From:
To:
Subject:
Date:
Attachments:
Christina Abel
*OAH_RuleComments.OAH
Docket# 8-0900-30570
Wednesday, July 24, 2013 11:23:14 AM
Response to Comment Submitted by Ms.docx
Notes on Minnesota reported meningococcal disease.docx
Dear Judge Lipman,
The first attachment is my letter in response to the MDH comments about
my letter on Minnesota's reported meningococcal disease cases. The second attachment is the reported meningococcal disease data I
requested and received from the MDH for 2006-2012. Also added 20062012 total number of reported meningococcal disease cases from
Meningococcal Disease Statistics Statistics for meningococcal disease in
Minnesota.
I also color coded the data to recheck for the numbers of reported
meningococcal disease cases, serogroups and vaccine history for the 1122 years of age group.
Vaccine preventable cases
Not vaccine preventable cases/vaccinated or non-vaccine strains
If there are any number errors please let me know.
Thank you,
Chris Abel
Minnesota’s Reported Meningococcal Disease
“Ms. Abel, in her testimony and submitted comments, made some statements that did not fully
represent the data that MDH provided her. The department will briefly address these
Inaccuracies.
However, looking at historical data comparing cases and fatalities before meningococcal vaccine
for adolescents shows a different picture of the disease. In 2005, meningococcal vaccine was
recommended for routine vaccination of adolescents.
During the immediate pre-recommendation time period, from 2000 through 2005, there were 42
cases of meningococcal disease among 11–22 year olds in Minnesota with six deaths (14%). Of
these six deaths, five were vaccine-preventable strains (4 serogroup C and 1 serogroup Y).”
The reason for using the 2006-2012 data was to see what happened after the 2005 ACIP vaccine
recommendation. There was a decline in the number of reported meningococcal disease cases in
this age group, 42 cases/2000-2005 compared to 29 cases (28 persons) /2006-2012, which is a
good thing. This was done without any requirements.
“In the US the incidence has declined since a peak of disease in 1981 (Figure 1). Even before
routine use of a meningococcal conjugate vaccine in adolescents was recommended in 2005 …
Since 2005, declines have occurred among all age groups and in all of the serogroups (strains of
the bacteria) both vaccine strains and non-vaccine strains.”
http://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-jun10.pdf
2006-2012, 7 years, there were 29 cases and one death (3%) compared to 2000-2005, 6 years, 42
cases and 6 deaths (14%).
The 2006 death was not a vaccine-preventable strain.
“Ms. Abel also commented that the majority of cases from 2006 to 2012 were from serogroups
not included in the vaccine. This is not correct. The majority of cases from 2006 to 2012 (16/28,
57%) were vaccine-preventable strains.”
This is what I wrote: “From 2006 through 2012, 12 (41%) of the 29 reported cases (28
persons) 11-22 years of age group, were from serogroups not included in the vaccine.
41% is a not a majority.
If I used the 28 persons the 12 would represent 43% of persons had strains not included in the
vaccines.
2007, Two cases - one person, serogroup included in the vaccine “cases” twice, as
unvaccinated and vaccinated:
1) Serogroup Y; 19 years-old; college student at time of disease; negative vaccine history (i.e. did
not receive vaccine); this case had a second bout of disease 2) Was still 19 years-old at time of disease; he had received MPSV (Menomune) after his first
bout of disease
My graphs/numbers use the number of cases, 29, not number of persons, 28.
“Looking at data before vaccination in adolescents, from 2000 to 2005, 28 of 42 (67%)
meningococcal cases among 11 to 22 year olds were serogroups now covered by the vaccine.”
And since the recommendation, 2006-2012, 17 of 29 (59%) meningococcal cases with
meningococcal disease were serogroups covered by the vaccine. But five cases were vaccinated.
So 17 minus 5 vaccinated equals 12 of 29 (41%) meningococcal cases could have been
considered “vaccine preventable” because the 12 cases included vaccine strains and were not
vaccinated.
“Again, Ms. Abel’s data only represents disease incidence (number of new cases of disease) that
occurred after the recommendations were implemented and do not reflect disease prerecommendation incidence.”
But there are fewer reported cases in the last 7 years.
The only reported meningococcal disease data I requested and received from the MDH was for
2006-2012. The graph numbers should be correct for the years 2006 – 2012.
“The graphs that Ms. Abel submitted also misrepresent data that was provided to her. They are
incomplete.”
