Proposed Vaccine Information Materials for Measles, Mumps, Rubella, and Varicella Vaccines, 48715-48719 [2010-19785]
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Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
vaccination. People with a mild illness
can usually get the vaccine.
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5. When should I get influenza vaccine?
You can get the vaccine as soon as it
is available, usually in the fall, and for
as long as illness is occurring in your
community. Influenza can occur any
time, but most influenza occurs from
November through May. In most
seasons, most infections occur in
January and February.
Getting vaccinated in December, or
even later, will still be beneficial in
most years. Adults and older children
need one dose of influenza vaccine each
year. But some children younger than 9
years of age need 2 doses to be
protected. Ask your provider.
Influenza vaccine may be given at the
same time as other vaccines.
6. What are the risks from LAIV?
A vaccine, like any medicine, could
possibly cause serious problems, such
as severe allergic reactions. The risk of
a vaccine causing serious harm, or
death, is extremely small.
Live influenza vaccine viruses very
rarely spread from person to person.
Even if they do, they are not likely to
cause illness.
LAIV is made from weakened virus
and does not cause influenza. The
vaccine can cause mild symptoms in
people who get it (see below).
Mild problems:
Some children and adolescents 2–17
years of age have reported mild
reactions, including:
• Runny nose, nasal congestion or
cough
• Fever
• Headache and muscle aches
• Wheezing
• Abdominal pain or occasional
vomiting or diarrhea
Some adults 18–49 years of age have
reported:
• Runny nose or nasal congestion
• Sore throat
• Cough, chills, tiredness/weakness
• Headache
Severe problems:
• Life-threatening allergic reactions
from vaccines are very rare. If they do
occur, it is usually within a few minutes
to a few hours after the vaccination.
• If rare reactions occur with any
product, they may not be identified
until thousands, or millions, of people
have used it. Millions of doses of LAIV
have been distributed since it was
licensed, and no serious problems have
been identified. Like all vaccines, LAIV
will continue to be monitored for
unusual or severe problems.
Any unusual condition, such as a
high fever or behavior changes. Signs of
a severe allergic reaction can include
difficulty breathing, hoarseness or
wheezing, hives, paleness, weakness, a
fast heart beat or dizziness.
What should I do?
• Call a doctor, or get the person to
a doctor right away.
• Tell the doctor what happened, the
date and time it happened, and when
the vaccination was given.
• Ask your provider to report the
reaction by filing a Vaccine Adverse
Event Reporting System (VAERS) form.
Or you can file this report through the
VAERS Web site at www.vaers.hhs.gov,
or by calling 1–800–822–7967.
VAERS does not provide medical
advice.
8. The National Vaccine Injury
Compensation Program
The National Vaccine Injury
Compensation Program (VICP) was
created in 1986.
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 Web site at
www.hrsa.gov/vaccinecompensation.
9. How can I learn more?
• Ask your provider. They can give
you the vaccine package insert or
suggest other sources of information.
• 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 Web site at www.cdc.gov/
flu.
Department of Health and Human
Services, Centers for Disease Control
and Prevention, Vaccine Information
Statement, Live, Attenuated Influenza
Vaccine, (00/00/0000) (Proposed) 42
U.S.C. 300aa–26.
Dated: August 3, 2010.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2010–19788 Filed 8–10–10; 8:45 am]
BILLING CODE 4163–18–P
7. What if there is a severe reaction?
What should I look for?
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Proposed Vaccine Information
Materials for Measles, Mumps, Rubella,
and Varicella Vaccines
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
Under the National
Childhood Vaccine Injury Act (NCVIA)
(42 U.S.C. 300aa–26), the CDC must
develop vaccine information materials
that all health care providers are
required to give to patients/parents prior
to administration of specific vaccines.
CDC seeks written comment on
proposed new vaccine information
materials for measles, mumps rubella
(MMR); varicella, and measles, mumps,
rubella; and varicella (MMRV).
DATES: Written comments are invited
and must be received on or before
October 12, 2010.
ADDRESSES: Written comments should
be addressed to Anne Schuchat, M.D.,
Director, National Center for
Immunization and Respiratory Diseases,
Centers for Disease Control and
Prevention, Mailstop E–05, 1600 Clifton
Road, NE., Atlanta, Georgia 30333.
FOR FURTHER INFORMATION CONTACT: Skip
Wolfe, National Center for
Immunization and Respiratory Diseases,
Centers for Disease Control and
Prevention, Mailstop E–52, 1600 Clifton
Road, NE., Atlanta, Georgia 30333,
telephone (404) 639–8809.
SUPPLEMENTARY INFORMATION: The
National Childhood Vaccine Injury Act
of 1986 (Pub L. 99–660), as amended by
section 708 of Public Law 103–183,
added section 2126 to the Public Health
Service Act. Section 2126, codified at 42
U.S.C. 300aa–26, requires the Secretary
of Health and Human Services to
develop and disseminate vaccine
information materials for distribution by
all health care providers in the United
States to any patient (or to the parent or
legal representative in the case of a
child) receiving vaccines covered under
the National Vaccine Injury
Compensation Program.
Development and revision of the
vaccine information materials, also
known as Vaccine Information
Statements (VIS), have been delegated
by the Secretary to the Centers for
Disease Control and Prevention (CDC).
Section 2126 requires that the materials
be developed, or revised, after notice to
the public, with a 60-day comment
SUMMARY:
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period, and in consultation with the
Advisory Commission on Childhood
Vaccines, appropriate health care
provider and parent organizations, and
the Food and Drug Administration. The
law also requires that the information
contained in the materials be based on
available data and information, be
presented in understandable terms, and
include:
(1) A concise description of the
benefits of the vaccine,
(2) A concise description of the risks
associated with the vaccine,
(3) A statement of the availability of
the National Vaccine Injury
Compensation Program, and
(4) Such other relevant information as
may be determined by the Secretary.
The vaccines initially covered under
the National Vaccine Injury
Compensation Program were diphtheria,
tetanus, pertussis, measles, mumps,
rubella and poliomyelitis vaccines.
Since April 15, 1992, any health care
provider in the United States who
intends to administer one of these
covered vaccines is required to provide
copies of the relevant vaccine
information materials prior to
administration of any of these vaccines.
