[Federal Register Volume 66, Number 44 (Tuesday, March 6, 2001)]
[Notices]
[Pages 13540-13544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5377]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Proposed Vaccine Information Materials for Pneumococcal 
Conjugate, Diphtheria, Tetanus, Acellular Pertussis (DTaP/DT) and 
Hepatitis B 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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SUMMARY: Under the National Childhood Vaccine Injury Act (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 pneumococcal conjugate 
vaccine, and revised vaccine information materials for diphtheria, 
tetanus, acellular pertussis (DTaP/DT) vaccines and hepatitis B 
vaccine.

DATES: Written comments are invited and must be received on or before 
May 7, 2001.

ADDRESSES: Written comments should be addressed to Walter A. Orenstein, 
M.D., Director, National Immunization Program, Centers for Disease 
Control and Prevention, Mailstop E-05, 1600 Clifton Road, NE., Atlanta, 
Georgia 30333.

FOR FURTHER INFORMATION CONTACT: Walter A. Orenstein, 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.
    Development and revision of the vaccine information materials 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. Instructions for use of the vaccine 
information materials and copies of the materials can be found on the 
CDC website 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).

Pneumococcal Conjugate Vaccine Information Materials

    With the December 18, 1999, addition of pneumococcal conjugate 
vaccine to the National Vaccine Injury Compensation Program, CDC, as 
required under 42 U.S.C. 300aa-26, is proposing vaccine information 
materials covering that vaccine, which are included in this notice.

Revised Vaccine Information Materials for Diphtheria, Tetanus, 
Acellular Pertussis (DTaP/DT) Vaccines and Hepatitis B Vaccine

    This notice also includes proposed revised vaccine information 
materials for diphtheria, tetanus and acellular pertussis vaccines 
(other than Td vaccine) and hepatitis B vaccine.
    The DTaP/DT materials are being revised to remove references to DTP 
(whole cell pertussis-containing vaccine) because this vaccine is no 
longer used in the United States. In addition, these proposed revised 
materials reflect a new adverse event profile for DTaP, including 
updated adverse event information on acellular pertussis vaccine.
    The hepatitis B materials are being revised to note a recently 
approved two dose schedule for administration to adolescents 11 to 15 
years of age as an alternative to the three dose schedule. Interim 
revised hepatitis B vaccine information materials were published in a 
September 1, 2000 Federal Register notice (65 FR 53316) for use pending 
completion of the formal revision process.

Development of New/Revised Vaccine Information Materials

    The proposed vaccine information materials included in this notice 
were drafted in consultation with the Advisory Commission on Childhood 
Vaccines, the Food and Drug Administration, the American Academy of 
Pediatrics, American Pharmaceutical Association, Association of 
American Indian Physicians, Every Child by Two, Immunization Action 
Coalition, Immunization, Education and Action Committee, Infectious 
Disease Society of America, National Association for Pediatric Nurse 
Associates and Practitioners and the National Vaccine Advisory 
Committee. Also, CDC provided copies of the draft materials to other 
organizations and sought their consultation; however, those 
organizations did not provide comments. Comments provided by the 
consultants were considered in drafting

[[Page 13541]]

the proposed vaccine information materials included in this notice.
    We invite written comment on the proposed vaccine information 
materials that follow, entitled ``Pneumococcal Conjugate Vaccine: What 
You Need to Know,'' ``Diphtheria, Tetanus & Pertussis Vaccines: What 
You Need to Know,'' and ``Hepatitis B 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 use.
    We also propose to revise the December 17, 1999, Instructions for 
Use of Vaccine Information Materials (Vaccine Information Statements), 
and interim instructions dated September 6, 2000, to add the 
requirement for use of the pneumococcal conjugate vaccine information 
materials and to note the new edition dates for the revised vaccine 
information materials covering diphtheria, tetanus, pertussis (DTaP/DT) 
vaccines and hepatitis B vaccine.
    Pneumococcal Conjugate Vaccine: What You Need to Know

