FR Doc 05-14924

[Federal Register: July 28, 2005 (Volume 70, Number 144)]
[Notices]
[Page 43694-43699]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jy05-34]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Proposed Vaccine Information Materials for Hepatitis A and
Influenza Vaccines; Interim Vaccine Information Materials for Influenza
Vaccines

AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).

ACTION: Notice with comment period.

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[[Page 43695]]

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 hepatitis A and
trivalent influenza vaccines. In addition, to ensure that influenza
vaccine information materials are available at the beginning of the
upcoming influenza vaccination season, this notice includes 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
September 26, 2005.

ADDRESSES: Written comments should be addressed to Stephen L. Cochi,
M.D., M.P.H., Acting Director, National Immunization Program, Centers
for Disease Control and Prevention, Mailstop E-05, 1600 Clifton Road,
N.E., Atlanta, Georgia 30333.

FOR FURTHER INFORMATION CONTACT: Stephen L Cochi, M.D., M.P.H., Acting
Director, National Immunization Program, Centers for Disease Control
and Prevention, Mailstop E-05, 1600 Clifton Road, N.E., 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.
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. Instructions for use of the vaccine
information materials and copies of the materials can be found on the
CDC Web site at: http://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).

Proposed Hepatitis A Vaccine Information Materials

Interim and Proposed Influenza Vaccine Information Materials

With the December 1, 2004 addition of hepatitis A vaccine and the
July 1, 2005 addition of trivalent influenza vaccines to the National
Vaccine Injury Compensation Program, CDC, as required under 42 U.S.C.
300aa-26, is proposing vaccine information materials covering those
vaccines, which are included in this notice. In addition, in order to
have Influenza Vaccine Information Statements available for use in the
upcoming influenza vaccination season, the proposed influenza vaccine
materials are also being issued as interim VISs through this notice.
These interim materials may be used by providers pending completion of
the final influenza vaccine information materials.

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 ``Hepatitis A Vaccine: What
You Need to Know,'' ``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 January 15, 2003 Instructions for the
Use of Vaccine Information Statements to add the requirement for use of
the hepatitis A and influenza vaccine information materials.

Use of Interim Influenza Vaccine Information Materials

The proposed influenza vaccine information materials included in
this notice are concurrently being issued through this notice as
interim Influenza Vaccine Information Statements, dated July 18, 2005.
Providers are encouraged to use these interim materials pending
issuance of the final influenza materials following completion of the
formal NCVIA development process. Copies of these interim influenza
VISs can be downloaded in PDF format from the CDC Web site at: http://www.cdc.gov/nip/publications/VIS/
.

Proposed Hepatitis A Vaccine Information Statement

Hepatitis A Vaccine: What You Need to Know

1. Why get vaccinated?
Hepatitis A is a serious liver disease caused by the hepatitis A
virus (HAV). HAV is found in the stool of people with hepatitis A. It
is usually spread by close personal contact and sometimes by eating
food or drinking water containing HAV.
Hepatitis A can cause:
Mild ``flu-like'' illness;
Jaundice (yellow skin or eyes);
Severe stomach pains and diarrhea.

[[Page 43696]]

People who become ill with hepatitis A often have to be
hospitalized.
About 100 people die from hepatitis A infection in the U.S. each
year.
A person who has hepatitis A can easily pass the disease to other
people in the same household. Hepatitis A vaccine can prevent hepatitis
A.
2. Who should get hepatitis A vaccine and when?
WHO?
Children and adolescents who live in states or communities
where routine vaccination has been recommended.
People 2 years of age and older traveling to or working in
countries where risk for catching hepatitis A is high. These include
countries located in Central or South America, the Caribbean, Mexico,
Asia (except Japan), Africa, and Eastern Europe.
Men who have sex with men.
People who use street drugs.
People with chronic liver disease.
People who are treated with clotting factor concentrates.
People 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 2
years of age.
WHEN?
Two doses of the vaccine are needed for lasting protection. These
doses should be given at least 6 months apart. If you miss the second
dose, get it as soon as you can. There is no need to start over.
--The hepatitis A vaccine series may be started whenever a person is at
risk of infection.
--For travelers, the vaccine works best if given at least one month
before traveling.
--Travelers who get the vaccine less than one month before traveling
may also get a second shot called Immune Globulin (IG). IG gives
immediate, temporary protection.
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 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.
People who are moderately or severely ill should usually
wait until they recover before getting hepatitis A 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.
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 believed 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 5 children);
Headache (about 1 out of 6 adults and 1 out of 20
children);
Loss of appetite (about 1 out of 12 children);
Tiredness (about 1 out of 14 adults).
If these problems occur, they usually last for 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 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 http://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 rare 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 the program's Web site at http://www.hrsa.gov/osp/vicp
.

