Protecting, maintaining and improving the health of all Minnesotans
July 17, 2013
The Honorable Eric Lipman
Office of Administrative Hearings
600 North Robert Street
Saint Paul, MN 55155
Re: In the Matter of the Minnesota Department of Health’s Proposed Amendments to Rules
Governing School and Child Care Immunizations, Minnesota Rules, Chapter 4604; Agency
comments following June 27, 2013 Administrative Hearing; OAH Docket No., 8-0900-30570,
Governor’s Tracking Number AR1052, Revisor’s ID Number RD4101.
Dear Judge Lipman:
By this letter the Minnesota Department of Health (“the department” or “MDH”) responds to
both testimony given at the June 27, 2013 hearing and the comments received afterwards about
the department’s proposed revisions to the Minnesota Immunization Rules. The department notes
that it had already considered and addressed most concerns expressed during its rule
development. Further, the department asserts that it has properly justified its proposed revisions
in the Statement of Need and Reasonableness (SONAR) and its appendices and attachments. We
respectfully provide you with the following:
Legal (and Constitutional) Authority to Adopt the Rules
The department outlined its statutory authority to adopt these proposed rule changes on pages 4
and 5 of the SONAR, so the department will not address this issue again.
Fulfillment of Procedural Requirements.
Ms. Patti Carroll testified that certain groups were left out of the process, implying that the law
or procedures were not followed.
1. First, the department complied with Minnesota Statutes, chapter 14 and Minnesota Rules,
chapter 1400, both of which outline specific requirements an agency must follow when
adopting rules. To engage public participation, MDH developed and used a comprehensive
additional notice plan, which was approved by Judge Eric Lipman on April 11, 2013. Under
this additional notice plan, the department notified people when it published the Request for
Comments in March 2012 and again when it published the Dual Notice on April 29, 2013.
Many interested organizations opposed to the proposed immunization rules were notified
both times. These organizations included the Minnesota Natural Health Coalition, Minnesota
Vaccine Awareness, Vaccine Safety Council of Minnesota, National Health Freedom
Coalition, and the Biological Education for Autism Treatment (BEAT). Thus through its
additional notice plan the department solicited opinions from all interested and concerned
stakeholders.
Infectious Disease Epidemiology, Prevention and Control Division • Immunization, Tuberculosis and International Health
Section • 625 N. Robert St.• PO Box 64975 • St. Paul, MN 55164 • 800-657-3970
www.health.state.mn.us/immunize
An equal opportunity employer
MDH Response to Comments to Immunization Rule Amendments
July 17, 2013
Page 2 of 12
2. Ms. Patti Carroll testified that certain groups opposed to the proposed immunization rule
changes were not included in the Advisory Group. Minnesota Statues, section 121A.15,
subdivision 11, requires that the department draw its proposed modifications of the
immunization requirements from the immunization recommendations of the Advisory
Committee on Immunization Practice (ACIP), American Academy of Pediatricians (AAP),
and American Association of Family Physicians (AAFP) The statute further requires that the
commissioner of health consult with certain groups when modifying the immunization
requirements. Specifically, the law says:
“(a) The commissioner of health may adopt modifications to the immunization requirements of this
section. A proposed modification made under this subdivision must be part of the current
immunization recommendations of each of the following organizations: the United States Public
Health Service’s Advisory Committee on Immunization Practices, the American Academy of
Family Physicians, and the American Academy of Pediatrics. In proposing a modification to the
immunization schedule, the commissioner must:
(1) consult with (i) the commissioner of education; the commissioner of human services; the
chancellor of the Minnesota State Colleges and Universities; and the president of the University of
Minnesota; and (ii) the Minnesota Natural Health Coalition, Vaccine Awareness Minnesota,
Biological Education for Autism Treatment (BEAT), the Minnesota Academy of Family
Physicians, the American Academy of Pediatrics-Minnesota Chapter, and the Minnesota Nurses
Association,” . . .
MDH appointed the Advisory Committee to help us select the recommended vaccines to include
in the school immunization law. Because the department’s sole purpose is to bring the
immunization rule up to date, MDH appointed two parents who have their children vaccinated to
be committee members. (Parents opposed to immunizations would not advance this necessary
vaccine selection. The law offers them the conscientious objection exemption as their remedy.)
The committee’s contribution in helping us choose the vaccines to add is one part of the whole
process, which allowed all interested parties an opportunity to participate. MDH, along with the
committee reviewed each one. The department chose not to include three recommended
vaccines: Rotavirus, Influenza, and HPV vaccines.
In addition, the law says that we must consult with the Minnesota Department of Education, the
Minnesota Department of Human Services, the University of Minnesota, and the Minnesota State
Colleges and Universities, which we did. But MDH did not appoint representatives from those
groups to the Advisory Committee. All groups on all sides of the issue had many opportunities to
express their comments and concerns. As noted above, the department’s extensive additional
notice plan was not only used when the department published its Dual Notice but also a year
earlier when the department published its Request for Comments. MDH held two public
meetings, one of which was a video conference with sites around the state. People asked
questions and expressed many points of view at these meetings. MDH staff also exchanged many
emails and phone calls with two persons who are members of Vaccine Awareness, the Minnesota
Natural Health Coalition, and the Minnesota Vaccine Safety Council. The department listened to
their concerns and suggestions but rejected them in favor of the rationale stated the SONAR.
MDH Response to Comments to Immunization Rule Amendments
July 17, 2013
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Consent and Information Provided to Parents on Possible Adverse Events, Vaccine
Adverse Events Reporting System (VAERS) and Exemptions
Ms. Patti Carroll and others testified that parents lack informed consent in the “current program
because of bad federal law.” (comment submitted by Patti Carroll). MDH disagrees with this
statement. While this issue is outside the scope the proposed rule amendments, a brief
description of how the federal and state laws work together is useful:
Federal law requires that every time a person receives a recommended vaccine, the health care
provider must give that person a Vaccine Information Statement (VIS), specific to the vaccine)s)
that are being administered. (See attached VIS) The VIS includes information on who should not
be vaccinated and possible risks of the vaccine. The federal Food and Drug Administration
(FDA) has regulatory oversight of vaccines, and all manufacturers are required to post their
product inserts on line. Moreover, the FDA determines what information is contained in the
vaccine’s product insert.
MDH diligently communicates to providers that they must share the VIS with patients. For
example, MDH’s “Got Your Shots News” (GYS) sent monthly by fax to over 2,000 subscribers
and by email to over 7,000 subscribers (which includes health care providers, clinics, and local
public health) contains a list of the current VISs each quarter or, if a new VIS is published,
sooner. (See attached January 2013 GYS). Moreover, every other year, health care clinics who
are in the Minnesota Vaccines for Children’s (MnVFC) Program receive a face-to-face visit from
either a state or local public health nurse to assist the clinic in reviewing their immunization
practices. These are part of the Immunization Practice Improvement (IPI) program. This includes
a review of the clinic’s procedures to ensure that the clinic has the most current VIS for each
vaccine and procedures to ensure a VIS is provided to all patients. There are over 800 health care
clinics in the MnVFC program and it essentially includes all providers who vaccinate children.
Second, a few testifiers also alleged that health care providers do not report to the Vaccine
Adverse Event Reporting System. MDH cannot respond to unsupported assertions. Similar to the
VIS, the department diligently reminds providers about reporting possible adverse events to
VAERS in the “Got Your Shots News.” In addition, during the face-to-face IPI visits the public
health nurses review VAERS information with clinic staff. The department takes this legislative
mandate under Minnesota Statutes, section 121A.15, subdivision 3, very seriously.
Many testifiers and commenters deemed the National Vaccine Injury Compensation Program
(NVICP) to be inadequate. Yet at the same time, they cited this program to show that people
were compensated for injuries related to vaccines. This federal program is outside the scope of
these proposed rules so MDH makes no further comment.
Finally, a few testifiers expressed the opinion that parents or guardians are not aware that they
can take a conscientious exemption. Again, the department takes seriously its state legislative
mandate to educate providers and the public about this option. Information that is provided to
providers, schools, child care facilities, and posted on our website for parents contains a
statement about this exemption. (See attached “Pupil Immunization Record” and “Child Care
Immunization Records” and “Are Your Kids Ready for School”) In fact, if the department
receives information that a school is not complying with the law, a staff person follows up with
MDH Response to Comments to Immunization Rule Amendments
July 17, 2013
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the school to ensure it does comply. The need to follow-up has become fewer and farther
between because school noncompliance has diminished.
Response to Ms. Jerri Johnson’s Testimony on Standards of Safety for a Vaccine.
Ms. Johnson testified that, “the standards of safety for a vaccine need to be much higher than
they are for our medical treatments when someone has a disease.” (See hearing transcript, page
111) The department agrees because vaccines are already held to a higher standard than other
medical treatments. As stated in Ms. Ehresmann’s testimony at the hearing (Exhibit Y), before
immunizations are approved, they must go through three clinical phases and once approved there
is a specific vaccine post-surveillance system in place. This is not the case with most other
medical treatments or drugs.
Comment on Studies Comparing Vaccinated vs. Unvaccinated Populations.
Opponents of the proposed immunization laws argue that the only valid safety study would
compare vaccinated and unvaccinated children. In her testimony Ms. Ehresmann explained that a
prospective study of this type would be unethical because “it requires a random sample of
children from whom to withhold vaccination and it is unethical to withhold a medical product
that is known to have significant benefit to children and adults.” (Exhibit Y) But Ms. Ehresmann
did not explain the limitations of a retrospective study in this area. In a retrospective cohort
study, there is no ability to randomize people to address potential confounding factors, e.g.
factors that could distort the study’s results and conclusions.
Response to Ms. Jerri Johnson’s Reference to Ms. Diane Peterson’s Testimony on the
Institute of Medicine Report
Ms. Jerri Johnson testified on Ms. Diane Peterson’s reference to an Institute of Medicine (IOM)
report on vaccine safety. Ms. Johnson said that she “read quite a bit of that exhaustive statement
from IOM,” and “what they actually said was….” She was implying that Ms. Peterson’s
statement about the report was incorrect. At the time, the department indicated that it would
respond to Ms. Johnson’s testimony in our post-hearing response. (See hearing transcript, page
185.) Upon further review, however, the department realized that Ms. Johnson and Ms. Peterson
were referring to different IOM reports. Ms. Peterson was referring to a 2013 report by the IOM
entitled “The Childhood Immunization Schedule and Safety,” (See hearing transcript, pages 7980) while Ms. Johnson was referring to a 2012 report entitled “Adverse Effects of Vaccines
Evidence and Causality.”
