Evusheld repeat dosing update – On June 29, 2022, the FDA made a recommendation for the repeat dosage of EVUSHELD in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) is 300 mg of tixagevimab and 300 mg of cilgavimab be administered every 6 months. Repeat dosing should be timed from the date of the most recent EVUSHELD dose. The recommendations for dosing are based on the totality of the scientific evidence including clinical pharmacology data, antiviral activity data, and clinical trial data. Please review the Evusheld EUA fact sheet (fda.gov).
The spectrum of medical therapies to treat COVID-19 is rapidly evolving. Currently Paxlovid, Lagevrio(Molnupiravir) and Bebtelovimab are therapeutic products available that have received Emergency Use Authorizations (EUAs) from the Food and Drug Administration (FDA). These therapeutics are for the treatment of mild to moderate COVID-19 in non-hospitalized patients with laboratory-confirmed SARS-CoV-2 infection who are at high risk for progressing to severe disease and/or hospitalization. Tixagevimab/Cilgavimab (Evusheld) is used for the prevention of severe illness in immunocompromised individuals. Distribution for these therapeutics is provided by US Health and Human Services and facilitated by WA Department of Health.
Monoclonal Antibodies (mAbs)
Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens. The following products have been granted Emergency Use Authorization by the Food and Drug Administration:
- Bebtelovimab is a neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2 that maintains binding and neutralizing activity across currently known and reported variants of concern, including Omicron and BA.2.
Oral antiviral drugs are prescription medicines that fight against the COVID-19 virus in the body. Antiviral drugs are not sold over the counter, and can only be received from a licensed healthcare provider. Antiviral drugs are different from antibiotics, which fight against bacterial infections. Two products have been granted EUAs by the FDA:
- Molnupiravir (Merck) - these are activated through metabolization in the body and disrupt the virus's reproduction. This is administered orally via a pill.
- Paxlovid (Pfizer) - these work inside the cell inhibiting an enzyme that the virus makes to replicate itself. This is administered orally as a pill.
Pre-exposure Prophylaxis (PrEP)
Pre-exposure Prophylaxis (PrEP) is authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not been exposed to an individual infected with SARS-CoV-2. The authorization also requires individuals either have:
- moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination (examples of such medical conditions or treatments can be found in the fact sheet for healthcare providers) or;
- a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines, therefore vaccination with an available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended.
There is one product that has been granted Emergency Use Authorization by the FDA.
- Tixagevimab/Cilgavimab (EVUSHELD) - these work by supplying antibodies to resist breakdown in cells. This is administered as an intramuscular injection.
Find Providers with COVID-19 Therapeutics
The COVID-19 Therapeutic Locator map provided by HHS displays locations that have received shipments of U.S. Government-procured COVID-19 therapeutics under the U.S Food and Drug Administration (FDA) Emergency Use Authorization (EUA) authority. The locations displayed in the locator have reported stock on hand within the last 2 weeks.
For a detailed list of providers who have received COVID-19 therapeutics, please download the COVID-19 Therapeutic Allocation Data (XLSX) report.