Since then, the following vaccines have
been added to the National Vaccine
Injury Compensation Program, requiring
use of vaccine information materials for
them as well: Hepatitis B, haemophilus
influenzae type b (Hib), varicella
(chickenpox), pneumococcal conjugate,
rotavirus, hepatitis A, meningococcal,
human papillomavirus (HPV), and
trivalent influenza vaccines.
Instructions for use of the vaccine
information materials and copies of the
materials can be found on the CDC Web
site at: https://www.cdc.gov/vaccines/
pubs/VIS/. In addition, single cameraready copies may be available from
State health departments. A list of State
health department contacts for obtaining
copies of these materials is included in
a December 17, 1999 Federal Register
notice (64 FR 70914).
Proposed Measles, Mumps, Rubella
(MMR); Varicella; and Measles,
Mumps, Rubella & Varicella (MMRV)
Vaccine Information Materials
On May 7, 2010 the Advisory
Committee on Immunization Practices
(ACIP) published recommendations on
the use of combined Measles, Mumps,
Rubella and Varicella (MMRV) vaccine.
Because CDC/ACIP are now expressing
a preference for use of MMRV vaccine
(over MMR + V given separately) in
some circumstances and the two
separate vaccines in other
circumstances, CDC is proposing
publication of unique vaccine
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information materials for MMRV
vaccine, which are included in this
notice. In addition, CDC is proposing
updated versions of the separate MMR
and varicella vaccine information
materials, containing information about
MMRV vaccine.
Development of Vaccine Information
Materials
The vaccine information materials
referenced in this notice are being
developed in consultation with the
Advisory Commission on Childhood
Vaccines, the Food and Drug
Administration, and parent and health
care provider groups.
In addition, we invite written
comment on the proposed vaccine
information materials that follow,
entitled ‘‘Measles, Mumps, Rubella
(MMR) Vaccine: What You Need to
Know;’’ ‘‘Varicella Vaccine: What You
Need to Know;’’ and ‘‘Measles, Mumps,
Rubella and Varicella (MMRV) Vaccine:
What You Need to Know.’’ Comments
submitted will be considered in
finalizing these materials. When the
final materials are published in the
Federal Register, the notice will include
an effective date for their mandatory
use.
We also propose to revise the June 9,
2010 Instructions for the Use of Vaccine
Information Statements to include a
reference to these vaccine information
materials.
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Proposed MMR Vaccine Information
Statement
miscarriage or her baby could be born
with serious birth defects.
You or your child could catch these
diseases by being around someone who
has them. They spread from person to
person through the air.
Measles, mumps, and rubella (MMR)
vaccine can prevent these diseases.
Most children who get their MMR shots
will not get these diseases. Many more
children would get them if we stopped
vaccinating.
2. Who should get MMR vaccine and
when?
Children should get 2 doses of MMR
vaccine:
—The first at 12–15 months of age
—and the second at 4–6 years of age.
These are the recommended ages. But
children can get the second dose at any
age, as long as it is at least 28 days after
the first dose.
Some adults should also get MMR
vaccine: Generally, anyone 18 years of
age or older who was born after 1956
should get at least one dose of MMR
vaccine, unless they can show that they
have had either the vaccines or the
diseases.
Ask your provider for more
information.
MMR vaccine may be given at the
same time as other vaccines.
Note: Children 12 years of age and younger
can receive a ‘‘combination’’ vaccine called
MMRV, which contains both MMR and
varicella (chickenpox) vaccines. See the
MMRV Vaccine Information Statement for
more information.
Measles, Mumps and Rubella (MMR)
Vaccines: What You Need to Know
3. Some People Should Not Get MMR
Vaccine or Should Wait
1. Why get vaccinated?
• People should not get MMR vaccine
who have ever had a life-threatening
allergic reaction to gelatin, the antibiotic
neomycin, or to a previous dose of MMR
vaccine.
• People who are moderately or
severely ill at the time the shot is
scheduled should usually wait until
they recover before getting MMR
vaccine.
• Pregnant women should wait to get
MMR vaccine until after they have given
birth. Women should avoid getting
pregnant for 4 weeks after getting MMR
vaccine.
• Some people should check with
their doctor about whether they should
get MMR vaccine, including anyone
who:
—Has HIV/AIDS, or another disease that
affects the immune system.
—Is being treated with drugs that affect
the immune system, such as steroids,
for 2 weeks or longer.
—Has any kind of cancer.
Measles, mumps, and rubella are
serious diseases.
Measles
• Measles virus causes rash, cough,
runny nose, eye irritation, and fever.
• It can lead to ear infection,
pneumonia, seizures (jerking and
staring), brain damage, and death.
Mumps
• Mumps virus causes fever,
headache, and swollen glands.
• It can lead to deafness, meningitis
(infection of the brain and spinal cord
covering), painful swelling of the
testicles or ovaries, and rarely sterility
or death.
Rubella (German Measles)
• Rubella virus causes rash, mild
fever, and arthritis (mostly in women).
• If a woman gets rubella while she
is pregnant, she could have a
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—Is taking cancer treatment with x-rays
or drugs.
—Has ever had a low platelet count (a
blood disorder).
• People who recently had a
transfusion or were given other blood
products should ask their doctor when
they may get MMR vaccine.
Ask your provider for more
information.
4. What are the risks from MMR
vaccine?
A vaccine, like any medicine, is
capable of causing serious problems,
such as severe allergic reactions. The
risk of MMR vaccine causing serious
harm, or death, is extremely small.
Getting MMR vaccine is much safer
than getting any of these three diseases.
Most people who get MMR vaccine do
not have any problems with it.
Mild Problems
• Fever (up to 1 person out of 6)
• Mild rash (about 1 person out of 20)
• Swelling of glands in the cheeks or
neck (rare)
If these problems occur, it is usually
within 7–12 days after the shot. They
occur less often after the second dose.
Moderate Problems
• Seizure (jerking or staring) caused
by fever (about 1 out of 3,000 doses)
• Temporary pain and stiffness in the
joints, mostly in teenage or adult
women (up to 1 out of 4)
• Temporary low platelet count,
which can cause a bleeding disorder
(about 1 out of 30,000 doses)
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Severe Problems (Very Rare)
• Serious allergic reaction (less than 1
out of a million doses).
