Families of Children with Special Needs.txt

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Partnering with Families of Children 
Julie A. Ray, Julia Pewitt-Kinder, 
and Suzanne George 

�There�s no good way to tell you. Your baby has 
Down syndrome,� said the pediatrician. My world 
instantly stopped, and I felt a black fog closing 
in. I couldn�t move or breathe or speak. The only 
sound I heard was my husband sobbing. My first 
thoughts were �No, I can�t do this. How do we go 
from expecting a perfectly healthy baby to receiving 
a stranger?� Finding out that our daughter 
Ella had Down syndrome was like being told that 
the baby we dreamed of had died and now we 
had a child we knew absolutely nothing about. 

�Baby Ella�s Mother (One of the Authors) 

Families may learn their child has a disability 

during pregnancy, at birth (as baby Ella�s parents did), or 
even later, when their child enters a child care program 
in a home or classroom setting. Although a family�s reaction 
to the news that their child has a special need may 
depend upon the child�s age, the severity of the disability, 
and the family�s cultural view of disabilities (Muscott 2002), 
researchers liken the experience to the grieving process 
that Kubler-Ross (1969) describes in her classic book, On 
Death and Dying. Reactions move from denial of the disability 
to anger at the diagnosis, to bargaining with the experts 

Julie A. Ray, PhD, is an associate professor of education at 
Southeast Missouri State University in Cape Girardeau. Julie has 
taught courses in family involvement for more than 13 years and 
is the coauthor of the textbook Home, School, and Community 
Collaboration: Culturally Responsive Family Involvement. 

jaray@semo.edu 
Julia Pewitt-Kinder, DO, is a board-certified family practice physician 
and writer in Cape Girardeau, Missouri. Dr. Pewitt-Kinder 
speaks about Down syndrome to children in elementary schools 
and to students and professionals at colleges, hospitals, and 
conferences nationwide. As a volunteer for the Down Syndrome 

Association of St. Louis, she offers family support. 
drjuliado@yahoo.com 
Suzanne George, PhD, is a professor of early childhood at 

Missouri State University in Springfield. She has been a special 

educator and teacher educator in early childhood and special 
education. SueGeorge@missouristate.edu 
This article is available online at www.naeyc.org/yc. 


� 2, 3, 7 

� Fred Lynch, 
Southeast Missourian 
involved in the diagnosis, depression, and to acceptance of 
the disability. Acceptance of the diagnosis can take years, 
as frequent reminders of the disability cause families to 
reexperience the grief. For example, one parent said, �Grief 
may hit you when you least expect it�during a Christmas 
shopping trip . . . when you buy baby toys for a 9-year-old� 
(Naseef 2001, 207). 

Stages of adjustment 

Some parents criticize this �grief� view of adjustment 
to a disability as being patronizing and not fitting their 
experiences. Ulrich and Bauer (2003) propose instead that 
the adjustment experience occurs in four levels as parents 
gradually become aware of the impact of their child�s disability. 
These levels include the following: 


with Special Needs 
1. The ostrich phase. Parents do not deny a disability but 
do not fully realize its impact. For example, a parent may 
say, �He�s all boy. He just doesn�t like to sit still and read 
a book.� 
2. Special designation. Parents begin to realize that their 
child has a special need and seek help or ask for special 
services. 
3. Normalization. Parents try to make the differences 
between their child and children without disabilities less 
apparent and may actually request a decrease in services 
and more regular classroom time. 
4. Self-actualization. Parents do not view being different 
as better or worse, just different. They support their child 
in learning about his or her disability, including how to be a 
self-advocate. 
As an educator, you may find that it is not as important 
to classify families by stages of adjustment to the child�s 
disability as it is to understand that families have varied 
reactions and may work through their feelings in a different 
way and pace. It is helpful to realize that you and the family 
may not be operating at the same level or stage of understanding 
about the child rather than to make comments 
like �That family is so demanding� or �If the dad would get 
over his anger, we would be able to work together better� 
(Ulrich & Bauer 2003, 20). Listening to families is key in 
working with them as partners in supporting the learning 
and development of their child with special needs. Unless 
you have a child with a disability, you cannot fully understand 
the experience. 

As you get to know the child and family, it is also important 
to learn about and participate in the development 
of the child�s Individualized Family Service Plan (IFSP) or 
Individualized Education Program (IEP). 

