NUVAXOVID (SARS-CoV-2 Spike protein adjuvanted with Matrix-M) - COVID-19

The Committee deems that the clinical benefit of NUVAXOVID (SARS-CoV-2 Spike protein adjuvanted with Matrix-M) is substantial for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older, in accordance with the current HAS recommendations.

Considering:

• the persistent need to have access to vaccines in the prevention of SARS-CoV-2 infections based on the evolution of the epidemiological situation and the regular emergence of new variants, particularly in individuals who do not wish to or cannot receive an mRNA vaccine;
• the data taken into account by the current HAS recommendations, i.e.:
  • evidence versus placebo of the vaccine efficacy of original monovalent NUVAXOVID (SARS-CoV-2 Spike protein adjuvanted with Matrix-M) in terms of the reduction in the number of symptomatic COVID-19 cases, including in individuals over 65 years of age, with a vaccine efficacy estimated to be 89.7%, 95% CI [80.2; 94.6] in 15,139 subjects aged 18 to 84 years for the 2019nCoV-302 trial conducted in the United Kingdom (inclusions from 28/09/20 to 28/11/20) and 90.4%, 95% CI [82.9; 94.6] in 29,582 adult subjects in the 2019nCoV-301 trial conducted in the USA and Mexico;
  • the immunogenicity data obtained with the different variants in primary and booster vaccination taken into account to draw up the current vaccine recommendations;
  • new data added to the file which, to date, has not been used to update the vaccination recommendations;
  • an acceptable safety profile, with reported cases of myocarditis, the course of which is not different from the course of myocarditis in general;

and despite:

• the absence of new clinical efficacy data in addition to the available immunogenicity data;
• the long-term uncertainties, in particular with respect to the duration of protection provided,

the Committee deems that, like SPIKEVAX (COVID-19 mRNA (modified nucleoside) vaccine), the clinical benefit of NUVAXOVID (SARS-CoV-2 Spike protein adjuvanted with Matrix-M) is substantial (CAV II) for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older, in accordance with the current HAS recommendations.