December ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. To sign up for ID updates to your inbox, register here.
 

December 2021

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • December 9: The US FDA amends the Pfizer-BioNTech COVID-19 vaccine EUA to authorize the use of a single booster dose to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech vaccine.
  • December 8: The US FDA issues an EUA for tixagevimab co-packaged with cilgavimab and administered together for the pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals (≥12 years of age weighing ≥40 kg). Authorization is only for individuals who are not currently infected with SARS-CoV-2 and who have not recently been exposed to an infected individual. The EUA also requires that individuals either have a moderate to severely compromised immune system or a history of severe adverse reaction to vaccination.
  • December 3: The US FDA amends the EUA of bamlanivimab and etesevimab (previously authorized for pediatric patients ≥12 years of age weighing ≥40 kg), authorizing the combination for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death. This revision also authorizes the combination for post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalization or death. Fact sheet here.
  • November 23: The US FDA amends the EUA for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. 
  • November 4: The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK authorizes the use of the orally administered drug molnupiravir (Lagevrio) for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease. The authorized dose is 800 mg (four 200 mg capsules) every 12 hours for 5 days.
  • CDC: Interim public health recommendations for fully vaccinated people here.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2021 Nov 22 [online ahead of print]). Available at PMC.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.
  • Saudi Critical Care Society practice guidelines on the management of COVID-19 in the ICU: therapy section (J Infect Public Health 2021 Oct 20 [online ahead of print]). Last updated in 2020. Available at PMC.

US FDA New Product Approval

  • Maribavir* for the treatment of adults and pediatric patients (≥12 years of age, weight ≥35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet. Maribavir inhibits human CMV-encoded kinase pUL97, an important enzyme in viral replication. HCMV pUL97 is also responsible for the activation of ganciclovir. Recommended dosage: 400 mg (two 200 mg tablets) po twice daily, with or without food.

New or Updated Practice Guidelines

  • Executive summary. Guidelines for chlamydial urethritis, from the Asian Association of Urinary Tract Infection and Sexually Transmitted Infection (J Infect Chemother 2021 Dec 6 [online ahead of print]).
  • Joint Healthcare Infection Society (JIS) and Infection Prevention Society (IPS) guidelines for the prevention and control of methicillin-resistant Staphylococcus aureus (MRSA) in healthcare facilities (J Hosp Infect 2021;118S:S1).
  • Prevention, diagnosis, and management of post-surgical mediastinitis in adults: consensus guidelines of the Spanish Society of Cardiovascular Infections, the Spanish Society of Thoracic and Cardiovascular Surgery, and the Biomedical Research Centre Network for Respiratory Diseases (J Clin Med 2021;10(23):5566). Available at PMC.
  • Clinical practice guidelines for the prevention and management of tick-borne illness in the United States, from the Wilderness Medical Society (Wilderness Environ Med 2021 Oct 9 [online ahead of print]). PDF available here.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of December 13, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since November 8, 2021:
      • Amphotericin B injection
      • Doxycycline oral suspension
      • Rifapentine tablets
    • Shortage recently resolved:
      • Cefotetan injection
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Gentamicin sulfate 3% ophthalmic ointment
        • Neomycin tablets
        • Tobramycin injection
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefepime injection
        • 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),
        • Ceftazidime injection
        • Ceftolozane-tazobactam injection
      • Clindamycin injection
      • Ethambutol tablets
      • Fluoroquinolones:
        • Ciprofloxacin 0.3% ophthalmic solution
        • Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Ampicillin-sulbactam injection
        • Dicloxacillin capsules
        • Piperacillin-tazobactam injection
      • Topical (miscellaneous) antibacterials:
        • Bacitracin ophthalmic ointment
        • Neomycin and Polymyxin B sulfates GU irrigant
        • Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment
        • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
        • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply
      • Clotrimazole 10 mg oral troches
      • Hydroxychloroquine tablets
      • Tocilizumab injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant
  • Antimicrobial drugs recently discontinued: 
    • 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)