Vaccine Information Statement for Hepatitis A Vaccine; Revised Instructions for Use of Vaccine Information Statements, 30938-30940 [E6-8350]
Download as PDF
<![CDATA[
30938
Federal Register / Vol. 71, No. 104 / Wednesday, May 31, 2006 / Notices
and cost-effectiveness analysis,
information systems, primary care, and
management and policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Topic Nominations
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panels (SEP): HIV IV—Rapid
Test Algorithms for Diagnosis of HIV
Infection and Improved Linkage to
Care, Program Announcement Number
(PA) PS06–002.
Vaccine Information Statement for
Hepatitis A Vaccine; Revised
Instructions for Use of Vaccine
Information Statements
The purpose of this solicitation for
new topics by CDC and the Task Force
is to create a balanced portfolio of
relevant topics for the current Task
Force library. The current library is
based on reviews and recommendations
across a broad range of high burden,
high interest topic areas: Changing
health risk behaviors (adolescent health,
physical activity, tobacco product use,
nutrition, sexual behavior, alcohol
abuse and misuse, substance abuse);
addressing specific health conditions
(cancer, diabetes, mental health, motor
vehicle occupant injury, obesity, oral
health, vaccine-preventable diseases,
and violence prevention); and
addressing the environment (improving
health through changing the social
environment, worksite health
promotion). Selection of suggested
topics will be made on the basis of
qualifications of nominations as
outlined above (see basic topic
nomination requirements) and the
current expertise of the Task Force.
Topics That Have Been Reviewed:
Diabetes, Informed Decision Making
for Cancer Screening, Motor Vehicle
Occupant Injury, Oral Health, Physical
Activity, Skin Cancer Prevention, Social
Environment, Tobacco, Vaccine
Coverage, Vaccine Coverage in Adults at
High Risk.
Topics Currently Under Review:
Adolescent Health, Alcohol, Cancer
Screening (Breast, Cervical, and
Colorectal), Improving Pregnancy
Outcomes, Mental Health, Nutrition,
Obesity, Sexual Behavior, Violence
Prevention, Worksite Health Promotion.
Dated: May 23, 2006.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E6–8351 Filed 5–30–06; 8:45 am]
jlentini on PROD1PC65 with NOTICES
BILLING CODE 4163–18–P
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting:
Name: Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): HIV IV—Rapid
Test Algorithms for Diagnosis of HIV
Infection and Improved Linkage to Care,
PA PS06–002.
Time and Date: 12 p.m.–5 p.m., June
23, 2006 (Closed).
Place: Teleconference.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section
552b(c)(4) and (6), Title 5 U.S.C., and
the Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters to be Discussed: The meeting
will include the review, discussion, and
evaluation of applications received in
response to ‘‘HIV IV—Rapid Test
Algorithms for Diagnosis of HIV
Infection and Improved Linkage to Care,
PA PS06–002.’’
For Further Information Contact: Jim
Newhall, PhD, Scientific Review
Administrator, Office of Public Health
Research, CDC, 1600 Clifton Road NE,
Mailstop D72, Atlanta, GA 30333,
Telephone 404–639–4641.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: May 24, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–8346 Filed 5–30–06; 8:45 am]
BILLING CODE 4163–18–P
VerDate Aug<31>2005
17:52 May 30, 2006
Jkt 208001
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
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.
On July 28, 2005, CDC published a
notice in the Federal Register (70 FR
43694) seeking public comments on
proposed new vaccine information
materials for hepatitis A vaccine.
Following review of the comments
submitted and consultation as required
under the law, CDC has finalized the
hepatitis A vaccine information
materials. The final hepatitis A
materials are contained in this notice.
Also noted are edits to the instructions
for use of vaccine information materials.
DATES: Beginning no later than July 1,
2006, each health care provider who
administers any hepatitis A vaccine to
any child or adult in the United States
shall provide copies of the relevant
vaccine information materials contained
in this notice, dated March 21, 2006, in
conformance with the April 7, 2006
CDC Instructions for the Use of Vaccine
Information Statements.
FOR FURTHER INFORMATION CONTACT:
Anne Schuchat, M.D., Director, National
Immunization Program, Centers for
Disease Control and Prevention,
Mailstop E–05, 1600 Clifton Road, NE.,
Atlanta, Georgia 30333, telephone (404)
639–8200.
