SHINGRIX (adjuvanted recombinant herpes zoster vaccine) - Zoster vaccine)

The Committee deems that the clinical benefit of SHINGRIX (adjuvanted recombinant herpes zoster vaccine) is substantial in prevention of herpes zoster and post-herpetic neuralgia in adults 65 years of age and older, and adults 18 years of age and older at increased risk of herpes zoster, according to the HAS guidelines in force dated 29 February 2024.

In view of:

• the persistent medical need for vaccines with evidence of efficacy in prevention of herpes zoster and post-herpetic neuralgia, in particular in individuals with risk factors:
• the evidence versus placebo of vaccine efficacy (VE) of SHINGRIX (adjuvanted recombinant herpes zoster vaccine) on reduction in the number of herpes zoster cases, estimated at:
  • 3%, CI95% = [86.8; 94.5] in the grouped analysis of the randomised phase III studies, Zoster-006 and Zoster-022, in immunocompetent individuals 50 years of age and older,
  • 2%, CI95% = [55.6; 77.5] dans Zoster-002 study in immunocompromised individuals 18 years of age and older, such as autologous HSC transplant recipients;
• the data considered for the HAS guidelines in force, in particular:
  • efficacy data from the systematic reviews available such as the meta-analysis by Mbinta et al. supporting the real-life VE findings in respect of SHINGRIX (adjuvanted recombinant herpes zoster vaccine) (79.3%, CI95% = [57.6; 89.7]), and the network meta-analysis by Tricco et al. suggesting superiority of SHINGRIX (adjuvanted recombinant herpes zoster vaccine) in relation to ZOSTAVAX (live attenuated herpes zoster vaccine) in herpes zoster prevention (confirmed cases and suspected cases),
  • Immunogenicity data obtained from immunocompetent individuals 50 years of age and older, as well as immunocompromised individuals 18 years of age and older or individuals with chronic illnesses;
  • data from the ZOE-LFTU (ten-year) follow-up study suggesting an overall VE of Shingrix vaccine of 81.6%.
• a favourable safety profile;

and despite:

• the lack of robust comparative data in immunocompetent individuals in relation to the available vaccine ZOSTAVAX (live attenuated herpes zoster vaccine);
• long-term uncertainties, in particular with respect to the duration of protection provided and the need for booster doses, in particular in immunocompromised individuals. The need for booster doses following the primary vaccination schedule has not been established (see SPC),

the Committee deems that SHINGRIX (adjuvanted recombinant herpes zoster vaccine) provides moderate clinical added value (CAV III) in prevention of herpes zoster and post-herpetic neuralgia (PHN) in adults 65 years of age and older, and adults 18 years of age and older at increased risk of herpes zoster, according to the HAS guidelines in force dated 29 February 2024.