IFSP and IEP services 

Some early childhood teachers may feel overwhelmed 
and unprepared to have a child with special needs in their 
care. However, it is imperative that they learn about the special 
education process so they can support families in the 
myriad decisions they will face about their child�s education. 
The Individuals with Disabilities Education Act (IDEA) 
of 2004 ensures early intervention, special education, and 
related services for more than 6.5 million infants, toddlers, 
children, and youths with special needs (U.S. Department 
of Education 2009). A child younger than age 3 can receive 
early intervention services in the home or child care setting 
through an Individualized 
Family Service Plan developed 
specifically for the Listening to 
child by a team that may 

families is key 

include therapists, early 
intervention specialists, in working with 
teachers, caregivers, and 

them as partners

parents. For children with 
special needs age 3 or in supporting 
older, the local school sys


the learning and

tem develops and administers 
an Individualized development of 
Education Program. 

their child with 

Both the IFSP and the 
IEP state the goals and special needs. 
objectives for the child�s 

Reprinted from Young Children � 
September 2009 


IFSP and IEP Key Differences IFSP and IEP Key Differences 
Individualized Family Service Plan (IFSP) 

Birth through age 2 

Focuses on the family and parents� role in supporting the 
child�s learning and development 

Outcomes focus not only on the child, but on the family 

Includes the concept of natural environments as places where 
learning occurs, such as at home, in child care, outdoors in 
parks, and so on (services may be provided in the home) 

Involves many agencies in providing services because of 
the child�s age; the IFSP integrates the services 

Names a service coordinator, who assists the family in carrying 
out the plan 

Involves an initial meeting with the family to offer information 

and resources and to define the various agencies� roles 
and financial responsibility 


Typically includes a meeting with the family every six months 

Individualized Education Program (IEP) 

Ages 3 through 21 years 

Focuses on the child 
Outcomes focus on the child 
Focuses on school and classroom environments, with ser


vices provided in the school setting 
Assigns the local school district to manage the child�s services 
Authorizes the local school district to coordinate the program 
Involves a meeting with the family to develop long-term and 

short-term goals for the child, accommodations and modi


fications, services, and child placement 

Typically includes a meeting once a year 

Sources: Bruder 2000; PACER Center 2000; Concord Special Education Parent Advisory Committee 2001; United Cerebral Palsy 2009. 

developmental and educational progress. This plan or 
program also specifies who delivers the services, such as 
speech or occupational therapists, how the child�s progress 
is assessed, and if any special classroom placements are 
needed. The parents� agreement with all the plans in an 
IFSP or IEP is required. 

Educators and families both benefit in understanding the 
key differences between an IFSP and an 

From age 3 through age 21, the local school district acts as 
coordinator. 

Teachers and caregivers are important partners with 
families in the implementation of an IFSP or IEP. Families 
should be a part of the IFSP and IEP planning processes; 
educators can make sure this happens. For example, Ella�s 
parents and all of Ella�s caregivers and specialists attended 

and shared information during IFSP and 

Although there are some common themes 

IEP (see �ISFP and IEP Key Differences�). IEP meetings, which gave a view of her 
Families should be 
a part of the IFSP 
and IEP planning 
processes; edu 
cators can make 
sure this happens. 
development from several different per-

between the IFSP and the IEP, the dif


spectives. Educators facilitate the day�to


ferences focus on two main areas. In an 

day environment in which the child par-

IFSP, the concept of providing services in 

ticipates, so it is essential to communicate 

natural environments, such as the home 

with the family and other service provid


or child care setting, is an important 

ers, such as physical or developmental 

component. In an IEP, the school setting 

therapists, to know about and understand 

is typically where services are provided. 

their recommendations for appropriate 

Another major difference is the focus in 

activities and materials to use with the 

an IFSP on the needs of not only the child, 

child. For example, Ella�s occupational 

but also the family. 

IDEA legislation requires the coordination 
of services from various agencies to avoid fragmented 
delivery of these services. In the child�s first three years, a 
service coordinator assumes this responsibility, which may 
include any help needed for the family to function more 
effectively, such as food, shelter, health care, and education. 
When the child turns 3 and leaves the early intervention 
program, the service coordinator�s role concludes. 

therapist showed her preschool teacher 

how to help Ella hold pouring utensils so 
she didn�t soak herself at the classroom water table. 

As an educator, helping to implement objectives and 
obtain outcomes for the child with special needs is a major 
role for you, as well as reporting child outcomes to the IFSP 
and IEP teams. Also, asking family members questions to 
learn what you can about their child�s specific abilities and 
needs is appropriate and helpful throughout the process. 

Reprinted from Young Children � 
September 2009 


Transition from the IFSP to the IEP 

At age 3, children leave their state�s early intervention 
program and move into the public school system�s early 
childhood special education program. This transition from 
the natural home or infant/toddler child care setting to the 
typically more institutional classroom environment can be 
difficult and overwhelming for families, who must now learn 
about the IEP process and education laws, attend lengthy 
meetings, get acquainted with new therapists and school 
staff, and subject their child to new testing and evaluations. 

As Ella�s parents, we experienced a range of new emotions 
in this transition from the IFSP to the IEP. We felt sad, tired, 
concerned, angry, and surprised� 

�Overnight, our child went from a baby to a school girl!� 

�The complexity of our schedule increased with meetings, 
paperwork, and travel to numerous therapy locations.� 
�Our daughter would be exposed to illnesses in the class


room setting that she was protected from when receiving 
services at home.� 
�Strangers were telling us what they thought was best for 
our daughter based on a test score and a single meeting.� 
�We did not know we would have to fight for our daughter�s 
rights.� 

Supportive caregivers and teachers can ease the stress 
of the transition from an IFSP to an IEP. Explaining families� 
rights and the procedures in the special education process 
and encouraging families to learn about the process is one 
way to provide support. Preparing families for an IEP meet


ing, typically once a year, by informing them of who will be 
there, what each person�s role is, and what will happen in 
the meeting is also helpful. Let families know that they can 
bring advocates with them to this meeting. 

