Emergent’s mission is to protect and enhance life by providing vaccines and therapeutics for urgent public health threats, like the current mpox outbreak, and offering contract development and manufacturing services.

Image credit: Emergent BioSolutions

The World Health Organization (WHO) has called on manufacturers of mpox in vitro diagnostics (IVDs) to submit expressions of interest for Emergency Use Listing (EUL). This move, aimed at addressing the urgent need for effective diagnostics, comes as suspected mpox cases rise, particularly in the Democratic Republic of the Congo (DRC), which reported around 1000 suspected cases last week.¹

To combat the outbreak, WHO has increased testing capacity and established six new labs in affected provinces, including South Kivu. Testing rates have quadrupled in 2024 compared to the previous year. WHO’s updated diagnostic guidance now includes protocols for detecting a new viral strain, Ib, and additional tests are being dispatched to African countries, with 30,000 more scheduled for delivery in the coming weeks.¹

WHO’s updated diagnostic guidance includes protocols for detecting the new virus strain. Earlier, WHO issued target product profiles to assist manufacturers in developing new diagnostic tests. The organization has delivered approximately 150,000 tests globally since 2022, with over a quarter allocated to African countries. An additional 30,000 tests are set to be delivered to Africa in the coming weeks.¹

Concurrently, Emergent BioSolutions Inc announced that the FDA has approved its supplemental Biologics License Application (sBLA) for ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live). This approval expands the vaccine’s use to include mpox prevention in high-risk individuals. ACAM2000, initially approved for smallpox in 2007, is now also indicated for mpox, an infectious disease endemic to Africa.2

ACAM2000 is a single-dose vaccine delivered using a bifurcated needle. Originally approved by the FDA in 2007 for preventing smallpox, it is now also indicated for mpox.²

The approval comes as mpox cases surge globally, prompting the WHO to declare a public health emergency. The company has filed an Expression of Interest with WHO to add ACAM2000 to the EUL and will donate 50,000 doses for potential deployment in Central Africa.²

Emergent’s CEO, Joe Papa, emphasized, “This expanded indication for ACAM2000 comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases. We believe Emergent is poised to support the global response needed by actively engaging with world health leaders, as well as deploying product currently available in inventory based on the needs, as well as the ability to increase supply.”²

The 2022 global outbreak of clade II mpox saw over 95,000 cases across 115 non-endemic countries. The clade I variant, including the newly identified clade Ib strain, has shown more severe outcomes, increasing the urgency for effective vaccines like ACAM2000 in the present day.

ACAM2000 is also stockpiled in the US and internationally for bioterrorism emergencies and is licensed in Canada, Australia, and Singapore. The vaccine’s labeling includes warnings for individuals with severe immunodeficiency and risks such as myocarditis and skin infections.

References

1. WHO urges rapid access to mpox diagnostic tests, invites manufacturers to emergency review. WHO. August 29, 2024. Accessed September 3, 2024. https://www.who.int/news/item/29-08-2024-who-urges-rapid-access-to-mpox-diagnostic-tests–invites-manufacturers-to-emergency-review#:~:text=WHO%20has%20asked%20manufacturers%20of,particularly%20in%20low%2Dincome%20settings.

2. Emergent BioSolutions’ ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication; Public Health Mpox Outbreak Continues Across Africa & Other Regions. Emergent. August 29, 2024. Accessed September 3, 2024. https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-acam2000r-smallpox-and-mpox-vaccinia

Food poisoning-related terms, salmonella, listeria, etcS

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August 2, 2024: Metro Produce Distributors Inc announced a voluntary recall of all Lunds & Byerlys fresh guacamole products due to potential contamination with Listeria monocytogenes.

The affected products include Lunds & Byerlys Fresh Guacamole (14 oz), Lunds & Byerlys Fresh Smokin’ Guacamole (10 oz), Lunds & Byerlys Fresh Spicy Guacamole (10 oz), Lunds & Byerlys Pico de Gallo/Guacamole Tray (18 oz), and Lunds & Byerlys Deli Guacamole (56 oz). These items were sold at Lunds & Byerlys stores and select Taco Mas food bars in the Twin Cities and St Cloud, MI between July 27 and 31, and are packaged in clear plastic containers. The recall was initiated following a routine sampling that detected the potential presence of listeria. To date, no illnesses have been reported. Production and distribution of the products have been halted as the investigation continues under the oversight of the US Food & Drug Administration and the Minnesota Department of Agriculture.

August 4, 2024: Thal Golden Spices Inc recalls Bikano Moong Dal due to Salmonella risk

Thal Golden Spices Inc is recalling 640 packs of Bikano Moong Dal (350g) due to potential contamination with Salmonella. The affected product, distributed in California retail stores, is identified as Bikano Moong Dal Plain, with a best used by date of June 25, 2025. No illnesses have been reported to date. The recall follows an FDA inspection that revealed discrepancies in batch numbers and an oversight in the distribution process. The product was released without proper lab results.