• Several other severe problems have
been known to occur after a child gets
MMR vaccine. But this happens so
rarely, experts cannot be sure whether
they are caused by the vaccine or not.
These include:
—Deafness,
—Long-term seizures, coma, or lowered
consciousness,
—Permanent brain damage.
Note: The first dose of MMRV vaccine has
been associated with rash and higher rates of
fever than MMR and varicella vaccines given
separately. Rash has been reported in about
1 person in 20 and fever in about 1 person
in 5.
Seizures caused by a fever are also reported
more often after MMRV. These usually occur
5–12 days after the first dose.
5. What if there is a severe or moderate
reaction?
What should I look for?
Any unusual condition, such as a
high fever or behavior changes. Signs of
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a severe allergic reaction can include
difficulty breathing, hoarseness or
wheezing, hives, paleness, weakness, a
fast heart beat or dizziness.
What should I do?
• Call a doctor, or get the person to
a doctor right away.
• Tell the doctor what happened, the
date and time it happened, and when
the vaccination was given.
• Ask your provider to report the
reaction by filing a Vaccine Adverse
Event Reporting System (VAERS) form.
Or you can file this report through the
VAERS Web site at https://
www.vaers.hhs.gov, or by calling
1–800–822–7967.
VAERS does not provide medical
advice.
6. The National Vaccine Injury
Compensation Program
The National Vaccine Injury
Compensation Program (VICP) was
created in 1986.
Persons who believe they may have
been injured by a vaccine may file a
claim with VICP by calling 1–800–338–
2382 or visiting their Web site at
https://www.hrsa.gov/
vaccinecompensation.
7. How can I learn more?
• Ask your provider. They can give
you the vaccine package insert or
suggest other sources of information.
• 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)
—Visit CDC’s Web site at https://
www.cdc.gov/vaccines
Department of Health and Human
Services
Centers for Disease Control and
Prevention
Vaccine Information Statement
MMR Vaccine
(00/00/0000) (Proposed)
42 U.S.C. 300aa–26
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Proposed Varicella (Chickenpox)
Vaccine Information Statement
Chickenpox Vaccine: What You Need to
Know
1. Why get vaccinated?
Chickenpox (also called varicella) is a
common childhood disease. It is usually
mild, but it can be serious, especially in
young infants and adults.
• It causes a rash, itching, fever, and
tiredness.
• It can lead to severe skin infection,
scars, pneumonia, brain damage, or
death.
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• The chickenpox virus can be spread
from person to person through the air,
or by contact with fluid from
chickenpox blisters.
• A person who has had chickenpox
can get a painful rash called shingles
years later.
• Before the vaccine, about 11,000
people were hospitalized for
chickenpox each year in the United
States.
• Before the vaccine, about 100
people died each year as a result of
chickenpox in the United States.
Chickenpox vaccine can prevent
chickenpox.
Most people who get chickenpox
vaccine will not get chickenpox. But if
someone who has been vaccinated does
get chickenpox, it is usually very mild.
They will have fewer blisters, are less
likely to have a fever, and will recover
faster.
2. Who should get chickenpox vaccine
and when?
Routine
Children who have never had
chickenpox should get 2 doses of
chickenpox vaccine at these ages:
1st Dose: 12–15 months of age
2nd Dose: 4–6 years of age (may be
given earlier, if at least 3 months after
the 1st dose)
People 13 years of age and older (who
have never had chickenpox or received
chickenpox vaccine) should get two
doses at least 28 days apart.
Catch-Up
Anyone who is not fully vaccinated,
and never had chickenpox, should
receive one or two doses of chickenpox
vaccine. The timing of these doses
depends on the person’s age. Ask your
provider.
Chickenpox vaccine may be given at
the same time as other vaccines.
Note: Children 12 years of age and younger
can receive a ‘‘combination’’ vaccine called
MMRV, which contains both MMR and
varicella (chickenpox) vaccines. See the
MMRV Vaccine Information Statement for
more information.
3. Some People Should Not Get
Chickenpox Vaccine or Should Wait
• People should not get chickenpox
vaccine if they have ever had a lifethreatening allergic reaction to a
previous dose of chickenpox vaccine or
to gelatin or the antibiotic neomycin.
• People who are moderately or
severely ill at the time the shot is
scheduled should usually wait until
they recover before getting chickenpox
vaccine.
• Pregnant women should wait to get
chickenpox vaccine until after they have
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given birth. Women should not get
pregnant for 1 month after getting
chickenpox vaccine.
• Some people should check with
their doctor about whether they should
get chickenpox vaccine, including
anyone who:
—Has HIV/AIDS or another disease that
affects the immune system
—Is being treated with drugs that affect
the immune system, such as steroids,
for 2 weeks or longer
—Has any kind of cancer
—Is getting cancer treatment with
radiation or drugs
• People who recently had a
transfusion or were given other blood
products should ask their doctor when
they may get chickenpox vaccine.
Ask your provider for more
information.
4. What are the risks from chickenpox
vaccine?
A vaccine, like any medicine, is
capable of causing serious problems,
such as severe allergic reactions. The
risk of chickenpox vaccine causing
serious harm, or death, is extremely
small.
Getting chickenpox vaccine is much
safer than getting chickenpox disease.
Most people who get chickenpox
vaccine do not have any problems with
it. Reactions are usually more likely
after the first dose than after the second.
Mild Problems
• Soreness or swelling where the shot
was given (about 1 out of 5 children and
up to 1 out of 3 adolescents and adults)
• Fever (1 person out of 10, or less)
• Mild rash, up to a month after
vaccination (1 person out of 25). It is
possible for these people to infect other
members of their household, but this is
extremely rare.
Moderate Problems
• Seizure (jerking or staring) caused
by fever (very rare).
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Severe Problems
• Pneumonia (very rare).
Other serious problems, including
severe brain reactions and low blood
count, have been reported after
chickenpox vaccination. These happen
so rarely experts cannot tell whether
they are caused by the vaccine or not.
If they are, it is extremely rare.
Note: The first dose of MMRV vaccine has
been associated with rash and higher rates of
fever than MMR and varicella vaccines given
separately. Rash has been reported in about
1 person in 20 and fever in about 1 person
in 5.
