Medical Analysis
Update: VICP
Advisory Commission on Childhood Vaccines
June 10-11, 2010
Rosemary Johann-Liang, MD
Rjohann-liang@hrsa.gov
Number of Petitions for Medical Analysis
5 year period: FY 2005-2009
700
600
500
400
300
200
Non-autism cases
Newly-filed autism
Activated-autism
Total for review
100
0
2005
2006
2007
2008
2009
Claims filed to VICP
Comparing %age-bands 10 years apart
70
60
FY 1998
50
40
30
20
10
0
0-23mo
2-17yrs
18-29yrs 30-49yrs 50-85yrs
FY 2008
FY 2009 Claims Filed to VICP
30
by age-band % claims
25
20
15
10
5
0
0 - 23mo
2 - 17 yrs
18 - 29
30 - 49
50-85
2010 Medical (MO) Reviews:
New Reports
FY 2010
• 8 months so far
• N=498 reports total
• N=155 are activated autism
reviews
3/10-5/10 MO Reviews: Age
50
45
by age-band % claims
40
35
30
25
20
15
10
5
0
Autism
NA-Kids
Adults
3/10-5/10 MO Reviews:
Vaccines Alleged (non-autism)
Vaccine Alleged
% of total
Vaccine Alleged
% of total
Influenza
45%
Rotavirus
4%
HPV
13%
Meningococcal
4%
Tetanus
8%
Varicella
2%
Hepatitis B
6%
MMR
5%
Multiple
12.5%
3/10-5/10 MO Reviews:
Adverse Events (non-autism)
AE
% of total
AE
% of total
GBS
30%
Death
6%
Other Demyelinating
12%
Underlying Disorder
5%
Skin (rash, allergy,
fascitis)
7%
Immune/Rheum,
5%
autoimmune Injuries
Shoulder/Arm
Injuries (BN, CRPS)
6%
Encephalitis, Sz
Encepholopathy,
6%
Miscellaneous
(gastrointestinal,
cardiac,
hematologic, etc.)
TM/ADEM/CIDP/NMO/MS
24%
HPV Claim: Demographics
• Total # of claims thus far since 2008 = 54
with 5 death claims
• Average age = 16.5 years for all female claims with
range (12 – 27 yrs)
• Only one male claim (age over 50 years).
• 39% had HPV x 1; 32% had HPV x 2 and 29% had
HPV x 3
• 16% of total had other concurrent vaccines
(meningococcal, hepatitis A, hepatitis B, and
Tetanus-containing)
HPV MO Reviews On-going:
Injuries Claimed
Claimed Injury
% of total
Claimed Injury % of total
Neurologic (other)
Including seizures
24%
Syncope
GBS
6%
“serious sequelae”
17%
Miscellaneous
12%
(GI, cardiac,
hematologic)
TM/ADEM
7%
Rheumatologic
19%
CTD
6%
Death Claims
• under review (hypercoagulable
state, cardiac)
• some waiting for records
• those with autopsy – we will
request slides for independent
pathology review
Shoulder Injury Case Series
• Bodor M and Montalvo E. Vaccination-related
shoulder dysfunction; Vaccine 25 (2007) 585-587
– Case reports of 2 patients; pain within 2 days
following vaccination; injection too high on shoulder?
• Medical Analysis of VICP Claims from 2006-2009;
11 claims identified with significant shoulder pain
and dysfunction following vaccine administration
Shoulder Series: Initial Analyses
• 82% female; Mean age = 52 (range 29-83)
• Vaccine Administered; 64% influenza; 36% tetanuscontaining
• Pain onset is less than 24 hrs in 91% from vaccine
administration with 64% recalling immediate
symptom onset.
• Diagnoses: bursitis, rotator cuff injury, adhesive
capsulitis
• Concern: long-term sequelae
• Concern: where and how administered