The only reported meningococcal disease data I requested and received from the MDH was for
2006-2012. The graph numbers should be correct for the years 2006-2012 and 2008-2012.
“There were more cases of meningococcal disease than were represented on her graphs.”
For the years 2006 – 2012 there were a total of 29 meningococcal cases. See attachment
There were 12 vaccine preventable cases, cases that had strains covered by the vaccine and were
not vaccinated.
17 cases were not vaccine preventable cases, 5 had vaccine strains but were vaccinated and 12
with non-vaccine strains.
“Moreover, she continued to only use data from 2008 to 2012.”
The reasons I also used the 2008-2012 time period:
- The ACIP recommended by 2008 / the goal will be routine vaccination with MCV4 of all
adolescents beginning at age 11 years. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5407a1.htm
- 2008-2012, would have been the time period that the MDH might have required the
meningococcal vaccine for 7th grade students but did not. If the MDH had “required” the
vaccine in 2008 would the requirement of the vaccine been given credit for the decline?
Ms. Abel also references a 2013 ACIP recommendation that said the following,
“The case-fatality ratio was similar among persons who had received vaccine compared with
those who were unvaccinated (CDC, unpublished data, 2012).”ACIP, Recommendations and
Reports, March 22, 2013 / 62(RR02);1-22, p 7 http://www.cdc.gov/mmwr/pdf/rr/rr6202.pdf .).
This statement in the MMWR refers to the 30 cases reported to CDC who had received vaccine
and had breakthrough disease from the bacteria itself, not the vaccine.
Among those 30 individuals the case-fatality ratio was similar to people who received no
vaccine, not among all people who received vaccine. There are several possible reasons why
these individuals did not develop an immune response, including timing from vaccine to disease
onset, and underlying conditions.”
I never inferred the vaccine caused the disease.
The word “breakthrough disease” is another way of saying a vaccinated person was not protected
by the vaccine and still became infected with “a disease with a high mortality rate and a high rate
of severe disability among survivors, particularly affecting healthy adolescents”.
In Minnesota only one meningococcal disease death was reported after the vaccine was
recommended in 2005.
2006, the Wisconsin parents of the young adult who died from meningococcal disease in
Minnesota assumed their vaccinated child was protected from meningococcal disease until they
found out the strain she had was not included in the vaccine.
2006 – 2012, There were 29 (28 persons) reported cases in the 11-22 years of age group
with one death, a 3% death rate. But this death was not vaccine preventable. The 2006
death was in a vaccinated 19-year-old student who died from bacteremia attributed to
serogroup B, not found in the vaccine. http://www.kare11.com/news/news_article.aspx?storyid=125227
Are there any studies that say the vaccine reduces the severity of the disease? I could not find
any.
“Overall, vaccine effectiveness from a case-control study was 69% with the highest effectiveness
(82%) following the first year after vaccination.
In a disease with such a high mortality rate and a high rate of severe disability among survivors,
particularly affecting healthy adolescents, preventing any illness is the goal. Data varies from
year to year and while certainly the vaccine has already had a positive impact on reducing cases,
the risk of teens and young adults not being vaccinated is a serious risk without a vaccine rule
requirement.”
Since the overall vaccine effectiveness is 69% and in Minnesota 17 of 29 reported cases (59%)
(12 with serogroup not in vaccine and 5 vaccine serogroup cases vaccinated) after 2005 were not
vaccine preventable why not introduce education? It would be more logical since vaccinating
more students would not have prevented this dangerous disease in the majority of the 17 nonvaccine preventable cases in the last 7 years.
From the ACIP, 2000 about education when there is an increase risk of disease.
Meningococcal Disease and College Students: Recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR. 2000; 49 (RR-7): 11-20. This report provides information
regarding the modestly increased risk for meningococcal disease among college freshmen,
particularly those who live in dormitories or residence halls. It presents recommendations
developed by the Advisory Committee on Immunization Practices regarding the education of
students and parents about meningococcal disease and the polysaccharide meningococcal
vaccine so that they (my emphasis) can make informed decisions regarding vaccination.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4907a2.htm
Hopefully this is understandable with all the numbers and especially the different meanings of
the words “vaccine-preventable strains” and “vaccine preventable disease”.
