There continues to be a shortage of the currently authorized monoclonal antibodies (mAb) and increased demand for treatment. This bulletin includes the most recently available updates on mAb shipping and supply and COVID-19 treatment recommendations. Additional details are available in the attached update from the New York State Department of Health (DOH), which will also be posted to the DOH COVID-19 mAb therapeutics webpage.
Bamlanivimab, Etesevimab, REGEN-COV Updates
Due to the Omicron variant’s increasing frequency, the US Department of Health and Human Services (HHS) has paused allocations of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV pending updated data from the Centers for Disease Control and Prevention. DOH did not receive an allocation of these products the week of December 27. DOH has shipped all orders from December 20 and has distributed all product from the last ordering cycle. New requests for these mAb treatments cannot be fulfilled at this time. Providers that submitted a request last week should resubmit their request when the DOH ordering form is open for order submissions this Thursday.
New York State has received a very limited supply of sotrovimab, another mAb treatment, which appears to remain effective against the Omicron variant for prevention of severe disease. HHS shipped 55,000 doses of sotrovimab last week, of which approximately 4,000 went to New York State. DOH has shipped all available product to providers that placed an order. An additional 300,000 doses of sotrovimab will be available for national distribution in January. The amount that will be allocated to New York State is currently unknown, and DOH expects its next allocation to arrive the week of January 3. GNYHA will continue working closely with DOH and will share updates as they become available.
Oral Antivirals Updates – Paxlovid and Molnupiravir
The Food and Drug Administration (FDA) recently issued emergency use authorization for two oral antivirals, paxlovid and molnupiravir. DOH expects the products to ship on December 28, and will begin filling orders to select pharmacies on December 29. The list of pharmacies that will receive oral antiviral shipments is in the appendix of the attached DOH notice. Additional pharmacies will receive shipments as more product is available.
Providers should contact pharmacies to confirm treatment availability. GNYHA will continue to communicate supply and shipment information.
Updated Treatment Recommendations
The National Institutes of Health has issued updated mAb treatment recommendations in light of product shortages and certain product inactivity against the Omicron variant. Recommendations include the use of remdesivir via IV infusion on an outpatient basis. Remdesivir is currently FDA-approved for hospitalized individuals. Use of the drug for outpatient treatment would be an off-label indication. DOH updated its prioritization guidance in accordance with these recommendations and in light of the shortages. New guidance is attached and will soon be available on the DOH monoclonal antibodies page.
Providers considering this option should note that the recommendation is for three infusions over three consecutive days. The administration setting should be able to manage severe hypersensitivity reactions and observe the patients during the infusion plus one hour after. Providers are encouraged to identify a facility offering this option and make arrangements in advance. Patients should not be sent to the hospital to request treatment.
Additional mAb Information
The New York City Department of Health and Mental Hygiene will update its COVID-19 treatment and provider pages when information is available. Additionally, GNYHA continues to list available New York City, Long Island, and Westchester mAb treatment sites on the HITE (Health Information Tool for Empowerment) website. Please e-mail email@example.com to update your listing if your services have changed.