White House unveils revised dual-use and pandemic pathogen research oversight policy

News brief

The White House yesterday announced the release of the administration's Office of Science Technology Policy (OSTP) revised policy on oversight of dual-use research of concern (DURC) and pathogens with enhanced pandemic potential (PEPPs). It also released an implementation guidance document to accompany the updated policy.

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In January 2022, the National Institutes of Health asked its federal advisory group, the National Science Advisory Board for Biosecurity (NSABB), to review government policies on work with potentially dangerous pathogens. The NSABB formed two working groups to revise the research oversight policies, a process that included listening sessions with stakeholders.

The advisers issued draft recommendations in January 2023, which said current PEPP definitions were too narrow and focused too much on "highly transmissible" and "highly virulent."

More specific list of pathogens

Thomas Inglesby, MD, who directs the Center for Health Security at Johns Hopkins School of Public Health, today on a LinkedIn blog post commended the OSTP on the release of its revised oversight policy and said it represents a significant stride forward in safeguarding public health and establishing common sense and strong biosafety and biosecurity surrounding pathogens that pose the greatest risk in the event of accidents or misuse.

He said some of the valuable new elements include defined roles, clear levels of oversight, and a more appropriate list of pathogens covered. Inglesby also listed several areas that need further clarification, such as whether category 2 should cover animal and plant global threats and issues around transparency in reporting.

Xofluza may lower secondary flu attack rate better than Tamiflu

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Xofluza (baloxavir marboxil, BMX) appears to be more effective than oseltamivir (OTV, Tamiflu) in lowering the secondary attack rate (SAR) of flu, according to a new study based on transmission dynamics in Japanese households. The study was published yesterday in Influenza and Other Respiratory Viruses.

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Both flu antivirals are approved for use in the United States and Japan, and the study assessed secondary transmission rates among 185 index case-patients (116 treated with BXM and 69 treated with OTV) and 410 household contacts. Almost all index patients (97.8%) had influenza A infection.

More adherence for BMX

The secondary attack rate in household contacts of index cases treated with BXM and OTV was 10.8% and 18.5%, respectively. The authors calculated that the adjusted relative reduction in SAR was 41.8% (95% confidence interval, 1.0% to 65.7%).

In a subgroup of index patients 12 years and under, BMX performed better than OTV. This may because of adherence, the authors said, as BMX is a single dose versus twice daily dosing for 5days for OTV.

The secondary influenza illness attack rate was lower in household contacts exposed to BXM-treated than OTV-treated index case.

"The secondary influenza illness attack rate was lower in household contacts exposed to BXM-treated than OTV-treated index case," the authors concluded. "The more rapid reduction in infectious virus titers associated with BXM compared to OTV treatment may explain BXM's greater reduction in secondary household transmission than observed with OTV."

Long-COVID symptoms in kids appear to differ by age

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Symptoms associated with long COVID in children differ based on the child's age, according to a nationwide, multisite study presented at the Pediatric Academic Societies 2024 Meeting late last week in Toronto. 

Researchers grouped infants, toddlers, and preschool-age children (birth to 5 years), school-age children (6 to 11 years), adolescents (12 to 17 years), and young adults (18 to 25 years) to compare symptoms and long-COVID trends. The participants included 7,229 caregivers and children enrolled in the National Institutes of Health's Researching COVID to Enhance Recovery (RECOVER)-Pediatrics study, 75% of whom had reported having had a COVID-19 infection.

Preschoolers more likely to report general symptoms

School-age children, adolescents, and young adults all reported more fatigue, headaches, and trouble concentrating and focusing. Change in smell or taste was more commonly described by adolescents and young adults.

Chest pain and palpitations were more common in young adults, but not in the younger age groups, the authors said. 

In general, children 5 and younger with a history of COVID-19 infection were more likely to report general symptoms, including poor appetite, trouble sleeping, and fussiness compared to peers with no history of COVID infection. 

These findings underscore the importance of characterizing Long COVID in children while researchers are still discovering the long-term effects of COVID-19 infection in this age group.

"These findings underscore the importance of characterizing Long COVID in children while researchers are still discovering the long-term effects of COVID-19 infection in this age group, " said Rachel Gross, MD, associate professor of pediatrics and population health at New York University Grossman School of Medicine and a presenting author. "This research is important because clinicians can appropriately diagnose and treat Long COVID when they better understand how different age groups are affected by the condition."

WOAH report shows rise in antimicrobial use in animals

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Global use of antimicrobials in food-producing animals rose by 2% from 2019 to 2021, according to a report published yesterday by the World Organization for Animal Health (WOAH). The increase comes after several years of declines.

The report, released at yesterday's meeting of the Global Leaders Group (GLG) on Antimicrobial Resistance (AMR), includes data submitted to ANIMUSE (the global database on ANimal antiMicrobial USE) by 152 (84%) of WOAH's 182 members. The data come mainly from sales and import figures of antimicrobial agents.