Thank you,
Chris Abel
Notes on Minnesota reported meningococcal disease, 2006-2012
Vaccine preventable cases
Not vaccine preventable cases/vaccinated or non-vaccine strains
Death
2012 Meningococcal Disease, 3 cases occurred among 11-22 year olds
1)Serogroup B: 22 years-old, unknown vaccine history
2) Serogroup B: 21 years-old, had received vaccine for meningococcal infection but type
unknown to us
3) Serogroup B: < 1 years-old, negative vaccine history (i.e. did not receive vaccine)
4) Serogroup B: 1 years-old, negative vaccine history (i.e. did not receive vaccine)
5) Serogroup B: 1 years-old, negative vaccine history (i.e. did not receive vaccine)
6) Serogroup C: 44 years-old, negative vaccine history (i.e. did not receive vaccine)
7) Serogroup Y: 17 years-old, had received vaccine for meningococcal infection but type
unknown to us
8) Serogroup Y: 73 years-old, negative vaccine history (i.e. did not receive vaccine)
9) Serogroup Y: 72 years-old, unknown vaccine history
10) Serogroup Y: 54 years-old, unknown vaccine history - Death
11) Serogroup Y: 49 years-old, negative vaccine history (i.e. did not receive vaccine)
12) Serogroup Y: 72 years-old, unknown vaccine history
2011 Meningococcal Disease, 0 case occurred among 11-22 year olds
Fifteen cases of Neisseria meningitidis invasive disease (0.28 per 100,000 population) were
reported in 2011,Cases ranged in age from 5 months to 98 years, with a median of 48 years
There were no fatalities.
Again, there were nine that were not vaccine-preventable:
1) Serogroup B; <1 year-old; too young for vaccine
2) Serogroup B; <1 year-old; too young for vaccine
3) Serogroup B; 57 years-old; not a college student at time of disease; not vaccinated
4) Serogroup B; 1 year-old; too young for vaccine
5) Serogroup B; 47 years-old; not a college student at time of disease; not vaccinated
6) Serogroup B; <1 year-old; too young for vaccine
7) Serogroup B; 54 years-old; not a college student at time of disease; not vaccinated
8) Serogroup B; 29 years-old; not a college student at time of disease; not vaccinated
9) Ungroupable;72 years-old; not a college student at time of disease; not vaccinated
Otherwise:
10) Serogroup W135; <1 year-old; too young for vaccine
11) Serogroup Y; 54 years-old; not a college student at time of disease; vaccine history unknown
to us
12) Serogroup Y; 81 years-old; not a college student at time of disease; negative vaccine history
(i.e. did not receive vaccine)
13) Serogroup Y; 98 years-old; not a college student at time of disease; vaccine history unknown
to us
14) Serogroup Y; 67 years-old; not a college student at time of disease; vaccine history unknown
to us
15) Serogroup Y; <1 year-old; too young for vaccine
In April 2011, the Food and Drug Administration approved the use of a quadrivalent
meningococcal conjugate vaccine (MenACWY-D) (Menactra, Sanofi Pasteur) as a 2-dose
primary series among children aged 9 through 23 months (1). October 14, 2011 ACIP
recommend for high risk babies
2010, Meningococcal Disease, 1 case occurred among 11-22 year olds
Nine cases of Neisseria meningitidis invasive disease (0.2 per 100,000 population) were reported
in 2010, Cases ranged in age from 2 months to 85 years, with a median of 40 years. One death
occurred in a case less than 1 year of age with bacteremia attributed to serogroup C. - Vaccine
Not approved until 2011 for children aged 9 through 23 months
1) case occurred among 11-22 year olds. The case had serogroup Y disease, was 20 years old,
was not vaccinated, and was not in school. The case was eligible for the MCV4 study.
2009, Meningococcal Disease, 5 cases occurred among 11-22 year olds
Sixteen cases of Neisseria meningitidis invasive disease (0.3 per 100,000 population) were
reported in 2009,Cases ranged in age from 4 months to 86 years, with a median of 20 years. One
death occurred in a 69-year-old who died of meningitis attributed to serogroup B.
1) Serogroup B; 22 years-old; not a college student at time of disease; unknown vaccine history
2) Serogroup C; 18 years-old; college student at time of disease; had received MCV4
(Menactra) vaccine
3) Serogroup C; 20 years-old; college student at time of disease; unknown vaccine history (but
presumably not vaccinated)
4) Serogroup Y; 17 years-old; presumably in high school at time of disease; negative vaccine
history (i.e. did not receive vaccine)
5) Serogroup Y; 17 years-old; presumably in high school at time of disease; unknown vaccine
history (but presumably not vaccinated)
2008, Meningococcal Disease, 6 casesoccurred among 11-22 year olds
Thirty cases of Neisseria meningitidis invasive disease (0.6 per 100,000 population) were
reported in 2008, Case-patients ranged in age from 2 months to 92 years, with a median of 23
years. Three deaths occurred; a 5-year-old died of bacteremia attributed to serogroup C
The 5 year-old had no underlying conditions.