Seizures caused by a fever are also reported
more often after MMRV. These usually occur
5–12 days after the first dose.
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5. What if there is a severe or moderate
reaction?
Proposed MMRV Vaccine Information
Statement
What should I look for?
Measles, Mumps, Rubella & Varicella
(MMRV) Vaccine: What You Need To
Know
Any unusual condition, such as a
high fever or behavior changes. Signs of
a severe allergic reaction can include
difficulty breathing, hoarseness or
wheezing, hives, paleness, weakness, a
fast heart beat or dizziness.
What should I do?
• Call a doctor, or get the person to
a doctor right away.
• Tell the doctor what happened, the
date and time it happened, and when
the vaccination was given.
• Ask your provider to report the
reaction by filing a Vaccine Adverse
Event Reporting System (VAERS) form.
Or you can file this report through the
VAERS Web site at https://
w.vaers.hhs.gov, or by calling 1–800–
822–7967.
VAERS does not provide medical
advice.
6. The National Vaccine Injury
Compensation Program
The National Vaccine Injury
Compensation Program (VICP) was
created in 1986.
Persons who believe they may have
been injured by a vaccine may file a
claim with VICP by calling 1–800–338–
2382 or visiting their Web site at
https://www.hrsa.gov/
vaccinecompensation.
7. How can I learn more?
• Ask your provider. They can give
you the vaccine package insert or
suggest other sources of information.
• 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)
—Visit CDC’s Web site at https://
www.cdc.gov/vaccines
Department of Health and Human
Services
Centers for Disease Control and
Prevention
Vaccine Information Statement
Varicella Vaccine
(00/00/0000) (Proposed)
42 U.S.C. 300aa–26
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1. Measles, Mumps, Rubella, and
Varicella
Measles, Mumps, Rubella, and
Varicella (chickenpox) can be serious
diseases:
Measles
• Causes rash, cough, runny nose, eye
irritation, fever.
• Can lead to ear infection,
pneumonia, seizures (jerking and
staring), brain damage, and death.
Mumps
• Causes fever, headache, swollen
glands.
• Can lead to deafness, meningitis
(infection of the brain and spinal cord
covering), infection of the pancreas,
painful swelling of the testicles or
ovaries, and rarely sterility or death.
Rubella (German Measles)
• Causes rash and mild fever; and can
cause arthritis (mostly in women).
• If a woman gets rubella while she
is pregnant, she could have a
miscarriage or her baby could be born
with serious birth defects.
Varicella (Chickenpox)
• Causes rash, itching, fever,
tiredness.
• Can lead to severe skin infection,
scars, pneumonia, brain amage, or
death.
• Can re-emerge years later as a
painful rash called shingles.
These diseases can spread from
person to person through the air.
Varicella can also be spread through
contact with fluid from chickenpox
blisters.
Before vaccines, these diseases were
very widespread in the United States.
2. MMRV Vaccine
MMRV vaccine may be given to
children from 1 through 12 years old to
protect them from these four diseases.
Two doses of MMRV vaccine are
recommended:
—The first dose at 12 through 15
months of age
—The second dose at 4 through 6 years
of age
These are recommended ages. But
children can get the second dose up
through 12 years as long as it is at least
3 months after the first dose.
Children may also get these vaccines
as 2 separate shots: MMR (measles,
mumps and rubella) and varicella.
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1 Shot (MMRV) or 2 Shots (MMR &
Varicella)?
• Both options give the same
protection.
• Fewer injections with MMRV.
• MMRV has been associated with
more fevers and fever-related seizures
than MMR and varicella vaccines given
separately (first dose only).
Unless you specifically request
otherwise, CDC recommends separate
MMR and varicella vaccines for the first
dose and MMRV vaccine for the second
dose.
Your health-care provider can give
you more information, including the
Vaccine Information Statements for
MMR and Varicella vaccines.
Anyone 13 or older who needs
protection from these diseases should
get MMR and varicella vaccines
separately.
MMRV may be given at the same time
as other vaccines.
3. Some Children Should Not Get
MMRV Vaccine or Should Wait
Children should not get MMRV
vaccine if they:
• Have ever had a life-threatening
allergic reaction to a previous dose of
MMRV vaccine, or to either MMR or
varicella vaccine
• Have ever had a life-threatening
allergic reaction to any component of
the vaccine, including gelatin or the
antibiotic neomycin. Tell the doctor if
your child has any severe allergies.
• Have HIV/AIDS, or another disease
that affects the immune system
• Are being treated with drugs that
affect the immune system, such as high
doses of steroids by mouth, for 2 weeks
or longer
• Have any kind of cancer
• Are being treated for cancer with
radiation or drugs
Check with your doctor if the child:
• Has a history of seizures, or has a
parent, brother or sister with a history
of seizures
• Has a parent, brother or sister with
a history of immune system problems
• Has ever had a low platelet count,
or another blood disorder
• Recently had a transfusion or
received other blood products
• Might be pregnant
Children who are moderately or
severely ill at the time the shot is
scheduled should usually wait until
they recover before getting MMRV
vaccine.
Ask your provider for more
information.
4. What are the risks from MMRV
vaccine?
A vaccine, like any medicine, is
capable of causing serious problems,
VerDate Mar<15>2010
16:52 Aug 10, 2010
Jkt 220001
such as severe allergic reactions. The
risk of MMRV vaccine causing serious
harm, or death, is extremely small.
Getting MMRV vaccine is much safer
than getting any of these four diseases.
Most children who get MMRV vaccine
do not have any problems with it.
Mild Problems
• Fever (about 1 child out of 5)
• Mild rash (about 1 child out of 20)
• Swelling of glands in the cheeks or
neck (rare)
If these problems occur, it is usually
within 5–12 days after the first dose.
They occur less often after the second
dose.
Moderate Problems
• Seizure caused by fever (about 1
child in 1,250). These seizures usually
occur 5–12 days after the first dose.
They occur less often when MMR and
varicella vaccines are given together as
separate injections (about 1 child in
2,500), and rarely after a 2nd dose of
MMRV.
