Groups call on Congress to improve FDA's veterinary antibiotic stewardship efforts

News brief

Pigs in a holding pen — DarcyMaulsby / iStock

Nearly 20 public health, environmental, and food safety groups last week sent a letter to US lawmakers calling for changes to federal legislation that would improve veterinary antibiotic stewardship.

The letter urges Senate leadership to revise the Animal Drug User Fee Act (ADUFA) with specific changes that require the Food and Drug Administration (FDA) to measure and report on whether its antibiotic stewardship activities have actually improved the use of medically important antibiotics in livestock and poultry. The legislation, first passed in 2003, needs to be reauthorized every 5 years and is set to expire on September 30.

The groups note that the FDA's current 5-year antibiotic stewardship action plan, published in 2018, failed to establish consistent indicators for measuring stewardship in US food-animal production from one year to the next and doesn't include quantifiable goals for improving stewardship over time.

"Absent both stewardship indicators and goals, this plan has left the FDA lacking the fundamental ability to demonstrate whether antibiotic stewardship in animals today is better, worse, or the same as it was in 2017, before the current plan was initiated," the groups wrote.

Critics say FDA not doing enough

While the FDA initially reported some decline in sales of medically important antibiotics for use in cows, pigs, chickens, and turkeys in 2017 (the year after it banned the use of antibiotics for growth promotion), sales have risen since then, and critics say medically important antibiotics continue to be overused on US farms. They also say that the FDA could do much more to track and measure antibiotic use in meat production.

"There is clear statutory authority for the FDA to do this kind of tracking and measuring," David Wallinga, MD, of the Natural Resources Defense Council (which signed the letter), and Sameer Patel, MD, MPH, of Northwestern University's Feinberg School of Medicine, wrote in a blog post. "Through its actions, however, the FDA has demonstrated an unwillingness to exert that authority unless Congress directs it to do so."

SARS-CoV-2 infections may trigger islet autoantibodies in kids at risk for diabetes

News brief

Stephanie Soucheray, MA

Children with a high genetic risk of developing type 1 diabetes see an increase in islet autoantibodies, which develop against pancreatic β-cell proteins, shortly after infection with SARS-CoV-2, illustrating a temporal relationship between COVID-19 and islet autoantibodies not seen with influenza. The study was published in JAMA.

The findings came from the European Primary Oral Insulin Trial, which enrolled 1,050 infants (517 girls) aged 4 to 7 months with more than a 10% genetically defined risk of type 1 diabetes from February 2018 to March 2021. Follow-up continued through September 2022. During follow-up, children submitted blood samples for SARS-CoV-2 antibody testing.

Of 885 children who agreed to participate in the study, SARS-CoV-2 antibodies developed in 170 children at a median age of 18 months, and islet autoantibodies developed in 60 children. Six of the 60 children tested positive for islet autoantibodies and SARS-CoV-2 antibodies at the same time, and six tested positive for islet antibodies after having tested positive for SARS-CoV-2 antibodies 2 to 6 months earlier.

Children under 18 months most at risk

Overall, the incidence rate of islet autoantibodies was 3.5 (95% confidence interval [CI], 2.2 to 5.1) per 100 person-years in children without SARS-CoV-2 antibodies and 7.8 (95% CI, 5.3 to 19.0) per 100 person-years in children with SARS-CoV-2 antibodies.

The findings indicate that SARS-CoV-2 infections are associated with an increased risk of islet autoimmunity in young children.

Children younger than 18 months had an increased hazard ratio of developing islet autoantibodies after SARS-CoV-2 antibody development (hazard ratio [HR], 5.3; 95% CI, 1.5 to 18.3).

The study builds on the understanding of type 1 diabetes and COVID-19, the researchers said. Many clinicians reported a significant increase in type 1 pediatric cases early in the pandemic, and islet autoantibodies have previously been linked to viral infections. Children who develop multiple islet autoantibodies usually progress to clinical type 1 diabetes within 10 years, but this study didn't detect a relationship between islet autoantibodies and H1N1 antibodies.

