Global consultation on postmarketin surveillance of rotavirus vaccines

1. Global consultation on post-marketing
surveillance of rotavirus vaccines
CICG, Geneva
12-13 December 2006
“Rotavirus vaccine introduction in
Venezuela”
Professor Hans Salas-Maronsky
Sección de Enfermedades Entéricas
Instituto de Biomedicina,Caracas
Universidad Central de Venezuela
2006

2. Post-marketing surveillance (PMS) of Rv
vaccine safety, diarrheal disease and rotavirus
strains in Venezuela
Objetives
 To identify possible adverse events associated
with the vaccine.
 To evaluate the causality of adverse events
related to vaccination.
 To assess vaccine impact after routine rotavirus
vaccine administration.
 To monitor the circulation of rotavirus strains
during PMS.

3. Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela
 Monitoring adverse events following administration
of rotavirus vaccine through a pharmacovigilance
program.
 PMS of adverse events that may be related with the
Rv vaccine during a 10-31 day post-vaccination
period in children < 6 months of age implemented to
identify adverse events.
 Surveillance of intussusception following rotavirus
vaccination in children < 12 months age.

4. Post-marketing surveillance (PMS) of Rv
vaccine safety, diarrheal disease and rotavirus
strains in Venezuela
Monitoring the impact of the rotavirus
vaccine in Venezuela:
 Surveillance of hospitalized gastroenteritis
episodes in children < 5 years of age attending
sentinel hospital.
 Surveillance of rotavirus strains.

5. Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela
Status of the rotavirus vaccine in
Venezuela
 Date of lincense : September, 2005.
 Private administration: November 2005.
 Public administration: April 2006.
 No. of nationally administrated doses:118.000.
 No. Of privately distributed doses:22.000.

6. Characteristics of the Pharmacovigilance
Program implemented in Venezuela
 Inter-institucional (MS, INH “RR”, PAHO, IB,
FUVESIN)
 Centralized: guides and programs
 Technical advise of academics
 Methodology for analysis of information: descriptive
statistical evaluation
 Lack of supervision
Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela

7. Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela

8. Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela

9. Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela

10. Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela

11. Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela
Regarding the notifications of adverse
events, the following characteristics of the
researched variables are shown:
 Sex.
 Modal age notification.
 Notification Intervals.
 Severity of notified events.
 Intussusception.
 Association.
 Clinical Evolution.

12. Critical issues about the report of
adverse events in Venezuela
 58% (7/12) were reported before the national
introduction of the rotavirus vaccine into EPI
 58%(7/12) were intussusception
 83%(10/12) were reported by private physicians
 47%(3/7) of intussusceptions were reported in
Carabobo state
Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela

13. Surveillance of hospitalized gastroenteritis
episodes in children < 12 months of age
attending sentinel hospital
 September, 2004: Program implemented by Ministry
of Health in 3 sentinel hospitals from 3 states.
 October 2006: Six new hospitals from e states were
incorporated to this program.
 Supported by PAHO.
Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela

14. Determination of rotavirus (RV) G genotypes by RT-PCR in
Hospital Julio Criollo Caracas-Venezuela, 2004-2006
0
10
20
30
40
50
60
70
2004 2005 2006
G1
G3
G9
mixed (G3 + G9)
nontypeable
Percentage
RV = 49% (177/359)
Note: 87(60%) of RV positive samples were tested by RT-PCR

15. Conclusions
 In Venezuela the post-marketing surveillance
(PMS) of rotavirus vaccine safety presented
operative difficulties.
 In developing countries this kind of surveillance
are not routinely implemented.
 Improvement of PMS may be archieved with the
operative functions.
Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela

16. Recommendations
 Improvement of passive surveillance
 Use of cumulative frecuency for:
 Serious adverse event.
 Potencially serious.
 Non-serious (-AEFI-).
Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela

17. Challenges for PMS in developing
countries
 Passive surveillance Active surveillance
 Increased coverage
 Increase sensitivity
Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela

18. Challenges for PMS in developing
countries
 Success
 Alarm
Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela

19. AGE
(Months) No % Cumulative
%
1 0 0 0
2 15 5,96 5,96
3 27 11,01 16,97
4 57 22,94 39,91
5 57 22,94 62,85
6 40 16,06 78,91
7 19 7,80 86,71
8 15 5,96 92,67
9 9 3,67 96,34
10 9 3,67 100
11 0 0 0
12 0 0 0
TOTAL 248 100 100
INTUSSUSCEPTION. ESTIMATION <1 AÑO
Median: 5 m; Average: 5 m 6 d; Deviation: 1 m 28 d; Modal Age: 4 m 15 d
2 4 6 8 10
Edad en meses
0%
5%
10%
15%
20%
%
Age (months)

20. Challenges for PMS in developing
countries
 Use of longitudinal studies and analytical
methods to take decisions
Post-marketing surveillance (PMS) of Rv vaccine
safety, diarrheal disease and rotavirus strains in
Venezuela

21. Thanks…