Response to Testimony on Antigens and Vaccine Ingredients
A few of those opposed to the proposed immunization requirements said that children receive too
many vaccines. Ms. Ehresmann and Dr. Jacobson addressed this in their testimony, which can be
found on pages 28 to 29 and 47 to 48 of the hearing transcript. This is also addressed in Exhibit
N on pages 6 and 7. MDH stands by its proposed rules.
Ms. Kate Birch and a few others testifying alleged that the ingredients used as preservatives and
adjuvants in vaccines are unsafe. As stated earlier under the VAERS discussion, the FDA
regulates vaccines, which includes the ingredients, and has approved all the recommended
vaccines, including the ones that the department is proposing to add. Therefore this testimony is
outside the scope of these proposed rules. MDH, however, in this response, is adding two
MDH Response to Comments to Immunization Rule Amendments
July 17, 2013
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authorities about vaccine ingredients. One is a fact sheet prepared by the American Academy of
Pediatrics that gives further information about the ingredients used in the vaccine and their
purpose. The other is an excerpt from a fact sheet titled “Clear Answers & Smart Advice about
Your Baby’s Shots” by Dr. Ari Brown on vaccine ingredients. Exhibit N on pages 6 and 7 also
addresses this question. Finally, the FDA, the agency that regulates vaccines, has reviewed the
safety of these ingredients and approved licensure of these recommended vaccines.
The department had considered these concerns during the rulemaking process, and rejected them
in favor of its proposed rules as justified in the SONAR.
Response to Comment Submitted by Ms. Chris Abel on States Requiring the
Meningococcal Vaccine.
Ms. Abel was correct in her written comment that six of the 22 states that the department cited
for required meningococcal vaccination have only an education requirement. The department
should have delineated the difference between an educational mandate and a vaccine
requirement. There are 16 states with a meningococcal vaccine mandate and six with an
education-only mandate.
Response to Comment Submitted by Ms. Chris Abel on the Meningococcal Vaccine
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.
First, in her testimony and comments, Ms. Abel frequently cited data from the years 2006 to
2012 to support her testimony that meningococcal disease is rare in Minnesota and a requirement
is not needed at present. 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. (There was
another vaccine that was licensed but not routinely recommended – the big change occurred in
2005.) 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).
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. 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. 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 pre-recommendation incidence.
The graphs that Ms. Abel submitted also misrepresent data that was provided to her. They are
incomplete. There were more cases of meningococcal disease than were represented on her
graphs. Moreover, she continued to only use data from 2008 to 2012. The department stands by
the graphs on page 47 of the SONAR, which depict a more accurate portrait of disease incidence.
MDH Response to Comments to Immunization Rule Amendments
July 17, 2013
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It is important to also note that even if Minnesota did not have any deaths or major outbreaks, the
disease is a threat and other states have seen outbreaks and deaths, as Ms. Marso testified. (See
transcript, page 120). The disease has not been eradicated and could occur at any time with
devastating effect in healthy adolescents.
Ms. Abel also references a 2013 ACIP recommendation that said the following, “The casefatality 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.
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.
Response to Ms. Johnson’s and Other Testimony on Hepatitis B
Ms. Jerri Johnson and others testified that they believed the hepatitis B vaccine is unsafe, citing
many adverse events reported to VAERS regarding the vaccine. The SONAR on pages 26 to 28
and attachment H addresses the safety and efficacy of the hepatitis B vaccine, which the
department rests on for the necessary and reasonableness of the proposed requirement. It is
important to stress that Ms. Johnson and others rely on VAERS reports and anecdotal evidence
for their assertion. Such reliance is misplaced. As stated in the SONAR and at the hearing,
VAERS cannot be relied upon to make any inferences of causation, a fact that Ms. Johnson
acknowledged in her testimony (See hearing transcript, page 112). The Institute of Medicine and
the Vaccine Safety Data Link have studied the hepatitis B vaccine and determined its safety.
In addition, Ms. Johnson in her testimony (See hearing testimony, pages 174 to 175) cited data
on the incidence of hepatitis B infection in children in Minnesota. It is not an appropriate use of
MDH’s data to assign an incidence rate. Despite explanations of the appropriate use of MDH
data, Ms. Johnson misinterpreted the data that MDH provided to her. The data collected by MDH
on hepatitis B are based on cases of hepatitis B diagnosed by providers and reported to MDH.
Because hepatitis B infection is often asymptomatic or mild in children, cases of hepatitis B in
that age group may go undetected. Also, routine universal screening for hepatitis B is not
recommended, so chronic infections may not be detected until later in life. The way data are
reported and collected makes the burden of hepatitis B in Minnesota children difficult to
describe. Ms. Johnson also made inferences in her testimony and comments regarding the 27
Minnesota children who were reported with chronic hepatitis B disease. (See Exhibit AP). The
MDH Response to Comments to Immunization Rule Amendments
July 17, 2013
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data provided to Ms. Johnson does not allow for those inferences so the statistics she cites cannot
be verified.
The department cannot know the number of children with acute hepatitis B disease because most
children will be asymptomatic but still infectious. MDH only tracks reported cases.
Response to Comment about Blood Donors with Hepatitis B Histories – Exhibit AO
Submitted by Ms. Chris Abel
Ms. Abel submitted Exhibit AO, “Hepatitis B Vaccine for Daycare.” In the exhibit she implies
that the Red Cross allows people to donate blood even if they had a history of hepatitis B before
age 11. The document specifically refers to viral hepatitis, which includes all forms of hepatitis,
including A, B, C, D, and E. However, she incorrectly cites the information. The information she
provides is used for screening purposes. If a person answers yes to having had a viral hepatitis
before age 11, he or she can donate the blood. The blood, however, is then screened and if the
hepatitis B virus is found, the blood cannot be used for donation. Per the FDA, under 21 CFR
610.41, persons with a history of a positive (confirmed) test for hepatitis B virus surface antigen
(HBsAg), regardless of age at the time of the positive test, may not serve as a donor of human
blood, plasma, or serum.
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/QuestionsaboutBlood/DonatingBlood/
and http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol7/xml/CFR-2011-title21-vol7-sec610-41.xml
In addition, the FDA recommends that “for blood and blood components intended for
transfusion, anti-HBc testing should be performed, using an FDA-licensed test kit, and test
results interpreted according to the manufacturer’s instructions as described in the package
insert.” And, “if the donor is repeatedly reactive for anti-HBc on a second occasion, regardless of
the time interval (even if less than eight weeks), the donor should be indefinitely deferred and the
product(s) should not be used for transfusion.”
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Ot
herRecommendationsforManufacturers/MemorandumtoBloodEstablishments/UCM062847.pdf
Combined, these FDA regulations and recommendations mean that blood from persons with past
or present hepatitis B infection regardless of age at infection is not used for transfusions.
Response to Argument that Hepatitis A, Hepatitis B, and Meningococcal are Rare Diseases.
Those opposed to the proposed new immunization requirements argued that since these diseases
are rare in children and adolescents, adding them to the Minnesota school and child care law is
not reasonable or necessary. The department considered these arguments and addressed them in
the SONAR on pages 22 to 29, 30 to 38, and 44 to 52 respectively. Opponents to the
immunization law also argue better hygiene and sanitation resulted in the disappearance of many
diseases. Better hygiene and sanitation, plus improved living standards, have undoubtedly had a
direct impact on disease but those developments do not account for all improvement in public
health. To the contrary, examining actual disease incidence (number of new cases of disease)
over the years shows there is little doubt of the significant and direct impact vaccines has had on
diseases.
MDH Response to Comments to Immunization Rule Amendments
July 17, 2013
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The inset graphs for measles incidence reflects periodic peaks and valleys over time, but the real,
permanent drop coincided with licensure and wide use of the measles vaccine in 1963. (Centers
for Disease Control and Prevention. Measles – United States 1997. MMWR. 1998;47(14):273276)
The Haemophilus-influenzae type b (Hib) vaccine is another recent example of a vaccine’s
impact on disease. The Hib vaccine was licensed in 1990 when approximately 20,000 cases were
diagnosed annually. By 1993, the disease incidence had dropped to 1,419 cases and today only a
handful of cases occur per year (http://www.cdc.gov/vaccines/vac-gen/whatifstop.htm).
Critics of vaccination often use charts and graphs showing that a disease declined before
mandating or even introducing the vaccine. Such graphs, however, usually only report the cases
of death from the disease. They do not show the actual number of cases or complications because
of the disease. Advances in medical treatment have helped in preventing death due to the disease,
but these advances did not reduce the number of cases of the disease. That happened once the
vaccine was licensed.
It is important to reiterate that these diseases are much rarer than they used to be because of our
strong vaccination program and school immunization laws. Many studies have shown that strong
immunization laws lead to higher vaccination rates. (Briss PA, et al. Reviews of evidence
regarding interventions to improve vaccination coverage in children, adolescents, and adults. Am
J Prev Med 2000;18(1S):97-140.) While at the same time, vaccine-preventable disease outbreaks
occur in areas with high exemption and low vaccination rates. (Salmon DA, et al. Health
consequences of religious and philosophical exemptions from immunization laws: individual and
societal risk of measles. JAMA. 1999;28247-53 and Omer SB, et al. Nonmedical exemptions to
school immunization requirements: secular trends and association of state policies with pertussis
incidence. JAMA 2006;296:1757-63) More studies on the impact of low vaccination rates can be
MDH Response to Comments to Immunization Rule Amendments
July 17, 2013
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found at the following website: http://www.immunize.org/catg.d/p2069.pdf.
Response to Concerns Regarding Conflict of Interest and Vaccines
Critics claim that decision makers at the Advisory Committee on Immunization Practices (ACIP)
and other national medical organizations have a financial incentive to see the vaccines approved
and recommended, so they cannot make unbiased decisions. Critics believe that since researchers
and decisions makers are so beholden to the pharmaceutical and other biotech companies and
possible profit from these vaccine recommendations, the department should not look to their
recommendations when considering mandating a vaccine.
Conflict of interest is a paradoxical issue: we need excellent, objective experts to inform vaccine
decisions; yet it is virtually impossible for an individual to gain such expertise without having
had some relationship to or interest in pharmaceutical-company funded research projects.
The concern about conflict of interest is very real and is shared by state and federal governments.
So much so, in fact, that Congress and the CDC have put extensive safeguards in place to ensure
vaccine integrity. These safeguards range from the FDA’s lengthy approval process to numerous
laws and polices about financial disclosure of staff and advisors – described in some detail
below.
