Regeneron Perspectives

Helping the several million immunocompromised Americans who are still “Prisoners of the Pandemic”

George D. Yancopoulos, MD, PhD
Co-founder, President and Chief Scientific Officer of Regeneron
November 9, 2021

Regeneron has received numerous queries about making our REGEN-COV® (casirivimab and imdevimab) antibody cocktail available to protect immunocompromised individuals who do not respond to COVID19 vaccines. This blog reflects our thinking and the current scientific evidence related to this question.

The rapid development of new weapons to fight the COVID-19 pandemic is a testament to the power of science, as well as to the commitment of the biopharmaceutical community and our academic and government partners. Physicians and patients now have important new tools including diagnostics, vaccines and monoclonal antibodies. In addition, oral antivirals will be added to the mix shortly. It is therefore tragic that several of these weapons – particularly monoclonal antibodies – are not being utilized optimally. A recent CNN article1 by Elizabeth Cohen on monoclonal antibodies titled Doctors are often unaware of the only treatment for early COVID-19 quotes Dr. Anthony Fauci, the President’s senior medical advisor. He describes use of monoclonal antibodies to treat early infection as “a very effective intervention for COVID-19.  It is underutilized, and we recommend strongly that we utilize this to its fullest … I've been trying to get attention paid to how easy it should be to get this done, but I understand that a lot of doctors don't fully appreciate that." The article also quotes Dr. Peter Chin-Hong, an infectious disease expert and professor at the UCSF School of Medicine, who says, "It's unconscionable ... We have an evidence-based drug, and it's provided free by the government, but there are barriers built into the system to get it."

Our failure to fully utilize the power of monoclonal antibodies has many unfortunate consequences – perhaps the most tragic relates to our failure to help the most vulnerable among us – i.e., the immunocompromised. The Centers for Disease Control and Prevention (CDC) estimates that 3% of U.S. adults are moderately to severely immunocompromised,2 which equates to several million Americans. These individuals are either on immunosuppressive medicines (i.e., for organ transplants, or certain autoimmune diseases such as multiple sclerosis) or have conditions (i.e., certain cancers such as lymphoma or myeloma, or primary immunodeficiencies) that impair their immune response to vaccination. At Regeneron, we appreciate that universal vaccination is the best way to broadly protect the population from COVID-19; and we also believe that other options are required for the immunocompromised, who remain “prisoners of the pandemic” because many of them respond sub-optimally or not at all to vaccination. In the interests of scientific exchange, I outline in this document Regeneron’s thinking with regard to the science that supports the use of monoclonal antibodies to prevent SARS-CoV-2 infection in immunocompromised people.

In response to the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has authorized a number of medicines under Emergency Use Authorization (EUA). Thus, while monoclonal antibodies targeting SARS-CoV-2 have not yet been approved in the U.S., they are currently authorized by the FDA for use in certain people who are at high risk of serious consequences from COVID-19:

  • Treatment of non-hospitalized infected patients.3-5
  • Post-exposure prophylaxis for uninfected individuals who have been exposed to an infected person or are at high risk of such an exposure (e.g., if they are living in a nursing home or prison setting during an outbreak).3-4

In the U.S., monoclonal antibodies are not currently authorized as a substitute for vaccination against COVID-19, or for pre-exposure prophylaxis for prevention of COVID-19, or for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.

A recent study from Johns Hopkins University found that, despite vaccination, certain immunocompromised individuals were far more likely to have a breakthrough infection leading to hospitalization or death than other vaccinated individuals.6 Since many immunocompromised people cannot efficiently make their own antibodies, it would make sense to compensate for this immunodeficiency by proactively providing these individuals with monoclonal antibodies produced in the laboratory. Although monoclonal antibodies are authorized by the U.S. FDA to treat early COVID-19 in certain patients, they are not yet authorized for chronic protection of the immunocompromised.3-5 Several experts have advocated for increased use in this setting:

