Proposed Vaccine Information Materials for Influenza Vaccine, 48712-48715 [2010-19788]
Download as PDF
48712
Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
Dated: August 3, 2010.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2010–19784 Filed 8–10–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Proposed Vaccine Information
Materials for Influenza Vaccine
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 trivalent influenza
vaccines. In addition, to ensure that
influenza vaccine information materials
are available at the beginning of the
upcoming influenza vaccination season,
the proposed materials included in this
notice are also considered interim
vaccine information materials covering
influenza vaccines for use pending
issuance of final influenza materials
following completion of the formal
NCVIA development process.
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
sroberts on DSKD5P82C1PROD with NOTICES
SUMMARY:
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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
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.
Proposed Influenza Vaccine
Information Materials
The Advisory Committee on
Immunization Practices (ACIP)
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recommendations for use of trivalent
influenza have changed only slightly
since the previous Vaccine Information
Statements were published. For the
2010–2011 influenza season, 2009 H1N1
influenza vaccine is being incorporated
into the seasonal vaccine formulation.
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 ‘‘Inactivated Influenza Vaccine:
What You Need to Know’’ and ‘‘Live
Intranasal Influenza 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 update references to these
vaccine information materials.
Influenza Vaccine Information
Materials—Additional Considerations
CDC has traditionally issued a new
Vaccine Information Statement annually
for influenza vaccines since the
formulation of antigens contained in the
vaccine is specific for each year.
However, known benefits and risks for
each year’s influenza vaccine are
generally the same. In such cases, the
only revision to the influenza VIS is the
notation of the flu season for which the
VIS has been issued (e.g., 2009–10).
Therefore, we propose that when the
VIS for a particular influenza season is
identical to the previous year’s edition,
except for the date notation and any
reference to the influenza strain content
of that year’s vaccine (if the safety
profile is expected to be comparable to
that of previous years’ influenza
vaccines), CDC will no longer publish a
Federal Register notice seeking
comment on such edition. Instead, each
new year’s edition of the influenza VIS
will be published on the CDC Web site
at: https://www.cdc.gov/vaccines/
publications/VIS/. In addition, the
Instructions for the Use of Vaccine
Information Statements will be updated
at that time to note new edition dates for
influenza Vaccine Information
Statements. New edition influenza
Vaccine Information Statements for the
upcoming flu season will generally be
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Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
available on the CDC Web site by [insert
month] of each year.
Whenever substantive revisions are
going to be made to an influenza VIS,
the full development process, including
consultation and publication of a
Federal Register notice with
opportunity for comment, will be
utilized.
We invite comment on this proposed
method of issuing revised influenza
Vaccine Information Statements in the
future.
*
*
*
*
*
As noted above, the vaccine
information materials which follow will
serve as interim influenza Vaccine
Information Statements for use when
administering any 2010–11 influenza
vaccine until final materials are
effective and available for distribution.
*
*
*
*
*
Proposed (and Interim) Influenza
Vaccine Information Statements:
sroberts on DSKD5P82C1PROD with NOTICES
Inactivated Influenza Vaccine: What
You Need to Know 2010–2011
Vaccine Information Statements are
available in Spanish and many other
languages. See www.immunize.org/vis
1. Why get vaccinated?
Influenza (‘‘flu’’) is a contagious
disease.
It is caused by the influenza virus,
which can be spread by coughing,
sneezing, or nasal secretions.
Other illnesses can have the same
symptoms and are often mistaken for
influenza. But only an illness caused by
the influenza virus is really influenza.
Anyone can get influenza, but rates of
infection are highest among children.
For most people, it lasts only a few
days. It can cause:
• Fever
• Sore throat
• Chills
• Fatigue
• Cough
• Headache
• Muscle aches
Some people, such as infants, elderly,
and those with certain health
conditions, can get much sicker. Flu can
cause high fever and pneumonia, and
make existing medical conditions
worse. It can cause diarrhea and
seizures in children. Each year
thousands of people die from seasonal
influenza and even more require
hospitalization. Influenza vaccine can
prevent influenza.