1. Why Get Vaccinated?

    Pneumococcal disease is a serious disease that causes sickness and 
death. In fact, it is the leading cause of bacterial meningitis in the 
United States. (Meningitis is a serious infection of the covering of 
the brain).
    Each year pneumococcal disease causes in children under five:

 17,000 cases of invasive disease, including 700 cases of 
meningitis
 About 5 million ear infections
 About 200 deaths
    It can also lead to other health problems, including:

 Pneumonia
 Deafness
 Brain damage

    Children under 2 years old are at highest risk for serious disease.
    Pneumococcus bacteria are spread from person to person through 
close contact.
    Pneumococcal infections can be hard to treat because some bacteria 
have become resistant to drugs that have been used to treat them. This 
makes prevention of the disease even more important.
    Pneumococcal conjugate vaccine can prevent serious pneumococcal 
disease, such as meningitis and blood infections. It also prevents some 
ear infections. But ear infections have many causes, and pneumococcal 
vaccine is effective against only some of them.

2. Pneumococcal Conjugate Vaccine

    Pneumococcal conjugate vaccine is approved for infants and 
toddlers. Protection lasts at least 3 years, so children who are 
vaccinated as infants will be protected when they are at greatest risk 
for serious disease.
    Some older children and adults may get a different vaccine called 
pneumococcal polysaccharide vaccine. There is a separate Vaccine 
Information Statement for people getting the pneumococcal 
polysaccharide vaccine.

3. Who Should Get the Vaccine and When?

    Children under 2 years of age:

 2 months
 4 months
 6 months
 12-15 months
    Children who weren't vaccinated at these ages can still get the 
vaccine. The number of doses needed depends on the child's age. Ask 
your health care provider for details.
     Children between 2 and 5 years of age:
    Pneumococcal conjugate vaccine is also recommended for children 
between 2 and 5 years old who have not already gotten the vaccine and 
are at high risk of serious pneumococcal disease. This includes 
children who:

 Have sickle cell disease,
 Have a damaged spleen or no spleen,
 Have HIV/AIDS,
 Have other diseases that affect the immune system, such as 
diabetes, cancer, or liver disease, or
 Take medications that affect the immune system, such as 
chemotherapy or steroids.
    Other children who are at increased risk of serious pneumococcal 
disease include those who:
 Are under 3 years of age,
 Are of Alaska Native, American Indian or African American 
descent, or
 Attend group day care.
    The number of doses needed depends on the child's age. Ask your 
health care provider for more details.
    Pneumococcal conjugate vaccine may be given at the same time as 
other routine childhood vaccines.

4. Some Children Should Not Get Pneumococcal Conjugate Vaccine or 
Should Wait

    Children should not get pneumococcal conjugate vaccine if they had 
a severe (life-threatening) allergic reaction to a previous dose of 
this vaccine, or have a severe allergy to a vaccine component. Tell 
your health-care provider if your child has ever had a severe reaction 
to any vaccine, or has any severe allergies.
    Children with minor illnesses, such as a cold, may be vaccinated. 
But children who are moderately or severely ill should usually wait 
until they recover before getting the vaccine.

5. What Are the Risks From Pneumococcal Conjugate Vaccine?

    In clinical trials (nearly 60,000 doses), pneumococcal conjugate 
vaccine was associated with only mild reactions:
     Up to about 1 infant out of 4 had redness, tenderness, or 
swelling where the shot was given.
     About 1 out of 3 had a fever of over 100.4  deg.F, and up 
to about 1 in 50 had a higher fever (over 102.2  deg.F).
     Some children also became fussy or drowsy, or had a loss 
of appetite.
    So far, no moderate or severe reactions have been associated with 
this vaccine. However, a vaccine, like any medicine, could cause 
serious problems, such as a severe allergic reaction. The risk of this 
vaccine causing serious harm, or death, is extremely small.

