[Federal Register Volume 70, Number 217 (Thursday, November 10, 2005)]
[Notices]
[Pages 68461-68465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22441]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Vaccine Information Statements for Influenza Vaccines; 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.

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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 trivalent 
influenza vaccines and hepatitis A vaccines. The 60 day comment period 
ended on September 26, 2005. Following review of the comments submitted 
and consultation as required under the law, CDC has finalized the 
influenza vaccine information materials. The final influenza materials, 
and revised instructions for their use and for use of materials for 
other covered vaccines, are contained in this notice. The final 
hepatitis A vaccine information materials will be published later.

DATES: Beginning no later than January 1, 2006, each health care 
provider who administers any trivalent influenza vaccine to any child 
or adult in the United States shall provide copies of the relevant 
vaccine information materials contained in this notice, dated October 
20, 2005, in conformance with the November 4, 2005 CDC Instructions for 
the Use of Vaccine Information Statements, also contained in this 
notice.

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, 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.
    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 downloaded in PDF format from 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).

New Vaccine Information Materials

Inactivated Influenza Vaccine Information Statement; Live, Intranasal 
Influenza Vaccine Information Statement; Hepatitis A Vaccine 
Information Statement

    Following the addition of hepatitis A and trivalent influenza 
vaccines to the National Vaccine Injury Compensation Program, CDC, as 
required under 42 U.S.C. 300aa-26, proposed vaccine information 
materials covering those vaccines in a Federal Register notice 
published on July 28, 2005 (70 FR 43694). In order to have Influenza 
Vaccine Information Statements available for voluntary use in the 
current influenza vaccination season, the proposed influenza vaccine 
materials were also issued as interim VISs through that notice.
    The new 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 trivalent influenza vaccines 
have been finalized and are contained in this notice. These Vaccine 
Information Statements, dated October 20, 2005, are entitled: 
``Inactivated Influenza Vaccine: What You Need to Know'' and ``Live, 
Intranasal Influenza Vaccine: What You Need to Know.'' CDC has also 
revised the ``Instructions for the Use of Vaccine Information 
Statements.'' The vaccine information materials covering hepatitis A 
vaccine will be finalized and published at a later date.
    With publication of this notice, as of January 1, 2006, all health 
care providers will be required to provide

[[Page 68462]]

copies of influenza vaccine information materials prior to immunization 
in conformance with CDC's November 4, 2005 ``Instructions for the Use 
of Vaccine Information Statements'' which are contained in this notice.
* * * * *

Instructions for the Use of Vaccine Information Statements

Required Use

1. Provide Vaccine Information Statement (VIS) When Vaccination Is 
Given
    As required under the National Childhood Vaccine Injury Act (42 
U.S.C. 300aa-26), all health care providers in the United States who 
administer to any child or adult any vaccine containing diphtheria, 
tetanus, pertussis, measles, mumps, rubella, polio, Haemophilus 
influenzae type b (Hib), hepatitis B, trivalent influenza (use of 
influenza VISs required effective January 1, 2006), pneumococcal 
conjugate, or varicella (chickenpox) vaccine shall, prior to 
administration of each dose of the vaccine, provide a copy to keep of 
the relevant current edition vaccine information materials that have 
been produced by the Centers for Disease Control and Prevention (CDC):
     To the parent or legal representative* of any child to 
whom the provider intends to administer such vaccine, and
     To any adult to whom the provider intends to administer 
such vaccine. (In the case of an incompetent adult, relevant VISs shall 
be provided to the individual's legal representative.* If the 
incompetent adult is living in a long-term care facility, all relevant 
VISs may be provided at the time of admission, or at the time of 
consent if later than admission, rather than prior to each 
immunization.)
    The materials shall be supplemented with visual presentations or 
oral explanations, as appropriate.
    If there is not a single VIS for a combination vaccine, use the 
VISs for all component vaccines.
     A Legal representative is defined as a parent or other 
individual who is qualified under State law to consent to the 
immunization of a minor child or incompetent adult.
2. Record information for each VIS provided
    Health care providers shall make a notation in each patient's 
permanent medical record at the time vaccine information materials are 
provided indicating (1) the edition date of the Vaccine Information 
Statement distributed and (2) the date the VIS was provided.
    This recordkeeping requirement supplements the requirement of 42 
U.S.C. 300aa-25 that all health care providers administering these 
vaccines must record in the patient's permanent medical record (or in a 
permanent office log): (3) The name, address and title of the 
individual who administers the vaccine, (4) the date of administration 
and (5) the vaccine manufacturer and lot number of the vaccine used.