  • The Director of the FDA’s Center for Biologics Evaluation and Research (CBER), Dr. Peter Marks, who is widely considered as the nation’s leading expert on vaccine regulation, in October shared these personal views during a COVID-19 clinician call:7From the standpoint of having been a leukemia doctor, there are things we can do that are really simple though. If you have an individual who has received an anti-CD20 monoclonal antibody for either a hematologic malignancy or for an autoimmune disease in the past 6-12 months, it is unlikely that they are going to respond to vaccination and you probably want to consider pursuing prophylactic strategies such as using a monoclonal.” Patients who take anti-CD20 monoclonal antibodies are immunocompromised because these medicines impact the part of their immune system that makes antibodies.
  • In a touching autobiographical essay,8 There might finally be a COVID solution for immunocompromised people like me,” Dr. Lindsay Ryan, an immunocompromised physician working in the emergency room of a busy hospital, outlines how she was able to receive monoclonal antibodies in the preventative setting based on her ongoing workplace exposure. She notes that monoclonal antibodies are available for chronic prevention only for a “privileged” few due to “logistics and lack of awareness among both doctors and patients,” and she advocates for broader access for the immunocompromised.
  • The former FDA commissioner Scott Gottlieb, in his appearance on Face the Nation on October 24,9 noted that he fully understands the struggles of the immunocompromised, having been an adult cancer chemotherapy patient himself. He states “Look, I don't think anyone should die from COVID now … There's two pockets of vulnerability: young children, who we will eventually be able to vaccinate; and then people who are immune-incompetent. They can't mount an effective response to the vaccines ... We have the tools to protect them. We could be using the antibody drugs on a prophylactic basis, giving them regular infusions, probably monthly infusions, to protect them ... There is an emergency use authorization sitting with the FDA right now for that specific use.”

The pleas of these public health experts are a response to the increasing evidence that the immunocompromised are particularly susceptible. Unfortunately, widespread vaccination of the general population will not protect the immunocompromised, many of whom will not make their own antibodies in response to vaccination.10-15 Because significant numbers of asymptomatic or symptomatic breakthrough infections still occur among the vaccinated, even with a high level of vaccination, the SARS-CoV-2 virus will likely continue to circulate. Thus, if immunocompromised individuals try to resume their normal lives, they will encounter infected individuals and be at high risk of developing serious disease. If we fail to protect them, the immunocompromised will remain tragic “prisoners of the pandemic."

At Regeneron, we agree with outside experts that there is compelling rationale and real-world clinical trial data supporting the use of monoclonal antibodies to provide chronic (ongoing) protection for immunocompromised individuals who do not respond adequately to vaccines. Some of the data is summarized as follows:

  • Many of the immunocompromised do not respond to vaccination, with approximately 40-60% having no antibodies generated by the vaccines after their second dose. In addition, between 50-100% of immunocompromised people who didn’t respond to their second dose remained seronegative after a third dose (based on research in people with certain blood cancers,10 solid organ transplants11-14 and hemodialysis15).
  • Clinical trials of monoclonal antibodies have shown that infected patients who lack their own antibodies – an important characteristic shared by the immunocompromised – had higher viral loads, took longer to resolve their symptoms and had worse clinical outcomes.16-18 Administering monoclonal antibodies to such patients helped to rapidly decrease viral levels (>95% within 2 days17), significantly shortened symptom duration and reduced the risk of progressing to more severe disease – i.e., hospitalization and death – by approximately 70%16.
  • Clinical trials have shown that prophylactic dosing with monoclonal antibodies can prevent symptomatic COVID-19 disease in uninfected individuals even if they live in the same household as an infected person.19 In a one-month prevention trial, the risk of symptomatic disease was reduced by 72% in the first week after receiving prophylactic antibody treatment (i.e., pre- and post-exposure prophylaxis), and 93% in the subsequent 2-4 weeks (pre-exposure prophylaxis).19 Recently, Regeneron announced additional, long-term findings from this same prevention trial, showing that a single dose of monoclonal antibodies prevented more than 80% of COVID-19 cases for the eight-month assessment period.20
  • In publications describing individual cases,21-23 as well as in four case series,24-27 treatment of immunocompromised individuals with monoclonal antibodies led to rapid viral clearance as well as rapid clinical improvement in the majority.

Monoclonal antibodies are currently authorized3-5 to treat individuals, including the immunocompromised, who are already infected, or have been exposed to an infected individual or are at high risk of such an exposure. Prevailing clinical trial evidence16-19 indicates that the earlier antibodies are administered during disease progression, the better the outcomes, with prevention before infection being the most powerful. In an increasingly vaccinated world, the immunocompromised will remain the most vulnerable without additional protection, such as what monoclonal antibodies might be able to provide.

