respiratory syncytial virus (RSV) vaccine (recombinant, adjuvanted): clinical use

Prescribing considerations

• Confirm that the person falls within the licensed adult indication and applicable official recommendations.
• Postpone vaccination during acute severe febrile illness; a minor infection such as a cold does not itself require deferral.
• Ensure facilities and trained staff are available to manage anaphylaxis.
• Use caution with thrombocytopenia or coagulation disorders because intramuscular injection may cause bleeding.
• Immunosuppression or immunodeficiency may reduce immunogenicity; safety and immunogenicity data in immunocompromised people are limited.
• Record the product name and batch number for traceability.

Contraindications and cautions

• Hypersensitivity to the active substances or any excipient.
• Do not administer intravascularly or intradermally.

Monitoring

• Watch for immediate hypersensitivity and injury related to fainting around administration.
• Advise recipients to seek assessment for neurological symptoms compatible with Guillain–Barré syndrome.
• No routine laboratory monitoring is specified.

Clinical pharmacology

RSVPreF3 is a recombinant RSV F glycoprotein stabilised in its prefusion form. The AS01E adjuvant contains MPL and QS-21 and enhances antigen presentation, cellular immunity and neutralising-antibody responses.

Formulation and product differences

• Supplied as a white antigen powder and a separate opalescent, colourless-to-pale-brown adjuvant suspension in vials.
• The components require reconstitution before intramuscular administration.
• Contains polysorbate 80, which can cause allergic reactions; it is essentially sodium-free and potassium-free.