In March 2024, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for Pemivibart, a long-acting monoclonal antibody against the spike protein of SARS-CoV-2. Sold under the brand name Pemgarda (Invivyd, Inc.), this medication is designed to be given as an intravenous infusion. Pemivibart is authorized for prevention of COVID‑19 disease in people who meet certain criteria:
- Age —12 years of age or older
- Weight — At least 88 pounds (40 kg)
- Immune status — Moderately or severely immune compromised due to certain medical conditions or receipt of immunosuppressive medications or treatments, making one unlikely to mount an adequate immune response to COVID-19 vaccination
- COVID-19 exposure or infection status — Not currently infected with SARS-CoV-2 and no known recent exposure to someone infected with SARS-CoV-2
Monoclonal antibodies are preparations that contain a large number of a single type of antibody. In this case, the preparation contains significant quantities of an antibody that binds the spike protein. Because these antibodies are not produced by the person benefitting from them, this is known as passive immunity. While some antibodies used for passive immunization come from animals or other people (e.g., maternal antibodies), antibodies in Pemivibart are made in a laboratory. For more information on monoclonal antibodies, see the factsheet and video offered by the National Foundation for Infectious Diseases (NFID). For more information about passive immunity, check the Vaccine Education Center’s webpage, “Types of Immunity.”
Pemivibart adds an important tool to our repertoire because immune-compromised individuals are disproportionally affected by COVID-19. In a 2022 study from the United Kingdom published in The Lancet, while only 3.9% of the study population was immune compromised, about a quarter of the morbidity and mortality associated with COVID-19 disease was found in that subgroup (22% of COVID-19-associated hospitalizations, 28% of COVID-19-associated ICU admissions, and 24% of COVID-19-associated deaths). Additionally, immune-compromised people may not mount an effective immune response following vaccination. Looking at The Lancet study, outcomes among participants who received at least three doses of COVID-19 vaccine diverged when comparing immune-compromised individuals with the general population. The researchers found that immune-compromised participants remained at increased risk of severe COVID-19 outcomes. The adjusted incidence rate ratio (aIRR) for hospitalization varied depending upon condition but was elevated for all study groups with immune-compromising conditions:
- Solid organ transplant: 13.1
- Stem cell transplant: 11.0
- Recent treatment for hematological malignancy: 10.6
- Moderate to severe primary deficiency: 9.7
Results were similar for COVID-19-associated ICU admissions and deaths.
The Pemivibart infusion should only be given in settings prepared to manage anaphylaxis, which was observed in 0.6% of participants in a pre-licensure trial. Notably, all participants with anaphylaxis were adults who had moderate to severe immune compromise that included complex underlying medical conditions. Of the four participants who experienced anaphylaxis, two had this complication during the first infusion and two during the second infusion.
Currently, Pemivibart is authorized for pre-exposure prophylaxis (PrEP), not treatment of COVID-19. A company press release in March 2024 stated that Invivyd is evaluating “protective clinical benefits of [monoclonal antibody] prophylaxis for symptomatic COVID-19 disease in future studies.”
For more information, check the FDA’s resources on Pemivibart:
- Fact Sheet for Healthcare Providers: Emergency Use Authorization of Pemgarda (Pemivibart) (PDF)
- Fact Sheet for Patients, Parents, and Caregivers Emergency Use Authorization (EUA) of PEMGARDA (pemivibart) for Coronavirus Disease 2019 (COVID-19) (PDF)
- Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products (webpage)
- Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products — 11-page letter from FDA to Invivyd regarding EUA for Pemivibart (PDF)
In March 2024, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for Pemivibart, a long-acting monoclonal antibody against the spike protein of SARS-CoV-2. Sold under the brand name Pemgarda (Invivyd, Inc.), this medication is designed to be given as an intravenous infusion. Pemivibart is authorized for prevention of COVID‑19 disease in people who meet certain criteria:
- Age —12 years of age or older
- Weight — At least 88 pounds (40 kg)
- Immune status — Moderately or severely immune compromised due to certain medical conditions or receipt of immunosuppressive medications or treatments, making one unlikely to mount an adequate immune response to COVID-19 vaccination
- COVID-19 exposure or infection status — Not currently infected with SARS-CoV-2 and no known recent exposure to someone infected with SARS-CoV-2
Monoclonal antibodies are preparations that contain a large number of a single type of antibody. In this case, the preparation contains significant quantities of an antibody that binds the spike protein. Because these antibodies are not produced by the person benefitting from them, this is known as passive immunity. While some antibodies used for passive immunization come from animals or other people (e.g., maternal antibodies), antibodies in Pemivibart are made in a laboratory. For more information on monoclonal antibodies, see the factsheet and video offered by the National Foundation for Infectious Diseases (NFID). For more information about passive immunity, check the Vaccine Education Center’s webpage, “Types of Immunity.”
Pemivibart adds an important tool to our repertoire because immune-compromised individuals are disproportionally affected by COVID-19. In a 2022 study from the United Kingdom published in The Lancet, while only 3.9% of the study population was immune compromised, about a quarter of the morbidity and mortality associated with COVID-19 disease was found in that subgroup (22% of COVID-19-associated hospitalizations, 28% of COVID-19-associated ICU admissions, and 24% of COVID-19-associated deaths). Additionally, immune-compromised people may not mount an effective immune response following vaccination. Looking at The Lancet study, outcomes among participants who received at least three doses of COVID-19 vaccine diverged when comparing immune-compromised individuals with the general population. The researchers found that immune-compromised participants remained at increased risk of severe COVID-19 outcomes. The adjusted incidence rate ratio (aIRR) for hospitalization varied depending upon condition but was elevated for all study groups with immune-compromising conditions:
- Solid organ transplant: 13.1
- Stem cell transplant: 11.0
- Recent treatment for hematological malignancy: 10.6
- Moderate to severe primary deficiency: 9.7
Results were similar for COVID-19-associated ICU admissions and deaths.
The Pemivibart infusion should only be given in settings prepared to manage anaphylaxis, which was observed in 0.6% of participants in a pre-licensure trial. Notably, all participants with anaphylaxis were adults who had moderate to severe immune compromise that included complex underlying medical conditions. Of the four participants who experienced anaphylaxis, two had this complication during the first infusion and two during the second infusion.
Currently, Pemivibart is authorized for pre-exposure prophylaxis (PrEP), not treatment of COVID-19. A company press release in March 2024 stated that Invivyd is evaluating “protective clinical benefits of [monoclonal antibody] prophylaxis for symptomatic COVID-19 disease in future studies.”
For more information, check the FDA’s resources on Pemivibart:
- Fact Sheet for Healthcare Providers: Emergency Use Authorization of Pemgarda (Pemivibart) (PDF)
- Fact Sheet for Patients, Parents, and Caregivers Emergency Use Authorization (EUA) of PEMGARDA (pemivibart) for Coronavirus Disease 2019 (COVID-19) (PDF)
- Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products (webpage)
- Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products — 11-page letter from FDA to Invivyd regarding EUA for Pemivibart (PDF)