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: http://www.cdc.gov/hepatitis or http://www.cdc.gov/nip.
Department of Health and Human Services, Centers for Disease

Control and Prevention, National Immunization Program.
Vaccine Information Statement, Hepatitis A, (00/00/0000)
(Proposed), 42 U.S.C. 300aa-26.

Interim and Proposed Inactivated Influenza Vaccine Information
Statement

Inactivated Influenza Vaccine: What You Need to Know

[[Page 43697]]

2. Inactivated influenza vaccine
There are two types of influenza vaccine:
An inactivated (killed) vaccine, given as a shot, has been used in
the United States for many years.
A live, weakened vaccine was licensed in 2003. It is sprayed into
the nostrils. This vaccine is described in a separate Vaccine
Information Statement.
Influenza viruses are constantly changing. Therefore, influenza
vaccines are updated every year, and an annual vaccination is
recommended.
For most people influenza vaccine prevents serious illness caused
by the influenza virus. It will not prevent ``influenza-like''
illnesses caused by other viruses. It takes about 2 weeks for
protection to develop after the shot and protection can last up to a
year. Inactivated influenza vaccine may be given at the same time as
other vaccines, including pneumococcal vaccine.
Some inactivated influenza vaccine contains thimerosal, a
preservative that contains mercury.
Some people believe thimerosal may be related to developmental
problems in children. In 2004 the Institute of Medicine published a
report concluding that, based on scientific studies; there is no
evidence of such a relationship. If you are concerned about thimerosal,
ask your doctor about thimerosal-free influenza vaccine.
3. Who should get inactivated influenza vaccine?
Influenza vaccine can be given to people 6 months of age and older.
It is recommended for people who are at risk of serious influenza or
its complications, and for people who can spread influenza to those at
high-risk (including all household members):
People at high risk for complications from influenza:
All children 6-23 months of age.
People 65 years of age and older.
Residents of long-term care facilities housing persons
with chronic medical conditions.
People who have long-term health problems with:
--Heart disease;
--Kidney disease;
--Lung disease;
--Metabolic disease, such as diabetes;
--Asthma;
--Anemia, and other blood disorders.
People with certain conditions (such as neuromuscular
disorders) that can cause breathing problems.
People with a weakened immune system due to:

--HIV/AIDS or other diseases affecting the immune system;
--Long-term treatment with drugs such as steroids;
--Cancer treatment with x-rays or drugs.

People 6 months to 18 years of age on long-term aspirin
treatment (these people could develop Reye Syndrome if they got
influenza).
Women who will be pregnant during influenza season.
People who can spread influenza to those at high risk:
Household contacts and out-of-home caretakers of infants
from 0-23 months of age.
Physicians, nurses, family members, or anyone else in
close contact with people at risk of serious influenza.
Influenza vaccine is also recommended for adults 50-64 years of age
and anyone else who wants to reduce their chance of catching influenza.
An annual flu shot should be considered for:
People who provide essential community services.
People living in dormitories or under other crowded
conditions, to prevent outbreaks.
People at high risk of flu complications who travel to the
Southern hemisphere between April and September, or to the tropics or
in organized tourist groups at any time.
4. When should I get influenza vaccine?
The best time to get influenza vaccine is in October or November.
Influenza season usually peaks in February, but it can peak any
time from November through May. So getting the vaccine in December, or
even later, can be beneficial in most years.
Some people should get their flu shot in October or earlier:

--People 50 years of age and older,
--Younger people at high risk from influenza and its complications
(including children 6 through 23 months of age),
--Household contacts of people at high risk,
--Healthcare workers, and
--Children younger than 9 years of age getting influenza vaccine for
the first time.

Most people need one flu shot each year. Children younger than 9
years of age getting influenza vaccine for the first time should get 2
doses, given at least one month apart.
5. Some people should talk with a doctor before getting influenza
vaccine
Some people should not get inactivated influenza vaccine or should
wait before getting it.
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 have had a severe reaction after a previous 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.
6. 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;
Fever;
Aches.
If these problems occur, they usually begin soon after the shot and
last 1-2 days.
Severe problems:
Life-threatening allergic reactions from vaccines are very
rare. If they do occur, it is within a few minutes to a few hours after
the shot.
In 1976, a certain 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.
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 serious allergic reaction can include

[[Page 43698]]

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 http://www.vaers.hhs.gov
, or by calling 1-800-822-7967.

VAERS does not provide medical advice.
8. 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 http://www.hrsa.gov/osp/vicp.

9. How can I learn more?
Ask your immunization 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 http://www.cdc.gov/flu.

Department of Health and Human Services, Centers for Disease
Control and Prevention, National Immunization Program.
Vaccine Information Statement, Inactivated Influenza Vaccine, (6/
18/05) (Interim), 42 U.S.C. 300aa-26.