Emphasize beforehand to the families their importance in 
the IEP meeting, and suggest they prepare and bring a list 
of their goals for their child. If needed, help them identify 
their concerns, family strengths, and priorities for their 
child. Encourage families to raise questions at the meeting 
about things they don�t understand to make sure they agree 
with the IEP before they sign it (North Bay Regional Center 
2008; PACER Center n.d.). 

Strategies for working with families of 
children with disabilities 

Families of children with special needs often have ideas from 
their perspective as parents about other ways educators can 
show support. Some collected suggestions focus on understanding 
family life, learning about disabilities, communicating 
frequently, and working through challenges with families. 

Understand family life 

Appreciating and respecting the extra work it takes for 
families to care for and educate children with special needs 
is important. At the age of 3 months, Ella began a weekly 
schedule of six hours of physical, speech, developmental, 
music, and occupational therapies. She engaged in oral-
motor exercises three times daily. 


Courtesy of Julia Pewitt-Kinder 

We taught all of Ella�s caregivers how to feed, 
carry, and play with her. To accomplish the innumerable 
daily therapy goals, we kept lengthy, 
detailed checklists for separate caregivers. We 
asked caregivers to work on occupational therapy 
tasks such as having Ella pick up objects 
with clothespins and tongs or blow bubbles or 
suck drinks through thin straws to work on oral-
motor (speech) therapy. All play activities were 
tailored to meet therapy objectives, as were 
the toys and books we purchased. Ella is now 
5 years old, and our lives revolve around her 
therapies. 

Our family�s life is not unique in the strain that 
a child with special needs can place upon family 
time. Whether it is a therapy session, exercises, 
medical treatment done at home, or an unexpected 
hospital stay, there are extra demands 
for families of children with special needs. 
For working parents who cannot rearrange 
their daily schedule to fit therapies or doctors� 
appointments, difficult choices between their 
child�s care and workplace requirements cause 
additional stress. 

Reprinted from Young Children � 
September 2009 


Supportive teach-


edge about their 
ers and caregivers 

child�s disability, 
help ease parents� 

beyond their per-
stress, whether it is 

sonal experience. 
implementing daily 

Providing informatherapies 
or offer


tion that you�ve 
ing a sympathetic 

learned about the 
listener�s ear. Some 

disability helps to 
parents may not be 

support them. 
aware of all the services 
needed to meet 

Communicate 

their child�s needs 

frequently with

or be able to afford 

families 

them. Thus, informing 
families about 

As is true with 
resources in the 

families of all 
community and how 

children, ongoing 
to access them is an 

two-way commuimportant 
teacher 

nication between 
contribution. For 

teachers and 
example, because of 

families is key in 
a mother�s limited 

working success-
literacy abilities, 

fully with families 
one early childhood 

of children with 
teacher helped her 

disabilities. You can 

� Sara Starbuck, Southeast Missouri State University/Marketing and University Relations 

fill out the paperwork 
necessary to get home medical equipment for her 
preschool child with severe disabilities. 

Learn about the disability 

As an educator, you may be familiar with a particular disability 
diagnosis, such as Down syndrome, but there is wide 
variation in its manifestations among children. Therefore, it 
is crucial to learn as much as you can about the individual 
child. The child�s family may be the best resource for information, 
as well as the child�s other teachers, caregivers, 
pediatricians, and therapists. 

Borrow books and familiarize yourself with resources and 
free newsletters from national organizations. For example, 
the Council for Exceptional Children (CEC) Division of Early 
Childhood (DEC) offers several publications and professional 
development opportunities on the education and 
development of children with disabilities (www.dec-sped. 
org/About_DEC/Whats_New). Understanding a disability 
can help you better plan for the child�s learning. Some of the 
families you work with may not have resources or knowl-

Informing families about resources in 
the community and how to access them 
is an important teacher contribution. 
arrange a meeting 
with the child�s parents prior to the child�s start in your 
program or school. To get to know each other, find out as 
much as possible about the child and the family�s goals for 
their child�s learning and development, and tell parents 
how you design your program to meet individual children�s 
needs. Provide a simple questionnaire for the family to 
specify important information about the child�s likes, dislikes, 
personality traits, skills, special health needs or medications, 
and emergency contacts. As one father advised, 
�The first thing is to listen to us . . . because we know our 
kids better than anybody� (Blue-Banning et al. 2004, 175). 

