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10. ?7-!@!;)/&,#'%ABC%#%DE!

11. Calendario de vacunaciones CAV-AEP
Recomendaciones 2014
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14. WEB Comité Asesor de Vacunas
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15. Rotavirus

16. Calendario de vacunaciones CAV-AEP
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27. Ra B, et al. Expert Rev Vaccines 2014 ?7-!@!;)/&,#'%ABC%#%DE!
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28. Reducción de hospitalizaciones por
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Dey A, et al. Med J Aust 2012

29. Clarke MF, et al. Vaccine 2011
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30. Gastañaduy P, et al. JAMA 2013
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33. !(';(6;>1A5;<C3(43>7<36(;<(C1A5>5@51(/(
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34. Rotateq. Ficha técnica 2012.
ACIP-CDC. MMWR 2009.
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35. Rotateq. Ficha técnica 2012.
ACIP-CDC. MMWR 2009.
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36. ?7-!@!;)/&,#'%ABC%#%DE!
Vacuna rotavirus(
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37. ?7-!@!;)/&,#'%ABC%#%DE!
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38. ?7-!@!;)/&,#'%ABC%#%DE!
Vacuna rotavirus(
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Weintraub ES, et al. NEJM 2014

39. ?7-!@!;)/&,#'%ABC%#%DE!
Vacuna rotavirus(
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0F]0c(](--%%N(0J-'f+(B-(J&"#fJ&#$J+&(
Weintraub ES, et al. NEJM 2014

40. Vacuna rotavirus(
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--%%N(0J-'f+(B-(J&"#fJ&#$J+&(
Glass R, Parashar U. NEJM 2014

41. O (#@;6=53(?6;453(3(3@=7<3(C1858(
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Vacuna rotavirus(
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42. O (,6;>37>5_<9(<1(>1<2635<C5>3>5_<((
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43. Yen C, et al. Vaccine 2011
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44. Smith, et al. Vaccine 2011
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45. O (#@;6=53(?6;453(3(3@=7<3(C1858(
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Vacuna rotavirus(
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46. O ('o<C61A;(C;(5<2;8Z<1(>1621(
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Si no tratamiento inmunosupresor, se considera que
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CDC. MMWR Recomm Rep. 2009
Vacuna rotavirus(
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47. O ('o<C61A;(C;(5<2;8Z<1(>1621(X5@;1821Ao3(
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Vacuna rotavirus(
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?7-!@!;)/&,#'%ABC%#%DE!

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49. wHH(DEFGHIE18HJH11
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50. Papilomavirus

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52. Es prioritario
mejorarlas
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53. Es prioritario
mejorarlas
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54. Es prioritario
mejorarlas
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56. L8N1&+1Q9=@$1(.O,/6)/'1&'()*'71;<=;!
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57. Adolescencia y riesgo : Universidad Pontificia Comillas-ICAI-ICADE, 2009

58. :*R,((4P*1L8N1,*1*),+6/.15,94.!
Castellsagué X, et al. J Med Virol 2012

59. :*R,((4P*1L8N1,*1*),+6/.15,94.!
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60. -C3C(43>7<3>5_<(W6;<2;(3(
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61. -C3C(43>7<3>5_<(W6;<2;(3(
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62. Calendario de vacunaciones CAV-AEP
Recomendaciones 2014
?7-!@!;)/&,#'%ABC%#%DE!

63. Fuente: eCDC

64. 0;>1A;<C3>51<;8(1p>53@;8((
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Fuente: eCDC - vaccine scheduler (último acceso: 24 ene 2014)
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65. 0;>1A;<C3>51<;8(1p>53@;8((
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Fuente: WHO vaccine preventable disease – monitoring system (último acceso: 24 ene 2014)
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66. Es prioritario
mejorarlas
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67. Regiones con programas escolares
de vacunación VPH
GALICIA
ASTURIAS
CASTILLA Y LEON
EXTREMADURA
ANDALUCIA
CASTILLA-LA MANCHA
MURCIA
VALENCIA
CATALUÑA
ARAGON
NAVARRA
RIOJA
PAÍS
VASCO
CANTABRIA
BALEARES
CEUTA MELILLA
MADRID
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CANARIAS

