mNEXSPIKE XBB.1.5 (SARS-CoV-2 spike protein (mRNA) XBB.1.5) COVID-19 Vaccine
mNEXSPIKE XBB.1.5 is a vaccine approved to prevent COVID-19 caused by SARS-CoV-2, in individuals aged 12 years and older. mNEXSPIKE XBB.1.5 contains the active ingredient SARS-CoV-2 spike protein (mRNA) XBB.1.5.
mNEXSPIKE XBB.1.5 is a COVID-19 vaccine approved for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus. Australian healthcare professionals can give the vaccine to people aged 12 years and older.
COVID-19 first emerged in late 2019 and continues to circulate globally. Over time, the virus can change slightly (these changes are called variants), which may affect how well the immune system recognises the virus.
Vaccines such as mNEXSPIKE XBB.1.5 are designed to better match SARS-CoV-2 variants that are circulating. Some people, such as older adults and people with chronic health conditions or weakened immune systems, are at higher risk of severe illness from COVID-19. Vaccination is an important way to reduce the rate of severe COVID-19 disease and death in protected individuals.
mNEXSPIKE XBB.1.5 is a vaccine designed to stimulate your body’s immune system to fight the SARS-CoV-2 virus. The vaccine works by teaching your body to produce protection (antibodies) against the virus that causes COVID-19.
mNEXSPIKE XBB.1.5 uses messenger ribonucleic acid (mRNA) to carry instructions to cells in the body to make key parts of the spike protein that is also on the virus. Your body then makes antibodies against the spike protein to help the body fight off the virus and protect against COVID-19 disease.
A number of clinical studies were conducted to assess the effectiveness and safety of mNEXSPIKE XBB.1.5 in people aged 12 years and older. Some studies compared mNEXSPIKE XBB. 1.5 to a similar mRNA COVID-19 vaccine (Spikevax).
Key findings from clinical studies
- In people over 12 years of age, mNEXSPIKE XBB.1.5 was shown to provide similar effectiveness against COVID-19 compared with Spikevax. Effectiveness was measured using COVID-19 infection rates after vaccination and antibody blood test results.
- The effectiveness of mNEXSPIKE XBB.1.5 was similar across the age groups of 12-65 and 65 years and older.
- In the overall study population, adverse reactions within 7 days after vaccination were lower for mNEXSPIKE XBB.1.5 compared with Spikevax. People also reported less pain at the injection site after the mNEXSPIKE XBB.1.5. vaccination.
- The most reported adverse reactions following mNEXSPIKE XBB.1.5 were injection site pain (68.5%), fatigue (50.4%), headache (44.2%), muscle pain (38.2%), joint pain (29.7%), chills (22.7%), armpit swelling or tenderness (19.7 %), and nausea and/or vomiting (12.1%).
- Overall, the safety of mNEXSPIKE XBB.1.5 was similar to the safety of Spikevax.
The TGA decided that the application has provided sufficient evidence supporting the safety and effectiveness of mNEXSPIKE XBB.1.5 and the medicine can be registered for use in Australia.
More detailed information on why the TGA approved mNEXSPIKE XBB.1.5 will be published in the upcoming Australian Public Assessment Report (AusPAR).
The information in this decision summary will not be updated to include any subsequent changes, so may not represent the most current information for a medicine. For current information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMI for mNEXSPIKE XBB.1.5 can be accessed through the ARTG hyperlinks provided below.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions, and potential side effects.
The Australian PI for mNEXSPIKE XBB.1.5 can be accessed through the ARTG hyperlinks provided below.
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
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For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.