Safety and efficacy of the NVX-CoV2373 COVID-19 vaccine


Early clinical studies of the Novavax COVID-19 vaccine, NVX-CoV2373, consisting of 5 mg of a recombinant nanoparticle spike protein plus 50 mg of Matrix-M adjuvant, have shown that a two-dose regimen administered 21 days apart was safe and was associated with a robust immune response in healthy adult participants.

The publication cited presents data from the 2019nCoV-302 study, a phase 3, randomized, observer-blinded, placebo-controlled trial to evaluate the efficacy, immunogenicity, and safety of 

NVX-CoV2373 in preventing Covid-19 in participants between the ages of 18 and 84 in the United Kingdom.

A total of 15,187 participants were randomly selected, and 14,039 were included in the per-protocol efficacy population. Of the participants, 27.9% were 65 years of age or older, and 44.6% had coexisting illnesses. A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARSCoV-2 infection, and showed high efficacy against the B.1.1.7 variant.

The results of this trial provide further evidence that immunization with a protein-based, adjuvanted vaccine such as NVX-CoV2373 can prevent Covid-19 caused by either B.1.1.7 or non-B.1.1.7 variants. In addition, NVX-CoV2373 can be stored at standard refrigeration temperatures and has the potential to induce a broad epitope response to the spike protein antigen. Both of these attributes are important for the efficient implementation of this vaccine globally.  

Source: Heath PT, Galiza EP, Baxter DN, et al. Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. N Engl J Med. (2021) doi: 10.1056/NEJMoa2107659.

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