The holidays are coming, when many of us will gather with friends and family, confident that the vaccines we received will protect us from the worst effects of this virus. We are anxious to help provide a similar confidence to the “prisoners of this pandemic,” so they too can enjoy the happiness and normalcy that comes with gathering with others, by providing chronic protection via regular monoclonal antibody treatments. We will work closely with the FDA towards this goal.  

The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.

AUTHORIZED USES AND IMPORTANT SAFETY INFORMATION

REGEN-COV has not been approved by the Food and Drug Administration (FDA), but is currently authorized under an EUA to treat people who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis setting. Post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19 or for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.

This authorization is for the duration of the declaration that circumstances exist justifying the authorization of the emergency uses under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply, with Roche primarily responsible for development and distribution outside the U.S. Regeneron and Roche share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and have been working with the WHO and other groups to determine how to best support access in low- and lower-middle-income countries, including through drug donations to be made in partnership with public health organizations.

Treatment:

REGEN-COV is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death

Limitations of Authorized Use (Treatment)

  • REGEN-COV is not authorized for use in patients:
    • who are hospitalized due to COVID-19, OR
    • who require oxygen therapy due to COVID-19, OR
    • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity
  • Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation

Post-Exposure Prophylaxis

REGEN-COV is authorized in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:

  • not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) and
    • have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC) or
    • who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons)

Limitations of Authorized Use (Post-Exposure Prophylaxis)

  • Post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19
  • REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19

REGEN-COV has not been approved, but has been authorized for emergency use by FDA

These uses are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized uses of REGEN-COV and mandatory requirements of the EUA and must comply with the requirements of the EUA. The FDA Letter of Authorization is available for reference, as well as the Dear Healthcare Provider Letter and Patient Fact Sheet.

Important Safety Information

REGEN-COV (casirivimab and imdevimab) is an unapproved investigational therapy, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use

  • Contraindication:
    REGEN-COV is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to REGEN-COV
  • Warnings and Precautions:
    • Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions: Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of REGEN-COV. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy. Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of REGEN-COV under EUA. Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of REGEN-COV. These reactions may be severe or life threatening
      • Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, nausea, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g., pre-syncope, syncope), dizziness, fatigue and diaphoresis. Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs
    • Clinical Worsening After REGEN-COV Administration: Clinical worsening of COVID-19 after administration of REGEN-COV has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to REGEN-COV use or were due to progression of COVID-19
    • Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19: Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. Therefore, REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19–related comorbidity
  • Adverse Reactions:
    • COV-2067 (Treatment): Infusion-related reactions (adverse event assessed as causally related by the investigator) of grade 2 or higher severity have been observed in 10/4,206 (0.2%) of those who received REGEN-COV at the authorized dose or a higher dose. Three subjects receiving the 8,000 mg dose of REGEN-COV, and one subject receiving the 1,200 mg casirivimab and 1,200 mg imdevimab, had infusion-related reactions (urticaria, pruritus, flushing, pyrexia, shortness of breath, chest tightness, nausea, vomiting, rash) which resulted in permanent discontinuation of the infusion. All events resolved. Anaphylactic reactions have been reported in the clinical program in subjects receiving REGEN-COV. The events began within 1 hour of completion of the infusion, and in at least one case required treatment including epinephrine. The events resolved
    • COV-2069 (Post-exposure prophylaxis): In subjects who were SARS-CoV-2 negative at baseline (Cohort A), injection site reactions (all grade 1 and 2) occurred in 55 subjects (4%) in the REGEN-COV group and 19 subjects (2%) in the placebo group. The most common signs and symptoms of injection site reactions which occurred in at least 1% of subjects in the REGEN-COV group were erythema and pruritus. Hypersensitivity reactions occurred in 2 subjects (0.2%) in the REGEN-COV group and all hypersensitivity reactions were grade 1 in severity. In subjects who were SARS-CoV-2 positive at baseline (Cohort B), injection site reactions, all of which were grade 1 or 2, occurred in 6 subjects (4%) in the REGEN-COV group and 1 subject (1%) in the placebo group. The most common signs and symptoms of injection site reactions which occurred in at least 1% of subjects in the REGEN-COV group were ecchymosis and erythema
    • COV-2093 (Subcutaneous Dosing): Injection site reactions occurred in 12% and 4% of subjects following single dose administration in the REGEN-COV and placebo groups, respectively. Remaining safety finding following subcutaneous administration in the REGEN-COV group were similar to the safety findings observed with intravenous administration in COV-2067. With repeat dosing, injection site reactions occurred in 252 subjects (35%) in the REGEN-COV group and 38 subjects (16%) in the placebo group; all injection site reactions were grade 1 or 2 in severity. Hypersensitivity reactions occurred in 8 subjects (1%) in the REGEN-COV group; and all hypersensitivity reactions were grade 1 or 2 in severity. There were no cases of anaphylaxis.