6. What If There Is a Moderate or Severe Reaction?

What Should I Look For?
    Look for any unusual condition, such as a serious allergic 
reaction, high fever, or unusual behavior.
    Serious allergic reactions are extremely rare with any vaccine. If 
one were to occur, it would be within a few minutes to a few hours 
after the shot. Signs can include difficulty breathing, hoarseness or 
wheezing, hives, paleness, weakness, a fast heart beat, dizziness, and 
swelling of the throat.
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 health care provider to file a Vaccine Adverse 
Event Reporting System (VAERS) form, or call VAERS yourself at 1-800-
822-7967.

7. The 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 their website at http://www.hrsa.gov/bhpr/vicp

[[Page 13542]]

8. 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's immunization 
program.
 Contact the Centers for Disease Control and Prevention (CDC):

    --Call 1-800-232-2522 (English) or 1-800-232-0233 (Espanol)
    --Visit the National Immunization Program's website at http://
www.cdc.gov/nip
U.S. Department of Health & Human Services Centers for Disease Control 
and Prevention, National Immunization Program
Vaccine Information Statement
Pneumococcal Conjugate Vaccine
(00/00/0000) (Proposed)
42 U.S.C. 300aa-26

Diphtheria, Tetanus & Pertussis Vaccines: What You Need To Know

1. Why Get Vaccinated?

    Diphtheria, tetanus, and pertussis are serious diseases caused by 
bacteria. Diphtheria and pertussis are spread from person to person. 
Tetanus enters the body through cuts or wounds.
    Diphtheria causes a thick covering in the back of the throat.
     It can lead to breathing problems, paralysis, heart 
failure, and even death.
    Tetanus (Lockjaw) causes painful tightening of the muscles, usually 
all over the body.
     It can lead to ``locking'' of the jaw so the victim cannot 
open his mouth or swallow. Tetanus leads to death in about 3 out of 10 
cases.
    Pertussis (Whooping Cough) causes coughing spells so bad that it is 
hard for infants to eat, drink, or breathe. These spells can last for 
weeks.
     It can lead to pneumonia, seizures (jerking and staring 
spells), brain damage, and death.
    Diphtheria, tetanus, and pertussis vaccine (DTaP) can prevent these 
diseases. Most children who are vaccinated with DTaP will be protected 
throughout childhood. Many more children would get these diseases if we 
stopped vaccinating.
    DTaP is a safer version of an older vaccine called DTP. DTP is no 
longer used in the United States.

2. Who Should Get DTaP Vaccine and When?

    Children should get 5 doses of DTaP vaccine, one dose at each of 
the following ages:

--2 months
--4 months
--6 months
--15-18 months
--4-6 years

    DTaP may be given at the same time as other vaccines.

3. Some Children Should Not Get DTaP Vaccine or Should Wait

     Any child who has had a life-threatening allergic reaction 
after a dose of DTaP should not get any more doses.
     Any child who suffered a brain or nervous system disease 
within 7 days after a dose of DTaP should not get any more doses.
     Talk with your doctor if your child:
--Had a seizure or collapsed after a previous dose of DTaP,
--Cried non-stop for 3 hours or more after a previous dose of DTaP,
--Had a high fever (over 105  deg.F) after a previous dose of DTaP.

     Children who are moderately or severely ill at the time 
the shot is scheduled should usually wait until they recover before 
getting DTaP vaccine.
    Ask your health care provider for more information. Children who 
should not get the pertussis part of the vaccine can get a vaccine 
called DT, which doesn't contain pertussis.

4. Older Children and Adults

    DTaP should not be given to anyone 7 years of age or older. 
Pertussis can still strike older children, adolescents, and adults, but 
the pertussis vaccine is currently licensed only for children under 7.
    Adolescents and adults still need protection from tetanus and 
diphtheria. A booster shot called Td is recommended at 11-12 years of 
age. It should be repeated every 10 years. There is a separate Vaccine 
Information Statement for Td vaccine.

