2022-02-08-世界卫生组织-NVX-CoV2373_recombinant,_adjuvanted_COVID-19_vaccine_7页_209kb

报告摘要

COVID-19 Vaccine NVX-CoV2373 (Covovax™/Nuvaxovid™) Summary

Description: This vaccine is a recombinant, adjuvanted protein subunit vaccine against COVID-19, utilizing SARS-CoV-2 spike protein fragments in nanoparticles with Matrix-M adjuvant. Approved by WHO on December 17, 2021 (Covovax™) and December 20, 2021 (Nuvaxovid™) for individuals aged ≥18 years. Produced by Serum Institute of India and Novavax CZ.
Efficacy: Phase 3 trials show 90% efficacy against mild/moderate/severe COVID-19 in the UK and Mexico/USA, and 87% in South Africa during variant predominance. Benefits outweigh known risks, supported by WHO.
Administration: Recommended doses of 0.5 mL each, delivered intramuscularly into the deltoid muscle. Primarily for ages 18+, with a schedule of two doses given 3-4 weeks apart. Booster doses under assessment.
Safety: Common side effects include pain at injection site, fatigue, and headache, more frequent after the second dose, with short duration. Contraindications include anaphylaxis to vaccine components, and precautions advised for immunocompromised, elderly, pregnant, and lactating individuals. Post-marketing surveillance ongoing.
Special Populations: Vaccinated for comorbidities, elderly, pregnant women (with risk-benefit assessment), lactating mothers, and immunocompromised individuals (requiring extended primary series if needed). Not recommended in early pregnancy without risk-benefit evaluation.
Storage: Store in refrigerator at +2 to +8°C, protected from light; unpreserved. Shelf life varies by packaging.
Additional Resources: See details in WHO publications.