WHO prequalifies simplified version of oral cholera vaccine

News brief

Amid a severe shortage of oral cholera vaccine and outbreaks in many countries, EuBiologics and the International Vaccine Institute (IVI) announced this week that the World Health Organization (WHO) has prequalified Euvichol-S, a new oral cholera vaccine (OCV) produced with a simplified method that can streamline formulation and manufacturing by 40% compared to its existing vaccine.

cholera outbreak
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Prequalification means the vaccine meets the WHO's quality, efficacy, and safety standards, which paves the way for United Nations agencies and Gavi, the Vaccine Alliance, to buy vaccine for countries experiencing outbreaks.

EuBiologics now able to supply 3 vaccines

EuBiologics, based in South Korea, said it will now be able to supply three oral cholera vaccines. Efficacy for Euvichol-S was show last year in a phase 3 trial in Nepal in 2023. Development was supported by the Bill and Melinda Gates Foundation. 

After scale-up, the vaccine will be mass produced at two facilities in South Korea starting in the second quarter of the year. 

Julia Lynch, MD, who directs IVI's cholera program, said in the statement, "The addition of Euvichol-S to global health market will contribute to easing the shortage of OCV supply amid a dire global cholera situation. IVI will continue efforts to enhance the availability of OCV worldwide and develop new and improved vaccines that are equally safe, effective, and affordable."

1 in 5 adults with diabetes experienced functional decline during pandemic

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A study yesterday based on Canadian adults with diabetes found that roughly 20% experienced functional decline for the first time during the pandemic, including challenges with activities of daily living, including climbing stairs, getting in and out of chairs, and walking several blocks. 

The study, published in the Canadian Journal of Diabetes, was based on participants in the Canadian Longitudinal Study on Aging. The study included 6,045 adults who reported no functional limitations from 2015 through 2018.

People with diabetes were more likely to be men (60.7% vs 46.2%), obese (36.5% vs 18.6%), and have one or more chronic condition (36.0% vs 29.6%), compared to adults without diabetes.

Income may play a role

A total of 18.9% of adults with diabetes reported a functional limitation with an onset after 2020, compared to 13.2% of adults without diabetes. Overall, the odds of developing at least one functional limitation outcome was 1.28-fold higher (95% confidence interval, 1.02 to 1.60) among people with diabetes compared to those without.

For both adults with or without diabetes, the greatest risk factor for developing a functional limitation was earning less than $50,000 annually. 

People with low socioeconomic status face disproportionate stressors over their lifetime that may adversely impact their physical functioning in older age

"People with low socioeconomic status face disproportionate stressors over their lifetime that may adversely impact their physical functioning in older age, such as working more physically demanding jobs, worse nutrition, and living in areas with less greenspace and walkability," said co-author Paul Villeneuve, PhD, in a press release from the University of Toronto. 

COVID-19 caused 21% excess of respiratory infections last winter, analysis finds

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A new study based on German data shows that SARS-CoV-2 caused a 21% excess of acute respiratory infections (ARIs) during the winter of 2022-23. The study was published this week in the International Journal of Infectious Diseases and suggests COVID-19 will add a significant burden during cold and flu seasons. 

The study was based on answers to an online survey about ARIs during the past 7 months sent to 70,000 registered participants in a digital health study in March 2023. At that point, 3 years after the pandemic began, many people in Germany and elsewhere no longer regularly tested for COVID-19, or testing at home and did not report official results. 

A total of 37,708 participants reported 54,813 ARIs, including 9,358 SARS-CoV-2 infections confirmed with either at-home or clinical tests. Twenty-eight percent—10,638 people—reported no infections.

There were 45,455 ARIs without a positive SARS-CoV-2 test, the authors said. For 11,699 of those, no SARS-CoV-2 test was available, while the others had a negative test. The proportion of positive tests among all conducted tests was 21%.

Adults 30 to 39 hit hardest 

The highest incidence for all ARIs was observed in December 2022, with 26 infections per 100 people. Adults aged 30 to 39 years had the highest cumulative incidence, with 208 infections per 100 people across the 7 months. 

"Decision makers need to be aware of this burden to adapt and create new policies with the goal of reducing infection incidences, for example by establishing new strategies on vaccinations." the authors wrote. 

Decision makers need to be aware of this burden to adapt and create new policies with the goal of reducing infection incidences

"While the risk of severe SARS-CoV-2 infections is reduced due to the achieved immunity in the population, we will likely face a higher burden of ARI than before the pandemic, even if no new SARS-CoV-2 variants will appear," the authors concluded. "This additional burden of ARI has to be considered particularly with respect to the implications for the work force."