References:

  1. Cohen E. Doctors are often unaware of the only treatment for early Covid-19. CNN Health. Updated October 25, 2021. Available at: https://www.cnn.com/2021/10/25/health/covid-antibody-treatment-doctors/index.html
  2. Centers for Disease Control and Prevention (CDC). COVID-19 Vaccines for Moderately to Severely Immunocompromised People. Last viewed October 28, 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html
  3. Regeneron. Fact Sheet for Health Care Providers: Emergency Use Authorization (EUA) of REGEN-COV® (casirivimab and imdevimab). Last viewed October 28, 2021. Available at: https://www.regeneron.com/downloads/treatment-covid19-eua-fact-sheet-for-hcp.pdf
  4. Eli Lilly. Fact Sheet for Health Care Providers: Emergency Use Authorization (EUA) of bamlanivimab and etesevimab. Last viewed October 28, 2021. Available at: http://pi.lilly.com/eua/bam-and-ete-eua-factsheet-hcp.pdf
  5. GlaxoSmithKline. Fact Sheet for Health Care Providers: Emergency Use Authorization (EUA) of sotrovimab. Last viewed October 28, 2021. Available at: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/​Sotrovimab/​pdf/SOTROVIMAB-EUA.PDF#nameddest=HCPFS
  6. Qin CX, Moore LW, Anjan S, et al. Risk of breakthrough SARS-CoV-2 infections in adult transplant recipients [Letter to the Editor]. Transplantation. November 2021; 105(11): e265-e266. Available at: https://journals.lww.com/transplantjournal/pages/currenttoc.aspx
  7. Infectious Diseases Society of America (IDSA). CDC/IDSA COVID-19 Clinician Call: COVID-19 Vaccine Boosters, the Immune Compromised & Protecting the Most Vulnerable. Webinar. October 23, 2021. Available at: https://www.idsociety.org/multimedia/clinician-calls/cdcidsa-covid-19-clinician-call-covid-19-vaccine-boosters-the-immune-compromised--protecting-the-most-vulnerable/
  8. Ryan, L. There might finally be a COVID solution for immunocompromised people like me. Slate. October 12, 2021. Available at: https://slate.com/technology/2021/10/immunocompromised-pandemic-monoclonal-antibodies-prophylactic-use.html
  9. Face the Nation (transcript). CBS News. October 24, 2021. Available at: https://www.cbsnews.com/news/full-transcript-of-face-the-nation-on-october-24-2021/
  10. Re D, Seitz-Polski B, Carles M, et al. Humoral and cellular responses after a third dose of BNT162b2 vaccine in patients treated for lymphoid malignancies. MedRxiv. July 22, 2021. Available at: https://doi.org/10.1101/2021.07.18.21260669
  11. Del Bello A, Abravanel F, Marion O, et al. Efficiency of a boost with a third dose of anti-SARS-CoV-2 messenger RNA-based vaccines in solid organ transplant recipients [Letter to the Editor]. Transplant. July 31, 2021. Available at: https://doi.org/10.1111/ajt.16775
  12. Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients [Letter to the Editor]. N Engl J Med. 385(7); August 12, 2021: 661-662. Available at: https://www.nejm.org/doi/full/10.1056/NEJMc2108861
  13. Benotmane I, Gautier G, Perrin P, et al. Antibody response after a third dose of the mRNA-1273 SARS-CoV-2 vaccine in kidney transplant recipients with minimal serologic response to 2 doses [Research Letter]. JAMA. July 23, 2021; 326(11): 1063-1065. Available at: https://jamanetwork.com/journals/jama/fullarticle/2782538
  14. Werbel WA, Boyarsky BJ, Ou MT, et al. Safety and immunogenicity of a third dose of SARS-CoV-2 vaccine in solid organ transplant recipients: a case series [Letter to the Editor]. Ann Inter Med. September 2021; 174(9):1330-1332. Available at: https://doi.org/10.7326/L21-0282