2. Inactivated influenza vaccine
There are two types of influenza
vaccine:
1. Inactivated (killed) vaccine, or the
‘‘flu shot’’ is given by injection into the
muscle.
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2. Live, attenuated (weakened)
influenza vaccine is sprayed into the
nostrils. This vaccine is described in a
separate Vaccine Information
Statement.
A high-dose inactivated influenza
vaccine is available for people 65 years
of age and older. Ask your provider.
Influenza viruses are always
changing. Because of this, influenza
vaccines are updated every year, and an
annual vaccination is recommended.
Each year scientists try to match the
viruses in the vaccine to those most
likely to cause flu that year. When there
is a close match the vaccine protects
most people from serious influenzarelated illness. But even when there is
not a close match, the vaccine provides
some protection. The 2010–2011
vaccine provides protection against
H1N1 (pandemic) influenza, which is
expected to be one of the viruses
causing influenza this season. Influenza
vaccine will not prevent ‘‘influenza-like’’
illnesses caused by other viruses.
It takes up to 2 weeks for protection
to develop after the shot. Protection
lasts up to a year. Some inactivated
influenza vaccine contains a
preservative called thimerosal. Some
people have suggested that thimerosal
may be related to autism in children. In
2004 the Institute of Medicine reviewed
many studies looking into this theory
and concluded that there is no evidence
of such a relationship. Thimerosal-free
influenza vaccine is available.
3. Who should get inactivated influenza
vaccine and when ?
Who
• All people 6 months of age and
older.
People who got the 2009 H1N1
vaccine still need to get vaccinated with
the 2010–2011 influenza vaccine.
When
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, including
pneumococcal vaccine.
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4. Some people should not get
inactivated influenza vaccine or should
wait
• Tell your doctor if you have any
severe (life-threatening) allergies.
Allergic reactions to influenza vaccine
are rare.
—Influenza vaccine virus is grown in
eggs. People with a severe egg allergy
should not get the vaccine.
—A severe allergy to any vaccine
component is also a reason to not get
the vaccine.
—If you ever had a severe reaction after
a dose of influenza vaccine, tell your
doctor.
• Tell your doctor if you ever had
´
Guillain-Barre Syndrome (a severe
paralytic illness, also called GBS). You
may be able to get the vaccine, but your
doctor should help you make the
decision.
• People who are moderately or
severely ill should usually wait until
they recover before getting flu vaccine.
If you are ill, talk to your doctor or
nurse about whether to reschedule the
vaccination. People with a mild illness
can usually get the vaccine.
5. What are the risks from inactivated
influenza vaccine?
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.
Serious problems from influenza
vaccine are very rare. The viruses in
inactivated influenza vaccine have been
killed, so you cannot get influenza from
the vaccine. Mild problems:
• Soreness, redness, or swelling
where the shot was given
• Hoarseness; sore, red or itchy eyes;
cough
• Fever
• Aches
If these problems occur, they usually
begin soon after the shot and last 1–2
days. People 65 and older who get the
high-dose vaccine may be more likely to
experience some of these problems.
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 shot.
• In 1976, a type of influenza (swine
flu) vaccine was associated with
´
Guillain-Barre Syndrome (GBS). Since
then, flu vaccines have not been clearly
linked to GBS. However, if there is a
risk of GBS from current flu vaccines, it
would be no more than 1 or 2 cases per
million people vaccinated. This is much
lower than the risk of severe influenza,
which can be prevented by vaccination.
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11AUN1
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Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
6. 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.
7. The National Vaccine Injury
Compensation Program
2. Live, Intranasal Influenza Vaccine—
LAIV (Nasal Spray)
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.
Vaccine Information Statements are
available in Spanish and many other
languages.
See https://www.immunize.org/vis.
There are two types of influenza
vaccine:
1. Live, attenuated influenza vaccine
(LAIV) contains live but attenuated
(weakened) influenza virus. It is sprayed
into the nostrils. 2. Inactivated influenza
vaccine, or the ‘‘flu shot,’’ is given by
injection. Inactivated influenza vaccine
is described in a separate Vaccine
Information Statement.