There are two provisions of the Federal Advisory Committee Act (FACA) that cover the ACIP
and these provisions were designed to promote the objectivity of advisory committee
deliberations and protect from conflict of interest:
(1) FACA requires that “the membership of the advisory committee be fairly balanced in
terms of the points of view represented and the functions to be performed by the
committee…”
(2) The act requires “provisions to ensure that the advisory recommendations will not be
inappropriately influenced by the appointing authority or by any special interest, but will
instead be the result of the advisory committee’s independent judgment…” (Testimony of
James Dean, Director, Office of Government Policy, U.S. General Services
Administration, Hearing before the Committee on Government Reform, House of
Representatives, 106 Congress, June 15, 2000, Serial No. 106-239.)
Moreover, the CDC has addressed the potential conflict of interest by members serving on the
ACIP by establishing policies to assure the integrity of the advisory group. These policies ensure
that ACIP complies with ethics statutes and regulations regarding conflicts and the appearance of
financial conflicts of interest. Both before and after making ACIP appointments, CDC resolves
concerns about the potential for the appearance of conflict so that the appearance of conflict is
avoided altogether.
There are a number of specific vaccine-related interests that will generally disqualify a person
from committee membership. Examples of questions CDC asks to identify such interests are:
1. Do you or your employer have any grants that are funded by vaccine manufacturers? If
so, what is the nature of the grant?
MDH Response to Comments to Immunization Rule Amendments
July 17, 2013
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2. Do you or your spouse or dependent children own stock in any vaccine manufacturer or
parent company of a manufacturer?
3. Do you have a patent on any vaccine or candidate vaccine? If you are not a patent holder,
are you otherwise entitled to royalties or other compensation from such a patent?
4. Do you serve in any advisory role with a vaccine manufacturer?
5. During the past year, have you received any honoraria or travel funds from vaccine
manufacturers (of from educational grants from vaccine manufacturers) for presenting at
scientific meetings?
6. Do you serve in any fund-raising role with any organization that could involve
solicitation of funds from vaccine manufacturers?
There are also restrictions on financial practices of ACIP members and their families. ACIP
members must agree that while serving on the ACIP they will:
•
Forgo solicitation or acceptance of funds from vaccine manufacturers;
•
Not serve as a paid litigation consultant or expert witness in litigation involving the
vaccine manufacturer;
•
Not accept honoraria or travel reimbursement with a funding source from a vaccine
manufacturer for attendance at scientific meetings, with the exception of continuing
medical education (CME) presentations where the source of funding is an unrestricted
grant to the CME provider; and
•
Not own vaccine stocks during their committee tenure, except as allowed under the
Office of Government Ethics (OGE) regulator exemptions for small, inconsequential
amounts. In order to avoid even the appearance of conflict, ownership of any amount of
vaccine stocks is discouraged among all family members. ACIP members must disclose
any vaccine stock ownership at the beginning of each ACIP meeting. A member cannot
vote on vaccine recommendation if they own stock in the company that manufactures that
vaccine.
Finally, there are certain disclosures required of ACIP members. These include the following:
•
Office of Government Ethics (OGE) Confidential Financial Disclosure Reports. As
“Special Government Employees,” ACIP members must file these reports. CDC
evaluates and considers for waiver the related financial interest of the member based on
federal regulation, in particular whether the need for an individual’s service outweighs
the potential for conflict of interest. Where conflict exists, only limited 208(b)(3) waivers
are considered.
•
Public disclosure at the beginning of each ACIP meeting. To ensure the public is aware
of a member’s related financial interests, continued membership on the ACIP requires
that members publicly disclose all vaccine-related interests and work at the beginning of
each meeting.
In addition, federal law (18 U.S.C. Section 208) prohibits conflicts of interest among federal
executive-branch employees, including special government employees (e.g., ACIP). These
employees may not participate personally and substantially in any particular matter which, to
MDH Response to Comments to Immunization Rule Amendments
July 17, 2013
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their knowledge, has a direct and predictable effect on their financial interest. However,
Congress provides for limited waivers of the prohibition of conflict of interest under 18 U.S.C.
§208 (b)(3) when “the need for the individual’s services outweighs the potential for conflict of
interest created by the financial interest involved.” The federal Office of Government Ethics has
issued regulations interpreting this section of the law, including guidance on waivers. In
providing for such waivers, Congress has recognized that advisory committees, such as ACIP,
need experts who may have potential conflicts of interest because they are chosen for service
based on their expertise and experience in the areas in which they advise the government.
Limited waivers generally allow members to fully participate in committee discussion related to
the waived interest, with the condition that they will be prohibited from voting on the matter.
Further, they cannot serve as chairs of subcommittees or working groups considering issues
where conflict exists. And they cannot vote on any other vaccines manufactured by the company
funding the research or on any vaccines that are similar to the one(s) they are studying.
ACIP meetings are open to the public and time is reserved for public comment. Meetings are
only closed when potential proprietary information is discussed, e.g.: trade secrets. The ACIP
also uses subgroups of the committee to extensively review research data. Finally,
recommendations are subject to extensive review by CDC, FDA, outside expert consultants, and
vaccine manufacturers. “It is a public process and, at times, there is a very intense public review
by any number of people, whether it be the general public, the media, interest groups and so forth
and so on.” (James Dean, Director, Office of Government Policy, U.S. General Services
Administration testifying at a hearing before the Committee on Government Reform, House of
Representatives, 106 Congress, June 15, 2000, Serial No. 106-239.)
Safe, effective vaccines are in everyone’s best interest, particularly for the manufacturers that
make the vaccines, the advisory groups that recommend vaccines, and front line health care
workers that administer them. It is important to remember that most doctors, nurses, and other
health care professionals operate on the basis of integrity and professionalism. It would not be in
their best interest to approve a vaccine that might be dangerous. Finally, the doctors and nurses
on the front line who give the vaccines and sometimes do the research are also giving these same
vaccines to their children and their relatives’ children.
Response to Due Process and Equal Protection Arguments
The National Health Freedom Organization raised due process and equal protection arguments
about mandated vaccines. These comments too exceed the scope of these proposed rule
amendments. The department is bringing its existing immunization schedule up to date for
school requirements that were first enacted in 1967. Since then, the schedule has undergone
many legislative changes. As pointed out in the SONAR, the Minnesota legislature has given the
department rulemaking authority to make changes to immunization requirements that are in line
with the ACIP and AAP recommendations. All 50 states in the country have school and child
care immunization laws, which have been held constitutional. In their submitted comments, both
Ms. Diane Miller and Ms. Ann Tenner refer to Mary Holland’s article. (Exhibit AM) This article
correctly points out that the courts have found that the state’s police power allows them to
regulate matters related to health and safety, which includes immunizations. (See Jacobson v.
Massachusetts, 197 U.S. 11 (1905) and Zuch v. King, 260 U.S. 174 (1922))
MDH Response to Comments to Immunization Rule Amendments
July 17, 2013
Page 12 of 12
Theresa Deisher Manuscript and Testimony (Exhibit BN)
Ms. Theresa Deisher submitted a manuscript that is under review for publication in the Journal
of Pediatrics. Until the manuscript has been peer-reviewed and accepted, the department
considers any findings or conclusions in this article not sufficiently reliable to be scientifically or
evidence-based authority for these proposed rule changes. MDH relies instead on the authorities
it cited in the SONAR and hearing record.
Ms. Deisher also submitted the testimony that she gave to the Minnesota legislature in 2011
regarding her theory. Two University of Minnesota professors of genetics both testified to the
implausibility of Ms. Deisher’s theory. (See pages 23–27 from the testimony given to the
Minnesota legislature in 2011.)
CONCLUSION
The above response focuses on testimony and comments critical of MDH’s proposed rule
amendments. The department, however, received many supportive comments as well. These
comments stressed the importance of aligning the law with federal recommendations already in
place and the benefits that vaccines provide.
At the hearing and in comments, parents spoke and wrote about very real and quite severe health
problems their children suffer, conditions they attribute to vaccine injuries. Such suffering
garners sympathy and should not be minimized in any way. But, evidence for a causal
connection between vaccines and those injuries for many of the stories is weak or implausible.
The evidence shows that serious adverse reactions from vaccines are extremely rare. As Dorit
Reiss wrote, “The fact that a parent believes a child’s problems stem from a vaccine is relevant,
but often not sufficient, especially when the research goes the other way.” Ms. Reiss also
included a link to an AAP’s document entitled “Vaccine Safety: Examine the Evidence”
(http://www2.aap.org/immunization/families/faq/vaccinestudies.pdf) As she points out, “In
contrast, evidence for the harms of the diseases in question is well documented and supported by
medical evidence and objective tests.”
In conclusion, MDH has shown a rational basis for what the department has proposed, and the
rules are based on long standing public policy found in Minnesota and around the United States.
Moreover, it is important to note that any parent or guardian who is opposed to immunizations
can take a conscientious exemption and opt their child out of any or all immunization
requirements. The state is not coercing any child to be vaccinated. MDH asserts that the
proposed amendments to the reporting rules are necessary, reasonable, and in accordance with
law. We urge you to recommend in support of adopting these rules.
Sincerely,
Kristen Ehresmann
Director, Infectious Disease Epidemiology, Prevention and Control Division
Minnesota Department of Health
VACCINE INFORMATION STATEMENT
Hepatitis B Vaccine
Many Vaccine Information Statements are
available in Spanish and other languages.
See www.immunize.org/vis
What You Need to Know
Hojas de Informacián Sobre Vacunas están
disponibles en Español y en muchos otros
idiomas. Visite www.immunize.org/vis
1
What is hepatitis B?
Hepatitis B is a serious infection that affects the liver. It is
caused by the hepatitis B virus.
• In 2009, about 38,000 people became infected with
hepatitis B.
• Each year about 2,000 to 4,000 people die in the United
States from cirrhosis or liver cancer caused by
hepatitis B.
Hepatitis B can cause:
Acute (short-term) illness. This can lead to:
• diarrhea and vomiting
• loss of appetite
• tiredness
• jaundice (yellow skin or eyes)
• pain in muscles, joints, and stomach
cute illness, with symptoms, is more common among
A
adults. Children who become infected usually do not have
symptoms.
Chronic (long-term) infection. Some people go on to
develop chronic hepatitis B infection. Most of them do not
have symptoms, but the infection is still very serious, and
can lead to:
• liver damage (cirrhosis) • liver cancer • death
hronic infection is more common among infants and
C
children than among adults. People who are chronically
infected can spread hepatitis B virus to others, even if
they don’t look or feel sick. Up to 1.4 million people in
the United States may have chronic hepatitis B infection.
B vaccine:
2Hepatitis
Why get vaccinated?
Hepatitis B vaccine can prevent hepatitis B, and the serious
consequences of hepatitis B infection, including liver
cancer and cirrhosis.
Hepatitis B vaccine may be given by itself or in the same
shot with other vaccines.
