SARS-CoV-2 Monoclonal Antibody is not indicated for prophylaxis in CVID
Question:
4/16/2021
I am caring for a 68 year-old woman with quite severe CVID. Undetectable levels of IgA, IgM and IgE. Stable IgG with immunoglobulin replacement. As her IgG replacement would not provide her passive protection from SARS CoV2 for quite some time based on collection dates, is there a role for her to receive a monoclonal against SARS CoV2 such as Bamlanivimab prophylactically? If so, any suggestions on how to gain approval for this?
Answer:
Thank you for submitting your question to Ask the Expert.
First, the US has halted the use of Bamlanivimab as monotherapy. The COVID-19 Treatment Guidelines Panel instead recommends using one of the following combination anti-SARS-CoV-2 monoclonal antibodies to treat outpatients with mild to moderate COVID-19 who are at high risk of clinical progression, as defined by the Emergency Use Authorization (EUA) criteria.
Bamlanivimab 700 mg plus etesevimab 1,400 mg; or
Casirivimab 1,200 mg plus imdevimab 1,200 mg.
There are no data that would support the off-label use of monoclonal antibody therapy to lower one's risk of contracting COVID-19. However, if your patient becomes infected, primary immunodeficiency, such as CVID, meets criteria to receive one of these monoclonal antibody combinations. Treatment should be started as soon as possible after the patient receives a positive result on a SARS-CoV-2 antigen or nucleic acid amplification test (NAAT) and within 10 days of symptom onset. On a reassuring note, viral disease is generally not as much of a problem as bacterial infection with humoral immunodeficiency including CVID and reports thus far suggest that CVID patients do not seem to be at high risk for severe infection.
Refer to the COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Anti-SARS-CoV-2 Monoclonal Antibodies for the Treatment of COVID-19. Last updated April 8,2021.
https://www.covid19treatmentguidelines.nih.gov/statement-on-anti-sars-cov-2-monoclonal-antibodies-eua/
The opinion by experts throughout the world is that we should give our patients with Primary Immune Deficiency the COVID vaccine. Though it is less likely that a patient with CVID will make a specific antibody response, they will likely mount a T cell response. Dr Ballow and Dr Sullivan have several very helpful posts on the IDF website.
https://primaryimmune.org/
In an IDF interview with Dr Ballow, he recommends that the vaccine be given two weeks after IVIG administration.
https://primaryimmune.org/news/covid-19-update-vaccines-treatment-options
I give the same advice as flu-vaccine. Even if it provokes an attenuated benefit from T-cell response to reduce either the risk of infection or to make the illness less severe, then antibody deficient patients should receive the COVID Vaccine.
I hope you have found this helpful.
Respectfully submitted,
Jeffrey G. Demain, MD, FAAAAI