Continue to stay in regular contact through formal and 
informal conferences, phone calls, notes, and e-mails. Keep 
a record of all communication with family members, including 
dates and the content of the communication. Do not 
hesitate to ask the parents questions or request advice 
about learning or behavior issues that arise during the day 
and if they have experienced similar incidents at home. For 
example, after working cooperatively with a family, a kindergarten 
teacher determined that the reason their daughter 
refused to come inside at the end of recess was because 
the ringing bell on the school wall was painful to hear, due 
to her sensory integration disorder. After the class lined up 
in a different location away from the bell, the child willingly 
joined her class in line. 

In your communications as an educator, include positive 
comments about the child�s successes and express 
your respect for the parents� efforts in helping their child 

Reprinted from Young Children � 
September 2009 


develop as fully as possible. For non-English-speaking 
families, obtain translation services through your school, 
other family members, or the community. Use graphics or 
icons to convey information in your written communication 
(Al-Hassan & Gardner 2002). 

By using accurate terminology, educators gain the family�s 
trust. When you convey your knowledge, compassion, 
and respect, such as by saying �a child who is deaf� instead 
of �a deaf child,� you place the child as 

first and most important over the secondary 
concern, the disability. Avoid 
categorizing children in negative ways. 
Describing Marcus as a child who �has 
blue eyes, likes music, and has autism� 
frames the wholeness of the child in 
contrast to categorizing him as �an 
autistic kid.� 

It is disrespectful and trivializing to 
shorten the name of a disability by saying 
�a Downs child,� for example. Even 
�a child with Downs� sounds as absurd 
as �a child with Cerebral.� Educators 
should avoid making such references as 
�normal child� or �normal development� 
in discussions with families as well in 
professional dialogue. Such uses imply 
that children with special needs are 
abnormal; the correct terminology is a 
child with disabilities or a child with special 
needs and a child without disabilities. 

As an educator, you need to avoid 
making generalizations about children 
with disabilities. Saying that all children 
with Down syndrome �are developmentally 
delayed� or �mentally retarded� is 
not accurate. Due to individual differences, 
improved health care, early intervention, 
and new methods of teaching, 
children with Down syndrome can meet 
the same developmental guidelines as 
children without disabilities. Although 
Ella has special needs in fine and gross 
motor development, she does not have 
a cognitive disability and at age 5 is 
ahead of her peers in some developmental 
areas. It is important to learn about 
each child as an individual, beyond the 
label of �disability.� 

Children with disabilities may have 
a variety of teachers, from their daily 
child care provider or classroom 
teacher to a special educator, personal 
aide, or a speech, physical, or occupational 
therapist. Families may need help 

understanding how team teaching works (Salend 2006), 
being confused possibly about who is their child�s real 
teacher. Educators� communication efforts can help families 
learn about the different services their child receives. 

When explaining early intervention and special education 
services, avoid educational jargon and acronyms like LD 
(learning disabled), BD (behavior disorder), EMH (educably 
mentally handicapped), OT (occupational therapy), and 


Reprinted from Young Children � 
September 2009 


Conclusion 

In your communications as an educa 
tor, include positive comments about 
the child�s successes and express 
your respect for the parents� efforts 
in helping their child develop as fully 
as possible. 

PT (physical therapy), or the names of tests like DIAL-3 
(Developmental Indicators for the Assessment of Learning) 
or WISC-R (Wechsler Intelligence Scale for Children� 
Revised). These can be confusing to families and need to be 
fully explained. 

Working with challenging situations 

When working with families of children with special 
needs, you may encounter parents who appear angry, confrontational, 
mistrustful, or questioning about your teaching 
methods. Do not take this personally! Historically, families 
have had to be their own advocates for an appropriate education 
for their children with disabilities, and some families 
you are working with may have had negative experiences 
with the system in the past. They may have had to fight 
their medical insurance company for needed therapies or 
may have disagreed with school professionals about testing 
results or the best classroom placement for their child. 

Strive to listen to families, understand their point of view, 
and be patient. Avoid creating another adversarial experience 
for them, and work toward building a positive, collaborative 
relationship. 

Copyright � 2009 by the National Association for the Education of Young Children. See 
Permissions and Reprints online at www.naeyc.org/yc/permissions. 

In your efforts to partner with families in their child�s 
learning and development, you are the expert in child 
development and education, but they are the experts in 
their child and the child�s disability. Be a teammate with 
families, and do not try to work alone in educating their 
child. Together, you and the family can help their child 
reach his or her full potential. 

Finally, don�t fear or worry about having a child with 
special needs in your classroom, center, or school. See the 
whole child, not just the hearing impairment, the cerebral 
palsy, or the autism. Remember, they are just kids! 

References 

Al-Hassan, S., & R. Gardner. 2002. Involving immigrant parents of students 
with disabilities in the educational process. Teaching Exceptional 
Children 34 (5): 52�58. 

Blue-Banning, M., J.A. Summers, H.C. Frankland, L.L. Nelson, & G. Beegle. 
2004. Dimensions of family and professional partnerships: Constructive 
guidelines for collaboration. Exceptional Children 70(2): 167�84. 