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.
E:\FR\FM\31MYN1.SGM
31MYN1
jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 71, No. 104 / Wednesday, May 31, 2006 / Notices
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 June 1, 1999, health care
providers are also required to provide
copies of vaccine information materials
for the following vaccines that were
added to the National Vaccine Injury
Compensation Program: Hepatitis B,
haemophilus influenzae type b (Hib),
and varicella (chickenpox) vaccines. In
addition, use of vaccine information
materials for pneumococcal conjugate
vaccine has been required since
December 15, 2002 and materials for
trivalent influenza vaccines since
January 1, 2006.
Instructions for use of the vaccine
information materials and copies of the
materials can be downloaded in PDF
format from the CDC Web site at:
https://www.cdc.gov/nip/publications/
VIS. In addition, single camera-ready
copies are 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).
VerDate Aug<31>2005
17:52 May 30, 2006
Jkt 208001
New Vaccine Information Materials
Hepatitis A Vaccine Information
Statement
Following the addition of hepatitis A
vaccine to the National Vaccine Injury
Compensation Program, CDC, as
required under 42 U.S.C. 300aa–26,
proposed vaccine information materials
covering hepatitis A vaccine in a
Federal Register notice published on
July 28, 2005 (70 FR 43694).
The hepatitis A vaccine information
materials referenced in this notice were
developed in consultation with the
Advisory Commission on Childhood
Vaccines, the Food and Drug
Administration, the American Academy
of Family Physicians, American
Academy of Pediatrics, American
Medical Association, Emory Vaccine
Research Center, Every Child By Two,
Immunization Action Coalition and the
National PTA. Also, CDC sought
consultation with other organizations;
however, those organizations did not
provide comments.
Following consultation and review of
comments submitted, the vaccine
information materials covering hepatitis
A vaccine have been finalized and are
contained in this notice. The Vaccine
Information Statement (VIS), dated
March 21, 2006, is entitled: ‘‘Hepatitis A
Vaccine: What You Need to Know.’’
CDC has also revised the ‘‘Instructions
for the Use of Vaccine Information
Statements,’’ which are dated April 7,
2006, to add the VIS for hepatitis A and
to note the effective date for its
mandatory use.
With publication of this notice, as of
July 1, 2006, all health care providers
will be required to provide copies of
hepatitis A vaccine information
materials prior to immunization in
conformance with CDC’s April 7, 2006
‘‘Instructions for the Use of Vaccine
Information Statements.’’
Hepatitis A Vaccine Information
Statement
Hepatitis A Vaccine: What You Need
to Know.
1. What is hepatitis A?
Hepatitis A is a serious liver disease
caused by the hepatitis A virus (HAV).
HAV is found in the stool of persons
with hepatitis A. It is usually spread by
close personal contact and sometimes
by eating food or drinking water
containing HAV.
Hepatitis A can cause:
• Mild ‘‘flu-like’’ illness.
• Jaundice (yellow skin or eyes).
• Severe stomach pains and diarrhea.
People with hepatitis A often have to
be hospitalized (up to about 1 person in
5).
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
30939
Sometimes, people die as a result of
hepatitis A (about 3–5 deaths per 1,000
cases). A person who has hepatitis A
can easily pass the disease to others
within the same household. Hepatitis A
vaccine can prevent hepatitis A.
2. Who should get hepatitis A vaccine
and when?
WHO?
Some people should be routinely
vaccinated with hepatitis A vaccine:
• All children 1 year (12 through 23
months) of age.
• Persons 1 year of age and older
traveling to or working in countries with
high or intermediate prevalence of
hepatitis A, such as those located in
Central or South America, Mexico, Asia
(except Japan), Africa, and eastern
Europe. For more information see
www.cdc.gov/travel
• Children and adolescents through
18 years of age who live in states or
communities where routine vaccination
has been implemented because of high
disease incidence.
• Men who have sex with men.
• Persons who use street drugs.
• Persons with chronic liver disease.
• Persons who are treated with
clotting factor concentrates.
• Persons who work with HAVinfected primates or who work with
HAV in research laboratories.
