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RSV vaccine, recombinant (maternal)

Recombinant protein vaccine, stabilized prefusion F protein

ATC code: J07BX05

Updated · Methodology

Indications

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Contains stabilized RSV prefusion F protein subtypes A and B. No adjuvant. The pregnant woman at 32–36 weeks generates IgG to F protein that crosses the placenta and protects the newborn for the first 6 months – the most vulnerable period for severe RSV bronchiolitis. Per MATISSE trial (NEJM 2023), effectiveness against severe infant disease 81.8% in first 3 months and 69.4% in first 6 months.

Safety

Contraindications

  • Anaphylaxis to components
  • Pregnancy <32 or >36 weeks (outside recommended window)

Serious adverse effects

  • Preterm birth – small increased risk (4.2% vs 3.7% placebo, MATISSE)
  • Anaphylaxis (rare)

Common adverse effects

  • Injection-site pain (40%)
  • Fatigue
  • Headache
  • Myalgia

Pregnancy: can you take RSV vaccine, recombinant (maternal)?

Only at 32–36 weeks. Not given outside that window.

Breastfeeding: can you take RSV vaccine, recombinant (maternal)?

Hale L1 · Compatible

Fully compatible. Hale L1.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Single dose at 32–36 weeks of pregnancy, September to January (Northern Hemisphere). Not given postpartum – no transplacental transfer use.

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Frequently asked

What is RSV vaccine, recombinant (maternal) used for?

RSV vaccine, recombinant (maternal) is evaluated for the following indications with varying evidence strength: Maternal vaccination (evidence tier A), Vaccination during breastfeeding (evidence tier A). See the full indication matrix with dosing and citations above on this page.

What are the side effects of RSV vaccine, recombinant (maternal)?

Common side effects of RSV vaccine, recombinant (maternal) (≥ 1 in 100): Injection-site pain (40%), Fatigue, Headache, Myalgia. See the Safety section for uncommon and serious reactions.

Is RSV vaccine, recombinant (maternal) safe during pregnancy?

Only at 32–36 weeks. Not given outside that window.

Is RSV vaccine, recombinant (maternal) compatible with breastfeeding?

Fully compatible. Hale L1.

Who should not take RSV vaccine, recombinant (maternal)?

RSV vaccine, recombinant (maternal) is contraindicated in: Anaphylaxis to components; Pregnancy <32 or >36 weeks (outside recommended window). Full list in the Safety section.

Other drugs in this group

Tdap – tetanus, diphtheria, acellular pertussis vaccine, COVID-19 vaccine, mRNA (Moderna), COVID-19 vaccine, mRNA (Pfizer-BioNTech), Hepatitis A vaccine, inactivated, HPV vaccine, nonavalent, MMR – measles, mumps, rubella vaccine (live), Hepatitis B vaccine, recombinant, Inactivated influenza vaccine