Bruder, M.B. 2000. The Individualized Family Service Plan (IFSP). www.kid 
needs.com/diagnostic_categories/articles/indivfamilyserviceplan.htm 

Concord Special Education Parent Advisory Committee. 2001. What is 
an IEP? www.concordspedpac.org/WhatIEP.htm 

Kubler-Ross, E. 1969. On death and dying. New York: Touchstone. 

Muscott, H.S. 2002. Exceptional partnerships: Listening to the voices of 
families. Preventing School Failure 46 (2): 66�69. 

Naseef, R.A. 2001. The rudest awakening. In You will dream new dreams: 
Inspiring personal stories by parents of children with disabilities, eds. 

S.D. Klein & K. Schive, 206�09. New York: Kensington Books. 
North Bay Regional Center. 2008. What is the Individualized Family 
Service Plan? www.nbrc.net/plan.html 
PACER Center. 2000. What is the difference between an ISFP and an IEP? 
Minneapolis, MN: Author. 
PACER Center. n.d. Understanding the special education process. 
www.fape.org/pubs/FAPE-10.pdf 
Salend, S.J. 2006. Explaining your inclusion program to families. Teaching 
Exceptional Children 38 (4): 6�11. 
Ulrich, M.E., & A.M. Bauer. 2003. Levels of awareness: A closer look at 
communication between parents and professionals. Teaching Exceptional 
Children 35 (6): 20�24. 

United Cerebral Palsy. 2009. The difference between an IFSP and an IEP. 
www.mychildwithoutlimits.org/?page=ifsp-iep-comparison 

U.S. Department of Education. 2009. Building the legacy of IDEA 2004. 
http://idea.ed.gov 
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September 2009September 2009 


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Gaithersburg, MD 20878 4092 ZU 1-877-FLUMIST (358-6478) 
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Brief Summary of Prescribing Information 
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recommended dosage schedule for nasal administration is one 0.2 mL dose (0.1 mL per nostril) 
followed by a second 0.2 mL dose (0.1 mL per nostril) given at least 1 month later. 
For all other individuals, including children age 2-8 years who have previously received influenza 


vaccine, the recommended schedule is one 0.2 mL dose (0.1 mL per nostril). 
FluMist should be administered prior to exposure to influenza. Annual revaccination with 
influenza vaccine is recommended. 


CONTRAINDICATIONS 
Hypersensitivity 

FluMist is contraindicated in individuals with a history of hypersensitivity, especially anaphylactic 
reactions, to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions 
to previous influenza vaccinations. 

Concomitant Pediatric and Adolescent Aspirin Therapy and Reye�s Syndrome 

FluMist is contraindicated in children and adolescents (2-17 years of age) receiving aspirin 
therapy or aspirin-containing therapy, because of the association of Reye�s syndrome with aspirin 
and wild-type influenza infection. 

WARNINGS AND PRECAUTIONS 
Risks in Children <24 Months of Age 

Do not administer FluMist to children <24 months of age. In clinical trials, an increased risk of 
wheezing post-vaccination was observed in FluMist recipients <24 months of age. An increase in 
hospitalizations was observed in children <24 months of age after vaccination with FluMist. 

Asthma/Recurrent Wheezing 

FluMist should not be administered to any individuals with asthma or children < 5 years of age 
with recurrent wheezing because of the potential for increased risk of wheezing post vaccination 
unless the potential benefit outweighs the potential risk. 

Do not administer FluMist to individuals with severe asthma or active wheezing because these 
individuals have not been studied in clinical trials. 

Guillain-Barr� Syndrome 

If Guillain-Barr� syndrome has occurred within 6 weeks of any prior influenza vaccination, the 
decision to give FluMist should be based on careful consideration of the potential benefits and 
potential risks. 

Altered Immunocompetence 

Administration of FluMist, a live virus vaccine, to immunocompromised persons should be based 
on careful consideration of potential benefits and risks. Although FluMist was studied in 57 
asymptomatic or mildly symptomatic adults with HIV infection, data supporting the safety and 
effectiveness of FluMist administration in immunocompromised individuals are limited. 

Medical Conditions Predisposing to Influenza Complications 

The safety of FluMist in individuals with underlying medical conditions that may predispose them 
to complications following wild-type influenza infection has not been established. FluMist should 
not be administered unless the potential benefit outweighs the potential risk. 

Management of Acute Allergic Reactions 

Appropriate medical treatment and supervision must be available to manage possible anaphylactic 
reactions following administration of the vaccine. 

Limitations of Vaccine Effectiveness 

FluMist may not protect all individuals receiving the vaccine. 

ADVERSE REACTIONS 

FluMist is not indicated in children <24 months of age. In a clinical trial, among children 
6-23 months of age, wheezing requiring bronchodilator therapy or with significant respiratory 
symptoms occurred in 5.9% of FluMist recipients compared to 3.8% of active control (injectable 
influenza vaccine made by Sanofi Pasteur Inc.) recipients (Relative Risk 1.5, 95% CI: 1.2, 2.1). 
Wheezing was not increased in children 24 months of age. 

Hypersensitivity, including anaphylactic reaction, has been reported post-marketing. 