Other people might get hepatitis A
vaccine in special situations:
• Hepatitis A vaccine might be
recommended for children or
adolescents in communities where
outbreaks of hepatitis A are occurring.
Hepatitis A vaccine is not licensed for
children younger than 1 year of age.
WHEN?
For children, the first dose should be
given at 12–23 months of age. Children
who are not vaccinated by 2 years of age
can be vaccinated at later visits.
For travelers, the vaccine series
should be started at least one month
before traveling to provide the best
protection.
Persons who get the vaccine less than
one month before traveling can also get
a shot called immune globulin (IG). IG
gives immediate, temporary protection.
For others, the hepatitis A vaccine
series may be started whenever a person
is at risk of infection.
Two doses of the vaccine are needed
for lasting protection. These doses
should be given at least 6 months apart.
Hepatitis A vaccine may be given at
the same time as other vaccines.
3. Some people should not get
hepatitis A vaccine or should wait.
• Anyone who has ever had a severe
(life-threatening) allergic reaction to a
E:\FR\FM\31MYN1.SGM
31MYN1
jlentini on PROD1PC65 with NOTICES
30940
Federal Register / Vol. 71, No. 104 / Wednesday, May 31, 2006 / Notices
previous dose of hepatitis A vaccine
should not get another dose.
• Anyone who has a severe (life
threatening) allergy to any vaccine
component should not get the vaccine.
Tell your doctor if you have any severe
allergies. All hepatitis A vaccines
contain alum and some hepatitis A
vaccines contain 2-phenoxyethanol.
• Anyone who is moderately or
severely ill at the time the shot is
scheduled should probably wait until
they recover. Ask your doctor or nurse.
People with a mild illness can usually
get the vaccine.
• Tell your doctor if you are pregnant.
The safety of hepatitis A vaccine for
pregnant women has not been
determined. But there is no evidence
that it is harmful to either pregnant
women or their unborn babies. The risk,
if any, is thought to be very low.
4. What are the risks from hepatitis A
vaccine?
A vaccine, like any medicine, could
possibly cause serious problems, such
as severe allergic reactions. The risk of
hepatitis A vaccine causing serious
harm, or death, is extremely small.
Getting hepatitis A vaccine is much
safer than getting the disease.
Mild problems.
• Soreness where the shot was given
(about 1 out of 2 adults, and up to 1 out
of 6 children).
• Headache (about 1 out of 6 adults
and 1 out of 25 children).
• Loss of appetite (about 1 out of 12
children).
• Tiredness (about 1 out of 14 adults).
If these problems occur, they usually
last 1 or 2 days.
Severe problems.
• Serious allergic reaction, within a
few minutes to a few hours of the shot
(very rare).
5. What if there is a moderate or
severe reaction?
What should I look for?
• Any unusual condition, such as a
high fever or behavior changes. Signs of
a serious 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 your doctor what happened,
the date and time it happened, and
when the vaccination was given.
• Ask your doctor, nurse, or health
department 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.
VerDate Aug<31>2005
17:52 May 30, 2006
Jkt 208001
VAERS does not provide medical
advice.
6. The National Vaccine Injury
Compensation Program
In the event that you or your child has
a serious reaction to a vaccine, a federal
program has been created to help pay
for the care of those who have been
harmed.
For details about the National Vaccine
Injury Compensation Program, call 1–
800–338–2382 or visit their Web site at
https://www.hrsa.gov/
vaccinecompensation.
7. How can I learn more?
• Ask your doctor or nurse. 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–CDCINFO)
—Visit CDC Web sites at: https://
www.cdc.gov/hepatitis or https://
www.cdc.gov/nip
Department of Health and Human
Services, Centers for Disease Control
and Prevention, National Immunization
Program.
Vaccine Information Statement,
Hepatitis A (3/21/06), 42 U.S.C. 300aa–
26.
Dated: May 20, 2006.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E6–8350 Filed 5–30–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0202]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prior Notice of
Imported Food Under the Public Health
Security and Bioterrorism
Preparedness and Response Act of
2002
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
FDA’s regulations requiring that the
agency receive prior notice before food
is imported or offered for import into
the United States.
