The FDA has expanded the emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for postexposure prophylaxis for COVID-19 in adults and pediatric patients aged 12 years and older and weighing at least 40 kg.

The preventive use of the monoclonal antibody combination is limited to those who are at high risk for progression to severe COVID-19, including hospitalization or death.

That has special significance for pharmacists, who recently have been authorized to order and administer monoclonal antibody therapy. Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens, such as viruses like SARS-CoV-2.

"In this revision of the EUA, bamlanivimab and etesevimab, administered together, are authorized for use after exposure to the virus and are not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus," according to the FDA, which says that healthcare providers should review the fact sheet for detailed information about the use of this therapy for postexposure prophylaxis. 

An unusual twist to the EUA is that bamlanivimab and etesevimab are not authorized for use in states, territories, and U.S. jurisdictions in which the combined frequency of variants resistant to the combo treatment exceeds 5%. The list, available here, will be frequently updated.

The FDA notes that bamlanivimab and etesevimab, administered together, also remain authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patient—12 and older weighing at least 40 kg—who have received positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death.

"Post-exposure prophylaxis as authorized with bamlanivimab and etesevimab, administered together, is not a substitute for vaccination against COVID-19," the FDA emphasizes in a press release.

Bamlanivimab and etesevimab, administered together, are authorized as postexposure prophylaxis only in the following patients:

• Those at high risk for progression to severe COVID-19, including hospitalization or death, and

• Those not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, people with immunocompromising conditions, including those taking immunosuppressive medications), and have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per the CDC, or who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes or prisons).

Licensed pharmacists became authorized to order and administer certain COVID-19 therapeutics, including subcutaneous monoclonal antibodies, as the result of actions in early September by the Department of Health and Human Services. HHS announced an amendment to the COVID-19 Public Readiness and Emergency Preparedness (PREP) Act declaration to allow pharmacists to expand their practices in that way.

COVID-19 therapeutics included in the amendment are those given orally, subcutaneously, or intramuscularly and include current and future medications that are approved, authorized, cleared, or licensed to treat or prevent COVID-19. Perhaps most significant at this point are monoclonal antibodies.

At the urging of a range of pharmacy groups, authorized to administer the therapeutics are licensed pharmacists, licensed or registered pharmacy interns, and qualified pharmacy technicians who meet the criteria in the amendment.

"We applaud the PREP Act declaration amendment and look forward to continuing to work with HHS and the White House to further leverage the knowledge and skills of our pharmacy workforce to bring an end to this pandemic," said Tom Kraus, the ASHP's vice president of government relations of the American Society of Health-System Pharmacists. "The PREP Act declaration allowing pharmacists to order and administer COVID-19 therapeutics will significantly expand patient access to needed treatments and post-exposure prophylaxis, particularly in medically underserved areas. The ASHP has been excited to partner with HHS and the White House on this effort which will result in broader patient access to COVID-19 therapies that can prevent severe illness."

The ASHP points out that several states, including Arkansas, Mississippi, and Oregon, have already implemented statewide standing orders or protocols to allow pharmacists to independently order and administerÊREGEN-COVÊCOVID-19 monoclonal antibodies.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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