On November 30, 2022 The U.S. Food and Drug Administration announced that bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1., according to data included in the Health Care Provider Fact Sheet.
Nowcast data from the Centers for Disease Control and Prevention published last week estimates that the combined proportion of COVID-19 cases caused by the Omicron BQ.1 and BQ.1.1 subvariants to be above 57% nationally, and already above 50% in all individual regions but one, and data shows a sustained trend of increasing prevalence across all regions. Given that a COVID-19 infection is likely to be caused by a non-susceptible SARS-CoV-2 variant and consistent with the terms and conditions of the Letter of Authorization, bebtelovimab is not currently authorized for emergency use in any U.S. region at this time.
On July 6, 2022, the FDA revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. Please review the FDA announcement for additional details.
For continued updates on all Therapeutic products visit the ASPR COVID-19 Website.
The spectrum of medical therapies to treat COVID-19 is rapidly evolving. Currently Paxlovid, Lagevrio(Molnupiravir) 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. Currently, there is no mAbs authorized for emergency use. Check the ASPR website for the current Therapeutic products available.
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.