Applicability of State Law

    Health care providers should consult their legal counsel to 
determine additional State requirements pertaining to immunization. The 
Federal requirement to provide the vaccine information materials 
supplements any applicable State laws.

Availability of Copies

    Single camera-ready copies of the vaccine information materials are 
available from State health departments. Copies are also available on 
the Centers for Disease Control and Prevention's Web site at http://www.cdc.gov/nip/publications/VIS. Copies are available in English and 
in other languages.

Edition Dates of Current VISs

    Diphtheria, Tetanus, Pertussis (DTaP/DT): July 30, 2001.
    Haemophilus influenzae type b (Hib): December 16, 1998.
    Hepatitis B: July 11, 2001.
    Inactivated Influenza: October 20, 2005.
    Live, Intranasal Influenza: October 20, 2005.
    Measles, Mumps, Rubella (MMR): January 15, 2003.
    Pneumococcal conjugate: September 30, 2002.
    Polio: January 1, 2000.
    Tetanus Diphtheria (Td): June 10, 1994.
    Varicella (chickenpox): December 16, 1998.

Reference 42 U.S.C. 300aa-26: November 4, 2005.
* * * * *

Inactivated Influenza Vaccine Information Statement

Inactivated 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. 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, mostly among the elderly.
    Influenza vaccine can prevent influenza.
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.

[[Page 68463]]

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

     People with certain muscle or nerve disorders (such as 
seizure disorders or severe cerebral palsy) that can lead to breathing 
or swallowing 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 influenza 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 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.
--Vaccine Information Statement.
--(October 20, 2005) Inactivated Influenza Vaccine.

42 U.S.C. 300aa-26.

    Department of Health and Human Services, Centers for Disease 
Control

[[Page 68464]]

and Prevention, National Immunization Program.
* * * * *

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 those who can 
spread influenza to people at high risk, such as:
     Household contacts and out-of-home caretakers of infants 
from 0-23 months of age.
     Physicians and nurses, and family members or anyone else 
in close contact with people at risk of serious influenza.
    Influenza vaccine is also recommended for anyone else who wants to 
reduce their chance of catching influenza.
    LAIV may be considered for:
     People who provide essential community services.
     People living in dormitories or under other crowded 
conditions, to prevent outbreaks.
4. Who should not get LAIV?
    LAIV is not licensed for everyone. The following people 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
--Lung disease
--Asthma
--Kidney disease
--Metabolic disease, such as diabetes
--Anemia, and other blood disorders

     People with a weakened immune system.
     Children or adolescents on long-term aspirin treatment.
     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, 
but LAIV may be given as soon as it is available. 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.
6. What are the risks from LAIV?
    A vaccine, like any medicine, could possibly cause serious 
problems, such 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 
the 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?

[[Page 68465]]

     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.
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.
--Vaccine Information Statement.
--Live, Attenuated Influenza Vaccine.
    (October 20, 2005)

42 U.S.C. 300aa-26.

    Department of Health and Human Services, Centers for Disease 
Control and Prevention, National Immunization Program.

    Dated: November 4, 2005.
James D. Seligman,
Associate Director for Program Services, Centers for Disease Control 
and Prevention.
[FR Doc. 05-22441 Filed 11-9-05; 8:45 am]
BILLING CODE 4163-18-P