.3%) were reinfected with COVID-19 at least 90 days after their first infection.

The authors noted that 877 (63.9%) participants reported symptoms related to COVID-19 at 12 months. Among those with long COVID, 43.5% said fatigue was their most significant symptom.

Almost 60% had history of tropical disease

Among all participants, 806 (58.8%) reported a history of tropical diseases, including dengue, malaria, Zika, chikungunya, leprosy, and visceral leishmaniasis.

Female sex, non-White race, number of acute-phase symptoms, body mass index, and reinfection were independent predictors of long COVID, but not previous infection with tropical diseases.

Dengue accounts for 71% of all previous tropical disease cases and was associated with greater symptoms in the acute phase of COVID-19.

"Although more than half of the individuals reported previous tropical infection, this characteristic was not associated with post-COVID-19 symptoms. Interestingly, Dengue accounts for 71% of all previous tropical disease cases and was associated with greater symptoms in the acute phase of COVID-19, but it was not associated with COVID-19 long-term symptoms," the authors wrote.

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