What is it about?
This paper describes the pivotal phase 3 clinical trial which demonstrated the effectiveness of SpikoGen, a novel Advax-CpG55.2 adjuvanted protein-based COVID-19 vaccine, in 16,876 trial participants.
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Why is it important?
This trial demonstrated that protein-based vaccine approaches to COVID-19 protection remain viable alternatives to the more widely promoted mRNA vaccine approaches, delivering high rates of protection against severe disease, while being well tolerated and having no serious vaccine-associated side effects, such as thrombosis or myocarditis seen with other COVID-19 vaccine platforms.
Perspectives
While mRNA and adenoviral vector COVID-19 vaccine approaches received the most high profile media attention during the pandemic, being promoted by large multinational pharma companies and entire governments, protein-based COVID-19 approaches, arguably offered the best balance of efficacy, tolerability and safety, being based on well characterized and understood platforms. mRNA vaccines were incorrectly portrayed as being highly effective at preventing infection and inferred to prevent transmission based on flawed analyses of short-term data. Longer-term data showing that mRNA vaccines neither prevented infection nor transmission was largely ignored n all the marketing hype around this platform, thereby giving rise to the false impression that they were somehow superior to other vaccine platforms such as protein-based vaccines.
Professor Nikolai Petrovsky
Flinders University
Read the Original
This page is a summary of: Evaluating the efficacy and safety of SpikoGen®, an Advax-CpG55.2–adjuvanted severe acute respiratory syndrome coronavirus 2 spike protein vaccine: a phase 3 randomized placebo-controlled trial, Clinical Microbiology and Infection, February 2023, Elsevier,
DOI: 10.1016/j.cmi.2022.09.001.
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