Influenza viruses are always
changing. Because of this, influenza
vaccines are updated every year, and an
annual vaccination is recommended.
Each year scientists try to match the
viruses in the vaccine to those most
likely to cause flu that year. When there
is a close match the vaccine protects
most people from serious influenzarelated illness. But even when there is
not a close match, the vaccine provides
some protection. The 2010–2011
vaccine provides protection against
H1N1 (pandemic) influenza, which is
expected to be one of the viruses
causing influenza this season. Influenza
vaccine will not prevent ‘‘influenza-like’’
illnesses caused by other viruses.
It takes up to 2 weeks for protection
to develop after the vaccination.
Protection lasts up to a year. LAIV does
not contain thimerosal or other
preservatives.
1. Why get vaccinated?
3. Who can receive LAIV?
Influenza (‘‘flu’’) is a contagious
disease.
It is caused by the influenza virus,
which can be spread by coughing,
sneezing, or nasal secretions.
LAIV is recommended for healthy
people from 2 through 49 years of age,
who are not pregnant and do not have
certain health conditions (see #4,
below).
8. 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, Inactivated Influenza
Vaccine, (00/00/0000) (Proposed), 42
U.S.C. 300aa–26.
Live, Intranasal Influenza Vaccine:
What You Need To Know 2010–2011
sroberts on DSKD5P82C1PROD with NOTICES
Other illnesses can have the same
symptoms and are often mistaken for
influenza. But only an illness caused by
the influenza virus is really influenza.
Anyone can get influenza, but rates of
infection are highest among children.
For most people, it lasts only a few
days. It can cause:
• Fever
• Sore throat
• Chills
• Fatigue
• Cough
• Headache
• Muscle aches
Some people, such as infants, elderly,
and those with certain health
conditions, can get much sicker. Flu can
cause high fever and pneumonia, and
make existing medical conditions
worse. It can cause diarrhea and
seizures in children. Each year
thousands of people die from seasonal
influenza and even more require
hospitalization. Influenza vaccine can
prevent influenza.
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16:52 Aug 10, 2010
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People who got the 2009 H1N1
vaccine still need to get vaccinated with
the 2010–2011 influenza vaccine.
4. Some People Should Not Receive
LAIV
LAIV is not recommended for
everyone. The following people should
get the inactivated vaccine (flu shot)
instead:
• Adults 50 years of age and older or
children between 6 months and 2 years
of age. (Children younger than 6 months
should not get either influenza vaccine.)
• Children younger than 5 with
asthma or one or more episodes of
wheezing within the past year.
• People who have long-term health
problems with:
—Heart disease
—Kidney or liver disease
—Lung disease
—Metabolic disease, such as diabetes
—Asthma
—Anemia, and other blood disorders
• Anyone with certain muscle or
nerve disorders (such as seizure
disorders or cerebral palsy) that can lead
to breathing or swallowing problems.
• Anyone with a weakened immune
system.
• Anyone in close contact with
someone whose immune system is so
weak they require care in a protected
environment (such as a bone marrow
transplant unit). Close contacts of other
people with a weakened immune system
(such as those with HIV) may receive
LAIV. Healthcare personnel in neonatal
intensive care units or oncology clinics
may receive LAIV.
• Children or adolescents on longterm aspirin treatment.
• Pregnant women.
Tell your doctor if you ever had
´
Guillain-Barre Syndrome (a severe
paralytic illness, also called GBS). You
may be able to get the vaccine, but your
doctor should help you make the
decision.
Tell your doctor if you have gotten
any other vaccines in the past 4 weeks.
Anyone with a nasal condition
serious enough to make breathing
difficult, such as a very stuffy nose,
should get the flu shot instead.
Some people should talk with a
doctor before getting either influenza
vaccine:
• Anyone who has ever had a serious
allergic reaction to eggs or another
vaccine component, or to a previous
dose of influenza vaccine. Tell your
doctor if you have any severe allergies.
