Monoclonal Antibody Pemgarda Authorized as COVID Protection for At-Risk Groups

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People who have difficulty building immunity from COVID-19 vaccines now have a new medication to turn to for help.

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for Pemgarda, a preventative medication designed for immunocompromised individuals. The EUA was granted to Invivyd, a drug manufacturer based in Massachusetts.

What is Pemgarda?

Pemgarda, whose main ingredient is pemivibart, is a long-acting monoclonal antibody authorized for people aged 12 years and older with moderate-to-severe immune compromise resulting from a medical condition or immunosuppressant medications.

According to the FDA, people who would benefit from Pemgarda include:

• Those actively receiving treatment for solid tumors and hematologic malignancies
• People with different types of leukemia, organ transplant recipients who may be taking immunosuppressive therapy
• Patients who have received CAR-T-cell or hematopoietic stem cell transplants
• People with advanced or untreated HIV
• Patients undergoing active treatment with high-dose corticosteroids

“People who are immunocompromised continue to be disproportionately impacted by COVID-19 even after receiving multiple vaccine doses,” Dr. Cameron R. Wolfe, professor of medicine and transplant infectious disease at Duke University School of Medicine, said in a press release. “These types of patients, among others, continue to have both an impaired response to vaccines and a higher risk for severe COVID-19 outcomes,” he added.

Pemgarda should be “available for order imminently,” according to Invivyd CEO Dave Hering. The initial supply is already packaged and awaiting final release in the U.S.

How It Works

A dose of 4,500 mg of Pemgarda is administered as a single intravenous (IV) infusion. It works by blocking the virus from attaching and entering human cells, thereby neutralizing it.

The medication is not intended for use after a person has been diagnosed with COVID-19 It is also not meant as an alternative to COVID-19 vaccinations, according to Dr. Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research at the FDA.

“Pre-exposure prophylaxis with Pemgarda is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended,” Dr. Cavazzoni wrote, adding that Pemgarda should be administered at least two weeks after an individual receives the COVID-19 vaccine.

Side Effects

The FDA warns that the medication comes with side effects. Some of the most common include:

• Hypersensitivity reactions
• Infusion-related reactions (flushing, rash, fever, chills)
• Fatigue
• Nausea
• Headaches

Most notably, the FDA reported that four out of 623 participants, or 0.6 percent, experienced anaphylaxis, a potentially life-threatening severe allergic reaction, during clinical trials.

Pemgarda should only be administered in medical settings where health care providers have immediate access to medications that can counteract and treat anaphylaxis, as well as the ability to activate an emergency medical system, according to the FDA. Patients should be monitored during the entire 60-minute infusion and for at least two hours after the infusion is complete.

People  interested in taking Pemgarda should consult with their medical health professional.