Adverse Reactions in Clinical Trials 

Because clinical trials are conducted under widely varying conditions, adverse reaction rates 
observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials 
of another drug and may not reflect the rates observed in practice. 

A total of 9537 children and adolescents 1-17 years of age and 3041 adults 18-64 years of age 
received FluMist in randomized, placebo-controlled Studies D153-P501, AV006, D153-P526, 
AV019 and AV009 described below. In addition, 4179 children 6-59 months of age received 
FluMist in Study MI-CP111, a randomized, active-controlled trial. Among pediatric FluMist recipients 
6 months-17 years of age, 50% were female; in the study of adults, 55% were female. In 
MI-CP111, AV006, D153-P526, AV019 and AV009, subjects were White (71%), Hispanic (11%), 
Asian (7%), Black (6%), and Other (5%), while in D153-P501, 99% of subjects were Asian. 

Adverse Reactions in Children and Adolescents 

In a placebo-controlled safety study (AV019) conducted in a large Health Maintenance 
Organization (HMO) in children 1-17 years of age (n = 9689), an increase in asthma events, captured 
by review of diagnostic codes, was observed in children <5 years of age (Relative Risk 3.53, 
90% CI: 1.1, 15.7). This observation was prospectively evaluated in Study MI-CP111. 

In MI-CP111, an active-controlled study, increases in wheezing and hospitalization (for any 
cause) were observed in children <24 months of age, as shown in Table 1. 

Table 1 
Percentages of Children with Hospitalizations and Wheezing from MI-CP111 


Adverse Reaction Age Group FluMist Active Controla 
Hospitalizationsb 6-23 months (n = 3967) 4.2 % 3.2 % 
24-59 months (n = 4385) 2.1 % 2.5 % 
Wheezingc 6-23 months (n = 3967) 5.9 % 3.8 % 
24-59 months (n = 4385) 2.1 % 2.5 % 

a 

Injectable influenza vaccine made by Sanofi Pasteur Inc. 
b From randomization through 180 days post last vaccination. 

c 

Wheezing requiring bronchodilator therapy or with significant respiratory symptoms evaluated 

from randomization through 42 days post last vaccination. 
Most hospitalizations observed were gastrointestinal and respiratory tract infections and 
occurred more than 6 weeks post vaccination. In post hoc analysis, rates of hospitalization in 
children 6-11 months of age (n = 1376) were 6.1% in FluMist recipients and 2.6% in active 
control recipients. 

Table 2 shows an analysis of pooled solicited events, occurring in at least 1% of FluMist recipients 
and at a higher rate compared to placebo, post Dose 1 for Study D153-P501 and AV006 and 
solicited events post Dose 1 for Study MI-CP111. Solicited events were those about which 
parents/guardians were specifically queried after vaccination with FluMist. In these studies, 
solicited events were documented for 10 days post vaccination. Solicited events post Dose 2 for 
FluMist were similar to those post Dose 1 and were generally observed at a lower frequency. 

Table 2 
Summary of Solicited Events Observed within 10 Days after Dose 1 for Vaccinea and either 
Placebo or Active Control Recipients; Children 2-6 Years of Age 


D153-P501 & AV006 MI-CP111 
FluMist Placebo FluMist Active 
Controlb 
N=876-1759c N=424-1034c N=2170c N=2165c 
Event % % % % 
Runny Nose/ 
Nasal Congestion 58 50 51 42 
Decreased Appetite 21 17 13 12 
Irritability 21 19 12 11 
Decreased Activity (Lethargy) 14 11 7 6 
Sore Throat 11 9 5 6 
Headache 9 7 3 3 
Muscle Aches 6 3 2 2 
Chills 
Fever 
4 3 2 2 
100-101�F Oral 9 6 6 4 
101-102�F Oral 4 3 4 3 

a 

Frozen formulation used in AV006; Refrigerated formulation used in D153-P501 and 

MI-CP111. 
b 

Injectable influenza vaccine made by Sanofi Pasteur Inc. 

c 

Number of evaluable subjects (those who returned diary cards) for each event. Range reflects 

differences in data collection between the 2 pooled studies. 
In clinical studies D153-P501 and AV006, other adverse reactions in children occurring in at 
least 1% of FluMist recipients and at a higher rate compared to placebo were: abdominal pain 
(2% FluMist vs. 0% placebo) and otitis media (3% FluMist vs. 1% placebo). 

An additional adverse reaction identified in the active-controlled trial, MI-CP111, occurring in 
at least 1% of FluMist recipients and at a higher rate compared to active control was sneezing 
(2% FluMist vs. 1% active control). 

In a separate trial (MI-CP112) that compared the refrigerated and frozen formulations of FluMist 
in children and adults 5-49 years of age, the solicited events and other adverse events were 
consistent with observations from previous trials. Fever of >103�F was observed in 1 to 2% of 
children 5-8 years of age. 