August 8, 2024: North Fish USA Inc. recalls “Cold Smoked Capelin” due to Clostridium botulinum risk

North Fish USA Inc is recalling 9-ounce packages of “Cold Smoked Capelin” due to potential contamination with Clostridium botulinum, a bacterium that can cause botulism, a severe and potentially fatal foodborne illness. The recall affects products distributed in New York and Georgia and includes packages with UPC code 4811527003360 and best-before dates of 7.13.2024 and 1.5.2025. Consumers are advised not to use the product, even if it appears unaffected, and to return it for a full refund. The potential contamination was identified during a routine inspection by the New York State Department of Agriculture and Markets. No illnesses have been reported.

August 28, 2024: Boar’s Head ongoing listeria outbreak

The CDC updated its report on the listeria outbreak linked to Boar’s Head deli meat, which has now resulted in 9 deaths, 57 hospitalizations, and cases across 18 states. The outbreak is associated with Boar’s Head Ready-to-Eat Liverwurst produced between June 11 and July 17, 2024, with sell-by dates ranging from July 25 to August 30, 2024. The affected products include 3.5-pound loaves and various sliced packages, labeled with “EST. 12612” or “P-12612.” Boar’s Head has clarified that the recall specifically involves certain deli-sliced products and some pre-packaged items from one plant, while most of their products are unaffected. Businesses are advised to clean and sanitize all surfaces and discard any opened recalled products. Consumers should not consume the recalled items but instead, return or discard them.

References

1. Metro Produce Distributors Inc. Recalls Fresh Guacamole Because of Possible Health Risk. FDA. August 2, 2024. Accessed August 30, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/metro-produce-distributors-inc-recalls-fresh-guacamole-because-possible-health-risk

2. Thal Golden Spices Inc. Recalls Product Because of Possible Health Risk. FDA. August 4, 2024. Accessed August 30, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/thal-golden-spices-inc-recalls-product-because-possible-health-risk

3. North Fish USA Inc. Recalls “Cold Smoked Capelin” Because of Possible Health Risk. FDA. August 8, 2024. Accessed August 30, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/north-fish-usa-inc-recalls-cold-smoked-capelin-because-possible-health-risk

4. Listeria Outbreak Linked to Meats Sliced at Delis. CDC. August 28, 2024. Accessed August 30, 2024. https://www.cdc.gov/listeria/outbreaks/delimeats-7-24.html

A study found no statistically significant differences in surgical site infections between the two groups, suggesting that both antiseptics are effective when used consistently.

Povidone iodine was found non-inferior to chlorhexidine gluconate in the largest randomized trial to compare the alcohol-based solutions for skin antisepsis in surgery.The findings support the CDC recommendation that either can be used, and should serve as impetus for the WHO to reconsider recommending only chlorhexidine gluconate.¹

In an editorial accompanying the study, JAMA associate editors Anthony Charles, MD, MPH, Department of Surgery, University of North Carolina School of Medicine, Chapel Hill, NC, and Preeti Malani, MD, MS, Infectious Diseases and Geriatric Medicine, University of Michigan, Ann Arbor, MI, consider the implications for global surgery.²

“In addition to other evidence-based perioperative measures, the results of the study by Widmer et al provide more options for skin antisepsis, particularly in resource-limited settings given the large cost differential between povidone iodine and chlorhexidine gluconate in alcohol and the limited commercial availability of chlorhexidine gluconate-based antiseptics in some settings,” Charles and Malani indicate.

Andreas Widmer, MD, MS, University Hospital Basel and University of Basel, Basel, Switzerland, and colleagues evaluated outcomes in over 3000 patients after cardiac or abdominal surgery with skin antisepsis from the different alcohol-based solutions, in a cluster-randomized, crossover non-inferiority trial at 3 tertiary care hospitals.

“Currently the preferred preparation remains controversial because choice of drug, exposure time, and number of applications likely influence the results of skin preparation,” Widmer and colleagues observe.

“There has been a lack of standardization of these factors in previous trials, which did not compare compounds with similar alcohol-based formulations but also had relatively small sample sizes were single center, and/or were limited to specific surgical procedures,” they pointed out.

To address these gaps in evaluating the antiseptics, the investigators randomly assigned each of the 3 sites to one month periods of use of either povidone iodine or chlorhexidine, over 18 consecutive months between September 2018 and March 2020. The sites utilized consistent formulations of the antiseptics, and maintainedstandardized processes of disinfectant application consistent with published protocols.

“Importantly, postdischarge patient follow-up was exceptionally good and ensured adequate identification of outcomes,” the investigators noted. “The risk of confounding through contaminated operations, where proper skin preparation might be less relevant, was reduced by only including elective operations.”

The primary outcome was surgical site infection within 30 days after abdominal surgery and within 1 year after cardiac surgery; with noninferiority margin of 2.5%. Secondary outcomes included surgical site infections, stratified by depth of infection and type of surgery. A total of 1598 patients received povidone iodine and 1762 chlorhexidine gluconate.

Widmer and colleagues report surgical site infections occurred in 80 (5.1%) of those in the povidone iodine group and in 97 (5.5%) of those receiving chlorhexidine gluconate; a difference of 0.4% (95% CI, -1.1%-2.0%).When corrected for clustering, the difference was well within the margin for noninferiority. The calculated unadjusted relative risk for povidone iodine vs chlorhexidine gluconate was 0.92 (0.69-1.23).There were no statistically significant differences between groups by type of surgical procedure.

