SARS-CoV-2 recombinant spike protein: clinical use

Prescribing considerations

• Use according to current national recommendations and confirm eligibility.
• Defer during severe acute febrile illness or acute infection, but not solely for a minor infection or low-grade fever.
• Protection may be lower in immunosuppressed individuals.
• Assess bleeding risk and injection technique in people taking anticoagulants or with thrombocytopenia or coagulation disorders.
• Record the product name and batch number for traceability.

Contraindications and cautions

• Hypersensitivity to the active substance or any excipient, including consideration of polysorbate 80 allergy.
• Do not give another Nuvaxovid vaccination after anaphylaxis to a previous Nuvaxovid vaccination without specialist assessment and an alternative plan.

Monitoring

• Ensure treatment and supervision for anaphylaxis are immediately available and observe after vaccination.
• Advise recipients to seek immediate assessment for persistent chest pain, breathlessness or palpitations.
• Take precautions against injury from anxiety-related syncope.
• Report suspected adverse reactions through the Yellow Card scheme.

Clinical pharmacology

Purified recombinant JN.1 spike protein is stabilised in its prefusion conformation and combined with the saponin-based Matrix-M adjuvant. This activates innate immunity and promotes spike-specific neutralising antibodies and cellular immune responses; pharmacokinetic studies are not applicable.

Formulation and product differences

• Ready-to-use, single-use pre-filled syringe without a supplied needle.
• Must not be shaken, diluted or mixed with other medicinal products.
• The dispersion should be colourless to slightly yellow, clear to mildly opalescent and free from visible particles.
• Store refrigerated, protect from light and do not freeze.
• Contains Matrix-M, polysorbate 80 and small quantities of sodium and potassium.