Key takeaways:
Pemgarda (pemivibart) is an injectable medication. It’s designed to prevent COVID-19 in people ages 12 and older who are considered moderately to severely immunocompromised. Pemgarda is not a replacement for COVID vaccines, and it can’t be used to treat COVID, either.
Pemgarda is authorized only for emergency use — it’s not fully FDA-approved. It’s expected to be covered by Medicare and most commercial insurance plans when it becomes available.
Pemgarda infusions must be administered at a medical facility. You’ll be closely monitored for side effects during these infusions. Common Pemgarda side effects include infusion reactions, tiredness, and headache. Life-threatening allergic reactions with Pemgarda are also possible, yet extremely rare.
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Pemgarda (pemivibart) is an injectable medication that helps prevent COVID-19 in people ages 12 and older who have weakened immune systems. It’s not fully FDA-approved for use, but it’s available through an emergency use authorization (EUA).
While more research is needed for Pemgarda to gain full approval, current evidence suggests that this medication helps prevent COVID in certain people. It’s understood to be safe, too. But are you eligible to receive Pemgarda? And if you get Pemgarda, can you skip the COVID vaccine?
Here, we’ll answer seven of the most frequently asked questions about Pemgarda.
1. Who is eligible for Pemgarda?
Only certain people are eligible to receive Pemgarda. You must be at least 12 years old, weigh at least 88 lbs (40 kg), and be considered moderately to severely immunocompromised. People who are immunocompromised have a harder time fighting off infections, such as COVID.
Why the restrictions? After receiving the COVID vaccine, people with “healthy” immune systems make antibodies that work to fight off COVID. But if you have a weakened immune system, your body may not make enough of these protective antibodies. Pemgarda helps prevent COVID in immunocompromised people who may not fully respond to COVID vaccines.
A healthcare professional (HCP) who is familiar with your condition can let you know whether Pemgarda could work well for you.
2. How does Pemgarda work?
Pemgarda is a type of monoclonal antibody. This is a lab-made antibody that is very similar to antibodies produced by the immune system.
If you’re considered immunocompromised, this monoclonal antibody for COVID can mimic the antibodies that your immune system has trouble producing on its own. Pemgarda can latch onto the virus that causes COVID, the SARS-CoV-2 virus, if you’re exposed to it. The virus is less likely to enter cells in your body and cause an infection as a result.
Keep in mind that Pemgarda only works to prevent COVID. It’s a type of COVID pre-exposure prophylaxis (PrEP) medication. If you currently have COVID, you may have to wait a while before you can receive the medication.
3. How and where can I receive Pemgarda?
A licensed HCP can prescribe Pemgarda to you. But you won’t be able to receive it at home. The medication needs to be administered at a medical facility.
Pemgarda is given as an infusion into the vein and takes about 1 hour to receive. But if you experience side effects from Pemgarda, the infusion may need to be administered more slowly. This can prolong the administration process. Plan to stick around for at least 2 hours after each infusion so your healthcare team can monitor you for rare but serious side effects and reactions, including anaphylaxis.
After your first dose of Pemgarda, you’ll likely be asked to receive follow-up doses every 3 months. These additional doses will help make sure you stay protected against COVID over time.
4. Is Pemgarda effective against the Omicron variant?
Yes. Pemgarda is effective against the SARS-CoV-2 virus and some newer viral variants, including Omicron.
At the same time, viruses can change and form new variants. We don’t know how effective Pemgarda will be against future strains of the virus. The good news is that with current technology, Pemgarda can be altered to be effective against future variants.
No medication is foolproof, though. So it’s still important to continue taking precautions to protect yourself, including wearing a mask and washing your hands regularly.
You’ll also want to let an HCP know right away if you test positive for COVID or develop any COVID symptoms, including:
Cough
Headache
Sore throat
Fever or chills
Shortness of breath
Nausea or vomiting
Muscle or body aches
Congestion or runny nose
5. What are the potential side effects of Pemgarda?
Most of Pemgarda’s side effects are relatively mild and easy to manage. The most common risks and side effects of this monoclonal antibody for COVID are:
Infusion-related reactions, including bodywide symptoms such as chills and dizziness
Injection site reactions, including localized symptoms such as pain, redness, and soreness where the medication was injected
Infections, including upper respiratory tract infections
Tiredness
Headache
Nausea
If you experience any of these side effects during or after your infusion, let the infusion center staff know right away.
Serious side effects
Pemgarda has a boxed warning for the risk of anaphylaxis. This is the strongest warning that the FDA can give to a medication. Anaphylaxis, an extremely rare but life-threatening allergic reaction, can happen with Pemgarda. Some people have experienced it during and up to 24 hours after their infusions.
Seek emergency medical care right away if you experience any of the following symptoms of anaphylaxis:
Trouble breathing
Throat tightness
Swelling of your face, mouth, or throat
Skin rash
Severe itching
Chills
Fast or slow heart rate
Chest pain
Confusion
Nausea
Headache or dizziness
What’s more, if you’ve ever had an allergic reaction to a COVID vaccine, it’s important that you let your healthcare team know. Pemgarda contains an ingredient — called polysorbate 80 — that’s similar to an ingredient found in some COVID vaccines.
6. Is Pemgarda covered by insurance?
Yes. Pemgarda is expected to be covered by Medicare and most commercial insurance plans.
If you're interested in Pemgarda and believe you're eligible to receive it, reach out to your HCP. They can tell you how and where you can get it. They can also tell you what your expected out-of-pocket costs might be, if any.
7. Is Pemgarda a substitute for COVID-19 vaccines?
No. Pemgarda is not a substitute for COVID vaccines. It’s a supplement to them.
If your immune system is moderately to severely compromised, the CDC suggests that you receive 2 to 3 doses of the COVID vaccine. This includes at least one dose of the updated 2023-2024 COVID vaccine. This is true regardless if you receive Pemgarda.
Good to know: COVID vaccines offer the best defense against illness from COVID. Pemgarda infusions can enhance your protection. But it’s important to wait at least 2 weeks after you get the COVID vaccine before you receive Pemgarda. This will give Pemgarda the best chance to work effectively.
The bottom line
Pemgarda (pemivibart) is a medication used to prevent COVID-19 in people ages 12 and older who are considered moderately to severely immunocompromised. Pemgarda is authorized for emergency use, and it’s administered as an infusion at a medical facility. Common Pemgarda side effects include infusion reactions, tiredness, and headache. While they’re very rare, serious, life-threatening allergic reactions can happen during or after your infusions.
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References
American Cancer Society. (2020). What are infusion or immune reactions?
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Centers for Disease Control and Prevention. (2024). COVID-19 vaccines for people who are moderately or severely immunocompromised.
Centers for Disease Control and Prevention. (2024). How to protect yourself and others.
Invivyd, Inc. (2024). Invivyd announces FDA authorization for emergency use of Pemgarda (formerly VYD222) for pre-exposure prophylaxis (PrEP) of COVID-19.
Invivyd, Inc. (2024). Pemgarda FDA emergency use authorization.
Lontok, K. (2021). How effective are COVID-19 vaccines in immunocompromised people? American Society for Microbiology.
Shoham, S., et al. (2023). Vaccines and therapeutics for immunocompromised patients with COVID-19. eClinicalMedicine.
U.S. Food & Drug Administration. (2024). Fact sheet for healthcare providers: Emergency use authorization of Pemgarda (pemivibart).
U.S. Food & Drug Administration. (2024). Frequently asked questions on the emergency use authorization for Pemgarda (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19.