Routine hepatitis B vaccination was recommended for
some U.S. adults and children beginning in 1982, and for
all children in 1991. Since 1990, new hepatitis B infections
among children and adolescents have dropped by more than
95%—and by 75% in other age groups.
Vaccination gives long-term protection from hepatitis B
infection, possibly lifelong.
should get hepatitis B
3Who
vaccine and when?
Children and adolescents
• Babies normally get 3 doses of hepatitis B vaccine:
1st Dose:
Birth
2nd Dose:
1-2 months of age
3rd Dose:
6-18 months of age
Some babies might get 4 doses, for example, if a
combination vaccine containing hepatitis B is used. (This
is a single shot containing several vaccines.) The extra
dose is not harmful.
Hepatitis B virus is easily spread through contact with the
blood or other body fluids of an infected person. People can
also be infected from contact with a contaminated object,
where the virus can live for up to 7 days.
• Anyone through 18 years of age who didn’t get the
vaccine when they were younger should also be
vaccinated.
• A baby whose mother is infected can be infected at birth;
• Children, adolescents, and adults can become infected
by:
- contact with blood and body fluids through breaks in
the skin such as bites, cuts, or sores;
- contact with objects that have blood or body fluids on
them such as toothbrushes, razors, or monitoring and
treatment devices for diabetes;
- having unprotected sex with an infected person;
- sharing needles when injecting drugs;
- being stuck with a used needle.
Adults
• All unvaccinated adults at risk for hepatitis B infection
should be vaccinated. This includes:
- sex partners of people infected with hepatitis B,
- men who have sex with men,
- people who inject street drugs,
- people with more than one sex partner,
- people with chronic liver or kidney disease,
- people under 60 years of age with diabetes,
- people with jobs that expose them to human blood or
other body fluids,
- household contacts of people infected with hepatitis B,
- residents and staff in institutions for the
developmentally disabled,
- kidney dialysis patients,
- people who travel to countries where hepatitis B is
common,
- people with HIV infection.
• Other people may be encouraged by their doctor to get
hepatitis B vaccine; for example, adults 60 and older with
diabetes. Anyone else who wants to be protected from
hepatitis B infection may get the vaccine.
• Pregnant women who are at risk for one of the reasons
stated above should be vaccinated. Other pregnant
women who want protection may be vaccinated.
Adults getting hepatitis B vaccine should get 3 doses—with
the second dose given 4 weeks after the first and the third
dose 5 months after the second. Your doctor can tell you
about other dosing schedules that might be used in certain
circumstances.
should not get hepatitis B
4Who
vaccine?
• Anyone with a life-threatening allergy to yeast, or to any
other component of the vaccine, should not get hepatitis
B vaccine. Tell your doctor if you have any severe
allergies.
• Anyone who has had a life-threatening allergic reaction
to a previous dose of hepatitis B vaccine should not get
another dose.
• Anyone who is moderately or severely ill when a dose
of vaccine is scheduled should probably wait until they
recover before getting the vaccine.
Your doctor can give you more information about these
precautions.
Note: You might be asked to wait 28 days before donating
blood after getting hepatitis B vaccine. This is because the
screening test could mistake vaccine in the bloodstream
(which is not infectious) for hepatitis B infection.
are the risks from
5What
hepatitis B vaccine?
Hepatitis B is a very safe vaccine. Most people do not have
any problems with it.
The vaccine contains non-infectious material, and cannot
cause hepatitis B infection.
Some mild problems have been reported:
• Soreness where the shot was given (up to about 1 person
in 4).
• Temperature of 99.9°F or higher (up to about 1 person in
15).
Severe problems are extremely rare. Severe allergic
reactions are believed to occur about once in 1.1 million
doses.
A vaccine, like any medicine, could cause a serious
reaction. But the risk of a vaccine causing serious harm, or
death, is extremely small. More than 100 million people
in the United States have been vaccinated with hepatitis B
vaccine.
if there is a serious
6What
reaction?
What should I look for?
• Look for anything that concerns you, such as signs of
a severe allergic reaction, very high fever, or behavior
changes.
Signs of a severe allergic reaction can include hives,
swelling of the face and throat, difficulty breathing, a fast
heartbeat, dizziness, and weakness. These would start a
few minutes to a few hours after the vaccination.
What should I do?
• If you think it is a severe allergic reaction or other
emergency that can’t wait, call 9-1-1 or get the person to
the nearest hospital. Otherwise, call your doctor.
• Afterward, the reaction should be reported to the Vaccine
Adverse Event Reporting System (VAERS). Your doctor
might file this report, or you can do it yourself through
the VAERS web site at www.vaers.hhs.gov, or by
calling 1-800-822-7967.
VAERS is only for reporting reactions. They do not give
medical advice.
National Vaccine Injury
7The
Compensation Program
The National Vaccine Injury Compensation Program
(VICP) is a federal program that was created to compensate
people who may have been injured by certain vaccines.
Persons who believe they may have been injured by a
vaccine can learn about the program and about filing a
claim by calling 1-800-338-2382 or visiting the VICP
website at www.hrsa.gov/vaccinecompensation.
8
How can I learn more?
• Ask your doctor.
• Call your local or state health department.
• Contact the Centers for Disease Control and
Prevention (CDC):
- Call 1-800-232-4636 (1-800-CDC-INFO) or
- Visit CDC’s website at www.cdc.gov/vaccines
Vaccine Information Statement (Interim)
Hepatitis B Vaccine
2/2/2012
42 U.S.C. § 300aa-26
Office Use Only
VACCINE INFORMATION STATEMENT
Hepatitis A Vaccine
What You Need to Know
1
What is hepatitis A?
Hepatitis A is a serious liver disease caused by the
hepatitis A virus (HAV). HAV is found in the stool of
people with hepatitis A.
It is usually spread by close personal contact and
sometimes by eating food or drinking water containing
HAV. A person who has hepatitis A can easily pass the
disease to others within the same household.
Hepatitis A can cause:
• “flu-like” illness
• jaundice (yellow skin or eyes, dark urine)
• severe stomach pains and diarrhea (children)
People with hepatitis A often have to be hospitalized
(up to about 1 person in 5).
Adults with hepatitis A are often too ill to work for up to
a month.
Sometimes, people die as a result of hepatitis A (about
3–6 deaths per 1,000 cases).
Hepatitis A vaccine can prevent hepatitis A.
should get hepatitis A
2Who
vaccine and when?
WHO
Some people should be routinely vaccinated with
hepatitis A vaccine:
• All children between their first and second birthdays
(12 through 23 months of age).
• Anyone 1 year of age and older traveling to or working
in countries with high or intermediate prevalence of
hepatitis A, such as those located in Central or South
America, Mexico, Asia (except Japan), Africa, and
eastern Europe. For more information see www.cdc.
gov/travel.
• Children and adolescents 2 through 18 years of age
who live in states or communities where routine
vaccination has been implemented because of high
disease incidence.
• Men who have sex with men.
• People who use street drugs.
• People with chronic liver disease.
Many Vaccine Information Statements are
available in Spanish and other languages.
See www.immunize.org/vis
Hojas de Informacián Sobre Vacunas están
disponibles en Español y en muchos otros
idiomas. Visite www.immunize.org/vis
• People who are treated with clotting factor
concentrates.
• People who work with HAV-infected primates or who
work with HAV in research laboratories.
• Members of households planning to adopt a child, or
care for a newly arriving adopted child, from a country
where hepatitis A is common.
Other people might get hepatitis A vaccine in certain
situations (ask your doctor for more details):
• Unvaccinated children or adolescents in communities
where outbreaks of hepatitis A are occurring.
• Unvaccinated people who have been exposed to
hepatitis A virus.
• Anyone 1 year of age or older who wants protection
from hepatitis A.
Hepatitis A vaccine is not licensed for children younger
than 1 year of age.
WHEN
For children, the first dose should be given at 12
through 23 months of age. Children who are not
vaccinated by 2 years of age can be vaccinated at later
visits.
For others at risk, the hepatitis A vaccine series may be
started whenever a person wishes to be protected or is at
risk of infection.
For travelers, it is best to start the vaccine series at least
one month before traveling. (Some protection may still
result if the vaccine is given on or closer to the travel
date.)
Some people who cannot get the vaccine before
traveling, or for whom the vaccine might not be
effective, can get a shot called immune globulin
(IG). IG gives immediate, temporary protection.
Two doses of the vaccine are needed for lasting
protection. These doses should be given at least 6
months apart.
Hepatitis A vaccine may be given at the same time as
other vaccines.
people should not
3Some
get hepatitis A vaccine or
if there is a serious
5What
reaction?
• Anyone who has ever had a severe (life threatening)
allergic reaction to a previous dose of hepatitis A
vaccine should not get another dose.
What should I look for?
• Look for anything that concerns you, such as signs of
a severe allergic reaction, very high fever, or behavior
changes.
should wait.
• Anyone who has a severe (life threatening) allergy to
any vaccine component should not get the vaccine.
• Tell your doctor if you have any severe allergies,
including a severe allergy to latex. All hepatitis A
vaccines contain alum, and some hepatitis A vaccines
contain 2-phenoxyethanol.
• Anyone who is moderately or severely ill at the time
the shot is scheduled should probably wait until they
recover. Ask your doctor. People with a mild illness
can usually get the vaccine.
• Tell your doctor if you are pregnant. Because hepatitis
A vaccine is inactivated (killed), the risk to a pregnant
woman or her unborn baby is believed to be very low.
But your doctor can weigh any theoretical risk from
the vaccine against the need for protection.
are the risks from
4What
hepatitis A vaccine?
A vaccine, like any medicine, could possibly cause
serious problems, such as severe allergic reactions. The
risk of hepatitis A vaccine causing serious harm, or
death, is extremely small.
Getting hepatitis A vaccine is much safer than getting the
disease.
Signs of a severe allergic reaction can include hives,
swelling of the face and throat, difficulty breathing,
a fast heartbeat, dizziness, and weakness. These
would start a few minutes to a few hours after the
vaccination.
What should I do?
• If you think it is a severe allergic reaction or other
emergency that can’t wait, call 9-1-1 or get the person
to the nearest hospital. Otherwise, call your doctor.
• Afterward, the reaction should be reported to the
Vaccine Adverse Event Reporting System (VAERS).
Your doctor might file this report, or you can
do it yourself through the VAERS web site at
www.vaers.hhs.gov, or by calling 1-800-822-7967.
VAERS is only for reporting reactions. They do not give
medical advice.
National Vaccine Injury
6The
Compensation Program
The National Vaccine Injury Compensation Program
(VICP) is a federal program that was created to
compensate people who may have been injured by
certain vaccines.