68. Es prioritario
mejorarlas
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69. L'()*'+1L8N$11
S(!'+16T(*4('+!
Actualización reciente EMA/AEPMS
fichas técnicas de vacunas VPH
Mayo 2012 Diciembre 2013
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70. U4(!'16T(*4('19,1M,/&'/4V11
W7X5'1'(6)'74Y'(4P*1EDH$194(4,5O/,1;<=Z!
www.emea.europa.eu/humandocs/PDFs/EPAR/cervarix/H-721-PI-es.pdf
j ($-0"#0Jnr(es una vacuna indicada a partir de los 9 años de
edad para la prevención de lesiones genitales premalignas
(cervicales, vulvares y vaginales) y cáncer de cérvix
causados por determinados tipos oncogénicos del Virus del
Papiloma Humano (VPH)
j (",.Fb9(",.]F`H(Se demostró protección cruzada consistente
frente al VPH-31, 33 y 45 para las variables infección persistente a 6
meses y CIN2+ en todas las cohortes del estudio.!!!
(
j (L3(5<C5>3>5_<(;82t(S383C3(;<N(
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j P,!.%9(4'1,&/M#!.%!;p>3>53!%#!A7y;6;8(iFc(3!
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR/human/000721/WC500024634.pdf
j Se demostró protección cruzada consistente
frente al VPH-31, 33 y 45 para las variables infección persistente a 6
meses y CIN2+ en todas las cohortes del estudio.!!!

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<

72. Variable Grupo N n
Eficacia vacunal, %
(IC 95%)
CIN2+
Cervarix® 5.466 1
99.0 (94,2–100,0)
Control 5.452 97
CIN3+
Cervarix® 5.466 0
100.0 (85,5–100,0)
Control 5.452 27
Cohorte CTV-naïve (15-25 años)
Análisis al cierre del estudio1
100.0
!
!
Estudio PATRICIA
Eficacia frente a lesiones CIN2+ por VPH-16/18
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73. Cervarix1
Tipo de VPH EV %
(IC 95%)
VPH-31 89,4
(65,5-97,9)
VPH-33 82,3
(53,4- 94,7)
VPH-45 100
(41,7-100)
zO;;@;6(;2(3@H(L3<>;2(+<>1@1=q(TUFT(
-p>3>53(43>7<3@(W6;<2;(3(Z?18(1<>1=D<5>18(<1(43>7<3@;8(C;(
",.(;<($K"]<3{4;H($J&T|(
Con unas N parecidas y seguimientos parecidos (~ 4 años) la distribución de casos
en el grupo vacunal y en el grupo control es diferente
No se han realizado estudios comparativos de eficacia. Estas comparaciones son solo
informativas en CTV-naïve comparables
?7-!@!;)/&,#'%ABC%#%DE!

74. VPH-16/18 son los tipos de VPH más prevalentes
asociados al cáncer de cérvix invasivo
Sanjose, et al. Lancet Oncol 2010
Protección esperada de ~70% para una vacuna
100% eficaz frente a VPH-16 y -18
Otros
",.]Fb(q(F`(
?7-!@!;)/&,#'%ABC%#%DE!

75. Ficha técnica Cervarix 2013
Eficacia global frente a lesiones premalignas CIN3+
(estadio inmediatamente anterior al cáncer de cérvix)
93%
(78,9-98,7)
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W,4,.(!%#!%)!./4%[(!.%!8%1S,1/Z!
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76. Tipos VPH % EFICACIA 95% IC
31 70 32 – 88
31, 45 59 14 – 82
31, 33, 45, 52, 58 33 -0.3 – 55
31, 33, 35, 39, 45, 51, 52, 56, 58, 59 33 6 – 52
Brown DR, et al. J Infect Dis 2009
Garland S. FIGO 2009, Cape Town, RSA.
Eficacia de Gardasil
Protección cruzada en CIN 2/3 o AIS
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?7-!@!;)/&,#'%ABC%#%DE!

77. 7,T!BFDK!p!<()=9%!H!p!"44=%!C!p!%JDHBC!
¿Hay estudios comparando
Gardasil y Cervarix?
Draper E, et al. PloS One 2013
?7-!@!;)/&,#'%ABC%#%DE!