• Temporary low platelet count,
which can cause a bleeding disorder
(about 1 child out of 40,000)
Severe Problems (Very Rare)
48719
VAERS does not provide medical
advice.
6. The National Vaccine Injury
Compensation Program
The National Vaccine Injury
Compensation Program (VICP) was
created in 1986.
Persons who believe they may have
been injured by a vaccine may file a
claim with VICP by calling 1–800–338–
2382 or visiting their Web site at
https://www.hrsa.gov/
vaccinecompensation.
7. How can I learn more?
• Ask your provider. They can give
you the vaccine package insert or
suggest other sources of information.
• 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)
—Visit CDC’s Web site at https://
www.cdc.gov/vaccines.
Department of Health and Human
Services,
Centers for Disease Control and
Prevention,
Vaccine Information Statement,
MMRV Vaccine,
(00/00/0000) (Proposed)
42 U.S.C. 300aa–26.
*
*
*
*
*
Several severe problems have been
reported following MMR vaccine, and
might also occur after MMRV. These
include severe allergic reactions (fewer
than 4 per million), and problems such
as:
—Deafness
—Long-term seizures, coma, lowered
consciousness
—Permanent brain damage
Because these problems occur so
rarely, we can’t be sure whether they are
caused by the vaccine or not.
Dated: August 3, 2010.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
5. What if there is a severe reaction?
DEPARTMENT OF HOMELAND
SECURITY
[FR Doc. 2010–19785 Filed 8–10–10; 8:45 am]
BILLING CODE 4163–18–P
What should I look for?
Any unusual condition, such as a
high fever or behavior changes. Signs of
a severe allergic reaction can include
difficulty breathing, hoarseness or
wheezing, hives, paleness, weakness, a
fast heart beat or dizziness.
What should I do?
• Call a doctor, or get the person to
a doctor right away.
• Tell the doctor what happened, the
date and time it happened, and when
the vaccination was given.
• Ask your provider to report the
reaction by filing a Vaccine Adverse
Event Reporting System (VAERS) form.
Or you can file this report through the
VAERS Web site at https://
www.vaers.hhs.gov, or by calling 1–800–
822–7967.
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–1923–
DR; Docket ID FEMA–2010–0002]
Wyoming; Amendment No. 1 to Notice
of a Major Disaster Declaration
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
This notice amends the notice
of a major disaster declaration for the
State of Wyoming (FEMA–1923–DR),
dated July 14, 2010, and related
determinations.
SUMMARY:
DATES:
Effective Date: August 4, 2010.
FOR FURTHER INFORMATION CONTACT:
Peggy Miller, Recovery Directorate,
E:\FR\FM\11AUN1.SGM
11AUN1
]]>Agencies
[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Pages 48715-48719]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19785]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Proposed Vaccine Information Materials for Measles, Mumps,
Rubella, and Varicella Vaccines
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: Under the National Childhood Vaccine Injury Act (NCVIA) (42
U.S.C. 300aa-26), the CDC must develop vaccine information materials
that all health care providers are required to give to patients/parents
prior to administration of specific vaccines. CDC seeks written comment
on proposed new vaccine information materials for measles, mumps
rubella (MMR); varicella, and measles, mumps, rubella; and varicella
(MMRV).
DATES: Written comments are invited and must be received on or before
October 12, 2010.
ADDRESSES: Written comments should be addressed to Anne Schuchat, M.D.,
Director, National Center for Immunization and Respiratory Diseases,
Centers for Disease Control and Prevention, Mailstop E-05, 1600 Clifton
Road, NE., Atlanta, Georgia 30333.
FOR FURTHER INFORMATION CONTACT: Skip Wolfe, National Center for
Immunization and Respiratory Diseases, Centers for Disease Control and
Prevention, Mailstop E-52, 1600 Clifton Road, NE., Atlanta, Georgia
30333, telephone (404) 639-8809.
SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of
1986 (Pub L. 99-660), as amended by section 708 of Public Law 103-183,
added section 2126 to the Public Health Service Act. Section 2126,
codified at 42 U.S.C. 300aa-26, requires the Secretary of Health and
Human Services to develop and disseminate vaccine information materials
for distribution by all health care providers in the United States to
any patient (or to the parent or legal representative in the case of a
child) receiving vaccines covered under the National Vaccine Injury
Compensation Program.
Development and revision of the vaccine information materials, also
known as Vaccine Information Statements (VIS), have been delegated by
the Secretary to the Centers for Disease Control and Prevention (CDC).
Section 2126 requires that the materials be developed, or revised,
after notice to the public, with a 60-day comment
[[Page 48716]]
period, and in consultation with the Advisory Commission on Childhood
Vaccines, appropriate health care provider and parent organizations,
and the Food and Drug Administration. The law also requires that the
information contained in the materials be based on available data and
information, be presented in understandable terms, and include:
(1) A concise description of the benefits of the vaccine,
(2) A concise description of the risks associated with the vaccine,
(3) A statement of the availability of the National Vaccine Injury
Compensation Program, and
(4) Such other relevant information as may be determined by the
Secretary.
The vaccines initially covered under the National Vaccine Injury
Compensation Program were diphtheria, tetanus, pertussis, measles,
mumps, rubella and poliomyelitis vaccines. Since April 15, 1992, any
health care provider in the United States who intends to administer one
of these covered vaccines is required to provide copies of the relevant
vaccine information materials prior to administration of any of these
vaccines. Since then, the following vaccines have been added to the
National Vaccine Injury Compensation Program, requiring use of vaccine
information materials for them as well: Hepatitis B, haemophilus
influenzae type b (Hib), varicella (chickenpox), pneumococcal
conjugate, rotavirus, hepatitis A, meningococcal, human papillomavirus
(HPV), and trivalent influenza vaccines. Instructions for use of the
vaccine information materials and copies of the materials can be found
on the CDC Web site at: https://www.cdc.gov/vaccines/pubs/VIS/. In
addition, single camera-ready copies may be available from State health
departments. A list of State health department contacts for obtaining
copies of these materials is included in a December 17, 1999 Federal
Register notice (64 FR 70914).