In 2007, the license was approved to include 2 to10 year-olds, ACIP recommendation for
groups in the licensed age range previously determined to be at high risk.
as well as a 33-year-old and a 53-year-old both with meningitis attributed to serogroup B.
1) Serogroup B; 22 years-old; college student at time of disease; unknown vaccine history
2) Serogroup B; 14 years-old; presumably in high school at time of disease; unknown vaccine
history
3) Serogroup B; 18 years-old; not a college student at time of disease; negative vaccine history
(i.e. did not receive vaccine)
4) Serogroup C; 16 years-old; presumably in high school at time of disease; had received
MCV4 (Menactra) vaccine
5) Serogroup C; 18 years-old; not a college student at time of disease; unknown vaccine history
6) Serogroup B (culture-negative, PCR positive only); 18 years-old; unknown student status at
time of disease; unknown vaccine history
2007 Meningococcal Disease, 8 cases occurred among 11-22 year olds
Twenty-two cases of Neisseria meningitidis invasive disease (0.4 per 100,000 population) were
reported in 2007,Case-patients ranged in age from 1 to 82 years, with a median of 19 years.
One individual had two episodes of invasive meningococcal disease. All cases were sporadic,
with no definite epidemiologic links. One death occurred; a 5-year-old male died of meningitis
attributed to serogroup B.
1) Serogroup B; 20 years-old; not a college student at time of disease; had received MCV4
(Menactra) vaccine
2) Ungroupable; 16 years-old; presumably high school student at time of disease; vaccine
history unknown to us
3) Serogroup Y; 20 years-old; not a college student at time of disease; had received vaccine for
meningococcal infection but type unknown to us
Otherwise:
4) Serogroup C; 17 years-old; presumably high school student at time of disease; vaccine history
unknown to us
5) Serogroup C; 21 years-old; not a college student at time of disease; vaccine history unknown
to us
6) Serogroup Y; 19 years-old; college student at time of disease; negative vaccine history (i.e.
did not receive vaccine); this case had a second bout of disease 7) Was still 19 years-old at time of disease; he had received MPSV (Menomune) after his first
bout of disease. serogroup Y?
Eight cases occurred among 11-22 year-olds …The case-patients in this age group who had
serogroup C or serogroup Y disease had not received meningococcal vaccine except for the casepatient with recurrent disease who had received vaccine prior to the second episode of illness.
8) Serogroup Y; 14 years-old; presumably a junior high school student at time of disease;
vaccine history unknown to us
2006 Meningococcal Disease, 6 cases occurred among 11-22 year olds
Fifteen cases of Neisseria meningitidis invasive disease (0.3 per 100,000) were reported in 2006,
compared to 16 cases in 2005. Case-patients ranged in age from 2 months to 85 years, with a
median of 22 years. Three deaths occurred among cases reported in 2006. A 30-year-old male
and a 73-year-old male died of bacteremia attributed to serogroup Y. A 19-year-old female
died of bacteremia attributed to serogroup B.
The 30 year-old, nothing was checked off (including the box “None”) on the Case
Report Form completed by the hospital ICP for underlying conditions which could mean
the case-patient didn’t have any, but we called it “Unknown”.
ACIP recommendation for groups in the licensed age range previously determined to be
at high risk.
Regarding the six persons 11-22 years of age:
Three were due to serogroup B and thus were not vaccine-preventable:
1) Serogroup B; 21 years-old; college student at time of disease; had received MPSV
(Menomune) vaccine
2) Serogrop B; 18 years-old; college student at time of disease; had received MCV4 (Menactra)
vaccine
3) Serogroup B; 19 years-old; college student at time of disease; had received a vaccine for
meningococcal disease but type unknown to us (death)
4) Serogroup C; 22 years-old; unknown student status at time of disease but would appear not
based on our notes and LPH notes; unknown vaccine history
5) Serogroup C; 19 years-old; college student at time of disease; negative vaccine history (i.e.
did not receive vaccine)
6) Serogroup Y; 17 years-old; presumably in high school at time of disease; unknown vaccine
history