Overall, animal antibiotic use rose from 107.3 milligrams per kilogram (mg/kg) in 2019 to 107.9 mg/kg in 2021. Tetracyclines were the most-used antimicrobial class, accounting for 35.6% of the total amount. Bovine species accounted for 41% of antimicrobial use, followed by swine (21%), poultry (18%), and aquatic species (9%).

While a decline was observed in the Americas (–9%), Europe (–6%), and Asia and the Pacific (–0.7%), Africa saw an increase of 179%, which the report attributes to an improvement in reporting accuracy by some African countries.

Use of antimicrobials for growth promotion still a problem

WOAH has been monitoring the use of antimicrobials in food-producing animals since 2015 as part of its efforts to limit the emergence of drug-resistant bacteria. Overuse of medically important antimicrobials in food-producing animals is considered one of the forces contributing to rising rates of AMR. 

Notably, the report also showed that nearly 20% of WOAH member states reported using antimicrobials as growth promoters, a practice discouraged by WOAH and other global health agencies. Furthermore, 11% of member states reported using antimicrobials like colistin for growth promotion. Colistin is classified as one the highest priority, critically important antimicrobials for human medicine.

"I would like to call upon our Members to restrict their use of antimicrobials solely to those needed for veterinary medical purposes, and to actively work with all parties to achieve a total ban on the use of antimicrobials as growth promoters, starting with those that are critically important for human health," WOAH Director General Monique Eloit, DVM, said in a foreword to the report.

Funders join forces to address antimicrobial resistance, other global health challenges

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Three of the world's wealthiest philanthropic organizations yesterday announced a 3-year, $300 million joint initiative to tackle health challenges posed by climate change, antimicrobial resistance (AMR), and inadequate nutrition.

Under the partnership, the Bill & Melinda Gates Foundation, Wellcome, and the Novo Nordisk Foundation will each commit $100 million to support solutions to address the health impacts of climate change, infectious diseases and AMR, and a greater understanding of the interplay between nutrition, immunity, infectious and noncommunicable diseases, and developmental outcomes.

Efforts to address infectious diseases and AMR will include advancing disease surveillance and developing vaccines for respiratory infections, with the aim of reducing the burden of disease in low- and middle-income countries (LMICs) and preventing outbreaks from turning into global health crises. The initiative will also support efforts to build more resilient and sustainable food systems, protect the health of vulnerable populations in the face of climate change, and address the effects of over- and under-nutrition on health and development.

"In today's complex world, health challenges increasingly overlap," Wellcome CEO John-Arne Rottingen said in a press release. "We need global collaboration and cooperation more than ever to build healthier futures, and for society to thrive."

Support for research in LMICs       

The funding will include direct support for researchers and institutions based in LMICs, which are the countries most affected by these issues. The organizations say the funding is needed at a time when debt crises are forcing governments to cut funding for essential health programs.

"By pooling the vast experience and unique expertise of each organization—across research, technology, innovation, and enterprise—we can make advances that wouldn’t otherwise be possible," said Novo Nordisk Foundation CEO Mads Krogsgaard Thomsen.

Gates Foundation CEO Mark Suzman said he hopes the collaboration will encourage other philanthropic organizations and partners to contribute to efforts to solve these challenges.

"We’re on the cusp of so many scientific breakthroughs in agriculture, health, and nutrition, and with the right support these innovations will save and improve lives around the world," he said.

BARDA announces first next-generation countermeasure accelerator hubs

News brief

The Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS), yesterday announced the first two hubs in its next-generation BARDA Accelerator Network (BAN)—one that targets diagnostics and medical devices and the other focused on therapeutics and vaccines.

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The two hubs will be part of a five-part system designed to boost health security innovations with support for the development, evaluation, validation, and commercialization of next-generation medical countermeasures.

Supporting research and development

For diagnostics and medical devices, BARDA said the International Consortium for Research, Engineering, Acceleration of Technology Excellence (I-CREATE) will serve as the hub and will support game-changing tools to detect, prevent, or respond to medical consequences that result from health security threats. 

It will be led by University Lab Partners (ULP), a nonprofit incubator/accelerator based in Irvine, California. The group will collaborate with the consortium for Improving Medicine with Innovation and Technology at the Massachusetts General Hospital and Harvard Medical School and Science Exchange, a life sciences research and development marketplace.

Therapeutics and vaccines hub

Meanwhile, BARDA said the therapeutics and vaccines hub is geared toward supporting the development and acceleration of next-generation therapeutic and vaccine platforms and technologies. Called the Vaccine Innovation and Therapeutic Acceleration Launchpad (VITAL) Hub, the effort is led by Start2 Group, a global accelerator and startup ecosystem platform based in Cambridge, Massachusetts, in collaboration with Advise Connect Inspire, a global early-stage healthcare advisory group and BioInnovation Labs (BioLabs) a global support platform to speed the commercialization of life sciences innovations through 15 labs in the United States, Europe, and Japan.

The next three of five planned hubs will address digital health tools, special populations, and enabling technologies.

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