Most COVID-19 monoclonal antibody treatments are no longer available in the United States. The well-known options from earlier in the pandemic, including Regeneron, sotrovimab, bebtelovimab, and Evusheld, have all lost their emergency use authorizations because they don’t work against current variants. As of the most recent FDA updates, only one monoclonal antibody is authorized for COVID prevention, and it’s restricted to a narrow group of patients.
What’s Still Available
Pemgarda (pemivibart) is the only COVID-19 monoclonal antibody currently authorized for use in the U.S. It received emergency use authorization in March 2024 and is designed for pre-exposure prophylaxis, meaning it’s given before you get infected to reduce your risk. It is not a treatment you receive after testing positive.
This is an important distinction. If you already have COVID and are looking for monoclonal antibodies to treat your infection, there are currently no authorized monoclonal antibody treatments for mild-to-moderate COVID in non-hospitalized adults. Antiviral medications like Paxlovid and remdesivir remain available for treating active infections in high-risk patients. For hospitalized adults with severe COVID, tocilizumab (Actemra) has full FDA approval, and it remains authorized under emergency use for hospitalized children ages 2 to 17.
Who Qualifies for Pemgarda
Pemgarda is not available to the general public. It’s authorized only for people who are moderately to severely immunocompromised, at least 12 years old, and weigh more than 88 pounds. The FDA defines this group as people whose immune systems can’t mount an adequate response to vaccines or infections because of a medical condition or treatment.
Common qualifying conditions include being a solid organ transplant recipient, a stem cell transplant recipient, or receiving chemotherapy for blood cancers like lymphoma or leukemia. People on other immune-suppressing therapies may also qualify. Your prescribing doctor determines eligibility based on your specific medical situation.
How to Get a Prescription
You cannot walk into a pharmacy or urgent care and request Pemgarda. The process starts with the specialist managing your immunocompromising condition, whether that’s a transplant team, oncologist, or rheumatologist. They can evaluate whether you qualify and write a prescription. Your primary care doctor can also initiate the conversation and refer you if needed.
Because Pemgarda must be given in a medical setting equipped to handle severe allergic reactions, including anaphylaxis, you’ll receive it at a hospital infusion center, specialty clinic, or similar facility. It cannot be self-administered at home. After the infusion, you’ll typically be monitored for about 90 minutes to watch for adverse reactions before being sent home.
The HHS Treatments Locator at treatments.hhs.gov lists pharmacies and clinics that stock COVID-19 therapeutics, though the site notes that monoclonal antibodies may not appear on its map. Your best path is through your specialist’s office, which can coordinate where to send you for the infusion.
How Well Pemgarda Works
Pemgarda was originally authorized when the JN.1 variant dominated in the U.S. Lab testing showed its ability to neutralize that variant was comparable to earlier monoclonal antibodies that had proven clinical effectiveness for prevention. As newer variants emerged, the FDA continued evaluating whether it kept working.
Against the KP.3.1.1 and LB.1 variants that circulated in late 2024, Pemgarda required roughly 2 to 3 times more concentration to neutralize the virus compared to JN.1. The FDA assessed this as still adequate. However, the agency monitors this continuously and can revoke or limit the authorization if new variants escape the antibody’s reach, exactly as it did with every previous monoclonal antibody treatment.
Side Effects
The most common side effects reported in clinical trials were fatigue, nausea, and headache. The most serious risk is anaphylaxis, a severe allergic reaction that occurred in about 0.6% of trial participants (4 out of 623 people). Other milder allergic and infusion-related reactions were also reported. This is why the treatment must be given in a setting with emergency medications on hand, and why you’re monitored afterward.
If you experience anaphylaxis or any severe systemic reaction, the FDA says the treatment should be permanently discontinued. You would not receive a second dose.
Cost and Insurance Coverage
Because Pemgarda is still under emergency use authorization, coverage varies. Medicare Part B generally covers infusion therapy services and pays 80% of the approved amount, leaving you responsible for 20% plus the Part B deductible. What you actually owe depends on whether your provider accepts Medicare assignment and what other insurance you carry.
Private insurance coverage is less standardized. Some plans may cover the infusion as a specialty pharmacy benefit, while others may require prior authorization. Contact your insurer before scheduling the infusion to understand your out-of-pocket costs. Your specialist’s office can often help navigate prior authorization paperwork.
Why Most Treatments Were Pulled
Every monoclonal antibody works by binding to a specific part of the virus. As SARS-CoV-2 mutated, the shapes those antibodies targeted changed enough that the drugs could no longer latch on effectively. Regeneron’s cocktail (casirivimab and imdevimab) lost authorization in January 2022. Sotrovimab followed in April 2022. Bebtelovimab was pulled in November 2022. Evusheld, the previous prevention option for immunocompromised patients, was deauthorized in January 2023 after data showed it was unlikely to work against variants causing more than 90% of U.S. infections at the time.
This pattern is important context. Monoclonal antibodies are not a permanent solution. They work until the virus evolves past them, and every product authorized so far has eventually been sidelined for this reason. Pemgarda could face the same fate if future variants change enough in the region of the virus it targets.