• People who are moderately or
severely ill should usually wait until
they recover before getting flu vaccine.
If you are ill, talk to your doctor or
nurse about whether to reschedule the
E:\FR\FM\11AUN1.SGM
11AUN1
Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
vaccination. People with a mild illness
can usually get the vaccine.
sroberts on DSKD5P82C1PROD with NOTICES
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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16:52 Aug 10, 2010
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48715
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:
E:\FR\FM\11AUN1.SGM
11AUN1
Agencies
[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Pages 48712-48715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19788]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Proposed Vaccine Information Materials for Influenza Vaccine
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 trivalent influenza
vaccines. In addition, to ensure that influenza vaccine information
materials are available at the beginning of the upcoming influenza
vaccination season, the proposed materials included in this notice are
also considered interim vaccine information materials covering
influenza vaccines for use pending issuance of final influenza
materials following completion of the formal NCVIA development process.
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 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.
Proposed Influenza Vaccine Information Materials
The Advisory Committee on Immunization Practices (ACIP)
recommendations for use of trivalent influenza have changed only
slightly since the previous Vaccine Information Statements were
published. For the 2010-2011 influenza season, 2009 H1N1 influenza
vaccine is being incorporated into the seasonal vaccine formulation.
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 ``Inactivated Influenza
Vaccine: What You Need to Know'' and ``Live Intranasal Influenza
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 update
references to these vaccine information materials.
Influenza Vaccine Information Materials--Additional Considerations
CDC has traditionally issued a new Vaccine Information Statement
annually for influenza vaccines since the formulation of antigens
contained in the vaccine is specific for each year. However, known
benefits and risks for each year's influenza vaccine are generally the
same. In such cases, the only revision to the influenza VIS is the
notation of the flu season for which the VIS has been issued (e.g.,
2009-10). Therefore, we propose that when the VIS for a particular
influenza season is identical to the previous year's edition, except
for the date notation and any reference to the influenza strain content
of that year's vaccine (if the safety profile is expected to be
comparable to that of previous years' influenza vaccines), CDC will no
longer publish a Federal Register notice seeking comment on such
edition. Instead, each new year's edition of the influenza VIS will be
published on the CDC Web site at: https://www.cdc.gov/vaccines/publications/VIS/. In addition, the Instructions for the Use of Vaccine
Information Statements will be updated at that time to note new edition
dates for influenza Vaccine Information Statements. New edition
influenza Vaccine Information Statements for the upcoming flu season
will generally be
[[Page 48713]]
available on the CDC Web site by [insert month] of each year.
Whenever substantive revisions are going to be made to an influenza
VIS, the full development process, including consultation and
publication of a Federal Register notice with opportunity for comment,
will be utilized.
We invite comment on this proposed method of issuing revised
influenza Vaccine Information Statements in the future.
* * * * *
As noted above, the vaccine information materials which follow will
serve as interim influenza Vaccine Information Statements for use when
administering any 2010-11 influenza vaccine until final materials are
effective and available for distribution.
* * * * *
Proposed (and Interim) Influenza Vaccine Information Statements:
Inactivated Influenza Vaccine: What You Need to Know 2010-2011
Vaccine Information Statements are available in Spanish and many
other languages. See www.immunize.org/vis
1. Why get vaccinated?
Influenza (``flu'') is a contagious disease.
It is caused by the influenza virus, which can be spread by
coughing, sneezing, or nasal secretions.
Other illnesses can have the same symptoms and are often mistaken
for influenza. But only an illness caused by the influenza virus is
really influenza.
Anyone can get influenza, but rates of infection are highest among
children. For most people, it lasts only a few days. It can cause:
Fever
Sore throat
Chills
Fatigue
Cough
Headache
Muscle aches
Some people, such as infants, elderly, and those with certain
health conditions, can get much sicker. Flu can cause high fever and
pneumonia, and make existing medical conditions worse. It can cause
diarrhea and seizures in children. Each year thousands of people die
from seasonal influenza and even more require hospitalization.
