There's a New Drug to Help Prevent COVID. Here's How to Tell If You Need It

The Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for a monoclonal antibody called Pemgarda (pemivibart) to prevent COVID-19 for certain at-risk people.

If a monoclonal antibody to prevent COVID sounds vaguely familiar, it’s because it’s not the first. You might remember Evusheld, which was the same kind of treatment. However, the FDA pulled the EUA for Evusheld in 2023 when data started showing it wasn’t offering protection against new COVID variants.

Will Pemgarda be any different? And how do you know if you should take it? Here’s everything you need to know about the drug and how to get it.

What Is Pemgarda?

Researchers at Invivyd developed Pemgarda as COVID pre-exposure prophylaxis—or a preventive treatment—for certain people who are at very high risk for severe illness because they have very weak immune systems.

Pemgarda is for adults and adolescents aged 12 years and older who weigh at least 40 kilograms—or about 88 pounds. To be eligible for the treatment, a person must not currently have SARS-CoV-2 or have recently been exposed to the virus.

“Because people with weakened immune systems may not respond as well to vaccination and are much more likely to get severe COVID-19 infections, this medication is given pre-exposure to help prevent infection,” Tammy Lundstrom, MD, JD, associate professor of infectious diseases at Wayne State University School of Medicine, told Verywell.

The key word for Pemgarda is “prevention.” As Lundstrom said, “It is not used to treat a COVID-19 infection.”

Unlike Evusheld, Pemgarda should be effective against more recent COVID variants.

“The recent approval of a monoclonal antibody (mAb) shows that these treatments can still work well against the newest strains of COVID-19,” Wayne Winegarden, PhD, director of Pacific Research Institute’s Center for Medical Economics and Innovation, told Verywell.

How Does Pemgarda Prevent COVID-19?

Given as an intravenous (IV) infusion, Pemgarda is thought to boost the body’s defenses against the virus that causes COVID when a patient’s weak immune system would be no match for the virus without some help.

However, it’s an investigational drug, and there’s still a lot left to learn about Pemgarda. But by giving the drug an EUA, the FDA has cleared it for use in people who may benefit the most from it while researchers are still learning about the treatment.

Since the drug is still being researched, that means all the data on its safety and efficacy isn’t in yet. For example, researchers aren’t exactly sure how well it will work in “real-world” conditions compared to a study setting.

Pemgarda is also not a substitute for a COVID vaccine. People at high risk for COVID should still follow their provider’s recommendations for getting COVID shots and boosters.

Do I Need Pemgarda?

Not everyone needs Pemgarda, and you have to meet specific criteria to get it. Pemgarda is only for people who:

• Are at least 12 years old and weigh at least 88 lbs (40 kgs)
• Have a moderately to severely compromised immune system
• Do not currently have COVID
• Have not recently been exposed to someone who has COVID

If you’re not sure if you need Pemgarda or would even be eligible for it, the best person to ask is your regular healthcare provider or pharmacist.

Remember: Pemgarda is a preventive measure, not a treatment for COVID. It’s not like Paxlovid, which can be given to someone who has COVID to try to keep them from getting seriously ill.

You also can’t take Pemgarda if you’ve been exposed to COVID to try to prevent yourself from getting sick—what would be called “post-exposure prophylaxis.” While there are drugs being studied for this purpose, we’re not there yet. Other than the available vaccines, there is not yet a specific treatment to prevent you from getting COVID if you’ve been around someone who has it.

How to Get Pemgarda

A provider has to prescribe Pemgarda for you, and you have to go to a healthcare facility to get the IV infusion of the treatment. Before you start the treatment, you should make sure that your provider knows your medical history and about any existing health conditions you have.

You also need to make sure your provider is aware of any allergies you have and the medications or supplements you take. You also need to tell them if you’re pregnant, thinking about getting pregnant, or breastfeeding.

While Pemgarda is safe, it can still have side effects (commonly fatigue and irritation at the skin site where the infusion is given). Some side effects, like severe allergic reactions that could lead to life-threatening anaphylaxis, aren’t likely to happen, but they’re still possible (in the clinical trial of 623 patients, 4 had an anaphylactic reaction to the drug.) Due to the risk, people getting Pemgarda are watched closely by healthcare staff during and after the infusion.

“Because the medication must be given in the vein and there is potential for immediate allergic reaction within two hours, it must be given under medical supervision and is not likely to be available over-the-counter,” said Lundstrom.

If you’re a candidate for Pemgarda, you’ll need to talk to your provider about when to get it and how often. Since the goal is to get the treatment before you encounter COVID, a provider might recommend they get the infusions multiple times.

Invivyd, which makes Pemgarda, hasn’t announced the cost of the drug yet, so patients will have to work with their providers and insurance companies to see if they can afford the treatment.

It’s too soon to tell if Pemgarda will face the same fate as Evusheld. For now, it’s at least offering some protection for the most vulnerable people trying to live in a world where COVID is becoming a fact of life.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.