Monoclonal antibody treatments for active COVID-19 infections are no longer available in the United States. The FDA revoked authorization for earlier treatment products (like bamlanivimab, casirivimab/imdevimab, and others) after they lost effectiveness against newer variants. The one monoclonal antibody product still authorized, Pemgarda, is only for prevention in immunocompromised people, not for treating an active infection. If you’re currently sick with COVID-19, other treatments are available and work within a different timeline.
What Happened to Treatment Monoclonal Antibodies
During the first two years of the pandemic, several monoclonal antibody products were authorized for treating COVID-19 in high-risk patients. These lab-made proteins targeted the spike protein on the virus’s surface, blocking it from entering cells. The problem is that the virus mutates, and the spike protein changes shape. Products like bamlanivimab lost all protective activity against certain variants, while others like casirivimab showed substantial drops in effectiveness against strains carrying specific mutations.
As newer variants became dominant, the FDA pulled authorization for these treatments one by one. No monoclonal antibody product is currently authorized in the U.S. for treating someone who already has COVID-19.
Pemgarda: Prevention for Immunocompromised People
The only COVID-19 monoclonal antibody still authorized is Pemgarda (pemivibart), and it serves a very specific purpose: pre-exposure prevention for people whose immune systems can’t mount an adequate response to vaccination. It is not authorized for treating COVID-19 or for use after a known exposure to someone who is infected.
To qualify for Pemgarda, you must be 12 or older, weigh at least 88 pounds, and have moderate-to-severe immune compromise. The FDA defines that category to include people who are:
- Undergoing cancer treatment for solid tumors or blood cancers
- Living with certain blood cancers that respond poorly to vaccines regardless of treatment status, such as chronic lymphocytic leukemia, non-Hodgkin lymphoma, or multiple myeloma
- Organ or stem cell transplant recipients taking immunosuppressive medications
- Living with a primary immunodeficiency such as common variable immunodeficiency or severe combined immunodeficiency
- Living with advanced HIV with very low immune cell counts or a history of AIDS-defining illness
- Taking high-dose immunosuppressive drugs for extended periods, including certain corticosteroids, chemotherapy agents, or biologic drugs that suppress immune function
Pemgarda is given as a single intravenous infusion over at least 60 minutes. If ongoing protection is needed, the dose is repeated every three months. You’ll typically be monitored for at least one hour after the infusion is complete.
How to Get Pemgarda If You Qualify
You’ll need a prescription from your doctor. The most straightforward path is to bring it up with the specialist managing your immune condition, whether that’s an oncologist, transplant team, rheumatologist, or infectious disease doctor. They can evaluate whether you meet the eligibility criteria and refer you to an infusion center.
In practice, the referral process can vary. At large hospital systems, the infusion center often handles scheduling and patient contact once a referral is placed. In smaller or private practices, your doctor may need to identify a local infusion site and coordinate directly. If you test positive for COVID or have had a recent known exposure, you won’t qualify, since the authorization covers only pre-exposure prevention.
Medicare Part B covers FDA-authorized monoclonal antibody products with no out-of-pocket cost when you receive them from a Medicare provider. If you’re on a Medicare Advantage plan, check with your plan about specific coverage. For private insurance, coverage varies, so call your insurer before scheduling.
Treatment Options If You’re Sick Right Now
If you currently have COVID-19 and are at high risk for severe illness, antiviral medications have replaced monoclonal antibodies as the standard outpatient treatment. Treatment needs to start as soon as possible and within five to seven days of symptom onset, so acting quickly matters.
The first-choice option is an oral antiviral (ritonavir-boosted nirmatrelvir) taken twice daily for five days, started within five days of symptoms. A three-day course of intravenous remdesivir, started within seven days, is the second option. A third antiviral, molnupiravir, is available within five days of symptom onset when the other options aren’t suitable.
You’re considered high risk if you’re 50 or older, or if you have conditions like diabetes, heart disease, chronic kidney or liver disease, obesity, chronic lung conditions, cancer, an immunocompromised state, pregnancy, or several other conditions on the CDC’s list. The full list is broad and includes mental health conditions, substance use disorders, smoking history, and physical inactivity.
Getting Treated Quickly
The biggest barrier to COVID treatment has always been the clock. You need a positive test result and a prescription before the treatment window closes. If you develop symptoms and are at higher risk, test immediately with a home rapid test or at a clinic. Contact your doctor’s office right away with the result. Some clinicians have set up systems where patients can call or message directly with a positive test to fast-track a prescription, bypassing the need for an in-person visit.
Telehealth visits are another option for getting a prescription quickly. Many health systems and pharmacies now offer virtual consultations specifically for COVID treatment. The oral antiviral can be picked up at a pharmacy the same day, making it the fastest path from positive test to treatment. If your provider recommends intravenous remdesivir instead, you’ll need to visit an infusion center for three consecutive days, with each session requiring the infusion time plus a monitoring period afterward.