In a separate placebo-controlled trial (D153-P526) using the refrigerated formulation in a 
subset of older children and adolescents 9-17 years of age who received one dose of FluMist, 
the solicited events and other adverse events were generally consistent with observations from 
previous trials. Abdominal pain was reported in 12% of FluMist recipients compared to 4% of 
placebo recipients and decreased activity was reported in 6% of FluMist recipients compared 
to 0% of placebo recipients. 

Adverse Reactions in Adults 

In adults 18-49 years of age in Study AV009, summary of solicited adverse events occurring in 
at least 1% of FluMist recipients and at a higher rate compared to placebo include runny nose 
(44% FluMist vs. 27% placebo), headache (40% FluMist vs. 38% placebo), sore throat (28% 
FluMist vs. 17% placebo), tiredness/weakness (26% FluMist vs. 22% placebo), muscle aches 
(17% FluMist vs. 15% placebo), cough (14% FluMist vs. 11% placebo), and chills (9% FluMist 
vs. 6% placebo). 

In addition to the solicited events, other adverse reactions from Study AV009 occurring in at 
least 1% of FluMist recipients and at a higher rate compared to placebo were: nasal congestion 
(9% FluMist vs. 2% placebo) and sinusitis (4% FluMist vs. 2% placebo). 

Postmarketing Experience 

The following adverse reactions have been identified during postapproval use of FluMist. Because 
these reactions are reported voluntarily from a population of uncertain size, it is not always possible 
to reliably estimate their frequency or establish a causal relationship to vaccine exposure. 

Congenital, familial and genetic disorder: Exacerbation of symptoms of mitochondrial 
encephalomyopathy (Leigh syndrome). 

Gastrointestinal disorders: Nausea, vomiting, diarrhea 
Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial 
edema and urticaria) 


2727NAEYC�s Work to Connect 
Early Childhood Programs 
with Families and Communities 
In 2008, NAEYC created the Office of Family and 
Community Initiatives to 
1. provide leadership to the early childhood field 
on the importance of families and communities as 
crucial components of high-quality early childhood 
education and 
2. to prepare early childhood professionals to effectively 
engage families and communities. The work 
of this office aligns with NAEYC�s Early Childhood 
Program Standards 7 (Families) and 8 (Community 
Relationships) and the accreditation criteria related 
to them and provides a framework for NAEYC�s 
efforts in these areas. 
The office provides resources to help ensure that 
early childhood programs and professionals are 
competent and effective in 
� knowing, understanding, and communicating with 
families; 
� nurturing families as advocates for their children; 
� promoting the social and emotional health of the 
whole family; 
� linking with and accessing community resources; 
and 
� acting as responsible participants in the neighborhood 
and the early childhood community. 
Engaging Diverse Families (EDF), a current project 
of the Office of Family and Community Initiatives, 
is helping early childhood education programs 
effectively engage families with diverse cultures, 
languages, structures, and abilities in meaningful 
ways. EDF is identifying high-quality early childhood 
education programs that show strong evidence of 
effectively engaging diverse families and positive 
child outcomes. Profiles of the exemplary programs, 
a review of the literature on family engagement, and 
other materials developed through this project will 
provide the basis for a tool kit to help all early childhood 
education programs more effectively engage 
diverse families. 
Visit www.naeyc.org/ecp/trainings for more information 
about EDF and other NAEYC efforts related 
to families and communities. 
27NAEYC�s Work to Connect 
Early Childhood Programs 
with Families and Communities 
In 2008, NAEYC created the Office of Family and 
Community Initiatives to 
1. provide leadership to the early childhood field 
on the importance of families and communities as 
crucial components of high-quality early childhood 
education and 
2. to prepare early childhood professionals to effectively 
engage families and communities. The work 
of this office aligns with NAEYC�s Early Childhood 
Program Standards 7 (Families) and 8 (Community 
Relationships) and the accreditation criteria related 
to them and provides a framework for NAEYC�s 
efforts in these areas. 
The office provides resources to help ensure that 
early childhood programs and professionals are 
competent and effective in 
� knowing, understanding, and communicating with 
families; 
� nurturing families as advocates for their children; 
� promoting the social and emotional health of the 
whole family; 
� linking with and accessing community resources; 
and 
� acting as responsible participants in the neighborhood 
and the early childhood community. 
Engaging Diverse Families (EDF), a current project 
of the Office of Family and Community Initiatives, 
is helping early childhood education programs 
effectively engage families with diverse cultures, 
languages, structures, and abilities in meaningful 
ways. EDF is identifying high-quality early childhood 
education programs that show strong evidence of 
effectively engaging diverse families and positive 
child outcomes. Profiles of the exemplary programs, 
a review of the literature on family engagement, and 
other materials developed through this project will 
provide the basis for a tool kit to help all early childhood 
education programs more effectively engage 
diverse families. 
Visit www.naeyc.org/ecp/trainings for more information 
about EDF and other NAEYC efforts related 
to families and communities. 
Nervous system disorders: Guillain-Barr� syndrome, Bell�s Palsy 
Respiratory, thoracic and mediastinal disorders: Epistaxis 
Skin and subcutaneous tissue disorders: Rash 

DRUG INTERACTIONS 
Aspirin Therapy 

Do not administer FluMist to children or adolescents who are receiving aspirin therapy or aspirin-
containing therapy. 

