Are You At Risk for COVID Infection? Pemgarda For the Vulnerable?

There’s a lot of COVID vaccine hesitancy these days, largely due to reports of adverse reactions. We get it. A lot of people are worried that the vaccines are more dangerous than catching COVID. But that leaves a lot of people in a quandary. If they are immunocompromised and vulnerable to a second, third or fourth attack of COVID, is there anything they can do besides hide? The FDA has just issued emergency use authorization (EUA) for a monoclonal antibody infusion for immunocompromised individuals over the age of 12. It is called Pemgarda.

Pemgarda Is Not the First Monoclonal Antibody vs. COVID:

Remember back to October, 2020 when then President Donald Trump came down with COVID? He received an infusion of Regeneron’s REGEN-COV monoclonal antibodies (casirivimab and imdevimab). These monoclonals were designed to prevent severe complications from the SARS-CoV-2 virus.

By the way, the FDA and Regeneron pulled the REGEN-COV monoclonals off the market after their effectiveness faded. The virus had mutated enough with the omicron variant that this approach lost its mojo.

Pemgarda for Immunocompromised Patients:

Pemgarda (pemivibart) is different from previous monoclonals. It is not intended for people who have come down with COVID. It is intended for people with compromised immune systems before they catch COVID. Let me repeat: It is not supposed to be used to treat an active infection.

Pemgarda may need to be administered as often as every three months to prevent a COVID infection. The infusion takes about an hour and some people have side effects such as flulike symptoms, nausea, headache and fatigue. A few people in the clinical trial developed severe allergic reactions (4 out of 623 volunteers developed anaphylaxis).

Here is how the FDA Describes its decision:

“Based on the totality of scientific evidence available to FDA, including data from CANOPY (NCT06039449), a Phase 3 clinical trial evaluating PEMGARDA for protection against COVID- 19 based on an immunobridging approach, it is reasonable to believe that PEMGARDA may be effective for use as pre-exposure prophylaxis of COVID-19 in certain adults and adolescents, as described in the Scope of Authorization (Section II), and when used under the conditions described in this authorization, the known and potential benefits of PEMGARDA outweigh the known and potential risks of such product.”

Here is how the company, Invivyd, describes Pemgarda:

“The PEMGARDA EUA [Emergency Use Authorization] marks a transformational moment for Invivyd and for the many moderately to severely immunocompromised people who are vulnerable to COVID-19 disease in the U.S.

“Multiple medical conditions or treatments may result in moderate-to-severe immune compromise and an impaired immune response to COVID-19 vaccination including, for example, hematologic malignancies (blood cancers) or treatment with immunosuppressive therapy after a solid organ or stem cell transplant. Observational studies have demonstrated that people with immune dysfunction have a higher risk of COVID-19-related hospitalization and death, despite vaccination, than the general population.”

The company quotes a clinician:

“People who are immunocompromised continue to be disproportionally impacted by COVID-19 even after receiving multiple vaccine doses,” said Cameron R. Wolfe, M.B.B.S., M.P.H., Professor of Medicine, Transplant Infectious Disease at Duke University School of Medicine. “I’m excited to have PEMGARDA as an additional COVID-19 preventive option for moderately to severely immunocompromised adult and adolescent patients, such as solid organ transplant recipients and those with hematological malignancies. These types of patients, among others, continue to have both an impaired response to vaccines and a higher risk for severe COVID-19 outcomes.”

Here is the Company’s warning about Anaphylaxis:

“• Anaphylaxis has been observed with PEMGARDA in 0.6% (4/623) of participants in a clinical trial.
• Anaphylaxis was reported during the first and second infusion of PEMGARDA.
• Anaphylaxis can be life-threatening.
• Prior to administering PEMGARDA, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis.
• Administer PEMGARDA only in settings in which healthcare providers have immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system (EMS), as necessary.
• Clinically monitor individuals during the infusion and for at least two hours after completion of the infusion.
• Discontinue PEMGARDA immediately if signs or symptoms of anaphylaxis or any severe systemic reaction are observed and initiate appropriate medications and/or supportive therapy.”

The Company Warns About the following ADVERSE REACTIONS:

“The most common adverse events (all grades, incidence ≥2%) observed in participants who have moderate-to-severe immune compromise treated with PEMGARDA included systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache, and nausea.”

Final Words:

According to the Verywell website from March 29, 2024:

“In the last week, the CDC reported a total of 9,345 new hospital admissions related to COVID in the U.S. That was a -13.9% change (decrease) from the previous week.”

It is reassuring that COVID hospitalizations are trending down. Deaths are also decreasing. That’s good news. But vulnerable people are still dying from COVID every day.

There is no perfect antidote to COVID-19. We have no guaranteed preventive procedure and no 100% effective treatment. By the way, that is true for most viral infections, including influenza.

People who are especially vulnerable to COVID, such as those with compromised immune systems, may wish to consider Pemgarda. We are neither endorsing nor criticizing this new prophylactic infusion. Our goal is to provide you with enough data to make an informed decision.