78. 0;8?7;823(#>8(<;7263@5E3<2;8(W6;<2;(3(",.]Fb(q(F`(
Draper E, et al. PloS One 2013
?7-!@!;)/&,#'%ABC%#%DE!

79. 0;8?7;823(#>8(<;7263@5E3<2;8(W6;<2;(3(",.]VF(q([c(
Draper E, et al. PloS One 2013
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80. Brotherton J. et al: Lancet 2011
Gross et al. J Pediatr Adolesc Gynecol 2010
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Incidencia de CITOLOGÍAS ANÓMALAS en mujeres vacunadas con Gardasil en Australia.
■ Descenso Significativo del 47,5% en la incidencia en los citologías anómalas de Alto
Grado en mujeres de < 18
■ Datos similares encontrados en USA
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81. Abril 2007 comienza el
programa de vacunación
Porcentaje de nuevos diagnósticos de
verrugas genitales en Melbourne Sexual
Health Centre por año en <21 años
Q(.(4!%4'(4!.,'(4!&(#4R'=T%#!),!51/9%1,!%S/.%#&/,!.%!=#,!1%.=&&/M#!/95(1',#'%!%#!),!/#&/.%#&/,!
.%!),!%#$%19%.,.!5(1!<-3!%#!9=c%1%4!T!b(9W1%4!cMS%#%4k!T!&),1,9%#'%!&(#'1,4',#!&(#!)(!
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),!/#&/.%#&/,!.%!<^!%4'0!,=9%#',.(!%#!)(4!q)R9(4!,[(4!
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82. )D@=5>3 ( ("3<(K5;@;<(3<C(f1SS1(-%0+fJ&1TUFT(
j!6%.=&&/M#!.%)!HI2Do!.%!)(4!'1,',9/%#'(4!5,1,!<^!%#!E!,[(4!!X5!r!F2FFFDY!%#!9=c%1%4!
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83. Es prioritario
mejorarlas
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84. $-0"#0Jn(B+'(B+'J'(G]F[(3u18(XC5>(TUFV(
$;64365mH(M5>O3(2D><5>3(-:#(C5>5;AS6;(TUFV( ?7-!@!;)/&,#'%ABC%#%DE!

