لقاح الفيروس المخلوي التنفسي (RSV)

الرضع وكبار السن والأشخاص ذوو ضعف المناعة والحوامل (للحماية السلبية للمواليد).

Severe allergic reaction to previous dose or any component. Moderate to severe acute illness (defer). Abrysvo maternal use: avoid if preterm delivery risk is high (limited data in preterm). mRESVIA: PEG/polysorbate allergy caution (mRNA-LNP platform).

Arexvy — Very common: injection site pain (61%), fatigue (34%), myalgia (29%), headache (27%). Common: arthralgia, fever. Abrysvo — Very common: injection site pain (41% adults), fatigue (21%), headache (18%). Maternal: injection site pain (41%), headache (31%), myalgia (27%). mRESVIA — Very common: injection site pain (59%), fatigue (38%), headache (30%), myalgia (32%), arthralgia (22%). GBS signal: FDA monitoring for Arexvy/Abrysvo — no confirmed causal association; ACIP notes shared clinical decision-making partly due to this signal.

Adults ≥60 years: single 0.5 mL dose IM (deltoid). No booster currently recommended (under study). Maternal immunization (Abrysvo): single 0.5 mL dose IM at 32–36 weeks gestation during RSV season. mRESVIA: single 0.5 mL dose IM. Administer before RSV season onset (September–October in Northern Hemisphere).

Arexvy: 82.6% efficacy (95% CI 57.9–94.1%) against RSV-associated lower respiratory tract disease (LRTD) in ≥60y, season 1. Abrysvo (adults): 66.7% against RSV-LRTD with ≥2 symptoms. Abrysvo (maternal): 81.8% efficacy against severe RSV-LRTD in infants within first 90 days. mRESVIA: 83.7% efficacy against RSV-LRTD (≥2 symptoms) in ≥60y. Second-season data shows waning for all products.

Arexvy/Abrysvo: +2°C to +8°C. mRESVIA: -25°C to -15°C (frozen), thawed at +2°C to +8°C for up to 30 days. All: protect from light, do not freeze (Arexvy/Abrysvo).

Can be co-administered with seasonal influenza vaccine (no interference). Can be co-administered with COVID-19 mRNA vaccines (limited data, acceptable). Co-administration with other adult vaccines (Tdap, pneumococcal, shingles): limited data but expected to be safe (non-live vaccines). No known drug interactions.

Abrysvo: approved for maternal immunization at 32–36 weeks gestation. No teratogenicity in animal studies. FDA post-marketing surveillance ongoing for preterm birth signal (not confirmed but noted). Arexvy/mRESVIA: not indicated in pregnancy. Breastfeeding: expected safe for all products (non-live).

NOT approved for infants or children. Infant protection achieved via maternal Abrysvo vaccination OR nirsevimab (beyfortus) monoclonal antibody passive immunization.

Primary target population. Adults ≥60 years at highest risk of RSV-associated LRTD. Consider chronic cardiopulmonary conditions, diabetes, immunocompromised status as additional risk factors. Co-decision with patient given GBS signal.

Guillain-Barré syndrome (GBS): surveillance signal noted for Arexvy and Abrysvo in post-marketing data — contributes to shared clinical decision-making recommendation rather than universal recommendation. Maternal Abrysvo: seasonal timing important — benefit limited outside RSV season. Do not confuse with nirsevimab (monoclonal antibody for infants) — different product class. Single-season recommendation in Year 1; whether to repeat annually under study.