Noting that the most recent WHO guidelines recommending only chlorhexidene-alcohol are based on low to moderate quality of evidence, Charles and Malani declare, “the current study by Widmer and colleagues provides evidence to the contrary and should prompt a change in the WHO guidance.”

References

1.Widmer AF, Atkinson A, Kuster SP, et al. Povidone iodine vs chlorhexidine gluconate in alcohol for preoperative skin antisepsis. JAMA 2024;332(7):541-549.

2.Charles A, Malani PN. Skin antisepsis to prevent surgical site infections. Implications for global surgery. JAMA 2024;332(7):550.

Erika Lee, MD, MSc, Division of Clinical Immunology and Allergy, Department of Medicine, University of Toronto, Toronto, Ontario, Canada

Six classes of oral antibiotics were found to present increased risk of serious cutaneous adverse drug reactions (cADR) relative to macrolides, in a population-based study1 of over 21,000 patients requiring emergency department (ED) treatment or hospitalization for cADR from over 3 million receiving outpatient antibiotic prescriptions.

“Although speculation exists that some antibiotics are more likely than others to cause cADRS, no population-based studies have explored this claim,” observed Erika Lee, MD, MSc, Division of Clinical Immunology and Allergy, Department of Medicine, University of Toronto, Toronto, Ontario, Canada, and colleagues.

In their earlier review and meta-analysis2 of worldwide prevalence of the rare, but life-threatening Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), antibiotics were implicated for more than one-quarter of the cases worldwide.Among the antibiotic classes, however, they found macrolides associated with lowest risk. The investigators conducted this nested case-control population-based study to ascertain risk of other antibiotic classes relative to the macrolides.

“The present study looked at the class as a whole, but not individual antibiotics in that class,” Lee told Contagion.”The general approach is that once a patient has a severe allergic reaction to one antibiotic, the whole class is generally avoided due to the risk of cross-reactivity.”

The cohort comprised older adults, median age 75 years. This age group is at increased risk for cADRS, Lee and colleagues explain, with several possible contributing factors, including: disproportionately more antibiotic prescriptions than younger people, more exposure to polypharmacy, and more likely to have such comorbidities as kidney insufficiency, liver disease, and malignancies.

Lee and colleagues accessed administrative health databases in Ontario, Canada from April 1, 2002 to March 31, 2022, to identify a cohort of outpatients receiving at least 1 oral antibiotic over that period, and defining the case patients who required ED care or were hospitalized for cADR and who received an antibiotic prescription in the preceding 60 days.Each was matched with up to 4 controls from the same cohort on age, sex, and an antibiotic prescription in the preceding 60 days, but without subsequent cADR.

Patients were excluded if they had received antibiotics from more than 1 class in the 60 days preceding the index date; as well as for prescriptions for other medications associated with serious cADRS in the preceding 90 days, including anticonvulsants, nonsteroidal anti-inflammatory drugs, and allopurinol.

Among a total of 34,114,254 courses of antibiotics, 72,449 were associated with serious cADR requiring ED treatment or hospitalization; a crude rate of 2.12 antibiotic-associated cADRs per 1,000 prescriptions (95% CI, 2.11-2.14).

All antibiotic classes were associated with higher risk for serious cADR than macrolides, with the sulfonamides presenting the highest relative risk (adjusted OR. 2.9; 95% CI, 2.7-3.1). The risk relative to macrolides, in decreasing order are: cephalosporins (aOR, 2.6; 2.5-2.8); “other” antibiotics (aOR, 2.3; 2.2-2.5); nitrofurantoin (aOR, 2.2; 2.1-2.4), penicillins (aOR, 1.4; 1.3-1.5); and fluoroquinolones (aOR, 1.3; 1.2-1.4).

“The finding of nitrofurantoin-associated severe drug allergy is surprising,” Lee commented.” The only indication for this antibiotic is urinary tract infection (UTI), so it is not as commonly used in the general population compared to other antibiotics that are prescribed for various indications.

In our study that concentrated in older adults, and UTI is one of the most common infections in this age group, we were able to identify this association.It would be interesting to see if this association is reproducible in the general population,” Lee suggested.

The investigators advise that “prescribers should preferentially use lower-risk antibiotics when clinically appropriate,” Lee elaborated, in discussing the study and findings.

“When prescribing an antibiotic, there are many factors that go through a physician’s head to balance the safety and efficacy of the treatment,” Lee said. “When there are equally effective options available, our study adds to the knowledge of safety, to consider when selecting an optimal option for the patient.”

References

1. Lee EY, Gomes T, Drucker AM, et al. Oral antibiotics and risk of serious cutaneous adverse drug reactions JAMA Online August 8, 2024. doi:10.1001/jama.2024.11437. Accessed August 20, 2024.

2. Lee EY, Knox C, Phillips EJ. Worldwide prevalence of antibiotic-associated Stevens-Johnson and toxic epidermal necrolysis: A systematic review and meta-analysis. JAMA Dermatol 2023. 159(4):384-392.