Proposed Measles, Mumps, Rubella (MMR); Varicella; and Measles, Mumps,
Rubella & Varicella (MMRV) Vaccine Information Materials
On May 7, 2010 the Advisory Committee on Immunization Practices
(ACIP) published recommendations on the use of combined Measles, Mumps,
Rubella and Varicella (MMRV) vaccine. Because CDC/ACIP are now
expressing a preference for use of MMRV vaccine (over MMR + V given
separately) in some circumstances and the two separate vaccines in
other circumstances, CDC is proposing publication of unique vaccine
information materials for MMRV vaccine, which are included in this
notice. In addition, CDC is proposing updated versions of the separate
MMR and varicella vaccine information materials, containing information
about MMRV vaccine.
Development of Vaccine Information Materials
The vaccine information materials referenced in this notice are
being developed in consultation with the Advisory Commission on
Childhood Vaccines, the Food and Drug Administration, and parent and
health care provider groups.
In addition, we invite written comment on the proposed vaccine
information materials that follow, entitled ``Measles, Mumps, Rubella
(MMR) Vaccine: What You Need to Know;'' ``Varicella Vaccine: What You
Need to Know;'' and ``Measles, Mumps, Rubella and Varicella (MMRV)
Vaccine: What You Need to Know.'' Comments submitted will be considered
in finalizing these materials. When the final materials are published
in the Federal Register, the notice will include an effective date for
their mandatory use.
We also propose to revise the June 9, 2010 Instructions for the Use
of Vaccine Information Statements to include a reference to these
vaccine information materials.
* * * * *
Proposed MMR Vaccine Information Statement
Measles, Mumps and Rubella (MMR) Vaccines: What You Need to Know
1. Why get vaccinated?
Measles, mumps, and rubella are serious diseases.
Measles
Measles virus causes rash, cough, runny nose, eye
irritation, and fever.
It can lead to ear infection, pneumonia, seizures (jerking
and staring), brain damage, and death.
Mumps
Mumps virus causes fever, headache, and swollen glands.
It can lead to deafness, meningitis (infection of the
brain and spinal cord covering), painful swelling of the testicles or
ovaries, and rarely sterility or death.
Rubella (German Measles)
Rubella virus causes rash, mild fever, and arthritis
(mostly in women).
If a woman gets rubella while she is pregnant, she could
have a miscarriage or her baby could be born with serious birth
defects.
You or your child could catch these diseases by being around
someone who has them. They spread from person to person through the
air.
Measles, mumps, and rubella (MMR) vaccine can prevent these
diseases. Most children who get their MMR shots will not get these
diseases. Many more children would get them if we stopped vaccinating.
2. Who should get MMR vaccine and when?
Children should get 2 doses of MMR vaccine:
--The first at 12-15 months of age
--and the second at 4-6 years of age.
These are the recommended ages. But children can get the second
dose at any age, as long as it is at least 28 days after the first
dose.
Some adults should also get MMR vaccine: Generally, anyone 18 years
of age or older who was born after 1956 should get at least one dose of
MMR vaccine, unless they can show that they have had either the
vaccines or the diseases.
Ask your provider for more information.
MMR vaccine may be given at the same time as other vaccines.
Note: Children 12 years of age and younger can receive a
``combination'' vaccine called MMRV, which contains both MMR and
varicella (chickenpox) vaccines. See the MMRV Vaccine Information
Statement for more information.
3. Some People Should Not Get MMR Vaccine or Should Wait
People should not get MMR vaccine who have ever had a
life-threatening allergic reaction to gelatin, the antibiotic neomycin,
or to a previous dose of MMR vaccine.
People who are moderately or severely ill at the time the
shot is scheduled should usually wait until they recover before getting
MMR vaccine.
Pregnant women should wait to get MMR vaccine until after
they have given birth. Women should avoid getting pregnant for 4 weeks
after getting MMR vaccine.
Some people should check with their doctor about whether
they should get MMR vaccine, including anyone who:
--Has HIV/AIDS, or another disease that affects the immune system.
--Is being treated with drugs that affect the immune system, such as
steroids, for 2 weeks or longer.
--Has any kind of cancer.
[[Page 48717]]
--Is taking cancer treatment with x-rays or drugs.
--Has ever had a low platelet count (a blood disorder).
People who recently had a transfusion or were given other
blood products should ask their doctor when they may get MMR vaccine.
Ask your provider for more information.
4. What are the risks from MMR vaccine?
A vaccine, like any medicine, is capable of causing serious
problems, such as severe allergic reactions. The risk of MMR vaccine
causing serious harm, or death, is extremely small.
Getting MMR vaccine is much safer than getting any of these three
diseases.
Most people who get MMR vaccine do not have any problems with it.
Mild Problems
Fever (up to 1 person out of 6)
Mild rash (about 1 person out of 20)
Swelling of glands in the cheeks or neck (rare)
If these problems occur, it is usually within 7-12 days after the
shot. They occur less often after the second dose.
Moderate Problems
Seizure (jerking or staring) caused by fever (about 1 out
of 3,000 doses)
Temporary pain and stiffness in the joints, mostly in
teenage or adult women (up to 1 out of 4)
Temporary low platelet count, which can cause a bleeding
disorder (about 1 out of 30,000 doses)
Severe Problems (Very Rare)
Serious allergic reaction (less than 1 out of a million
doses).
Several other severe problems have been known to occur
after a child gets MMR vaccine. But this happens so rarely, experts
cannot be sure whether they are caused by the vaccine or not. These
include:
--Deafness,
--Long-term seizures, coma, or lowered consciousness,
--Permanent brain damage.
Note: The first dose of MMRV vaccine has been associated with
rash and higher rates of fever than MMR and varicella vaccines given
separately. Rash has been reported in about 1 person in 20 and fever
in about 1 person in 5.
Seizures caused by a fever are also reported more often after
MMRV. These usually occur 5-12 days after the first dose.
5. What if there is a severe or moderate reaction?
What should I look for?
Any unusual condition, such as a high fever or behavior changes.
Signs of a severe allergic reaction can include difficulty breathing,
hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or
dizziness.
What should I do?
Call a doctor, or get the person to a doctor right away.
Tell the doctor what happened, the date and time it
happened, and when the vaccination was given.
