JULY 2023

by Editorial Board last updated Jan 26, 2024 08:47 AM

SARS-CoV-2 / COVID-19

US Approval of Nirsevimab-alip

  • The US FDA has approved nirsevimab-alip (brand name Beyfortus), a monoclonal antibody that provides passive immunization against respiratory syncytial virus (RSV) by targeting the prefusion conformation of the fusion (F) glycoprotein. It is indicated for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Safety and efficacy are supported by three clinical trials. Nirsevimab has been available in the European Union since October 31, 2022. It will be available in the US ahead of the upcoming 2023-2024 RSV season.
  • Dosage for neonates and infants born during or entering their first RSV season:
    • Body weight at time of dosing <5 kg: 50 mg IM x1
    • Body weight at time of dosing ≥5 kg: 100 mg IM x1
  • Dosage for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season:
    • 200 mg IM x1, administered as two 100 mg injections
  • Product availability: Prefilled syringes, 50 mg/0.5 mL and 100 mg/mL
  • See FDA news release here.

New Product for Molluscum Contagiosum

  • The US FDA has approved cantharidin 0.7% topical solution (brand name Ycanth) for the treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. It is the first FDA-approved treatment for molluscum. Health care providers are to apply a single application to each lesion every three weeks as needed. See FDA news release here.

US Approval of Anthrax Vaccine Adsorbed, Adjuvanted

  • Cyfendus, an adjuvanted formulation of Biothrax, has been FDA approved for PEP only (not PrEP).
  • Cyfendus eliminates the need for a third dose at 4 weeks for PEP.  Concomitant antibiotics are still necessary.
  • This vaccine simplifies the response to a large-scale public health emergency involving anthrax.
  • 3 million doses of Cyfendus (labelled AV7909) are already in US government stockpiles.
  • Detailed guidelines for use are pending ACIP recommendations, but dose and timing will be per FDA labeling.
  • See Anthrax, Vaccine page for more information.

Locally Acquired Malaria in the US

  • CDC issued a Health Advisory (CDCHAN-00494) to share information regarding five US residents (four in Florida, one in Texas) diagnosed with locally-acquired, mosquito-transmitted Plasmodium vivax. In the US, most cases of malaria are diagnosed in people who have traveled to an endemic region. Locally acquired mosquito-borne malaria has not occurred in the US since 2003. Despite these cases, the risk of locally acquired malaria remains extremely low.

RSV Vaccine: Key Points

  • The CDC Advisory Committee on Immunization Practices (ACIP) now advises that adults aged ≥60 years MAY receive a single IM dose of a respiratory syncytial virus (RSV) vaccine with either Abrysvo (Pfizer; unadjuvanted) or Arexvy (GSK; uses same adjuvant as Shingrix), using shared clinical decision-making. Immunocompromised persons SHOULD be vaccinated even if such individuals were not included in the clinical trials.
  • Both vaccines demonstrated significant vaccine effectiveness against RSV induced lower respiratory tract infection among older adults that lasted over at least 2 consecutive seasons; a second dose after 1 year conferred no additional protection. Data were insufficient (few cases in placebo group) to determine statistically significant vaccine effectiveness in persons aged ≥75 years or against hospitalization. Co-administration with all types of influenza vaccine appears safe without statistically significant effect on vaccine effectiveness for either vaccine, although titers for each vaccine were somewhat lower. Availability of both vaccines is anticipated for the 2023-24 winter RSV season (mid-September through mid-May; peaks late December to mid-February). Vaccination is recommended as soon as vaccine becomes available. Cost is expected to be USD 180-270 for Abrysvo and USD 200-295 for Arexvy.
  • A review of the prevalence, clinical characteristics, and outcomes of RSV infections vs. influenza in adults hospitalized with acute respiratory illness over a three-year period suggests that outcomes are worse in persons with RSV, and they frequently have underlying cardiopulmonary conditions (Clin Infect Dis 2023;76:1980).

New Clinical Practice Guidelines

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of July 10, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • New shortages since June 12, 2023:
      • Cefdinir (all oral formulations)
      • Neomycin and Polymyxin B Sulfates GU Irrigant
      • Podofilox 0.5% topical gel
      • Tedizolid 200 mg tablets
    • Shortage recently resolved:
      • Azithromycin injection
      • Clotrimazole 10 mg oral troches
      • Rifampin injection
      • Rifapentine 150 mg tablets
      • Rifaximin tablets (200 mg, 550 mg)
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Neomycin tablets
        • Tobramycin injection
      • Bacitracin ophthalmic ointment (unavailable)
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefixime 400 mg capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin injection
        • Ciprofloxacin 0.3% ophthalmic solution
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin (all oral formulations)
        • Amoxicillin-clavulanate (all oral formulations)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection (Bicillin-LA)
        • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR)
        • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
      • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs: 
      • Amphotericin B injection
      • Amphotericin B Lipid Complex (ABLC)
    • Antimycobacterial drugs: 
      • Isoniazid injection (100 mg/mL)
      • Isoniazid 100 mg, 300 mg tablets
      • Rifampin capsules
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Oseltamivir capsules, powder for oral suspension
      • Ribavirin for inhalation solution
      • Valganciclovir tablets, powder for oral solution
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
    • Ritonavir oral solution 80 mg/mL (January 2023)
    • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
    • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
    • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
    • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)