Reason for request

Inclusion on list

Summary of opinion

Favourable opinion for reimbursement in the community and hospital setting “for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations”.

No clinical added value of the new single-dose forms compared to the forms already available.

Due to the rapidly evolving epidemic context, it is necessary to refer to national guidelines relative to the strategy for the use of COVID-19 treatments based on data on the sensitivity of circulating variants.


Clinical Benefit

Substantial

The clinical benefit of NUVAXOVID 0.5 ml (SARS-CoV-2 Spike protein adjuvanted with Matrix-M) dispersion for injection in
pre-filled single-dose vials/syringes remains substantial in the MA indication.


Clinical Added Value

no clinical added value

These medicinal products are range supplements in pre-filled single-dose vials/syringes that provide no clinical added value (CAV V) compared to the forms already listed.


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