85. • L38(>5<DZ>38(?363(",.]FbQF`(W7;61<(>1A?363S@;8(;<26;(@18(=67?18(C;(T]
C1858(:U9b(XG]F[(3u18(q(V]C1858(:U9F9b(XFc]Tc(3u18(q(8;(A3<2745;61<(
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",.(F`(
44 veces más
alto que tras
la infección
natural
GMT(UEL/mL)[IC95%]
Meses después de la primera dosis de vacuna
Infección natural
Meseta
Infección natural
Meseta
Meses después de la primera dosis de vacuna
20/20 Mo,6 (9-14años)
20/20 Mo,1,6 (15-25años)
20/20 Mo,6 (9-14 años)
20/20 Mo,1,6 (15-25 años)
",.(Fb(
GMT(UEL/mL)[IC95%]
1
10
100
1000
10000
100000
F! J! DB! DH! BE! KF! KJ! EB! EH! CE!
24 veces más
alto que con la
infección natural
1
10
100
1000
10000
100000
F! J! DB! DH! BE! KF! KJ! EB! EH! CE!
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(
Romanowski B y cols. EUROGIN 2013
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86. • L38(>5<DZ>38(?363(",.]VFQ[c(W7;61<(>1A?363S@;8(;<26;(@18(=67?18(C;(T]C1858(:U9b(XG]F[(
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(
(
1
10
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10000
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GMT(UEL/mL)[IC95%]
GMT(UEL/mL)[IC95%]
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1
10
100
1000
10000
0 6 12 18 24 30 36 42 48 54
20/20 Mo,6 (9-14 años)
20/20 Mo,1,6 (15-25 años)
20/20 Mo,6 (9-14 años)
20/20 Mo,1,6 (15-25 años)
",.([c(
Punto de corte del ensayo Punto de corte del ensayo
Meses después de la primera dosis de vacuna Meses después de la primera dosis de vacuna
$-0"#0Jn(B+'(B+'J'(G]F[(3u18(XC5>(TUFV(
Romanowski B y cols. EUROGIN 2013
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87. HPV-071:
Estudio de no inferioridad, aleatorizado, observador ciego para evaluar la
inmunogenicidad de 2 dosis de Cervarix vs Gardasil
" Países: Francia, Suecia, Hong-Kong, Singapur
" Tres grupos paralelos (N=1428): (1:1, estratificados por edad 9-11, 12-14) :
– 2 dosis de Cervarix a los 0, 6 meses en niñas de 9 a 14 años (N=358)
– 2 dosis de Gardasil a los 0, 6 meses en niñas de 9 a 14 años (N=358)
– 3 dosis de Gardasil a los 0,2, 6 meses en niñas de 9 a 14 años (N=358)
• Objetivo primario:
– No inferioridad/superioridad (si se consigue la no inferioridad) de 2 dosis de Cervarix
vs 2 dosis de Gardasil en niñas de 9 a 14 años un mes después de la última dosis
• Objetivos secundarios:
– No inferioridad/Superioridad de 2 dosis de Cervarix vs 2 dosis de Gardasil, en niñas de 9 a
14 años al mes 12, 18, 24 y 36*
– No inferioridad/superioridad de 2 dosis de Cervarix vs 3 dosis de Gardasil (0, 2, 6 meses) al
mes 7, 12, 18, 24, 36*
– Respuestas inmunes frente a VPH 16 y 18 mediante PBNA (en un subgrupo) al día 0, mes
7, 12, 18, 24, 36
– Respuesta inmune mediada por células (CMI) específica frente a VPH 16 y 18 (en un
subgrupo) al día 0, mes 7, 12, 24, 36
– Seguridad: reactogenicidad, seguridad y cumplimiento con la pauta vacunal
* Si se consigue el objetivo primario de no inferioridad
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88. Es prioritario
mejorarlas
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89. Giuliano AR. Gynecol Oncol 2010
DINAMICA INFECCION VPH EN VARONES
• Prevalencia general estimativa situada sobre
el 65% en hombres entre 18 y 70 años.
• >4'%!1/%4*(!%4!/#.%5%#./%#'%!.%!),!,l#/.,.!
4%Z=,)k!%4!4/9/),1!5,1,!O1A1(1(O;2;618;m73@;82!
• JA?1623<2;(?3?;@(;<(@3(263<8A585_<(,!9=c%1%4!
!
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90. De Vuyst Int J Cancer 2009
Cáncer de Cavidad Oral
Cáncer de Orofaringe
> 95%
> 95%
> 95%Cáncer de Laringe
16%
28%
Cancer de Pene
Cancer de Vulva
Cancer Cervical y CIN 2-3
Cancer Anal y AIN
Cancer de Vagina
> 90%
90%
70-75%
90%
90%
47%
40%
100%
84%
70%
21%
Todos los tipos VPH
(prevalence)
VPH 6/11/16/18
en cáncer VPH +
Carga enfermedad relacionada
con VPH en ambos sexos
Papilomatosis laríngea 90%
Verrugas genitales > 90%
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91. Cáncer relacionado con VPH en Europa
Varones vs Mujeres
Hartwig S, et al. BMC Cancer 2012
x x
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92. Vacunas VPH: empleo en varones
Actualmente solo está autorizado el
uso en varones de Gardasil
Mayo 2012 Diciembre 2013
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93. EFICACIA DE GARDASIL
VARONES HETEROSEXUALES
"#0+&-'(.-K-0+'-n%#L-'((
XDJ!O!BJ!,[(4Y!
!
!
GUH[a!!!
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-p>3>53(W6;<2;(3(@;851<;8(
=;<523@;8(;m2;6<38!
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THG(3u18(
Giuliano AR et al. NEJM 2011
"3>7<3(48(,@3>;S1(XFNF(
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94. "#0+&-'(.+:+'-n%#L-'((
XDJ!O!BJ!,[(4Y!
!
!
Palefsky et al. NEJM 2011
&IbUT(
THc(3u18(
FUUa!!!
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-p>3>53(W6;<2;(3(@;851<;8(
=;<523@;8(;m2;6<38!
kk9ca!!!
XJ$(GcaN(VG9b(}(GV9V(
-p>3>53(W6;<2;(3(#J&(?16(
",.]b9FF9Fb9F`!
EFICACIA DE GARDASIL
VARONES HOMOSEXUALES
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95. 8(b(1'%!--!5,1,!/#9=#(*%#/&/.,.!T!4=c%'(4!4%1(#%*,RS(4!W,4,)9%#'%!
Petäjä T, et al. J Adolesc Health 2009
•
•
•
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97. Agencia de Salud Pública de AUSTRALIA (PBAC, Dic 2011)
■ Financiación vacunación escolar en:
➨ niños de 12 a 13 años,
➨ con un catch-up a los 14-15 años,
+K0#'(0-$+:-&B#$J+&-'(+MJ$J#L-'(
"#$%&#$J+&(",.(-&("#0+&-'(
• Autoridades sanitarias de CANADÁ (NACI, enero 2012)
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Porcentaje de nuevos casos de Verrugas Genitales
0
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4
6
8
10
12
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20