DATES: Submit written or electronic
comments on the collection of
information by July 31, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
E:\FR\FM\31MYN1.SGM
31MYN1
]]>Agencies
[Federal Register Volume 71, Number 104 (Wednesday, May 31, 2006)]
[Notices]
[Pages 30938-30940]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8350]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Vaccine Information Statement for Hepatitis A Vaccine; Revised
Instructions for Use of Vaccine Information Statements
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Under the National Childhood Vaccine Injury Act (NCVIA) (42
U.S.C. Sec. 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. On July
28, 2005, CDC published a notice in the Federal Register (70 FR 43694)
seeking public comments on proposed new vaccine information materials
for hepatitis A vaccine. Following review of the comments submitted and
consultation as required under the law, CDC has finalized the hepatitis
A vaccine information materials. The final hepatitis A materials are
contained in this notice. Also noted are edits to the instructions for
use of vaccine information materials.
DATES: Beginning no later than July 1, 2006, each health care provider
who administers any hepatitis A vaccine to any child or adult in the
United States shall provide copies of the relevant vaccine information
materials contained in this notice, dated March 21, 2006, in
conformance with the April 7, 2006 CDC Instructions for the Use of
Vaccine Information Statements.
FOR FURTHER INFORMATION CONTACT: Anne Schuchat, M.D., Director,
National Immunization Program, Centers for Disease Control and
Prevention, Mailstop E-05, 1600 Clifton Road, NE., Atlanta, Georgia
30333, telephone (404) 639-8200.
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.
[[Page 30939]]
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 June 1, 1999, health care providers are also required
to provide copies of vaccine information materials for the following
vaccines that were added to the National Vaccine Injury Compensation
Program: Hepatitis B, haemophilus influenzae type b (Hib), and
varicella (chickenpox) vaccines. In addition, use of vaccine
information materials for pneumococcal conjugate vaccine has been
required since December 15, 2002 and materials for trivalent influenza
vaccines since January 1, 2006.
Instructions for use of the vaccine information materials and
copies of the materials can be downloaded in PDF format from the CDC
Web site at: https://www.cdc.gov/nip/publications/VIS. In addition,
single camera-ready copies are 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).
New Vaccine Information Materials
Hepatitis A Vaccine Information Statement
Following the addition of hepatitis A vaccine to the National
Vaccine Injury Compensation Program, CDC, as required under 42 U.S.C.
300aa-26, proposed vaccine information materials covering hepatitis A
vaccine in a Federal Register notice published on July 28, 2005 (70 FR
43694).
The hepatitis A vaccine information materials referenced in this
notice were developed in consultation with the Advisory Commission on
Childhood Vaccines, the Food and Drug Administration, the American
Academy of Family Physicians, American Academy of Pediatrics, American
Medical Association, Emory Vaccine Research Center, Every Child By Two,
Immunization Action Coalition and the National PTA. Also, CDC sought
consultation with other organizations; however, those organizations did
not provide comments.
Following consultation and review of comments submitted, the
vaccine information materials covering hepatitis A vaccine have been
finalized and are contained in this notice. The Vaccine Information
Statement (VIS), dated March 21, 2006, is entitled: ``Hepatitis A
Vaccine: What You Need to Know.'' CDC has also revised the
``Instructions for the Use of Vaccine Information Statements,'' which
are dated April 7, 2006, to add the VIS for hepatitis A and to note the
effective date for its mandatory use.
With publication of this notice, as of July 1, 2006, all health
care providers will be required to provide copies of hepatitis A
vaccine information materials prior to immunization in conformance with
CDC's April 7, 2006 ``Instructions for the Use of Vaccine Information
Statements.''
Hepatitis A Vaccine Information Statement
Hepatitis A Vaccine: What You Need to Know.
1. What is hepatitis A?
Hepatitis A is a serious liver disease caused by the hepatitis A
virus (HAV). HAV is found in the stool of persons with hepatitis A. It
is usually spread by close personal contact and sometimes by eating
food or drinking water containing HAV.
Hepatitis A can cause:
Mild ``flu-like'' illness.
Jaundice (yellow skin or eyes).
Severe stomach pains and diarrhea.
People with hepatitis A often have to be hospitalized (up to about
1 person in 5).
Sometimes, people die as a result of hepatitis A (about 3-5 deaths
per 1,000 cases). A person who has hepatitis A can easily pass the
disease to others within the same household. Hepatitis A vaccine can
prevent hepatitis A.
