[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Pages 48712-48715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19788]


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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.

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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. 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: http://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: http://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 http://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 http://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