Ask your provider to report the reaction by filing a
Vaccine Adverse Event Reporting System (VAERS) form. Or you can file
this report through the VAERS Web site at https://www.vaers.hhs.gov, or
by calling 1-800-822-7967.
VAERS does not provide medical advice.
6. The National Vaccine Injury Compensation Program
The National Vaccine Injury Compensation Program (VICP) was created
in 1986.
Persons who believe they may have been injured by a vaccine may
file a claim with VICP by calling 1-800-338-2382 or visiting their Web
site at https://www.hrsa.gov/vaccinecompensation vaccinecompensation.
7. How can I learn more?
Ask your provider. They can give you the vaccine package
insert or suggest other sources of information.
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)
--Visit CDC's Web site at https://www.cdc.gov/vaccines
Department of Health and Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
MMR Vaccine
(00/00/0000) (Proposed)
42 U.S.C. 300aa-26
* * * * *
Proposed Varicella (Chickenpox) Vaccine Information Statement
Chickenpox Vaccine: What You Need to Know
1. Why get vaccinated?
Chickenpox (also called varicella) is a common childhood disease.
It is usually mild, but it can be serious, especially in young infants
and adults.
It causes a rash, itching, fever, and tiredness.
It can lead to severe skin infection, scars, pneumonia,
brain damage, or death.
The chickenpox virus can be spread from person to person
through the air, or by contact with fluid from chickenpox blisters.
A person who has had chickenpox can get a painful rash
called shingles years later.
Before the vaccine, about 11,000 people were hospitalized
for chickenpox each year in the United States.
Before the vaccine, about 100 people died each year as a
result of chickenpox in the United States.
Chickenpox vaccine can prevent chickenpox.
Most people who get chickenpox vaccine will not get chickenpox. But
if someone who has been vaccinated does get chickenpox, it is usually
very mild. They will have fewer blisters, are less likely to have a
fever, and will recover faster.
2. Who should get chickenpox vaccine and when?
Routine
Children who have never had chickenpox should get 2 doses of
chickenpox vaccine at these ages:
1st Dose: 12-15 months of age
2nd Dose: 4-6 years of age (may be given earlier, if at least 3 months
after the 1st dose)
People 13 years of age and older (who have never had chickenpox or
received chickenpox vaccine) should get two doses at least 28 days
apart.
Catch-Up
Anyone who is not fully vaccinated, and never had chickenpox,
should receive one or two doses of chickenpox vaccine. The timing of
these doses depends on the person's age. Ask your provider.
Chickenpox vaccine may be given at the same time as other vaccines.
Note: Children 12 years of age and younger can receive a
``combination'' vaccine called MMRV, which contains both MMR and
varicella (chickenpox) vaccines. See the MMRV Vaccine Information
Statement for more information.
3. Some People Should Not Get Chickenpox Vaccine or Should Wait
People should not get chickenpox vaccine if they have ever
had a life-threatening allergic reaction to a previous dose of
chickenpox vaccine or to gelatin or the antibiotic neomycin.
People who are moderately or severely ill at the time the
shot is scheduled should usually wait until they recover before getting
chickenpox vaccine.
Pregnant women should wait to get chickenpox vaccine until
after they have
[[Page 48718]]
given birth. Women should not get pregnant for 1 month after getting
chickenpox vaccine.
Some people should check with their doctor about whether
they should get chickenpox vaccine, including anyone who:
--Has HIV/AIDS or another disease that affects the immune system
--Is being treated with drugs that affect the immune system, such as
steroids, for 2 weeks or longer
--Has any kind of cancer
--Is getting cancer treatment with radiation or drugs
People who recently had a transfusion or were given other
blood products should ask their doctor when they may get chickenpox
vaccine.
Ask your provider for more information.
4. What are the risks from chickenpox vaccine?
A vaccine, like any medicine, is capable of causing serious
problems, such as severe allergic reactions. The risk of chickenpox
vaccine causing serious harm, or death, is extremely small.
Getting chickenpox vaccine is much safer than getting chickenpox
disease. Most people who get chickenpox vaccine do not have any
problems with it. Reactions are usually more likely after the first
dose than after the second.
Mild Problems
Soreness or swelling where the shot was given (about 1 out
of 5 children and up to 1 out of 3 adolescents and adults)
Fever (1 person out of 10, or less)
Mild rash, up to a month after vaccination (1 person out
of 25). It is possible for these people to infect other members of
their household, but this is extremely rare.
Moderate Problems
Seizure (jerking or staring) caused by fever (very rare).
Severe Problems
Pneumonia (very rare).
Other serious problems, including severe brain reactions and low
blood count, have been reported after chickenpox vaccination. These
happen so rarely experts cannot tell whether they are caused by the
vaccine or not. If they are, it is extremely rare.
Note: The first dose of MMRV vaccine has been associated with
rash and higher rates of fever than MMR and varicella vaccines given
separately. Rash has been reported in about 1 person in 20 and fever
in about 1 person in 5.
Seizures caused by a fever are also reported more often after
MMRV. These usually occur 5-12 days after the first dose.
5. What if there is a severe or moderate reaction?
What should I look for?
Any unusual condition, such as a high fever or behavior changes.
Signs of a severe allergic reaction can include difficulty breathing,
hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or
dizziness.
What should I do?
Call a doctor, or get the person to a doctor right away.
Tell the doctor what happened, the date and time it
happened, and when the vaccination was given.
Ask your provider to report the reaction by filing a
Vaccine Adverse Event Reporting System (VAERS) form. Or you can file
this report through the VAERS Web site at https://w.vaers.hhs.gov, or by
calling 1-800-822-7967.
VAERS does not provide medical advice.
6. The National Vaccine Injury Compensation Program
The National Vaccine Injury Compensation Program (VICP) was created
in 1986.
Persons who believe they may have been injured by a vaccine may
file a claim with VICP by calling 1-800-338-2382 or visiting their Web
site at https://www.hrsa.gov/vaccinecompensation vaccinecompensation.
7. How can I learn more?
Ask your provider. They can give you the vaccine package
insert or suggest other sources of information.
