At IDWeek 2025, (the joint annual meeting of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, the Pediatric Infectious Diseases Society and the Society of Infectious Diseases Pharmacists) held from 19 to 22 October in Atlanta, Georgia, Dr Brian Metzger from Austin Infectious Diseases Consultants, a private practice in Austin, Texas, presented data on early real-world experience with use of pemivibart for the pre-exposure prophylaxis of Covid-19.
Invivyd’s pemivibart is an investigational monoclonal antibody (mAb). Since March 2024, pemivibart has been available in the US under an emergency use authorisation (EUA) for the pre-exposure prophylaxis of Covid-19 in adults and adolescents aged 12 and older, marketed under the brand name Pemgarda. It is intended for use in patients who are moderately to severely immunocompromised due to medical conditions or the use of immunosuppressive therapies, or those unlikely to mount a response to Covid-19 vaccination.
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Invivyd had also attempted to attain regulatory approval for pemivibart for the treatment of immunocompromised patients with mild-to-moderate Covid-19 infection with no alternative therapeutic options. However, this was rejected in February 2025 since pemivibart did not demonstrate superior antiviral activity to previously authorised, now inactive Covid-19 monoclonal antibodies (mAbs).
Pemivibart requires administration in a healthcare setting every three months. It is administered via intravenous infusion over approximately one hour. The drug has a boxed warning for anaphylaxis, which can be life-threatening. Consequently, patients are required to be observed in a healthcare setting post infusion.
Current lineage and neutralisation data for pemivibart show continued and consistent neutralising activity against current SARS-CoV2 variants including the most recent and dominant strain, XFG. Overall, pemivibart’s coverage of current SARS-CoV2 variants remains high at greater than 90%.
The retrospective cohort study of pemivibart comprised 48 patients who received one dose or more of pemivibart at infectious disease physician private practices and ambulatory infusion centres across the US between May 2024 and April 2025 following pemivibart’s EUA approval. In line with EUA criteria, all subjects were 12 or older, weighed 40kg or more, and were moderately to severely immunocompromised. Additionally, patients were not currently infected with SARS-CoV2, had no known recent exposure and were deemed unlikely to mount an immune response to Covid-19 vaccination. A previous history of Covid-19 infection was present in 25% of participants, and 73% had a history of Covid-19 vaccination.
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By GlobalDataPemivibart was most commonly administered due to the subject receiving treatment with immunosuppressive therapy, which occurred in 46% of cases, followed by the subject having a moderate-to-severe primary immunodeficiency disease, which occurred in 21% of cases, or the subject having active treatment for a solid tumour or haematologic malignancy, which occurred in 15% of cases.
Overall, patients received a median of four doses of pemivibart. All infusions were administered over one hour and subjects were observed in the healthcare setting for two hours post-infusion due to the risk of anaphylaxis. Pre-medications such as diphenhydramine, acetaminophen and methylprednisolone were administered prior to the infusion in 49% of cases.
The patients were found to be highly compliant with therapy, with 96% of infusions administered within four weeks of the scheduled date. Among the 48 patients, 11 discontinued treatment within the course of the study and 37 remained on the therapy. The most common reason for discontinuation was that the patient’s immunosuppression risk resolved. No cases of polymerase chain reaction (PCR)-confirmed Covid-19 infection were reported in the study, validating pemivibart’s effectiveness for pre-exposure prophylaxis. This is consistent with pemivibart’s high coverage of current SARS-CoV2 variants. Pemivibart was generally regarded as safe to administer and was associated with a low adverse event rate (4%). However, one case of anaphylaxis was reported. This required emergency treatment, with the patient making a full recovery.
Despite the small size of the cohort, this study provides valuable real-world data on the usage of pemivibart in a varied immunocompromised population, which will help inform practitioners’ decisions in terms of managing the risk of Covid-19 infection in vulnerable patients. Pemivibart remains an important prophylactic option for certain immunocompromised patients. However, it is unclear if the drug will be granted full regulatory approval for Covid-19 pre-exposure prophylaxis. Invivyd may choose to focus its resources on VYD2311, its next-generation injectable mAb for Covid-19 pre-exposure prophylaxis, which is expected to target a broader patient population including immunocompromised patients. The US Food and Drugs Administration has advised Invivyd on the pursuit of a traditional biologics licence application (BLA) pathway for VYD2311, and in October 2025, the agency cleared investigational new drug (IND) applications for this mAb, facilitating Phase III trial initiation.
