FDA Approves New Drug to Boost COVID-19 Protection for Immunocompromised People

FDA Approves New Drug to Boost COVID-19 Protection for Immunocompromised People
  • The FDA has authorized a new treatment that may help immunocompromised people be protected from COVID-19.
  • The treatment is a monoclonal antibody infusion that is expected to be available this April.
  • People with severely compromised immune systems may need regular infusions.

New emergency use authorization of a monoclonal antibody infusion by the Food and Drug Administration (FDA) means that immunocompromised people starting at age 12 will be able to add another layer of protection from COVID-19.

Pemgarda, made by the company Invivyd, is a successor to the previous monoclonal antibody Evusheld, which was withdrawn from use by the FDA in January of 2023 when it became clear that it was not effective against new COVID-19 variants. It could be a welcome relief for people whose immune systems are severely threatened by Covid itself — with infection leading to serious illness — or those for whom vaccination does not provoke enough protective immune responses.

Pemgarda, which is expected to become available in April, is administered as an hourlong infusion at a medical office. Invivyd believes that it will be covered under regular insurance plans and by Medicare. For people with severely compromised immune systems, it could be possible that a regular infusion — perhaps every three months — would be necessary.

What makes this treatment different from past infusions?

Both Pemgarda and Evusheld are monoclonal antibodies — a passive form of immunization as opposed to the active form provided by vaccines. Essentially, a vaccine’s role is to provoke antibodies to a particular disease in whomever receives it. But for people who are severely immunocompromised, like cancer patients, anyone with an autoimmune disease, or those who have had major organ transplants, the body’s response to a vaccine can be limited and not adequately create the antibodies needed. A monoclonal antibody helps to infuse the antibodies directly.

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No monoclonal antibody is intended to be a medicine for active COVID-19 infections.

It’s not a cure for the virus itself, just a shield for the most vulnerable. Pemgarda is expected to be available to about 6% of the population — the number of severely or moderately immunocompromised people in the U.S., according to the Centers for Disease Control and Prevention.

Monica Gandhi, MD, Ph.D, a professor of medicine and the associate division chief of the Division of HIV, Infectious Diseases, and Global Medicine at UCSF/San Francisco General Hospital, told Healthline that in addition to monoclonal antibodies, there are oral treatments for immunocompromised patients — and that vaccines shouldn’t be ruled out.

“The currently available oral treatments for COVID (molnupiravir and Paxlovid) work well in patients with immunocompromise and should be used if COVID is contracted,” Gandhi said. “The currently available COVID-19 vaccines actually work better among those with immunocompromise than often reported, although repeated booster are necessary.”

William Schaffner, MD, a professor of preventive medicine in the Department of Health Policy and a professor of medicine in the Division of Infectious Diseases at the Vanderbilt University School of Medicine in Tennessee, told Healthline that the evolution of the virus rendered Evusheld ineffective.

“With the changing virus, that combination of monoclonal antibodies that was included in Evusheld was no longer functional; it didn’t provide protection against Omicron and its severity. And so this new monoclonal antibody has been developed in response to the latest viral variants,” Schaffner said. “It doesn’t take all that to create the monoclonal antibody. What takes a little time is, of course, to test it in populations sufficient for the Food and Drug Administration to give it an emergency use authorization. So it’s the clinical testing that takes longer than, actually, the development of the monoclonal antibody.”

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Why was Evusheld not effective?

The development of new variants was a significant factor. Evusheld simply couldn’t keep up with how the COVID-19 virus was evolving. But another issue, according to Schaffner, was that Evusheld was not disbursed in an efficient enough manner.

“This is a well-awaited and welcome addition to our capacity to protect these most vulnerable people against COVID. Now the question is, can we get it widely used by the providers who take care of such patients?” Schaffner said, saying that the CDC’s Advisory Committee on Immunization Practices (ACIP) did not make specific recommendations for Evusheld, which was possibly a factor in it not being as widely promoted as it could have been. “The Advisory Committee on Immunization Practices has made recommendations for the use of another monoclonal antibody, Nirsevimab, which prevents serious RSV infections in infants and young children. And that’s been adopted very, very widely by pediatricians. So there are some of us who hope that the ACIP will review Pemgarda and provide some recommendations.”

Can this treatment prevent infection from new COVID variants?

“Most people are protected from a combination of vaccines and prior exposure to COVID-19 at this point,” said Gandhi. “This monoclonal antibody gives additional protection of antibodies against the circulating strains. It is effective against the most common circulating strain of COVID, which is JN.1.”

But as has been seen in the four years since the pandemic began, how the virus circulates and what type of protein spike evolutions occur in the future are not easily predictable. This makes it hard to determine how effective Pemgarda can be against new strains that haven’t been studied, Schaffner said.

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“It all depends on what the virus does,” Schaffner said. “If the virus develops a mutation that is substantially different than the current Omicron family of viruses, then we’ll have to go back to the beginning, and we would have to update our vaccine, and we would also have to update the Pemgarda.”

Takeaway Note

The Food and Drug Administration granted an emergency use authorization for Pemgarda, a monoclonal antibody for people who are immunocompromised.

Pemgarda would not be a treatment for active COVID-19 infections; it’s a preventative, passive form of immunization that provides people with several compromised immune systems with another level of protection.

Pemgarda should be available for about 6% of the U.S. population.


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