HHS advances plan to produce 4.8 million H5N1 vaccine doses

News brief

Response (ASPR) at the US Department of Health and Human Services (HHS) said officials are moving forward with a plan to produce 4.8 million doses of H5N1 avian flu vaccine for pandemic preparedness.

vaccine syringe vial
Alernon77 / iStock

Dawn O'Connell, JD, said health officials have identified a manufacturing line at one of its manufacturing partners for fill-and-finish steps, without disrupting production of seasonal flu vaccine. Currently, the vaccine is in bulk form and will be produced in multidose vials.

She said it takes a couple months to fill and finish the vaccine doses, which would save time in case a vaccine is needed. Federal health officials have said one of two H5N1 candidate vaccine viruses is well matched to the circulating strain.

Feds eye triggers for deploying vaccine

O'Connell added that active discussions are under way across federal agencies about what the key triggers would be for deploying H5N1 vaccine doses. She also said discussions are still under way with mRNA vaccine makers Pfizer and Moderna, with an announcement expected soon on how the companies might be involved in vaccine development.

Nirav Shah, MD, JD, principal deputy director at the Centers for Disease Control and Prevention (CDC) said potential trigger factors might include a change in transmission propensity, such as human-to-human in addition to animal-to-human spread, and any sign of increased illness severity.

He also said a change in the complexion of the cases might be a trigger, such as H5N1 infections cropping up in people who have no epidemiologic links to affected dairy farms. "And we're always looking for mutations," Shah said. "We're in rich discussions across federal agencies."

Surveillance study describes incidence of multidrug-resistant infections in US children

News brief
Carbapenem-resistant Enterobacterales
CDC / Stephanie Rossow

A surveillance study found that carbapenem-resistant Enterobacterales (CRE) infections occur less frequently than extended-spectrum beta-lactamase–producing Enterobacterales (ESBL-E) infections in US children, researchers reported today in Emerging Infectious Diseases.

Led by researchers with the Centers for Disease Control and Prevention's Emerging Infections Program (EIP), the surveillance study analyzed CRE incidence in children in 10 states from 2016 through 2020 and ESBL-E incidence in children in six states from 2019 through 2020. While most US studies have focused on the prevalence and epidemiology of these multidrug-resistant pathogens in adults, nationwide data on children are lacking.

From 2016 through 2020, a total of 159 incident CRE cases were identified in 142 children (median age, 5 years). Most CRE isolates were from urine (82.4%), and the most commonly reported infection type was lower urinary tract infection (UTI, 56.3%). The overall annual CRE incidence rate across the 10 EIP sites was 0.70 cases per 100,000 children.

From 2019 through 2020, 207 incident ESBL-E cases were identified in 184 children, with 94.7% of isolates found in urine and UTIs accounting for 74% of cases. The overall annual ESBL-E incidence rate was 23.08. CRE and ESBL-E incidence rates were more than two-fold higher in infants than in other age-groups and were nearly always higher for girls than boys, except in the youngest age-group. 

Rise in community-associated infections

Most CRE and ESBL-E cases were healthcare-associated community-onset (43.0% for CRE vs 23.7% for ESBL-E) or community-associated (27.2% for CRE vs 64.5% for ESBL-E). A greater proportion of children with CRE than ESBL-E underwent acute care hospitalization (46.8% vs 22.5%) or surgery (38.6% vs 9.5%) within 1 year before specimen collection, while ESBL-E cases were significantly more likely than CRE cases to have no reported healthcare exposures (65.1% vs 27.2%).

The study authors say the increasing prevalence of community-associated ESBL-E UTIs mirrors trends observed in adult patients and highlights the need to monitor pediatric populations for these pathogens.

"Continued implementation of national programs to detect, prevent, and treat multidrug-resistant infections must increasingly include pediatric populations and outpatient settings," they wrote.

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