Mild problems
• soreness where the shot was given (about 1 out of
2 adults, and up to 1 out of 6 children)
Persons who believe they may have been injured by a
vaccine can learn about the program and about filing a
claim by calling 1-800-338-2382 or visiting the VICP
website at www.hrsa.gov/vaccinecompensation.
• headache (about 1 out of 6 adults and 1 out of
25 children)
• loss of appetite (about 1 out of 12 children)
• Ask your doctor.
• tiredness (about 1 out of 14 adults)
• Call your local or state health department.
If these problems occur, they usually last 1 or 2 days.
• Contact the Centers for Disease Control and
Prevention (CDC):
- Call 1-800-232-4636 (1-800-CDC-INFO) or
- Visit CDC’s website at www.cdc.gov/vaccines
Severe problems
• serious allergic reaction, within a few minutes to a few
hours after the shot (very rare).
7
How can I learn more?
Vaccine Information Statement (Interim)
Hepatitis A Vaccine
10/25/2011
42 U.S.C. § 300aa-26
Office Use
Only
VACCINE INFORMATION STATEMENT
Tdap Vaccine
(Tetanus, Diphtheria,
and Pertussis)
Many Vaccine Information Statements are available in Spanish and other languages.
See www.immunize.org/vis
What You Need to Know
1
Why get vaccinated?
Tetanus, diphtheria and pertussis can be very serious
diseases, even for adolescents and adults. Tdap vaccine
can protect us from these diseases.
TETANUS (Lockjaw) causes painful muscle tightening
and stiffness, usually all over the body.
• It can lead to tightening of muscles in the head and
neck so you can’t open your mouth, swallow, or
sometimes even breathe. Tetanus kills about 1 out of
5 people who are infected.
DIPHTHERIA can cause a thick coating to form in the
back of the throat.
• It can lead to breathing problems, paralysis, heart
failure, and death.
PERTUSSIS (Whooping Cough) causes severe
coughing spells, which can cause difficulty breathing,
vomiting and disturbed sleep.
• It can also lead to weight loss, incontinence, and
rib fractures. Up to 2 in 100 adolescents and 5 in
100 adults with pertussis are hospitalized or have
complications, which could include pneumonia or
death.
These diseases are caused by bacteria. Diphtheria and
pertussis are spread from person to person through
coughing or sneezing. Tetanus enters the body through
cuts, scratches, or wounds.
Before vaccines, the United States saw as many as
200,000 cases a year of diphtheria and pertussis, and
hundreds of cases of tetanus. Since vaccination began,
tetanus and diphtheria have dropped by about 99% and
pertussis by about 80%.
Hojas de Información Sobre Vacunas están disponibles en Español
y en muchos otros idiomas. Visite www.immunize.org/vis
2
Tdap vaccine
Tdap vaccine can protect adolescents and adults from
tetanus, diphtheria, and pertussis. One dose of Tdap is
routinely given at age 11 or 12. People who did not get
Tdap at that age should get it as soon as possible.
Tdap is especially important for health care professionals
and anyone having close contact with a baby younger
than 12 months.
Pregnant women should get a dose of Tdap during every
pregnancy, to protect the newborn from pertussis. Infants
are most at risk for severe, life-threatening complications
from pertussis.
A similar vaccine, called Td, protects from tetanus and
diphtheria, but not pertussis. A Td booster should be
given every 10 years. Tdap may be given as one of these
boosters if you have not already gotten a dose. Tdap may
also be given after a severe cut or burn to prevent tetanus
infection.
Your doctor can give you more information.
Tdap may safely be given at the same time as other
vaccines.
Some people should not get
3
this vaccine
• If you ever had a life-threatening allergic reaction
after a dose of any tetanus, diphtheria, or pertussis
containing vaccine, OR if you have a severe allergy to
any part of this vaccine, you should not get Tdap. Tell
your doctor if you have any severe allergies.
• If you had a coma, or long or multiple seizures within
7 days after a childhood dose of DTP or DTaP, you
should not get Tdap, unless a cause other than the
vaccine was found. You can still get Td.
• Talk to your doctor if you:
- have epilepsy or another nervous system problem,
- had severe pain or swelling after any vaccine
containing diphtheria, tetanus or pertussis,
- ever had Guillain-Barré Syndrome (GBS),
- aren’t feeling well on the day the shot is scheduled.
4
Risks of a vaccine reaction
With any medicine, including vaccines, there is a chance
of side effects. These are usually mild and go away on
their own, but serious reactions are also possible.
Brief fainting spells can follow a vaccination, leading
to injuries from falling. Sitting or lying down for about
15 minutes can help prevent these. Tell your doctor if
you feel dizzy or light-headed, or have vision changes or
ringing in the ears.
Mild problems following Tdap
(Did not interfere with activities)
• Pain where the shot was given (about 3 in 4
adolescents or 2 in 3 adults)
• Redness or swelling where the shot was given (about
1 person in 5)
• Mild fever of at least 100.4°F (up to about 1 in
25 adolescents or 1 in 100 adults)
• Headache (about 3 or 4 people in 10)
• Tiredness (about 1 person in 3 or 4)
• Nausea, vomiting, diarrhea, stomach ache (up to 1 in
4 adolescents or 1 in 10 adults)
• Chills, body aches, sore joints, rash, swollen glands
(uncommon)
Moderate problems following Tdap
(Interfered with activities, but did not require medical
attention)
• Pain where the shot was given (about 1 in
5 adolescents or 1 in 100 adults)
• Redness or swelling where the shot was given (up to
about 1 in 16 adolescents or 1 in 25 adults)
• Fever over 102°F (about 1 in 100 adolescents or 1 in
250 adults)
• Headache (about 3 in 20 adolescents or 1 in 10 adults)
• Nausea, vomiting, diarrhea, stomach ache (up to 1 or
3 people in 100)
• Swelling of the entire arm where the shot was given
(up to about 3 in 100).
Severe problems following Tdap
(Unable to perform usual activities; required medical
attention)
• Swelling, severe pain, bleeding and redness in the arm
where the shot was given (rare).
A severe allergic reaction could occur after any vaccine
(estimated less than 1 in a million doses).
What if there is a serious
5
reaction?
What should I look for?
• Look for anything that concerns you, such as signs of
a severe allergic reaction, very high fever, or behavior
changes.
Signs of a severe allergic reaction can include hives,
swelling of the face and throat, difficulty breathing,
a fast heartbeat, dizziness, and weakness. These
would start a few minutes to a few hours after the
vaccination.
What should I do?
• If you think it is a severe allergic reaction or other
emergency that can’t wait, call 9-1-1 or get the person
to the nearest hospital. Otherwise, call your doctor.
• Afterward, the reaction should be reported to the
“Vaccine Adverse Event Reporting System” (VAERS).
Your doctor might file this report, or you can do
it yourself through the VAERS web site at
www.vaers.hhs.gov, or by calling 1-800-822-7967.
VAERS is only for reporting reactions. They do not give
medical advice.
The National Vaccine Injury
6
Compensation Program
The National Vaccine Injury Compensation Program
(VICP) is a federal program that was created to
compensate people who may have been injured by
certain vaccines.
Persons who believe they may have been injured by a
vaccine can learn about the program and about filing a
claim by calling 1-800-338-2382 or visiting the VICP
website at www.hrsa.gov/vaccinecompensation.
7
How can I learn more?
• Ask your doctor.
• Call your local or state health department.
• Contact the Centers for Disease Control and
Prevention (CDC):
- Call 1-800-232-4636 or visit
CDC’s website at www.cdc.gov/vaccines
Vaccine Information Statement (Interim)
Tdap Vaccine
05/09/2013
42 U.S.C. § 300aa-26
Office Use
Only
VACCINE INFORMATION STATEMENT
Meningococcal Vaccines
What You Need to Know
Many Vaccine Information Statements are
available in Spanish and other languages.
See www.immunize.org/vis
Hojas de Informacián Sobre Vacunas están
disponibles en Español y en muchos otros
idiomas. Visite www.immunize.org/vis
is meningococcal
1What
disease?
should get meningococcal
3Who
vaccine and when?
Meningococcal disease is a serious bacterial illness. It
is a leading cause of bacterial meningitis in children
2 through 18 years old in the United States. Meningitis
is an infection of the covering of the brain and the spinal
cord.
Routine vaccination
Two doses of MCV4 are recommended for adolescents
11 through 18 years of age: the first dose at 11 or 12
years of age, with a booster dose at age 16.
Meningococcal disease also causes blood infections.
About 1,000–1,200 people get meningococcal disease
each year in the U.S. Even when they are treated with
antibiotics, 10–15% of these people die. Of those who
live, another 11%–19% lose their arms or legs, have
problems with their nervous systems, become deaf, or
suffer seizures or strokes.
Anyone can get meningococcal disease. But it is most
common in infants less than one year of age and people
16–21 years. Children with certain medical conditions,
such as lack of a spleen, have an increased risk of getting
meningococcal disease. College freshmen living in
dorms are also at increased risk.
Meningococcal infections can be treated with drugs such
as penicillin. Still, many people who get the disease die
from it, and many others are affected for life. This is why
preventing the disease through use of meningococcal
vaccine is important for people at highest risk.
2
Meningococcal vaccine
There are two kinds of meningococcal vaccine in the
U.S.:
• Meningococcal conjugate vaccine (MCV4) is the
preferred vaccine for people 55 years of age and
younger.
• Meningococcal polysaccharide vaccine (MPSV4)
has been available since the 1970s. It is the only
meningococcal vaccine licensed for people older
than 55.
Both vaccines can prevent 4 types of meningococcal
disease, including 2 of the 3 types most common in the
United States and a type that causes epidemics in Africa.
There are other types of meningococcal disease; the
vaccines do not protect against these.
Adolescents in this age group with HIV infection should
get three doses: 2 doses 2 months apart at 11 or 12 years,
plus a booster at age 16.
If the first dose (or series) is given between 13 and
15 years of age, the booster should be given between
16 and 18. If the first dose (or series) is given after the
16th birthday, a booster is not needed.
Other people at increased risk
• College freshmen living in dormitories.
• Laboratory personnel who are routinely exposed to
meningococcal bacteria.
• U.S. military recruits.
• Anyone traveling to, or living in, a part of the world
where meningococcal disease is common, such as
parts of Africa.
• Anyone who has a damaged spleen, or whose spleen
has been removed.
• Anyone who has persistent complement component
deficiency (an immune system disorder).
• People who might have been exposed to meningitis
during an outbreak.
Children between 9 and 23 months of age, and anyone
else with certain medical conditions need 2 doses for
adequate protection. Ask your doctor about the number
and timing of doses, and the need for booster doses.
MCV4 is the preferred vaccine for people in these
groups who are 9 months through 55 years of age.