"The findings indicate that SARS-CoV-2 infections are associated with an increased risk of islet autoimmunity in young children with a high genetic risk of type 1 diabetes," the authors wrote.

Tests confirm H5N1 avian flu in Washington seals

News brief

Lisa Schnirring

Testing at the US Department of Agriculture (USDA) National Veterinary Services Laboratory has confirmed highly pathogenic H5N1 avian flu in three adult harbor seals found stranded on Marrowstone Island in Puget Sound. The animals initially tested positive at the Washington Animal Disease Diagnostic Laboratory.

A statement from National Oceanic and Atmospheric Administration (NOAA) Fisheries said it is the first high-path avian influenza (HPAI) detection in marine mammals on the West Coast. In 2022, 17 H5N1 detections were reported in harbor seals in Maine.

NOAA said the illnesses in Washington seals follows ongoing avian flu outbreaks since the middle of summer in sea birds on neighboring Marrowstone and Rat islands in the northern part of Puget Sound, which led to the deaths of about 1,700 birds.

Officials said the virus isn't expected to affect Puget Sound's larger seal population. Kristin Wilkinson, NOAA's regional stranding and entanglement coordinator, said, "The discovery of HPAI H5N1 in seals brings to light the potential for cross-species transmission and highlights the complexity of managing infectious diseases in wildlife populations." She added that the continuing investigation emphasizes the importance of collaboration among agencies.

NOAA urged people and their pets to avoid all contact with sick or dead wildlife. It added that although the risk to the general public remains low, beachgoers should not touch live or dead seals or allow pets to approach them.

Seal deaths in Denmark

In a similar development, Danish officials reported H5N1 in seals found dead at the end of August at Avno, a nature area along the Smalandsfarvandet waterway, according to a statement from the Statens Serum Institut translated and posted by Avian Flu Diary, an infectious disease news blog.

Officials also found carcasses of mute swans that had died earlier, and a sample from a swan was also positive for H5N1. Denmark had reported avian flu in two harbor seals in 2021. More tests are under way with collaborators from the University of Copenhagen to characterize the virus found in in the seals and birds.

About 1 in 10 mpox patients also had eye conditions, study finds

News brief

Mary Van Beusekom, MS

Eleven of 100 mpox patients also had eye-related conditions such as conjunctivitis and eyelid lesions, researchers at a single center in Mexico report.

The observational study took place at an HIV clinic in Mexico City from September to December 2022. The researchers reported the results late last week in The Journal of Infectious Diseases.

The cases were part of a global mpox outbreak that began in May 2022. Median patient age was 34 years, 90.9% were men, and 9 had HIV, 6 of whom were receiving antiretroviral therapy.

Routine ocular exam recommended in severe cases

All patients had classic mpox lesions, most often on the trunk (81.8%), anogenital area (72.7%), arms or legs (72.7%), face (72.7%), and palms and soles (45.4%). The most common systemic symptoms were fever (72.7%), muscle pain (72.7%), weakness (63.6%), swollen lymph nodes (63.6%), and headache (45.4%).

The most common findings in the 11 patients with ocular conditions were follicular conjunctivitis ("pink eye"; 6 patients), eyelid lesions (6), episcleritis (inflammation of the clear tissue layer covering the white parts of the eye; 1), and keratitis (inflammation of the cornea; 1).

The eye conditions resolved within 1 month in all but the keratitis patient, who improved after treatment with topical interferon alfa-2b (the antiviral drugs recommended for severe mpox aren't available in Mexico).

There may be cases with severe ocular affection and with a permanent vision impairment, even in immunocompetent people.

The researchers noted that the 11% rate of ocular manifestations is higher than those reported in previous studies, probably because they included an ocular assessment in the initial physical exam, and an ophthalmologic exam was performed for all patients with moderate to severe skin lesions.

While most patients with ocular manifestations had HIV, the patient with keratitis did not, "which could reflect that severe ocular involvement is not exclusive to people with immunosuppression," the authors wrote.

"There may be cases with severe ocular affection and with a permanent vision impairment, even in immunocompetent people," they concluded. "We suggest that besides those with ocular symptoms, in moderate and severe mpox disease an ophthalmological evaluation should be performed."