SPIKEVAX

What it is

SPIKEVAX XBB.1.5 (andusomeran) is a COVID-19 vaccine indicated for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 12 years of age and older. Each dose of 0.5 mL contains 50 micrograms of andusomeran, a COVID-19 mRNA vaccine embedded in lipid nanoparticles. Andusomeran is a single-stranded, 5'-capped messenger RNA produced using a cell-free in-vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 (Omicron XBB.1.5). The vaccine is provided as a suspension for injection with a white to off-white appearance.

Approved indications

— Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 12 years of age and older.

Dosing overview

For individuals 12 years of age and older receiving a primary series, the recommended dose is 2 doses of 0.5 mL each, containing 50 micrograms each, administered 28 days apart. For additional doses in previously vaccinated individuals, SPIKEVAX XBB.1.5 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine. In severely immunocompromised individuals who have been previously vaccinated, additional age-appropriate doses may be administered at least 2 months following the most recent dose of a COVID-19 vaccine at the discretion of the healthcare provider. The safety and efficacy of SPIKEVAX XBB.1.5 in children and adolescents less than 12 years of age have not yet been established.

Key safety warnings

Anaphylaxis has been reported in individuals who have received SPIKEVAX (original), and appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following administration of the vaccine. There is an increased risk for myocarditis and pericarditis following vaccination with SPIKEVAX XBB.1.5, which can develop within just a few days after vaccination and have primarily occurred within 14 days, with observations more often after the second dose and more often in adolescent and young adult males. Vaccine recipients should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as chest pain, shortness of breath, or palpitations following vaccination. The effectiveness and immunogenicity of the vaccine may be lower in severely immunocompromised persons, including those receiving immunosuppressive therapy, based on data from clinical studies in solid organ transplant recipients. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection, and precautions should be in place to avoid injury from fainting.

Contraindications

SPIKEVAX XBB.1.5 is contraindicated in individuals with hypersensitivity to the active substance or to any of the excipients, or in individuals with known severe allergic reactions (such as anaphylaxis) to a previous dose of SPIKEVAX (original), SPIKEVAX BIVALENT ORIGINAL/OMICRON (BA.1), SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 or SPIKEVAX XBB.1.5.

PBS listing

No information regarding PBS listing is available in the provided documents.

Regulatory history

SPIKEVAX XBB.1.5 (andusomeran) COVID-19 vaccine was first listed on the Australian Register of Therapeutic Goods (ARTG 418910 for the vial and ARTG 418911 for the pre-filled syringe) on 2023-10-10. The vaccine is subject to additional monitoring in Australia.