respiratory syncytial virus vaccine (bivalent, recombinant): clinical use

Prescribing considerations

• Confirm use accords with the licensed indication and current national programme or an individual clinical decision.
• Postpone during acute febrile illness, but not solely for a minor infection.
• Assess bleeding risk before intramuscular administration in thrombocytopenia, coagulation disorders or anticoagulant use.
• Do not mix with another vaccine or medicinal product in the same syringe.

Contraindications and cautions

• Hypersensitivity to an active substance or excipient, including a serious reaction to a previous dose.
• Do not use for routine RSV vaccination of young children.
• The licensed maternal product should not be used before the authorised gestational period.

Monitoring

• Ensure facilities and trained staff are available to manage anaphylaxis.
• Prevent injury from syncope or other anxiety-related reactions.
• Be alert to neurological symptoms suggesting Guillain–Barré syndrome.
• Record product name and batch number for traceability.
• Report suspected adverse reactions through the MHRA Yellow Card scheme.

Clinical pharmacology

Recombinant RSV-A and RSV-B prefusion F antigens induce neutralising antibodies. Adults receive active immunity; infant protection after maternal vaccination results from transplacental antibody transfer.

Formulation and product differences

• Supplied as a white antigen powder with clear, colourless water-for-injection solvent and requires reconstitution.
• Contains polysorbate 80 and is essentially sodium-free.
• Presentations may use a pre-filled solvent syringe with vial adaptor or separate powder and solvent vials.
• Store refrigerated and do not freeze; inspect the reconstituted solution for particles or discolouration.