  15. Espi M, Charmetant X, Barba T, et al. Justification, safety, and efficacy of a third dose of mRNA vaccine in maintenance hemodialysis patients: a prospective observational study. MedRxiv. July 6, 2021. Available at: https://doi.org/10.1101/2021.07.02.21259913
  16. Weinreich DM, Sivapalasingam S, Norton T, et al. REGEN-COV antibody combination and outcomes in outpatients with Covid-19. N Engl J Med. September 29, 2021; online ahead of print: 10.1056/NEJMoa2108163. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2108163
  17. Weinreich DM, Sivapalasingam S, Norton T, et al. REGN-COV2, a neutralizing antibody cocktail, in outpatients with Covid-19. N Engl J Med. 384(3); January 21, 2021: 238-251. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2035002
  18. Horby PW, Mafham M, Peto L, et al [RECOVERY Collaborative Group]. Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. MedRxiv. June 16, 2021. Available at: https://doi.org/10.1101/2021.06.15.21258542
  19. O’Brien MP, Forleo-Neto E, Musser BJ, et al. Subcutaneous REGEN-COV antibody combination to prevent Covid-19. N Engl J Med. 385; September 23, 2021: 1184-1195. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2109682
  20. Regeneron. New Phase 3 Analyses Show That a Single Dose of REGEN-COV® (casirivimab and imdevimab) Provides Long-term Protection Against COVID-19 [Press releasee]. November 8, 2021. Available at: https://newsroom.regeneron.com/news-releases/news-release-details/new-phase-3-analyses-show-single-dose-regen-covr-casirivimab-and
  21. Levy R, Zhang P, Bastard P, et al. Monoclonal antibody-mediated neutralization of SARS-CoV-2 in an IRF9-deficient child. PNAS. 118(45); 2021: e2114390118. Available at: https://www.pnas.org/content/118/45/e2114390118
  22. Luitel P, Vais D, Gidron A. Successful treatment of persistent coronavirus disease 2019 infection in a patient with hypogammaglobulinemia with REGN-COV2: a case report. Open Forum Infectious Diseases. 8(8); August 2021: ofab335. Available at: https://academic.oup.com/ofid/article/8/8/ofab335/6309029
  23. Palomba E, Carrabba M, Zuglian G, et al. Treatment of SARS-CoV-2 relapse with remdesivir and neutralizing antibodies cocktail in a patient with X-linked agammaglobulinaemia. International Journal of Infectious Diseases. 110; September 2021: 338–340. Available at: https://www.sciencedirect.com/science/article/pii/S1201971221006196?via%3Dihub
  24. Stein D, Oviedo-Orta E, Kampman WA, et al. Compassionate Use of REGEN-COV® in COVID-19 patients with immunodeficiency associated antibody disorders. MedRxiv. November 9, 2021. Available at: https://www.medrxiv.org/content/10.1101/2021.11.05.21265911v1
  25. Dhand A, Lobo SA, Wolfe K, et al. Casirivimab-imdevimab for treatment of COVID-19 in solid organ transplant recipients: an early experience [Letter to the Editor]. Transplantation. 105(7); July 2021: e68-e69. Available at: https://journals.lww.com/transplantjournal/Fulltext/2021/07000/​Casirivimab_imdevimab_for_Treatment_of_COVID_19_in.30.aspx
  26. Liu EC, Lee JH, Loo A, et al. Casirivimab-Imdevimab (REGN-COV2) for mild to moderate SARS-CoV-2 infection in kidney transplant recipients. Kidney Int Rep. September 6, 2021: Online ahead of print. Available at: https://doi.org/10.1016/j.ekir.2021.08.032
  27. Fernandes G, Devresse A, Scohy A, et al. Monoclonal antibody therapy for SARS-CoV-2 infection in kidney transplant recipients: a case series from Belgium [Letter to the Editor]. Transplantation. October 26, 2021; doi: 10.1097/TP.0000000000003974; Online ahead of print. Available at: https://journals.lww.com/transplantjournal/Citation/9000/​Monoclonal_Antibody_Therapy_for_SARS_CoV_2.95139.aspx
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