MPSV4 can be used for adults older than 55.
Some people should not get
4 meningococcal vaccine or
should wait.
• Anyone who has ever had a severe (life-threatening)
allergic reaction to a previous dose of MCV4 or
MPSV4 vaccine should not get another dose of either
vaccine.
• Anyone who has a severe (life threatening) allergy to
any vaccine component should not get the vaccine. Tell
your doctor if you have any severe allergies.
• Anyone who is moderately or severely ill at the time
the shot is scheduled should probably wait until they
recover. Ask your doctor. People with a mild illness
can usually get the vaccine.
• Meningococcal vaccines may be given to pregnant
women. MCV4 is a fairly new vaccine and has not
been studied in pregnant women as much as MPSV4
has. It should be used only if clearly needed. The
manufacturers of MCV4 maintain pregnancy registries
for women who are vaccinated while pregnant.
Except for children with sickle cell disease or without a
working spleen, meningococcal vaccines may be given
at the same time as other vaccines.
are the risks from
5What
meningococcal vaccines?
A vaccine, like any medicine, could possibly cause
serious problems, such as severe allergic reactions. The
risk of meningococcal vaccine causing serious harm, or
death, is extremely small.
Severe problems
Serious allergic reactions, within a few minutes to a few
hours of the shot, are very rare.
if there is a serious
6What
reaction?
What should I look for?
Look for anything that concerns you, such as signs of
a severe allergic reaction, very high fever, or behavior
changes.
Signs of a severe allergic reaction can include hives,
swelling of the face and throat, difficulty breathing, a
fast heartbeat, dizziness, and weakness. These would
start a few minutes to a few hours after the vaccination.
What should I do?
• If you think it is a severe allergic reaction or other
emergency that can’t wait, call 9-1-1 or get the person
to the nearest hospital. Otherwise, call your doctor.
• Afterward, the reaction should be reported to the
Vaccine Adverse Event Reporting System (VAERS).
Your doctor might file this report, or you can do it
yourself through the VAERS web site at
www.vaers.hhs.gov, or by calling 1-800-822-7967.
VAERS is only for reporting reactions. They do not give
medical advice.
National Vaccine Injury
7The
Compensation Program
The National Vaccine Injury Compensation Program
(VICP) is a federal program that was created to
compensate people who may have been injured by
certain vaccines.
Brief fainting spells and related symptoms (such
as jerking or seizure-like movements) can follow
a vaccination. They happen most often with
adolescents, and they can result in falls and injuries.
Persons who believe they may have been injured by a
vaccine can learn about the program and about filing a
claim by calling 1-800-338-2382 or visiting the VICP
website at www.hrsa.gov/vaccinecompensation.
Sitting or lying down for about 15 minutes after
getting the shot—especially if you feel faint—can
help prevent these injuries.
Mild problems
As many as half the people who get meningococcal
vaccines have mild side effects, such as redness or pain
where the shot was given.
If these problems occur, they usually last for 1 or 2 days.
They are more common after MCV4 than after MPSV4.
A small percentage of people who receive the vaccine
develop a mild fever.
8
How can I learn more?
• Ask your doctor.
• Call your local or state health department.
• Contact the Centers for Disease Control and
Prevention (CDC):
- Call 1-800-232-4636 (1-800-CDC-INFO) or
- Visit CDC’s website at www.cdc.gov/vaccines
Vaccine Information Statement (Interim)
Meningococcal Vaccine
Office Use Only
10/14/2011
42 U.S.C. § 300aa-26
GOT
An Immunization Update from the Minnesota Department of Health (MDH)
MDH vaccine ordering in MIIC
This is a reminder to all MnVFC-enrolled clinics to sign up for online
vaccine ordering in the Minnesota Immunization Information Connection
(MIIC). The current online ordering system will be inactivated on February
28, 2013. After this date, providers will need to order vaccine using MIIC
or a paper form. To get started, complete a short online form to tell us who
will be ordering vaccine for your clinic. This form is available at
www.health.state.mn.us/divs/idepc/immunize/vaxorder.html.
More details can be found in the Dec. 3, 2012, broadcast fax at
www.health.state.mn.us/divs/idepc/immunize/mnvfc/bfax.html.
2013 Immunization schedules
CDC will post the 2013 immunization schedule for children and
adolescents as well as the adult schedule on Monday, Jan. 28. The
child and adolescent schedule has formatting changes but little
changes in the recommended schedule. The adult schedule includes
recommendations made during 2012 for PCV13 for immunocompromised
adults 19 years and older and Tdap for pregnant women during every
pregnancy. Remember to read the footnotes for both schedules; they
offer a wealth of information that guides the use of the schedules. You
can find a link to the schedules at www.cdc.gov/mmwr.
VAERS reminder
Vaccines are developed with the highest standards of safety. However,
as with any medical procedure, vaccination has some risks albeit
rare. Providers should report any adverse event that occurs during or
following vaccination to the Vaccine Adverse Event Reporting System
(VAERS). A 10-minute video is available to give you an overview of how
VAERS works. Find it at: http://vaers.hhs.gov/index.
Flu FAQ
Here are the answers to a couple frequently asked questions about
influenza vaccination:
Should people who may not respond well to flu vaccine (e.g., elderly,
immunocompromised, etc.) get another dose later in the season?
No. Past studies show that with the exception of children 6 months
through 8 years old, a second dose is neither helpful nor recommended.
Are there vaccination considerations when antivirals are used?
Yes, but only with live attenuated influenza vaccine (LAIV) and when
oseltamivir or zanamivir are the antivirals. LAIV vaccination should be
deferred 48 hours after completion of an antiviral treatment; you can give
inactivated influenza vaccine instead. Additionally, if antiviral treatment is
necessary within 14 days of LAIV vaccination, revaccination is necessary.
MDH Immunization Program 1-800-657-3970
WS
January 2013
Clip and save 
Current VISs, January 2013
(Changes from last quarter are in bold italics.)
Chickenpox-interim
3/13/08
DTaP/DT/DTP
5/17/07
Hepatitis A
Hepatitis B-interim
Hib
Thank you to Dr. Dawn Martin!
The MDH Immunization Program would like to thank Dr. Dawn Martin
for her four years as chair of the Minnesota Immunization Practices
Advisory Committee (MIPAC). Dr. Martin’s commitment and leadership
have been of incredible value to the committee. We look forward to her
continued involvement with MIPAC and commend her for her work in
improving immunization services for all Minnesotans.
SHOTS
10/25/11
2/2/12
12/16/98
HPV Cervarix - interim
5/3/11
HPV Gardasil - interim
2/22/12
Influenza - LAIV
7/2/12
Influenza - TIV
7/2/12
Japanese encephalitis
Meningococcal - interim
12/7/11
10/14/11
MMR - interim
4/20/12
MMRV
5/21/10
Multi-vaccine - interim
11/16/12
PCV - interim
4/16/10
PPSV
10/6/09
Polio
11/8/11
Rabies
10/6/09
Rotavirus - interim
12/6/10
Shingles (zoster)
10/6/09
Td/Tdap - interim
1/24/12
Typhoid
5/29/12
Yellow Fever
3/30/11
Vaccine Information Statements are required by law
Federal law requires providers or anyone who vaccinates to give
patients, or their parents or legal guardians, the appropriate VIS before
giving vaccines covered by the National Vaccine Injury Compensation
Program (NVICP). However, CDC develops VISs for all vaccines and
encourages their use. For more information and VIS translations, see
www.cdc.gov/vaccines/pubs/vis/vis-facts.htm.
MIIC Tip: Document all flu vaccinations in MIIC
MIIC has received 1,345,768 flu vaccination records so far this flu
season! Please remember to document all of your flu vaccinations in
MIIC. You can find instructions here: www.health.state.mn.us/divs/
idepc/immunize/registry/hp/influenzavax.html.
Go green: Get GYS News via email
Simply go to www.health.state.mn.us/immunize and click on “Got Your
Shots News” under “For Health Care Providers.” Then, click on the red
envelope to sign up. You can unsubscribe at any time.
www.health.state.mn.us/immunize
Page 1 of 1
Pupil Immunization Record
Student Name __________________________________________________
Birthdate ______________________Student Number ___________________
FOR SCHOOL USE ONLY
( ) Complete; booster required in ____________
( ) In process; 8 mos. expires ______________
( ) Medical exemption for __________________
( ) Conscientious objection for ______________
( ) Parental/guardian consent ______________
Minnesota law requires children enrolled in school to be immunized against certain diseases or file a legal medical or
conscientious exemption.
Parent: Enter the MONTH, DAY, and YEAR for all vaccines your child received, MED for vaccines that are medically
contraindicated, or CO for vaccines that are conscientiously opposed. Sign appropriate signature boxes on reverse.
MED: Medical contraindication to immunization, history of disease, or laboratory evidence of immunity.
CO: Immunizations are contrary to parent or guardian’s conscientiously held beliefs.
School Personnel: Be sure to initial and date any new information that you add to this form after the parent/guardian submits
it. Also, record combination vaccines (e.g., DTaP+HepB+IPV, Hib+HepB) in each applicable space.
Type of Vaccine
DO NOT USE () or ()
1st Dose
Mo/Day/Yr
2nd Dose
Mo/Day/Yr
3rd Dose
Mo/Day/Yr
4th Dose
Mo/Day/Yr
5th Dose
Mo/Day/Yr
Required (The shaded boxes indicate doses that are not routinely given; however, if your child has received them, please
write the date in the shaded box.)
Diphtheria, Tetanus, and Pertussis (DTap, DTP)
Diphtheria and Tetanus (DT)
• for 6-year-olds and younger
Tetanus and Diphtheria (Tdap, Td)
• for 7-year-olds and older
Polio (IPV, OPV)
Measles, Mumps, and Rubella (MMR)
• minimum age: on or after 1st birthday
• required for kindergarten and 7th grade
Hepatitis B (hep B)
• required for kindergarten and 7th grade
Varicella (chickenpox)
• minimum age: on or after 1st birthday
• vaccine or disease history required for kindergarten and
7th grade
Recommended
Meningococcal (MCV, MPSV)
Human Papillomavirus (HPV)
Hepatitis A (hep A)
Additional exemptions:
• Children less than 7 years of age: The 5th dose of DTaP/DTP/DT (similarly, the 4th dose of polio vaccine) is not
necessary if the 4th DTaP/DTP/DT (3rd dose of polio) was administered after the 4th birthday.
• Children 7 years of age and older: A history of 3 doses of DTaP/DTP/DT/Td/Tdap and 3 doses of polio vaccine meets the
minimum requirements of the law.
