Nya vacciner. Mia Brytting och Kari Johansen

Transcription

1 Nya vacciner Mia Brytting och Kari Johansen

2 Förra säsongen i Sverige Sid

3 Vad är godkänt i Europa MF59 adjuvanted trivalent Fluad (1996) Quadrivalent inactivated Fluarix Tetra (2013) >36 mo available in Austria, Belgium, Czech Republic, France, Germany, Greece, Italy, Spain, Slovakia, Switzerland & UK (FluarixTetra, α-rix-tetra, Influsplit Tetra) Vaxigrip Tetra (2016) >36 mo plan to launch in some EU/EEA MSs in the coming season Nu även i Sverige Quadrivalent live attenuated Fluenz Tetra (2013) 2 years 17 years available in available in Austria, Finland, Germany, Norway, Spain, Sweden, UK Sid

4 Vad är på gång i Europa Intradermal trivalent years Intradermal tetravalent years (authorised in the US since 2014) High-dose trivalent >65 years (authorised in the US) High-dose tetravalent > 65 years (under development) MF59 adjuvanted tetravalent (under development) Sid

5 Proportion of influenza vaccine doses administered by type of vaccine and age group in Italy, 2016/2017 season >2 M MF59 adjuvanted used last season >1 M intradermal used last seasons >1 M quadrivalent used last season Sid Courtesy: C Rizzo, ISS, Italy

6 Quadrivalent seasonal influenza vaccines

7 Role of QIVs Systematic review immunogenicity QIV vs TIV Seroprotection rate (SPR) day 21 post-vaccinationagainst the two B-lineages In adults, inactivated QIV was as immunogenic as seasonal TIV, with equivalent efficacy against the shared three strains included in TIV, and a superior immunogenicity against the non-tiv B lineage. Sid. *Moa et al Immunogenicity and safety of inactivated quadrivalent influenza vaccine in adults: A systematic review and meta-analysis of randomised controlled trials. Vaccine Jul 29;34(35):

8 Adverse events during 0 7 days post vaccination QIV versus pooled TIV (TIV groups combined (TIV-B/Victoria & TIV-B/Yamagata); Sid. Moa et al Immunogenicity and safety of inactivated quadrivalent influenza vaccine in adults: A systematic review and meta-analysis of randomised controlled trials. Vaccine Jul 29;34(35):

9 High-dose trivalent inactivated seasonal influenza vaccine

10 Efficacy High-dose versus standard dose Protocoldefined ILI IIV3-HD (n=15,990) IIV3-SD (n=15,993) Relative efficacy no. (%) no. (%) % 95% CI 73 (0.5) 113 (0.7) Influenza A 56 (0.4) 82 (0.5) A/H1N1 7 (<0.1) 8 (0.1) 13 ( ) A/H3N2 49 (0.3) 74 (0.5) Influenza B 17 (0.1) 31 (0.2) DiazGranados et al Efficacy of High-Dose versus Standard-Dose Influenza Vaccine in Older Adults N Engl J Med 2014;371: Sid.

11 Effectiveness High-Dose Versus Standard-Dose & Rates of post-influenza death were and 0.038/10000 person-weeks in high-dose and standard-dose recipients, respectively. There was evidence of variation by season, in , an H3N2 season, highdose was 36.4% (95% CI, 9.0% 56%) more effective in reducing mortality; in , an H1N1 season it was 2.5% (95% CI, 47% to 35%). Sid. *Shay et al Comparative Effectiveness of High-Dose Versus Standard-Dose Influenza Vaccines Among US Medicare Beneficiaries in Preventing Postinfluenza Deaths During and J Infect Dis. 2017;215(4):

12 Safety High-Dose Versus Standard-Dose Sid. Halasa et al Randomized Double-Blind Study of the Safety and Immunogenicity of Standard-Dose Trivalent Inactivated Influenza Vaccine versus High-Dose Trivalent Inactivated Influenza Vaccine in Adult Hematopoietic Stem Cell Transplantation Patients Biology of Blood and Marrow Transplantation 2016;22(3)

13 MF59 adjuvanted trivalent inactivated seasonal influenza vaccine

14 Effectiveness Systematic review MF59-adjuvanted seasonal influenza vaccine in the elderly MF59-TIV displayed greater efficacy than non-adjuvanted vaccines in preventing hospitalizations due to pneumonia/influenza [adjusted risk ratio 0.75 (95% CI: )] and laboratory-confirmed influenza [adjusted odds ratio 0.37 ( )]. Sid. Domnich et al Effectiveness of MF59-adjuvanted seasonal influenza vaccine in the elderly: A systematic review and meta-analysis Vaccine 35 (2017)

15 Safety Percentages of subjects experiencing mild to moderate (and severe) solicited local and systemic adverse reactions within one week of vaccination Local adverse reactions ativ TIV N = 3505 N = 3495 Any (%) 32 (<1) 17 (<1) Pain (%) 25 (<1) 12 (<1) Erythema (%) 1 (0) 1 (0) Induration (%) 1 (0) <1 (0) Swelling (%) 1 (<1) 1 (<1) Tenderness (%) 21 (<1) 11 (<1) Systemic adverse reactions Any (%) 32 (<1) 26 (<1) Chills (%) 7 (<1) 5 (0) Myalgia (%) 15 (<1) 9 (1) Arthralgia (%) 8 (<1) 7 (1) Headache (%) 13 (<1) 10 (1) Fatigue (%) 13 (<1) 9 (1) Nausea (%) 3 (<1) 3 (<1) Vomiting (%) 1 (<1) 2 (<1) Diarrhea (%) 5 (<1) 5 (<1) Fever ( 38 C) (%) 4 (<1) 3 (<1) Analgesic/antipyretic use (%) 5 4 Sid.

16 MF 59 enhances functional antibody responses to HA-based vaccines by improving both epitope breadth and binding affinity Sid. Khurana et al MF59 adjuvant enhances diversity and affinity of antibody-mediated immune response to pandemic influenza vaccines Sci Transl Med Jun 1;3(85):85ra48