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)
--Visit CDC's Web site at https://www.cdc.gov/vaccines
Department of Health and Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
Varicella Vaccine
(00/00/0000) (Proposed)
42 U.S.C. 300aa-26
* * * * *
Proposed MMRV Vaccine Information Statement
Measles, Mumps, Rubella & Varicella (MMRV) Vaccine: What You Need To
Know
1. Measles, Mumps, Rubella, and Varicella
Measles, Mumps, Rubella, and Varicella (chickenpox) can be serious
diseases:
Measles
Causes rash, cough, runny nose, eye irritation, fever.
Can lead to ear infection, pneumonia, seizures (jerking
and staring), brain damage, and death.
Mumps
Causes fever, headache, swollen glands.
Can lead to deafness, meningitis (infection of the brain
and spinal cord covering), infection of the pancreas, painful swelling
of the testicles or ovaries, and rarely sterility or death.
Rubella (German Measles)
Causes rash and mild fever; and can cause arthritis
(mostly in women).
If a woman gets rubella while she is pregnant, she could
have a miscarriage or her baby could be born with serious birth
defects.
Varicella (Chickenpox)
Causes rash, itching, fever, tiredness.
Can lead to severe skin infection, scars, pneumonia, brain
amage, or death.
Can re-emerge years later as a painful rash called
shingles.
These diseases can spread from person to person through the air.
Varicella can also be spread through contact with fluid from chickenpox
blisters.
Before vaccines, these diseases were very widespread in the United
States.
2. MMRV Vaccine
MMRV vaccine may be given to children from 1 through 12 years old
to protect them from these four diseases.
Two doses of MMRV vaccine are recommended:
--The first dose at 12 through 15 months of age
--The second dose at 4 through 6 years of age
These are recommended ages. But children can get the second dose up
through 12 years as long as it is at least 3 months after the first
dose.
Children may also get these vaccines as 2 separate shots: MMR
(measles, mumps and rubella) and varicella.
[[Page 48719]]
1 Shot (MMRV) or 2 Shots (MMR & Varicella)?
Both options give the same protection.
Fewer injections with MMRV.
MMRV has been associated with more fevers and fever-
related seizures than MMR and varicella vaccines given separately
(first dose only).
Unless you specifically request otherwise, CDC recommends separate
MMR and varicella vaccines for the first dose and MMRV vaccine for the
second dose.
Your health-care provider can give you more information, including
the Vaccine Information Statements for MMR and Varicella vaccines.
Anyone 13 or older who needs protection from these diseases should
get MMR and varicella vaccines separately.
MMRV may be given at the same time as other vaccines.
3. Some Children Should Not Get MMRV Vaccine or Should Wait
Children should not get MMRV vaccine if they:
Have ever had a life-threatening allergic reaction to a
previous dose of MMRV vaccine, or to either MMR or varicella vaccine
Have ever had a life-threatening allergic reaction to any
component of the vaccine, including gelatin or the antibiotic neomycin.
Tell the doctor if your child has any severe allergies.
Have HIV/AIDS, or another disease that affects the immune
system
Are being treated with drugs that affect the immune
system, such as high doses of steroids by mouth, for 2 weeks or longer
Have any kind of cancer
Are being treated for cancer with radiation or drugs
Check with your doctor if the child:
Has a history of seizures, or has a parent, brother or
sister with a history of seizures
Has a parent, brother or sister with a history of immune
system problems
Has ever had a low platelet count, or another blood
disorder
Recently had a transfusion or received other blood
products
Might be pregnant
Children who are moderately or severely ill at the time the shot is
scheduled should usually wait until they recover before getting MMRV
vaccine.
Ask your provider for more information.
4. What are the risks from MMRV vaccine?
A vaccine, like any medicine, is capable of causing serious
problems, such as severe allergic reactions. The risk of MMRV vaccine
causing serious harm, or death, is extremely small.
Getting MMRV vaccine is much safer than getting any of these four
diseases.
Most children who get MMRV vaccine do not have any problems with
it.
Mild Problems
Fever (about 1 child out of 5)
Mild rash (about 1 child out of 20)
Swelling of glands in the cheeks or neck (rare)
If these problems occur, it is usually within 5-12 days after the
first dose. They occur less often after the second dose.
Moderate Problems
Seizure caused by fever (about 1 child in 1,250). These
seizures usually occur 5-12 days after the first dose. They occur less
often when MMR and varicella vaccines are given together as separate
injections (about 1 child in 2,500), and rarely after a 2nd dose of
MMRV.
Temporary low platelet count, which can cause a bleeding
disorder (about 1 child out of 40,000)
Severe Problems (Very Rare)
Several severe problems have been reported following MMR vaccine,
and might also occur after MMRV. These include severe allergic
reactions (fewer than 4 per million), and problems such as:
--Deafness
--Long-term seizures, coma, lowered consciousness
--Permanent brain damage
Because these problems occur so rarely, we can't be sure whether
they are caused by the vaccine or not.
5. What if there is a severe reaction?
What should I look for?
Any unusual condition, such as a high fever or behavior changes.
Signs of a severe allergic reaction can include difficulty breathing,
hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or
dizziness.
What should I do?
Call a doctor, or get the person to a doctor right away.
Tell the doctor what happened, the date and time it
happened, and when the vaccination was given.
Ask your provider to report the reaction by filing a
Vaccine Adverse Event Reporting System (VAERS) form. Or you can file
this report through the VAERS Web site at https://www.vaers.hhs.gov, or
by calling 1-800-822-7967.
VAERS does not provide medical advice.
6. The National Vaccine Injury Compensation Program
The National Vaccine Injury Compensation Program (VICP) was created
in 1986.
Persons who believe they may have been injured by a vaccine may
file a claim with VICP by calling 1-800-338-2382 or visiting their Web
site at https://www.hrsa.gov/vaccinecompensation vaccinecompensation.
7. How can I learn more?
Ask your provider. They can give you the vaccine package
insert or suggest other sources of information.
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)
--Visit CDC's Web site at https://www.cdc.gov/vaccines.
Department of Health and Human Services,
Centers for Disease Control and Prevention,
Vaccine Information Statement,
MMRV Vaccine,
(00/00/0000) (Proposed)
42 U.S.C. 300aa-26.
* * * * *
Dated: August 3, 2010.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and
Prevention.
[FR Doc. 2010-19785 Filed 8-10-10; 8:45 am]
BILLING CODE 4163-18-P