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107. Chao C, et al. J Intern Med 2012
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108. <-3k!S/1=4!.%)!5,5/)(9,!b=9,#(y!;;^k!,&(#'%&/9/%#'(!,.S%14(!*1,S%!
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(29.953 niñas y mujeres de 10–72 años)
" La reacción adversa más frecuente fue dolor en
el lugar de la inyección: la mayoría fueron leves
o moderadas y limitadas en el tiempo
" Cansancio, cefalea y mialgia fueron los
síntomas generales solicitados más frecuentes
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109. Extensos estudios clínicos, un riguroso programa de
vigilancia y farmacovigilancia confirman el buen
perfil de seguridad de las vacunas VPH
Estudiados durante una decada
en extensos estudios clínicos,
incluyendo >25,000 mujeres
de > 30 paises
Licenciada en 127 paises,
136 millones de dosis
vendidas a nivel mundial
Recogidos y evaluados
informes de acontecimientientos
ocurridos tras la vacunación
Programa de vigilancia,
Incluyendo estudios de
seguridad
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coordinación con agencias
reguladoras y autoridades
sanitarias nacionales
Ensayos Clinicos FarmacovigilanciaPrograma de vigilancia
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111. Meningococo B

112. Prevención de la enfermedad meningocócica
MENINGITIS: IMPACTO VACUNACIÓN EN ESPAÑA
NEUMOCOCOMENINGO CHAEMOPHILUS B
1998 1998 - 2000 2000 (Madrid 2007)
Heracles ISPPD 2012Sist Inform microbio 2008
Intr
od.
MC
C
Ministerio Sanidad y
MENINGO B
20137) 2013
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2001
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2002
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2003
N=493
2004
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2005
N=675
2006
N=592
2007
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2008
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2009
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119. G`(
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121. PARA VIAJES A ZONAS ENDEMICAS
,0-,#0#B+(
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122. Bexsero (Novartis)
Probable llegada
en próximos meses
Vacuna meningococo B(
(
?7-!@!;)/&,#'%ABC%#%DE!Fuente: AEMPS