• Students in grades 7-12: A Td or Tdap booster at age 11 years or later is not required for students in grades 7-12 whose
most recent Td was given after their 7th birthday but before their 11th birthday. Instead, it will be required 10 years after the
date of the most recent dose.
• Students 11-15 years of age: A 3rd dose of hepatitis B vaccine is not required for students who provide documentation of
the alternative 2-dose schedule.
• Students 10 years or older: May receive Tdap to fulfill the Td requirement for students in grades 7-12.
• Students 18 years of age or older: Do not need polio vaccine.
Developed by the Minnesota Department of Health - Immunization Program www.health.state.mn.us/immunize
(11/11) #140-0155
Student Name ________________________________________________
BOX 1: Certifying Immunization Status
BOX 3A: Medical Exemptions
BOX 2: Consent to Share Immunization Information
BOX 3B: Conscientious Exemptions
1. Choose one of the following to indicate student’s immunization status and the source of the information above:
A.I certify that this student has received all immunizations required by law.
_____________________________________________________________________________________________
Signature of parent/guardian or physician/public clinic Date
B. I certify that this student has received at least one dose of vaccine for diphtheria, tetanus, and pertussis (if ageappropriate), polio, hepatitis B (K and 7th), varicella (K and 7th), measles, mumps, and rubella and will complete his/
her diphtheria, tetanus, pertussis, hepatitis B, and/or polio vaccine series within the next 8 months. The dates on
which the remaining doses are to be given are:
_____________________________________________________________________________________________
_____________________________________________________________________________________________
Signature of physician/public clinic Date
2. Parental/Guardian Consent to Share Immunization Information:
Your child’s school is asking your permission to share your child’s immunization record with Minnesota’s immunization
registry to help us better protect students from disease. You are not required to sign this consent; it is voluntary. In
addition, all the information you provide is legally classified as private data and can only be released to those legally
authorized to receive it under Minnesota law.
I agree to allow school personnel to share my student’s immunization record with Minnesota’s immunization registry:
_______________________________________________________________________________________________
Signature of parent or legal guardian Date
3. Exemptions to School Immunization Law
A.Medical exemption:
No student is required to receive an immunization if they have a medical contraindication, history of disease, or
laboratory evidence of immunity. For a student to receive a medical exemption, a physician, nurse practitioner, or
physician assistant must sign this statement:
I certify the immunization(s) listed below are contraindicated for medical reasons, laboratory evidence of immunity, or that
adequate immunity exists due to a history of disease that was laboratory confirmed. (For varicella disease see * below.)
Exempted immunization(s):
_____________________________________________________________________________________________
_____________________________________________________________________________________________
Signature of physician/nurse practitioner/physician assistant Date
*History of varicella disease only. In the case of varicella disease, it was medically diagnosed or adequately described
to me by the parent to indicate past varicella infection in ___________.
Year
____________________________________________________________________________________________
Signature of physician/nurse practitioner/physician assistant
B.Conscientious exemption:
No student is required to have an immunization that is contrary to the conscientiously held beliefs of his/her parent or
guardian. However, not following vaccine recommendations may endanger the health or life of the student or others
they come in contact with. In a disease outbreak schools may exclude children who are not vaccinated in order to
protect them and others. To receive an exemption to vaccination, a parent or legal guardian must complete and sign
the following statement and have it notarized:
I certify by notarization that it is contrary to my conscientiously held beliefs for my child to receive the following vaccine(s):
_____________________________________________________________________________________________
_____________________________________________________________________________________________
Signature of parent or legal guardian Date
Subscribed and sworn to before me this _______ day of ______________________ 20______
____________________________________________________________
Signature of notary
Developed by the Minnesota Department of Health - Immunization Program www.health.state.mn.us/immunize
(11/11) #140-0155
Child Care Immunization Record
IMMUNIZATION HISTORY: Fill in the MO/DAY/YR information for children 2 months of age
and older. If child received a combined shot (like Hib-hep B), write the date in all the boxes that
apply. Vaccine doses that are circled
are not required by law.
Diphtheria, Tetanus, Pertussis (DTaP)
•3 doses during 1st year (at 2-month intervals)
•4th dose at 12-18 months
•5th dose at 4-6 years or at school entrance
Indicate vaccine type: DTaP or DT.
Polio (IPV and/or OPV)
•3 doses at 2-18 months
•4th dose at 4-6 years or at school entrance
Measles, Mumps, Rubella (MMR)
•Required for children 15 months and older
•Must be given on or after 1st birthday
•2nd dose at 4-6 years
Haemophilus influenzae type b (Hib)
•3-4 doses for children at 2-15 months
•1 dose given after 12 months or older required
•1 dose for previously unvaccinated children
15-59 months
•Not indicated for children 5 years or older
Varicella (Chickenpox)
•1st dose between 12-18 months
•2nd dose at 4-6 years or at school entrance
(required for kindergarten)
Pneumococcal Conjugate Vaccine (PCV)
•2-4 doses for children 2-24 months
•Consider for unvaccinated children at 24-59
months in child care
•Not indicated for children 5 years or older
Hepatitis B (Hep B)–required for kindergarten
•3 doses between birth and 18 months
Rotavirus
•2-3 doses between 2 and 6 months
Influenza (LAIV or TIV)
•1 dose annually for children 6 months or older
(1st time influenza immunization requires 2 doses)
Hepatitis A (Hep A)
•2 doses separated by 6 months for children
12-24 months
Vaccine
Dose
MO
DAY
YR
Birthdate:___________________________ Date of Enrollment:______________________
SIGNATURE(S)
1
2
3
4
5
Vaccine
Dose
A.
For children who are 15 months or older and who have received all the immunizations
required by law for child care:
MO
DAY
YR
1
2
3
4
Vaccine
Dose
Must be on file before a child attends child care.
Name: ___________________________________________________________________
I certify that the above-named child is at least 15 months of age and has completed the immunizations
which are required by law for child care.
Signature of Parent/Guardian or Physician/Nurse Practitioner/Physician Assistant/Public ClinicDate
B.
MO
DAY
YR
For children who are younger than 15 months OR have not received all required
immunizations:
I certify that the above-named child has received the immunizations indicated. In order to remain enrolled
this child must receive all required vaccines within 18 months from initial enrollment date.
1
Signature of Physician/Nurse Practitioner/Physician Assistant/Public ClinicDate
2
Vaccine
Dose
MO
DAY
YR
1
2
3
4
Vaccine
Dose
For children who have a history of disease or are medically exempt from vaccine (s):
The following immunization(s) are not indicated because of medical reasons, history of disease, or
laboratory confirmation of adequate immunity: (See below for varicella disease.)
__________________________________________________________________________________
MO
DAY
YR
1
2
Disease Date:
Dose
Vaccine
1
2
3
4
Dose
Vaccine
1
2
3
Dose
Vaccine
1
2
3
Dose
Vaccine
1
2
Dose
Vaccine
1
2
C.
MO
DAY
YR
Signature of Physician/Nurse Practitioner/Physician AssistantDate
Starting September 2010 (Before September 2010, a parent can sign.):
For children who are 18 months or older who have a history of varicella disease:
I certify that varicella immunization is not indicated for the above-named child due to a history of
varicella disease that I have diagnosed or had adequately described to me by the parent to indicate
past varicella infection in _________.
year
Signature of Physician/Nurse Practitioner/Physician Assistant (Before September 2010, a parent can sign.)Date
D.
If the parent/guardian conscientiously opposes required immunizations:
MO
DAY
YR
Not following vaccination recommendations may endanger the health or life of my child and others that
my child might come in contact with.
I hereby certify by notarization that:
MO
DAY
YR
I am opposed to all immunizations.
I am opposed to only the vaccines indicated. Vaccine(s) I oppose:
__________________________________________________________________________________
Signature of Parent/GuardianDate
MO
DAY
YR
MO
DAY
YR
Subscribed and sworn to before me this__________ day of _____________________ , 20___________ .
Signature of notary public (A copy of the notarized statement
will be forwarded to the commissioner of health.)
Notary Public Stamp
Minnesota Immunization Program: 651-201-5503 or 1-800-657-3970
(MDH, 4/2013)
Child Care Immunization Record - Instructions
Immunization information must be on file before a child attends child care.
Who should complete and sign this form?
Who signs depends on the child’s age and situation. Either the parent/guardian,
health care provider, or child care provider can fill in the child’s immunization
history.
• If the child is at least 15 months old and has had all the shots required by law, a
parent or guardian can sign the form in Section A.
• If the child is younger than 15 months or has not had all the shots required by law,
then a health care provider must sign in Section B, saying the child has begun the
required shots or can’t for medical reasons.
• Starting in September 2010, if the child is 18 months or older and has had
varicella disease (chickenpox), a health care provider must sign in Section C.
(Before September 2010, a parent can sign.)
• If a parent or guardian objects to a certain required shot or all required shots, the
parent or guardian must complete Section D and have it notarized by a notary public.
Notes for Parents
1. Give your child’s immunization history to the child care provider when you
enroll.
Minnesota law (Minn. Stat.121A.15) requires children enrolled in a Minnesota
child care to be immunized against certain diseases or have a legal exemption.
This form is designed to provide the child care provider with the information required by law. This or another form documenting immunizations or an exemption
must be kept on file with the child care provider. Electronic immunization records
are an allowable form.
2. Keep track of your child’s shots, and tell your child care provider each time
your child gets a shot.
It will save you time if you keep a shot record for each of your children. Be sure
to have the record updated each time your child receives a shot.
Child care will be the first of many times you will need the shot record. You will
also need this record for school, camp, college, and if you go to a new doctor or
clinic.
3. If your child is not up to date on his or her shots, you can catch up.
By law you have 18 months after enrolling for your child to have all his or her
required shots. Your child doesn’t have to restart a delayed series.
Minnesota children are still getting diseases like measles, mumps, and rubella.
These diseases are contagious. They can spread rapidly—especially among
groups of children who have not received their shots. And some of them, like
pertussis (whooping cough), are much more serious for children than they are
for adults. As a parent, you can protect your children by making sure they get all
their shots. Most shots are due by 2 years of age.
4. If your child has had chickenpox, he or she does not need a varicella shot.
But starting in September 2010, if the child is 18 months or older and has had
varicella disease (chickenpox), a health care provider must sign in Section C.
(Before September 2010, a parent can sign.)
Notes for Child Care Providers
1. Be sure you have a complete immunization history on file for all children 2
months of age and older.
When the provider GIVES parents immunization information about enrollment for
child care, the provider must use this form or a similar form approved by MDH as
required by law.
However, the record that is KEPT ON FILE that documents immunizations or an
exemption DOES NOT have to be this specific form. The form that must be kept
on file can be this or another form documenting immunizations; this can include
a report printed off of MIIC (the state immunization registry) or another electronic
health record system. The information must be on file before the child enrolls. If
a child enrolls at a younger age, you must obtain immunization information when
they reach 2 months of age.