White House releases new global health security strategy

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The Biden administration yesterday unveiled a new Global Health Security Strategy, which spells out the steps the United States will take over the next 5 years to prevent, detect, and effectively respond to biological threats.

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In a statement, President Joe Biden said Americans have witnessed the profound impact of the COVID pandemic and how the global challenge had local consequences. "No sector of society was immune. That's why—as my Administration worked to end the COVID-19 pandemic—we've also focused on ensuring our nation is prepared for any future pandemic, outbreak, or biological threat."

Building on COVID lessons

In a fact sheet, the White House said the strategy builds on lessons learned during the pandemic and describes steps to meet goals outlined in the 2022 national biodefense strategy and 2022 pandemic prevention legislation that was passed as part of the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023.

Three overarching goals include strengthening global health security capacities through bilateral partnerships, mobilizing political commitment, financing and leadership to achieve health security, and leveraging health security linkages between health security and complementary programs.

Details of the strategy are covered in a 64-page document. The White House notes targets for 2024, which include achieving and sustaining health capacity goals in 50 more countries and strengthening country ownership and resource mobilization. The White House also signaled that it would incorporate equity and social inclusion factors to protect all people from infectious disease threats.

GSK announces promising data for gonorrhea treatment

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New data released today by GSK show that the oral investigational antibiotic gepotidacin was non-inferior to the current standard treatment for uncomplicated urogenital gonorrhea.

The British drugmaker announced in a press release that results from the phase 3 EAGLE-1 trial showed that two doses of gepotidacin had a 92.6% success rate for the primary end point of microbiologic response at the test-of-cure visit 3 to 7 days after treatment, compared with a 91.2% success rate for intramuscular ceftriaxone and oral azithromycin. The safety and tolerability profile was consistent with results seen in earlier trials.

"These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide including drug resistant infections," said Chris Corsico, GSK's senior vice president for development. "The imperative for innovative treatments has never been clearer."

First-in-class antibiotic

Gepotidacin is a first-in-class triazaacenaphthylene antibiotic that works by inhibiting bacterial DNA replication. It's also being developed as a treatment for uncomplicated urinary tract infections. 

Gonorrhea is one of the most common sexually transmitted infections, with an estimated 82 million cases each year globally. While the combination of ceftriaxone and azithromycin is the recommended treatment for uncomplicated gonorrhea in most countries, rising resistance to both drugs is threatening its effectiveness. And because the Neisseria gonorrhoeae bacterium has developed resistance to every other antibiotic that's been used for treatment, treatment options are limited.

GSK said the results from the EAGLE-1 trial will be presented later this month at the European Society of Clinical Microbiology and Infectious Diseases Global Congress in Barcelona, Spain. 

These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide including drug resistant infections.

Study finds high exposure to antibiotics among Australian infants

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Analysis of data from a randomized clinical trial in Australia found that at least two thirds of children were exposed to antibiotics in the first 2 years of life, researchers reported today in the Journal of Antimicrobial Chemotherapy.

Looking at data from a subset of 1,201 infants enrolled in the BCG (Bacille Calmette-Guérin vaccine) for Allergy and Infection Reduction (MIS BAIR) trial, conducted in Melbourne, researchers from the Murdoch Children's Institute found that exposure to at least one course of antibiotics was 43% at age 1 and 67% at age 2, with the highest first antibiotic prescription rate from 9 to 18 months. In total, 26.5% of infants were inappropriately treated with antibiotics in the first year of life, with the largest proportion of inappropriate prescriptions (44%) occurring from 9 to 12 months.

The most common diagnoses for which antibiotics were prescribed were respiratory tract infections from 0 to 6 months and otitis media (ear infection) from 6 to 12 months. The most frequently prescribed antibiotics prescribed were amoxicillin (59%) and cefalexin (7%).

Risk factors for antibiotic exposure

Multivariable regression analysis found that delivery by caesarean section (adjusted odds ratio [aOR], 1.5; 95% confidence interval [CI], 1.1 to 1.9), birth in winter (aOR, 1.7; 95% CI, 1.2 to 2.4), maternal antibiotic exposure during the last trimester (aOR, 1.6; 95% CI, 1.1 to 2.3), cessation of breastfeeding by 6 months (aOR, 1.5; 95% CI, 1.1 to 2.0), and daycare attendance (aOR, 1.4; 95% CI, 1.1 to 1.8) were the primary factors associated with antibiotic use from 0 to 12 months.

The study authors note that the observed antibiotic exposure rate is higher than reported in most European countries. 

"Antibiotic exposure in the first 2 years of life in Australia is higher than in many other high-income countries," they wrote. "Future studies should focus on strategies to reduce inappropriate antibiotic prescribing."

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