Influenza vaccine can prevent influenza.
2. Inactivated influenza vaccine
There are two types of influenza vaccine:
1. Inactivated (killed) vaccine, or the ``flu shot'' is given by
injection into the muscle.
2. Live, attenuated (weakened) influenza vaccine is sprayed into
the nostrils. This vaccine is described in a separate Vaccine
Information Statement.
A high-dose inactivated influenza vaccine is available for people
65 years of age and older. Ask your provider.
Influenza viruses are always changing. Because of this, influenza
vaccines are updated every year, and an annual vaccination is
recommended.
Each year scientists try to match the viruses in the vaccine to
those most likely to cause flu that year. When there is a close match
the vaccine protects most people from serious influenza-related
illness. But even when there is not a close match, the vaccine provides
some protection. The 2010-2011 vaccine provides protection against H1N1
(pandemic) influenza, which is expected to be one of the viruses
causing influenza this season. Influenza vaccine will not prevent
``influenza-like'' illnesses caused by other viruses.
It takes up to 2 weeks for protection to develop after the shot.
Protection lasts up to a year. Some inactivated influenza vaccine
contains a preservative called thimerosal. Some people have suggested
that thimerosal may be related to autism in children. In 2004 the
Institute of Medicine reviewed many studies looking into this theory
and concluded that there is no evidence of such a relationship.
Thimerosal-free influenza vaccine is available.
3. Who should get inactivated influenza vaccine and when ?
Who
All people 6 months of age and older.
People who got the 2009 H1N1 vaccine still need to get vaccinated
with the 2010-2011 influenza vaccine.
When
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,
including pneumococcal vaccine.
4. Some people should not get inactivated influenza vaccine or should
wait
Tell your doctor if you have any severe (life-threatening)
allergies. Allergic reactions to influenza vaccine are rare.
--Influenza vaccine virus is grown in eggs. People with a severe egg
allergy should not get the vaccine.
--A severe allergy to any vaccine component is also a reason to not get
the vaccine.
--If you ever had a severe reaction after a dose of influenza vaccine,
tell your doctor.
Tell your doctor if you ever had Guillain-Barr[eacute]
Syndrome (a severe paralytic illness, also called GBS). You may be able
to get the vaccine, but your doctor should help you make the decision.
People who are moderately or severely ill should usually
wait until they recover before getting flu vaccine. If you are ill,
talk to your doctor or nurse about whether to reschedule the
vaccination. People with a mild illness can usually get the vaccine.
5. What are the risks from inactivated influenza vaccine?
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.
Serious problems from influenza vaccine are very rare. The viruses
in inactivated influenza vaccine have been killed, so you cannot get
influenza from the vaccine. Mild problems:
Soreness, redness, or swelling where the shot was given
Hoarseness; sore, red or itchy eyes; cough
Fever
Aches
If these problems occur, they usually begin soon after the shot and
last 1-2 days. People 65 and older who get the high-dose vaccine may be
more likely to experience some of these problems.
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 shot.
In 1976, a type of influenza (swine flu) vaccine was
associated with Guillain-Barr[eacute] Syndrome (GBS). Since then, flu
vaccines have not been clearly linked to GBS. However, if there is a
risk of GBS from current flu vaccines, it would be no more than 1 or 2
cases per million people vaccinated. This is much lower than the risk
of severe influenza, which can be prevented by vaccination.
[[Page 48714]]
6. 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.
7. 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.
8. 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, Inactivated
Influenza Vaccine, (00/00/0000) (Proposed), 42 U.S.C. 300aa-26.
Live, Intranasal Influenza Vaccine: What You Need To Know 2010-2011
Vaccine Information Statements are available in Spanish and many
other languages.
See https://www.immunize.org/vis.
1. Why get vaccinated?
Influenza (``flu'') is a contagious disease.
It is caused by the influenza virus, which can be spread by
coughing, sneezing, or nasal secretions.