123. Vacuna meningococo B(
(
?7-!@!;)/&,#'%ABC%#%DE!Fuente: AEMPS

124. Vacuna meningococo B(
(

125. Vacuna meningococo B(
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!
Ficha técnica Bexsero (Novartis)

126. EU5 2007/8* (1052):
78% [63, 90]4
Australia 2007–2011 (373): 76% [63, 87]6
Canada 2006–2009 (157): 66% [46, 78]1
Brazil 2010‡ (99): 81% [71, 95]3
Czech Republic 2007–2010 (108): 74% [58, 87]4
Norway (41): 85% [76, 98]
France (200): 85% [69, 93]
Germany (222): 82% [69, 92]
Italy (54): 87% [70, 93]
E&W (535): 73% [57, 87]
Spain 2008–2010 (300): 69% [48, 85]4
US 2000–2008† (442): 91% [72, 96]2
Greece 2008–2010 (52): 88% [60, 96]5
MATS Predicted Coverage for 4CMenB
Vogel et al. Lancet 2013, February epub
*All invasive capsular group B isolates tested. †Down weighted with respect to outbreak strains from Oregon.
‡Represents about 53% of capsular group B cases.
1. Bettinger J, et al. Presented at: 5th Vaccine and International Society for Vaccines (ISV) Annual Global Congress; 2-4 October 2011; Seattle, WA; 2. Kim E, et
al. Presented at: 19th International Pathogenic Neisseria Conference (IPNC). 9-14 September 2012. Würzburg, Germany. Poster P270; 3. Lemos AP, et al.
Presented at: 19th International Pathogenic Neisseria Conference (IPNC). 9-14 September 2012. Würzburg, Germany. Poster P272; 4. Vogel U, et al. Lancet
Infect Dis. 2012 [in press]; 5. Data on file, Novartis Vaccines and Diagnostics; 6. Nissen M, et al. Presented at: 19th International Pathogenic Neisseria
Conference (IPNC). 9-14 September 2012. Würzburg, Germany. Poster P269. Martinón-Torres, INMIS 2013
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http://www.gesunde.sachsen.de/12228.html
Recomendaciones de la Comisión de Vacunas de Sajonia sobre vacunaciones
en el Estado Libre de Sajonia Impfempfehlung E 1
Empfehlungen der Sächsischen Impfkommission zur Durchführung
von Schutzimpfungen im Freistaat Sachsen
Vom 02.09.1993; Stand: 01.01.2014
!
Änderungen gegenüber dem Stand vom 01.01.2013 sind kursiv gedruckt.
Jahre
Synopsis-Impfkalender für Kinder, Jugendliche und Erwachsene im Freistaat Sachsen
!
Stand: 1. Januar 2014
!
Impfstoff Geburt 7. Woche
1
3. Mon.
1
4. Mon.
1
5. Mon.
1
6. Mon.
1
13. Mon.
1
24. Mon.
1
6. Lbj.
1
11. Lbj.
1
13. Lbj.1
18. Lbj.
1
26. Lbj.
1 alle 10 über 50
Jahre
über 60
Jahre
Hepatitis B
3, 6
und
Hepatitis A 6
(HBV/HAV)
!
HBV 1 / HBV 2 3
!
HBV 3/4 3 od. HAV/HBV 6 HAV/HBV6
!
Diphtherie, Tetanus,
Pertussis
2, 3, 4
!
1.
DTPa
!
2.
DTPa
!
3.
4. DTPa
DTPa
!
5. DTPa
oder
Tdpa 4
!
Tdpa
!
Tdpa
!
Haemophilus
influenzae Typ b
2, 3
!
Polio (IPV)
2, 3
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!
Masern, Mumps,
Röteln (MMR)
!
Varizellen (VZV)
5
!
Meningokokken B 12
!
!
Meningokokken C
7
!
Influenza 8
!
Pneumokokken
!
Rotaviren
10
!
Humane Papilloma-
viren (HPV)
11
!
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!
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!
!
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!
!
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!
!
1. VZV
!
!
Meningokokken (Gruppe B)
!
!
Meningokokken (GruppeC)
!
!
!
!
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!
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!
!
!
!
!
!
!
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!
!
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!
!
!
!
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!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
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jährlich 8
!
!
!
!
!
!
!
!
!
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!
!
!
!
!
!
!
!
!
!
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!
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!
!
!
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• Hasta la fecha, el JCVI ha publicado una
actualización de su interim position del 24 julio 2013,
que sobre la base de las respuestas de las partes
interesadas y nuevas evidencias científicas, el JCVI
está realizando nuevos análisis de coste-efectividad.
Una vez que éstos se hayan completado, el Comité
formulará una recomendación a la Secretaría de
Estado de Salud
• El JCVI está evaluando los nuevos datos de C/E y
emitirá nuevo dictamen en 1Q 2014
• Puntos críticos en el nuevo análisis:
• Incidencia
• Secuelas
• Cobertura/MATS
• Factor de descuento

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