SPIKEVAX (elasomeran / davesomeran / andusomeran) - COVID-19

The Committee deems that the clinical benefit of SPIKEVAX (COVID-19 mRNA (modified nucleoside) vaccine) is substantial for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in the context of primary and booster vaccination, in adults over 30 years old, 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;
• the data taken into account by the current HAS recommendations, i.e.:
• demonstration versus placebo of the efficacy of the original monovalent SPIKEVAX vaccine (COVID-19 mRNA (modified nucleoside) vaccine) in terms of the reduction in the number of symptomatic COVID-19 cases, including in individuals over 65 years old, with a vaccine efficacy of 94.1%, CI95% = [89.3; 96.8] in primary vaccination in 30,415 adult subjects (phase 3 COVE P301 study),
• the immunogenicity data obtained with the different variants in primary and booster vaccination taken into account to draw up the current vaccine recommendations,
• observational data from real-word studies supporting the results in terms of hospitalisations and deaths in the context of primary and booster vaccination, particularly in France,
• pharmacovigilance and pharmaco-epidemiological data identifying a higher risk of myocarditis in subjects under 30 years old, leading to this population being excluded from the HAS recommendations;
• new data added to the file which, to date, has not been used to update the vaccination recommendations;

and despite:

• the absence of new clinical efficacy data in addition to the available immunogenicity data;
• the specific safety points, such as menstrual disorders, Parsonage-Turner syndrome, loss of hearing, hypertension and autoimmune diseases that are the subject of monitoring by the ANSM as part of the national pharmacovigilance survey relative to COVID-19 vaccines;
• the long-term uncertainties, in particular with respect to the duration of protection provided;

the Committee deems that SPIKEVAX (COVID-19 mRNA (modified nucleoside) vaccine) provides a substantial clinical added value (CAV II) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in the context of primary and booster vaccination, in adults over 30 years old, in accordance with the current HAS recommendations.