Opinion: Oncology Nurses Play a Vital Role in COVID-19 Prevention

Amanda Brink, DNP, APRN, FNP-BC, AOCNP

In the ever-evolving landscape of COVID-19 treatment and prevention, the healthcare community continues to seek innovative solutions to protect vulnerable populations and curb the spread of the virus. The recent emergency use authorization (EUA) of pemivibart (Pemgarda) by the FDA for pre-exposure prophylaxis (PrEP) of COVID-19 marks a significant milestone in these efforts.¹

Previously, tixagevimab and cilgavimab (Evusheld) had been available since December 2021 for PrEP for COVID-19. However, in January 2023, the FDA announced that Evusheld was ineffective against newer COVID-19 variants and, therefore, is no longer available.²

Pemgarda is currently approved for adults and adolescents aged 12 years and older who weigh at least 40 kg. It is administered as a 60-minute infusion at a dose of 4500 mg and can be given every 3 months for continued protection.³

Pemgarda is recommended for patients who are not currently infected with COVID-19, who have not recently been exposed to someone with COVID-19, and who have moderate-to-severe immune compromise due to a medical condition or immunosuppressive medications or treatments, making them unlikely to develop an adequate immune response to the COVID-19 vaccination.¹

The CDC provides guidance on who is considered immunocompromised.⁴ Generally speaking, many of the patients with cancer that oncology nurses care for would be considered immunocompromised and eligible for treatment with Pemgarda.

CANOPY Clinical Trial

Pemgarda was granted an EUA based on data from the ongoing phase 3 CANOPY clinical trial.⁵ This trial has two cohorts. Cohort A is a single-arm, open-label trial involving adults with moderate-to-severe immune compromise who received Pemgarda (n = 306). Cohort B is a randomized 2:1, placebo-controlled trial in which healthy adults without moderate-to-severe immune compromise received either Pemgarda (n = 317) or a placebo (n = 162).⁶

Although the trial is ongoing, initial data from cohort A demonstrates strong neutralizing activity against major COVID-19 variants, including JN.1. This indicates that Pemgarda can effectively prevent COVID-19 from infecting cells and replicating.⁶

Regarding the safety profile of Pemgarda, anaphylaxis was observed in 4 out of 623 participants (0.6%) in the CANOPY trial, all from Cohort A. Two participants experienced anaphylaxis during the first infusion and 2 during the second infusion. Three participants fully recovered from the anaphylaxis with no remaining symptoms or medical issues. One participant experienced a rapid improvement of their anaphylaxis but continued to have ongoing health issues due to a flare-up of an existing underlying condition as a result of the anaphylaxis. In Cohort B, 3 participants had mild, and 1 participant had a moderate systemic infusion-related reaction, but no anaphylaxis was observed.⁶

In Cohort A, the most common adverse events observed with Pemgarda included upper respiratory tract infections (6%), infusion site issues (such as infiltration and extravasation; 5%), viral infections (4%), influenza-like illness (3%), fatigue (3%), headache (2%), nausea (2%), and local infusion site reactions (2%).6

Nursing Considerations

The role of oncology nurses in ensuring the well-being of patients who are immunocompromised became more crucial than ever during the COVID-19 pandemic. Pemgarda is a promising new tool designed to provide an additional layer of protection for those at heightened risk for COVID-19 infection and complications. Therefore, it is important that oncology nurses understand the potential benefits of this medication and risks to effectively educate patients.

Due to the risk of anaphylaxis, Pemgarda should be administered only in healthcare settings where providers are prepared to treat anaphylaxis with medications such as epinephrine and antihistamines. Additionally, they should be capable of quickly transferring patients to a higher level of care with the assistance of emergency medical services if necessary. Patients should be monitored during the infusion and for at least 2 hours after its completion.

Oncology nurses may also need to assist patients in navigating the distinctions between COVID-19 treatment and PrEP. Patients should be informed that Pemgarda is intended for prevention, not treatment, of COVID-19. It should not be mistaken for medications such as remdesivir (Veklury) and molnupiravir (Lagevrio), which are indicated for treating COVID-19 infection.

In conclusion, oncology nurses can play a proactive role in preventing COVID-19 by discussing whether a patient is a candidate for Pemgarda with the patient’s oncologist or other treating provider during clinic visits. If patients have questions about potential adverse events associated with Pemgarda treatment, oncology nurses can share the available data thus far.

References

1. FDA Roundup: March 22, 2024. News release. FDA. March 22, 2024. Accessed May 18, 2024. https://www.fda.gov/news-events/press-announcements/fda-roundup-march-22-2024
2. FDA announces Evusheld is not currently authorized for emergency use in the U.S. News release. FDA. January 26, 2023. Accessed May 18, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-evusheld-not-currently-authorized-emergency-use-us
3. Fact Sheet for Healthcare Providers: Emergency Use Authorization of Pemgarda (Pemivibart). Fact sheet. FDA. March 2024. Accessed May 18, 2024. https://www.fda.gov/media/177067/download
4. People With Certain Medical Conditions. CDC. April 15, 2024. Accessed May 18, 2024. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html#immunocompromised
5. A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2. ClinicalTrials.gov. Accessed May 18, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT06039449
6. Invivyd Announces FDA Authorization for Emergency Use of Pemgarda (Formerly VYD222) for Pre-Exposure Prophylaxis (PrEP) of COVID-19. News release. Invivyd. March 22, 2024. Accessed May 18, 2024. https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-fda-authorization-emergency-use-pemgardatm