Other illnesses can have the same symptoms and are often mistaken
for influenza. But only an illness caused by the influenza virus is
really influenza.
Anyone can get influenza, but rates of infection are highest among
children. For most people, it lasts only a few days. It can cause:
Fever
Sore throat
Chills
Fatigue
Cough
Headache
Muscle aches
Some people, such as infants, elderly, and those with certain
health conditions, can get much sicker. Flu can cause high fever and
pneumonia, and make existing medical conditions worse. It can cause
diarrhea and seizures in children. Each year thousands of people die
from seasonal influenza and even more require hospitalization.
Influenza vaccine can prevent influenza.
2. Live, Intranasal Influenza Vaccine--LAIV (Nasal Spray)
There are two types of influenza vaccine:
1. Live, attenuated influenza vaccine (LAIV) contains live but
attenuated (weakened) influenza virus. It is sprayed into the nostrils.
2. Inactivated influenza vaccine, or the ``flu shot,'' is given by
injection. Inactivated influenza vaccine is described in a separate
Vaccine Information Statement.
Influenza viruses are always changing. Because of this, influenza
vaccines are updated every year, and an annual vaccination is
recommended.
Each year scientists try to match the viruses in the vaccine to
those most likely to cause flu that year. When there is a close match
the vaccine protects most people from serious influenza-related
illness. But even when there is not a close match, the vaccine provides
some protection. The 2010-2011 vaccine provides protection against H1N1
(pandemic) influenza, which is expected to be one of the viruses
causing influenza this season. Influenza vaccine will not prevent
``influenza-like'' illnesses caused by other viruses.
It takes up to 2 weeks for protection to develop after the
vaccination. Protection lasts up to a year. LAIV does not contain
thimerosal or other preservatives.
3. Who can receive LAIV?
LAIV is recommended for healthy people from 2 through 49 years of
age, who are not pregnant and do not have certain health conditions
(see 4, below).
People who got the 2009 H1N1 vaccine still need to get vaccinated
with the 2010-2011 influenza vaccine.
4. Some People Should Not Receive LAIV
LAIV is not recommended for everyone. The following people should
get the inactivated vaccine (flu shot) instead:
Adults 50 years of age and older or children between 6
months and 2 years of age. (Children younger than 6 months should not
get either influenza vaccine.)
Children younger than 5 with asthma or one or more
episodes of wheezing within the past year.
People who have long-term health problems with:
--Heart disease
--Kidney or liver disease
--Lung disease
--Metabolic disease, such as diabetes
--Asthma
--Anemia, and other blood disorders
Anyone with certain muscle or nerve disorders (such as
seizure disorders or cerebral palsy) that can lead to breathing or
swallowing problems.
Anyone with a weakened immune system.
Anyone in close contact with someone whose immune system
is so weak they require care in a protected environment (such as a bone
marrow transplant unit). Close contacts of other people with a weakened
immune system (such as those with HIV) may receive LAIV. Healthcare
personnel in neonatal intensive care units or oncology clinics may
receive LAIV.
Children or adolescents on long-term aspirin treatment.
Pregnant women.
Tell your doctor if you ever had Guillain-Barr[eacute] Syndrome (a
severe paralytic illness, also called GBS). You may be able to get the
vaccine, but your doctor should help you make the decision.
Tell your doctor if you have gotten any other vaccines in the past
4 weeks.
Anyone with a nasal condition serious enough to make breathing
difficult, such as a very stuffy nose, should get the flu shot instead.
Some people should talk with a doctor before getting either
influenza vaccine:
Anyone who has ever had a serious allergic reaction to
eggs or another vaccine component, or to a previous dose of influenza
vaccine. Tell your doctor if you have any severe allergies.
People who are moderately or severely ill should usually
wait until they recover before getting flu vaccine. If you are ill,
talk to your doctor or nurse about whether to reschedule the
[[Page 48715]]
vaccination. People with a mild illness can usually get the vaccine.
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.
7. 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 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