2. Keep track of the date when each child’s required immunizations are due
by law.
If a child is 2 months of age or older and has not yet received all their required
shots, you should note the date when these immunizations will be due by law: 18
months after the child enrolls in your facility.
Unless they are otherwise exempt, Minnesota law requires preschoolers in child
care to have shots for DTP, polio, MMR, PCV, Hib, and varicella. If the child has
had chickenpox disease, he or she does not need a varicella shot, but starting in
September 2010, they must have a health care provider’s signature to document
the year the child had chickenpox. Immunization against hepatitis A, hepatitis B,
rotavirus, and influenza are not required by law; however, it is strongly recommended for children in child care.
3. Be sure each child’s immunization history clearly indicates whether or not
they received pertussis vaccine. (DTaP and DTP contain pertussis vaccine;
DT does not.)
Nationwide there has been an increase in pertussis disease (whooping cough). If
an outbreak of pertussis occurs in your child care center, you will need to be able
to quickly identify which children are protected and which are not.
4. Remind parents to immunize children on time.
As a child care provider, you are in an excellent position to help remind parents
about immunizations.
Make sure the immunization records you have on file for each child are up to
date, and regularly remind parents when shots are due.
Ask your local health department for an updated immunization schedule each
calendar year, so you will have the latest information on hand.
Questions?
If you have a question about immunizations, call your clinic or your local public
health department.
Immunization Program
P.O. Box 64975
St. Paul, MN 55164-0975
651-201-5503 or 1-800-657-3970
www.health.state.mn.us/immunize
IC#140-0163 (MDH, 4/2013)
Are Your Kids Ready for School?
Minnesota’s School Immunization Law
Directions:
•
•
Find the child’s age/grade level and read across to the right.
Look to see whether the child had the number of shots shown by the checkmark(s) under each vaccine.
Note: Each row is meant to be read separately, so don’t add up the columns of checkmarks under each vaccine.
Example: A preschooler needs 4 DTaP, then to enter kindergarten he or she needs 1 more DTaP, for a total of 5 (not 9).
Hep B
DTaP/Tdap/Td
hepatitis B
diphtheria, tetanus,
pertussis
(whooping cough)
Polio
Preschool
(age 3-5)


Kindergarten


(through Age 6)**

Age 7 through
6th grade
Three doses
recommended
MMR
Hib
measles,
Haemophilus
mumps, rubella
influenzae
type b

At least
*
**
***
****

7th grade only***


5th shot not needed
if 4th was after age 4
4th polio not
needed if 3rd
was after age 4


At least
At least


Two doses
recommended
Two doses
recommended

7th grade only,
but recommended for 8-12th
grade
At least
7th through
12th grade
Varicella*
(chickenpox)

Plus one more shot at
age 11-12 years****

At least

If the child has already had chickenpox disease, varicella shots are not required but the child’s doctor must sign a form.
First graders who are 6 years old and younger must follow the polio and Tdap/DTaP/Td schedules for kindergarten.
An alternate 2-shot schedule of hepatitis B may also be used for kids from age 11 through 15 years.
If a child received a Td or Tdap at age 7-10 years they do not need another one at age 11-12 years. However, they must
receive another shot of Td or Tdap 10 years after their last one.
To go to school in Minnesota, students must show they’ve had
these immunizations or file a legal exemption with the school.
Parents may file a medical exemption signed by a healthcare provider or
a conscientious objection signed by a parent/guardian and notarized.
Other immunizations recommended for school kids, but not required by the School Immunization Law:
• Influenza (flu) – each year for children age 6 months through 18 years – especially those with risk factors like asthma and
diabetes.
• Hib – an additional two to three doses (depending on the product used) is recommended for all infants in addition to the one
dose at or after 12 months of age required for pre-school.
• Pneumococcal vaccine for all infants.
• Meningococcal at age 11-12 and a booster at age 16 years, all adolescents age 11-18 years should be vaccinated.
• Human papillomavirus (HPV) for adolescents age 11-18 years.
• Hepatitis A for children age 1 year and older.
Immunization Program
P.O. Box 64975
St. Paul, MN 55164-0975
651-201-5503 or 1-800-657-3970
www.health.state.mn.us/immunize
IC# 141-0903 (MDH, 8/2012)
Questions and Answers about Vaccine Ingredients
Q. What ingredients are in vaccines?
A. All vaccines contain antigens. Antigens make vaccines work. They prompt the body to create the immune
response needed to protect against infection. Antigens come in several forms. The form used in a vaccine is chosen
because studies show it is the best way to protect against a particular infection.
Antigen forms include:
•
•
•
•
Weakened live viruses. They are too weak to cause disease but can still prompt and immune response.
Measles, mumps, rubella, rotavirus, chickenpox, and one type of influenza vaccines contain weakened live
viruses.
Inactivated (or killed) viruses. These viruses cannot cause even a mild form of the disease, but the body
still recognizes the virus and creates and immune response to protect itself. In the United States, the polio,
hepatitis A, influenza and rabies vaccines contain inactivated viruses.
Partial viruses. These are made up of the specific part of the dead virus that will prompt a protective
immune response. Some vaccines are made this way including the hepatitis B and HPV vaccines.
Partial bacteria. These are made up of the specific part of the dead bacteria that will prompt a protective
immune response. Some vaccines are made this way including the Hib, pneumococcal, meningococcal,
diphtheria, tetanus, and pertussis (whooping cough) vaccines.
Vaccines also contain other ingredients, which help make them safer and more effective. They include:
•
•
•
•
Preservatives. They keep the vials from getting contaminated with germs.
Adjuvants. They help the body create a better immune response. These are aluminum salts.
Additives. They help the vaccine stay effective while being stored. Additives include gelatin, albumin,
sucrose, lactose, MSG, and glycine.
Residuals of the vaccine production process. Some ingredients are needed to make the vaccine. Although
these ingredients are removed, tiny (residual) amounts are left in the final product. Depending on how the
vaccine is made, it may include tiny amounts of antibiotics (neomycin), egg protein, or yeast protein.
Q. Are these other ingredients in vaccines safe?
A. Yes.
Q. Why are these other ingredients in vaccines?
A. Each ingredient has a specific function in a vaccine. These ingredients have been studied and are safe for humans
in the amount used in vaccines. This amount is much less than children encounter in their environment, food and
water.
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Aluminum salts. Aluminum salts help your body create a better immune response to vaccines. Aluminum
salts are necessary to make some of the vaccines we use more effective. Without an adjuvant like aluminum,
people could need more doses of shots to be protected. Everyone is exposed to aluminum because there is
much aluminum in the earth’s crust. It’s present in our food, air and water, including breast milk and
formula. The amount of aluminum in vaccines is similar to that found in 33 ounces of infant formula.
Aluminum has been used and studied in vaccines for 75 years and is safe.
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Formaldehyde. Formaldehyde is used to detoxify diphtheria and tetanus toxins or to inactivate a virus. The
tiny amount which may be left in these vaccines is safe. Vaccines are not the only source of formaldehyde
your baby is exposed to. Formaldehyde is also in products like paper towels, mascara and carpeting. Our
bodies normally have formaldehyde in the blood stream and at levels higher than in vaccines.
Antibiotics. Antibiotics, such as neomycin, are present in some vaccines to prevent bacterial contamination
when the vaccine is made. Trace amounts of antibiotics in vaccines rarely, if ever, cause allergic reactions.
Egg protein. Influenza and yellow fever vaccines are produced in eggs, so egg proteins are present in the
final product and can cause allergic reaction. Measles and mumps vaccines are made in chick embryo cells in
culture, not in eggs. The much smaller amount of remaining egg proteins found in the MMR (measles,
mumps, rubella) vaccine does not usually cause a reaction in egg allergic children.
Gelatin. Some vaccines contain gelatin to protect them against freeze-drying or heat. People with severe
allergies to gelatin should avoid getting gelatin-containing vaccines.
Q. Do vaccines contain antifreeze?
A: No. Antifreeze is typically made of ethylene glycol, which is unsafe. Confusion has arisen, because polyethylene
glycol (a chemical used personal care products like skin creams and toothpaste) is used in vaccines and is safe. It is
used to inactivate the influenza virus in some influenza vaccines. It is also used to purify other vaccines.
Q. Do vaccines contain mercury?
A: Almost all childhood vaccines do NOT contain any mercury. Methylmercury, which is found in fish and other
animals (including humans) can be toxic and lead to adverse effects in humans. Thimerosal, a mercury-based
preservative, was removed from most childhood vaccines in 2001. Thimerosal contains a different form of mercury
called ethylmercury, which is processed by the body very differently than methylmercury, and is not associated with
the same adverse effects. It is still present in some influenza vaccines. Thimerosal is still used in the manufacture of
some vaccines to prevent contamination. The thimerosal is removed at the end of the manufacturing process. In
some cases, a tiny amount of thimerosal remains. The remaining amount is so small, that it is not possible for it to
have any effect. Valid scientific studies have shown there is no link between thimerosal and autism. In fact, autism
rates have actually increased since thimerosal was removed from childhood vaccines. The American Academy of
Pediatrics (AAP), the American Medical Association (AMA), the Centers for Disease Control and Prevention CDC,
and the Institute of Medicine (IOM) agree that science does not support a link between thimerosal in vaccines and
autism. For the IOM report, go to http://www.iom.edu/CMS/3793/4705/4717.aspx.
Q. Do vaccines contain fetal tissue?
A. No. A few vaccines involve growing the viruses in human cell culture. Two cell lines provide the cultures needed
for producing vaccines. These lines were developed from two fetuses in the 1960s. The fetuses were aborted for
medical reasons, not for the purpose of producing vaccines. These cell lines have an indefinite life span, meaning
that no new aborted fetuses are ever used. No fetal tissue is included in the vaccines, either, so children are not
injected with any part of an aborted fetus.
Q. Should vaccines be “greener”?
A. The amount of each additive used in vaccines is very small. In fact, we are exposed to much higher levels of these
chemicals in our everyday lives. In vaccines, these ingredients are used to make the vaccine safer and more effective.
Each vaccine is tested many times to make sure it is safe and works. Taking ingredients out might affect the ability
of the vaccine to protect a child. Research is always being done to make sure that the ingredients in vaccines
continue to be the safest and best available for children.
The information contained in this publication should not be used as a substitute for the medical care and advice of your pediatrician. There may be
variations in treatment that your pediatrician may recommend based on individual facts and circumstances.
Copyright © American Academy of Pediatrics, January 2013