Pediatric & Adult
Prepared by Mawlana Mateen Khan MD and Mufti Adil Farooki MD
Summary
In patients with risk factors for significant morbidity and mortality, RSV vaccines or immunoglobulins may be taken after consultation with medical practitioners and Islamic scholars. For all others, the vaccines or immunoglobulins are impermissible. See the discussion below for the pregnant population.
Discussion
Respiratory syncytial virus (RSV) is an RNA virus known mostly as a childhood illness due to its ubiquity in the pediatric setting. The Centers for Disease Control and Prevention (CDC) estimates that each year RSV leads to 58,000-80,000 hospitalizations and 100-300 deaths in children less than 5 years old. It also carries some mortality and morbidity among susceptible adults. Although it causes mild upper respiratory tract disease for most adults, the CDC estimates that RSV causes up to 160,000 hospitalizations and 10,000 deaths each year among adults 65 years and older, particularly those with severe cardiopulmonary diseases and immunodeficiency.[i]
Pediatric Population
Two immunoglobulins are currently FDA-approved for use in the pediatric population: Nirsevimab (Beyfortus), and Palivizumab (Synagis)
Beyfortus
The package insert of Beyfortus describes it as “a respiratory syncytial virus F protein-directed fusion inhibitor, is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.” The immunoglobulin is a product of Chinese Hamster Ovary cells. As these cells are animal-derived from primary rodent cells, the cells and their contents are not permissible.[ii]
Synagis
The package insert of Synagis describes it as a “a humanized monoclonal antibody (IgG1к) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of RSV. Palivizumab is a composite of human (95%) and murine (5%) antibody sequences.” The production cell line is a murine myeloma NS0 cell line. As these cells are animal-derived from mice, the cells and their contents are not permissible.[iii]
Adult Population
Two vaccines are currently FDA-approved for use in adults: Arexvy and Abrysvo.
Arexvy
The package insert of Arexvy describes it as a “lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre-fusion conformation (RSVPreF3) as the antigen component, which must be reconstituted at the time of use with the accompanying vial of AS01E adjuvant as the adjuvant suspension component.”
The antigen is a product of Chinese Hamster Ovary cells. As these cells are animal-derived from primary rodent cells, the cells and their contents are not permissible. The manufacturer admits the possibility of further residual host cell contaminants.[iv] Additionally, the adjuvant contains liposomes and cholesterol, which may or may not be animal-derived.
Abrysvo
The package insert of Abrysvo describes it as containing RSV preF A and RSV preF B recombinant protein antigens as a product of Chinese Hamster Ovary cells. Additionally, the manufacturer admits the possibility of further residual host cell contaminants.[v] Similar to Arexvy, the cell products are impermissible.
As described above, RSV does carry the potential for significant morbidity and mortality for a subset of patients in both the pediatric and adult populations. However, the current vaccine and immunoglobulin formulations contain impermissible ingredients. As with other impermissible medications, practitioners and patients should employ shared clinical decision-making[vi] to determine if the vaccine constitutes a necessity in the Sharīʻah. Shared clinical decision-making ideally involves a discussion between the patient and a pious practicing Muslim practitioner adept at assessing the patient’s clinical risk for significant mortality and morbidity while considering the dictates of the Sharīʻah.
A necessity in the Sharīʻah is when there is a high likelihood (ghalabah al-ẓann) of significant morbidity or mortality by contracting RSV, such as in the very old or patients with pre-existing significant comorbidities. Ideally, the Sharī`ah prefers a competent Muslim physician to determine this need based on the evidence at hand. The physician should be pious and have a basic understanding of the relevant Sharī`ah rulings.[vii] In the absence of such an individual, an Islamic scholar should be consulted along with the practitioner. Vaccinations mandated by the government, workplaces, or schools may also constitute a strong need.[viii]
If the parties involved agree that there is a significant threat to the patient, they may take the vaccine or immunoglobulin to ward off that threat. This need-based permissibility is valid only until a permissible alternative becomes available.
Pregnant Population
As of 2023, the CDC advises that pregnant women receive the RSV vaccine between the 32nd and 36th weeks of pregnancy. This recommendation aims to protect newborns against RSV. [ix]
From an Islamic jurisprudential perspective, the Sharīʻah permits administering medications and vaccines containing otherwise impermissible ingredients when a clear necessity for the patient’s health is present. However, in the context of RSV vaccination during pregnancy, the necessity for such a vaccine is not evident for the pregnant woman herself. Similarly, there is no established necessity for the fetus while it remains in utero. Consequently, administering a vaccine with impermissible ingredients to this demographic is unjustified.
Post-delivery, the newborn’s health can be evaluated to determine if an immunoglobulin is necessary. If necessity is identified, the child may then receive one of the previously mentioned immunoglobulins.
Note: In cases where a fetus is anticipated to be born with significant health risks, such as congenital cardiopulmonary disease or a high likelihood of pre-term delivery, administering the vaccine to the mother while intending to vaccinate the fetus might be considered.[x] This approach should be decided upon through a process of shared clinical decision-making, as previously outlined. This decision considers the specific risks and benefits in each unique situation.
[i] Villanueva DH, Arcega V, Rao M. Review of respiratory syncytial virus infection among older adults and transplant recipients. Ther Adv Infect Dis. 2022 Apr 18;9:20499361221091413. doi: 10.1177/20499361221091413. PMID: 35464624; PMCID: PMC9019318.
RSV Surveillance & Research. https://www.cdc.gov/rsv/research/index.html
[ii] Beyfortus Package Insert: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761328s000lbl.pdf
[iii] EMA discussion: https://www.ema.europa.eu/en/documents/scientific-discussion/synagis-epar-scientific-discussion_en.pdf
Package Insert: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103770s5185lbl.pdf
[iv] Arexvy Package Insert: https://www.fda.gov/media/167805/download
[v] Abrysvo Package Insert: https://www.fda.gov/media/168889/download
[vi] https://www.cdc.gov/vaccines/acip/acip-scdm-faqs.html#scdm
[vii] وَجَوَّزَهُ فِي النِّهَايَةِ بِمُحَرَّمٍ إذَا أَخْبَرَهُ طَبِيبٌ مُسْلِمٌ أَنَّ فِيهِ شِفَاءً وَلَمْ يَجِدْ مُبَاحًا يَقُومُ مَقَامَهُ. قُلْت: وَفِي الْبَزَّازِيَّةِ وَمَعْنَى قَوْلِهِ – عَلَيْهِ الصَّلَاةُ وَالسَّلَامُ – «إنَّ اللَّهَ لَمْ يَجْعَلْ شِفَاءَكُمْ فِيمَا حُرِّمَ عَلَيْكُمْ» نَفْيُ الْحُرْمَةِ عِنْدَ الْعِلْمِ بِالشِّفَاءِ دَلَّ عَلَيْهِ جَوَازُ شُرْبِهِ لِإِزَالَةِ الْعَطَشِ (رد المحتار على الدر المختار)
[viii] Imdād al-Fatāwa Jadīd maʻa Hāshiyah Shabbīr Aḥmad al-Qāsimī, 9:262
[ix] RSV Vaccination for Pregnant People. Centers for Disease Control & Prevention. https://www.cdc.gov/vaccines/vpd/rsv/public/pregnancy.html
[x] Although the vaccine is being administered to the mother, who is without necessity, the fetus, who is with necessity, is the intended patient. This evokes the principle, “Actions are [judged] by their intentions.” And, Allah knows best.
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