2. Who should get hepatitis A vaccine and when?
WHO?
Some people should be routinely vaccinated with hepatitis A
vaccine:
All children 1 year (12 through 23 months) of age.
Persons 1 year of age and older traveling to or working in
countries with high or intermediate prevalence of hepatitis A, such as
those located in Central or South America, Mexico, Asia (except Japan),
Africa, and eastern Europe. For more information see www.cdc.gov/travel
Children and adolescents through 18 years of age who live
in states or communities where routine vaccination has been implemented
because of high disease incidence.
Men who have sex with men.
Persons who use street drugs.
Persons with chronic liver disease.
Persons who are treated with clotting factor concentrates.
Persons who work with HAV-infected primates or who work
with HAV in research laboratories.
Other people might get hepatitis A vaccine in special situations:
Hepatitis A vaccine might be recommended for children or
adolescents in communities where outbreaks of hepatitis A are
occurring.
Hepatitis A vaccine is not licensed for children younger than 1
year of age.
WHEN?
For children, the first dose should be given at 12-23 months of
age. Children who are not vaccinated by 2 years of age can be
vaccinated at later visits.
For travelers, the vaccine series should be started at least one
month before traveling to provide the best protection.
Persons who get the vaccine less than one month before traveling
can also get a shot called immune globulin (IG). IG gives immediate,
temporary protection.
For others, the hepatitis A vaccine series may be started whenever
a person is at risk of infection.
Two doses of the vaccine are needed for lasting protection. These
doses should be given at least 6 months apart.
Hepatitis A vaccine may be given at the same time as other
vaccines.
3. Some people should not get hepatitis A vaccine or should wait.
Anyone who has ever had a severe (life-threatening)
allergic reaction to a
[[Page 30940]]
previous dose of hepatitis A vaccine should not get another dose.
Anyone who has a severe (life threatening) allergy to any
vaccine component should not get the vaccine. Tell your doctor if you
have any severe allergies. All hepatitis A vaccines contain alum and
some hepatitis A vaccines contain 2-phenoxyethanol.
Anyone who is moderately or severely ill at the time the
shot is scheduled should probably wait until they recover. Ask your
doctor or nurse. People with a mild illness can usually get the
vaccine.
Tell your doctor if you are pregnant. The safety of
hepatitis A vaccine for pregnant women has not been determined. But
there is no evidence that it is harmful to either pregnant women or
their unborn babies. The risk, if any, is thought to be very low.
4. What are the risks from hepatitis A vaccine?
A vaccine, like any medicine, could possibly cause serious
problems, such as severe allergic reactions. The risk of hepatitis A
vaccine causing serious harm, or death, is extremely small.
Getting hepatitis A vaccine is much safer than getting the disease.
Mild problems.
Soreness where the shot was given (about 1 out of 2
adults, and up to 1 out of 6 children).
Headache (about 1 out of 6 adults and 1 out of 25
children).
Loss of appetite (about 1 out of 12 children).
Tiredness (about 1 out of 14 adults).
If these problems occur, they usually last 1 or 2 days.
Severe problems.
Serious allergic reaction, within a few minutes to a few
hours of the shot (very rare).
5. What if there is a moderate or severe reaction?
What should I look for?
Any unusual condition, such as a high fever or behavior
changes. Signs of a serious 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 your doctor what happened, the date and time it
happened, and when the vaccination was given.
Ask your doctor, nurse, or health department 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
In the event that you or your child has a serious reaction to a
vaccine, a federal program has been created to help pay for the care of
those who have been harmed.
For details about the National Vaccine Injury Compensation Program,
call 1-800-338-2382 or visit their Web site at https://www.hrsa.gov/
vaccinecompensation.
7. How can I learn more?
Ask your doctor or nurse. 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 Web sites at: https://www.cdc.gov/hepatitis or https://
www.cdc.gov/nip
Department of Health and Human Services, Centers for Disease
Control and Prevention, National Immunization Program.
Vaccine Information Statement, Hepatitis A (3/21/06), 42 U.S.C.
300aa-26.
Dated: May 20, 2006.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
[FR Doc. E6-8350 Filed 5-30-06; 8:45 am]
BILLING CODE 4163-18-P