Interim and Proposed Live, Intranasal Influenza Vaccine Information
Statement

Live, Intranasal Influenza Vaccine: What You Need to Know

1. Why get vaccinated?
Influenza (``flu'') is a very contagious disease.
It is caused by the influenza virus, which spreads from infected
persons to the nose or throat of others.
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 get much sicker. Influenza can lead to pneumonia and
can be dangerous for people with heart or breathing conditions. It can
cause high fever and seizures in children. Influenza kills about 36,000
people each year in the United States.
Influenza vaccine can prevent influenza.
2. Live, attenuated influenza vaccine (nasal spray)
There are two types of influenza vaccine:
Live, attenuated influenza vaccine (LAIV) was licensed in 2003.
LAIV contains live but attenuated (weakened) influenza virus. It is
sprayed into the nostrils rather than injected into the muscle. It is
recommended for healthy children and adults from 5 through 49 years of
age, who are not pregnant.
Inactivated influenza vaccine, sometimes called the ``flu shot,''
has been used for many years and is given by injection. This vaccine is
described in a separate Vaccine Information Statement. Influenza
viruses are constantly changing. Therefore, influenza vaccines are
updated every year, and annual vaccination is recommended.
For most people influenza vaccine prevents serious illness caused
by the influenza virus. It will not prevent ``influenza-like''
illnesses caused by other viruses. It takes about 2 weeks for
protection to develop after vaccination, and protection can last up to
a year.
3. Who can get LAIV?
Live, intranasal influenza vaccine is approved for healthy children
and adults from 5 through 49 years of age, including most healthcare
workers and household contacts of most people at high risk for
influenza complications. However, LAIV should not be given to pregnant
women or people with certain medical conditions.
4. Who should not get LAIV?
The following people should not get live intranasal influenza
vaccine. They should check with their health-care provider about
getting the inactivated vaccine.
Adults 50 years of age or older or children younger than
5.
People who have long-term health problems with:

--Heart disease;
--Kidney disease;
--Lung disease;
--Metabolic disease, such as diabetes;
--Asthma;
--Anemia, and other blood disorders.

People with a weakened immune system due to:

--HIV/AIDS or other diseases affecting the immune system;
--Long-term treatment with drugs that weaken the immune system, such as
steroids;
--Cancer treatment with x-rays or drugs.

Children or adolescents on long-term aspirin treatment
(these people could develop Reye syndrome if they get influenza).
Pregnant women.
Anyone with a history of Guillain-Barr[eacute] syndrome (a
severe paralytic illness, also called GBS).
Inactivated influenza vaccine (the flu shot) is the preferred
vaccine for people (including health-care workers, and family members)
coming in close contact with anyone who has a severely weakened immune
system (that is, anyone who requires care in a protected environment).
Some people should talk with a doctor before getting either
influenza vaccine:
Anyone who has ever had a serious allergic reaction to
eggs or to a previous dose of influenza vaccine.
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. When should I get influenza vaccine?
The best time to get influenza vaccine is in October or November.
Influenza season usually peaks in February, but it can peak any time
from November through May. So getting the vaccine in December, or even
later, can be beneficial in most years.
Most people need one dose of influenza vaccine each year. Children
younger than 9 years of age getting influenza vaccine for the first
time should get 2 doses. For LAIV, these doses should be given 6-10
weeks apart.
LAIV may be given at the same time as other vaccines. This includes
other live vaccines, such as MMR or chickenpox. But if two live
vaccines are not given on the same day, they should be given at least 4
weeks apart.
6. What are the risks from LAIV?
A vaccine, like any medicine, could possibly cause serious
problems, such

[[Page 43699]]

as severe allergic reactions. However, the risk of a vaccine causing
serious harm, or death, is extremely small.
Live influenza vaccine viruses 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 5-17 years of age have reported mild
reactions, including:
Runny nose, nasal congestion or cough;
Headache and muscle aches;
Fever;
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.
These symptoms did not last long and went away on their own.
Although they can occur after vaccination, they may not have been
caused by the vaccine.
Severe problems:
Life-threatening allergic reactions from vaccines are very
rare. If they do occur, it is within a few minutes to a few hours after
vaccination.
If rare reactions occur with any new product, they may not
be identified until thousands, or millions, of people have used it.
Over two million 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 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 http://www.vaers.hhs.gov
, or by calling 1-800-822-7967.

VAERS does not provide medical advice.
8. 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 http://www.hrsa.gov/osp/vicp
.

--Call 1-800-232-4636 (1-800-CDC-INFO)
--Visit CDC's Web site at http://www.cdc.gov/flu.

Department of Health and Human Services, Centers for Disease
Control and Prevention, National Immunization Program.
Vaccine Information Statement, Live, Intranasal Influenza Vaccine,
(6/18/05) (Interim), 42 U.S.C. 300aa-26.

Dated: July 22, 2005.
James D. Seligman,
Associate Director for Program Services, Centers for Disease Control
and Prevention.
[FR Doc. 05-14924 Filed 7-27-05; 8:45 am]

BILLING CODE 4163-18-P