Antiviral Agents Against Influenza A and/or B 

The concurrent use of FluMist with antiviral agents that are active against influenza A and/or 
B viruses has not been evaluated. However, based upon the potential for antiviral agents to reduce 
the effectiveness of FluMist, do not administer FluMist until 48 hours after the cessation of 
antiviral therapy and antiviral agents should not be administered until two weeks after administration 
of FluMist unless medically indicated. If antiviral agents and FluMist are administered 
concomitantly, revaccination should be considered when appropriate. 

Concomitant Inactivated Vaccines 

The safety and immunogenicity of FluMist when administered concurrently with inactivated 
vaccines have not been determined. Studies of FluMist excluded subjects who received any 
inactivated or subunit vaccine within two weeks of enrollment. Therefore, healthcare providers 
should consider the risks and benefits of concurrent administration of FluMist with inactivated 
vaccines. 

Concomitant Live Vaccines 

Concurrent administration of FluMist with the measles, mumps and rubella vaccine and the 
varicella vaccine was studied in 1245 children 12-15 months of age. Adverse events were 
similar to those seen in other clinical trials with FluMist. No evidence of interference with immune 
responses to measles, mumps, rubella, varicella and FluMist vaccines was observed. The safety 
and immunogenicity in children >15 months of age have not been studied. 

Intranasal Products 

There are no data regarding co-administration of FluMist with other intranasal preparations. 

USE IN SPECIFIC POPULATIONS 
Pregnancy 
Pregnancy Category C 

Animal reproduction studies have not been conducted with FluMist. It is not known whether 
FluMist can cause fetal harm when administered to a pregnant woman or can affect reproduction 
capacity. FluMist should be given to a pregnant woman only if clearly needed. 

The effect of the vaccine on embryo-fetal and pre-weaning development was evaluated in a developmental 
toxicity study using pregnant rats receiving the frozen formulation. Groups of animals 
were administered the vaccine either once (during the period of organogenesis on gestation day 
6) or twice (prior to gestation and during the period of organogenesis on gestation day 6), 
250 microliter/rat/occasion (approximately 110-140 human dose equivalents), by intranasal 
instillation. No adverse effects on pregnancy, parturition, lactation, embryo-fetal or pre-weaning 
development were observed. There were no vaccine related fetal malformations or other evidence 
of teratogenesis noted in this study. 

Nursing Mothers 

It is not known whether FluMist is excreted in human milk. Therefore, as some viruses are 
excreted in human milk and additionally, because of the possibility of shedding of vaccine 
virus and the close proximity of a nursing infant and mother, caution should be exercised if 
FluMist is administered to nursing mothers. 

Pediatric Use 

Safety and effectiveness of the vaccine has been demonstrated for children 2 years of age and 
older with reduction in culture-confirmed influenza rates compared to active control (injectable 
influenza vaccine made by Sanofi Pasteur Inc.) and placebo. FluMist is not indicated for use in 
children <24 months of age. FluMist use in children <24 months has been associated with 
increased risk of hospitalization and wheezing in clinical trials. 

Geriatric Use 

FluMist is not indicated for use in individuals ..65 years of age. Subjects with underlying high-
risk medical conditions (n=200) were studied for safety. Compared to controls, FluMist recipients 
had a higher rate of sore throat. 

Use in Individuals 50-64 Years of Age 

FluMist is not indicated for use in individuals 50-64 years of age. In Study AV009, effectiveness 
was not demonstrated in individuals 50-64 years of age (n=641). Solicited adverse events were 
similar in type and frequency to those reported in younger adults. 

PATIENT COUNSELING INFORMATION 

Vaccine recipients or their parents/guardians should be informed by the health care provider of 
the potential benefits and risks of FluMist, and the need for two doses at least 1 month apart in 
children 2-8 years old who have not previously received influenza vaccine. 

Asthma and Recurrent Wheezing 

Ask the vaccinee or their parent/guardian if the vaccinee has asthma. For children <5 years of age, 
also ask if the vaccinee has recurrent wheezing since this may be an asthma equivalent in this 
age group. 

Vaccination with a Live Virus Vaccine 

Vaccine recipients or their parents/guardians should be informed by the health care provider 
that FluMist is an attenuated live virus vaccine and has the potential for transmission to immunocompromised 
household contacts. 

Adverse Event Reporting 

The vaccine recipient or the parent/guardian accompanying the vaccine recipient should be 
told to report any suspected adverse events to the physician or clinic where the vaccine was 
administered. 

FluMist� is a registered trademark of MedImmune, LLC. 


Manufactured by: 

MedImmune Vaccines, Inc. 
Gaithersburg, MD 20878 
1-877-633-4411 
Issue Date: June 2008 RAL-FLUV8 

U.S. Government License No. 1652 FLU08-199A