5. What Are the Risks From DTaP Vaccine?

    Getting diphtheria, tetanus, or pertussis disease is much riskier 
than getting DTaP vaccine. However, a vaccine, like any medicine, is 
capable of causing serious problems, such as severe allergic reactions. 
The risk of DTaP vaccine causing serious harm, or death, is extremely 
small.
Mild Problems (Common)
 Fever (up to about 1 child in 4)
 Redness or swelling where the shot was given (up to about 1 
child in 4)
 Soreness or tenderness where the shot was given (up to about 1 
child in 4)

    These problems occur more often after the 4th and 5th doses of the 
DTaP series than after earlier doses.
    Another mild problem is swelling of the arm or leg in which the 
shot was given, after the 4th or 5th dose (up to about 1 child in 30).
    Other mild problems include:

     Fussiness (up to about 1 child in 3)
     Tiredness or poor appetite (up to about 1 child in 10)
     Vomiting (up to about 1 child in 50)

    These problems generally occur 1-3 days after the shot.
Moderate Problems (Uncommon)
 Seizure (jerking or staring) (about 1 child out of 14,000)
 Non-stop crying, for 3 hours or more (up to about 1 child out 
of 1,000)
 High fever, over 105  deg.F (about 1 child out of 16,000)
Severe Problems (Very Rare)
 Serious allergic reaction (less than 1 out of a million doses)
 Several other severe problems have been reported after DTaP 
vaccine. These include:
    --Long-term seizures, coma, or lowered consciousness
    --Permanent brain damage.

    These are so rare it is hard to tell if they are caused by the 
vaccine.
    Controlling fever is especially important for children who have had 
seizures, for any reason. It is also important if another family member 
has had seizures.
    You can reduce fever and pain by giving your child an aspirin-free 
pain reliever when the shot is given, and for the next 24 hours, 
following the package instructions.

6. What If There Is a Moderate or Severe Reaction?

What Should I Look For?
    Any unusual conditions, such as a serious allergic reaction, high 
fever or behavior changes. Signs of a serious allergic reaction include 
difficulty breathing, hoarseness or wheezing, hives, paleness, 
weakness, a fast heart beat or dizziness within a few minutes to a few 
hours after the shot. If a high fever or seizure occurs, it is usually 
within 2 weeks after the shot.
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 file a 
Vaccine Adverse Event Reporting System (VAERS) form, or call VAERS 
yourself at 1-800-822-7967.

[[Page 13543]]

7. 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 website at http://www.hrsa.gov/bhpr/vicp

8. How Can I Learn More?

     Ask your health care provider. They can give you the 
vaccine package insert or suggest other sources of information.
     Call your local or state health department's immunization 
program.
     Contact the Centers for Disease Control and Prevention 
(CDC):
--Call 1-800-232-2522 (English)
--Call 1-800-232-0233 (Espanol)
--Visit the National Immunization Program's website at http://
www.cdc.gov/nip
Department of Health & Human Services, Centers for Disease Control and 
Prevention, National Immunization Program
Vaccine Information Statement
DTaP
(00/00/0000) (Proposed)
42 U.S.C. 300aa-26

Hepatitis B Vaccine: What You Need To Know

1. Why Get Vaccinated?

Hepatitis B Is a Serious Disease
    The hepatitis B virus can cause short-term (acute) illness that 
leads to:
 Loss of appetite
 Diarrhea and vomiting
 Tiredness
 Jaundice (yellow skin or eyes)
 Pain in muscles, joints, and stomach

    It can also cause long-term (chronic) illness that leads to:

 Liver damage (cirrhosis)
 Liver cancer
 Death

    About 1.25 million people in the U.S. have chronic hepatitis B 
virus infection. If you are infected as a young child, you are much 
more likely to develop chronic illness.
    Each year it is estimated that:
 200,000 people, mostly young adults, get infected with 
hepatitis B virus
 More than 11,000 people have to stay in the hospital because 
of hepatitis B
 4,000 to 5,000 people die from chronic hepatitis B

    Hepatitis B vaccine can prevent hepatitis B. It is the first anti-
cancer vaccine because it can prevent a form of liver cancer.

2. How Is Hepatitis B Virus Spread?

    Hepatitis B virus is spread through contact with the blood and body 
fluids of an infected person.

    A person can get infected in several ways, such as:

 During birth when the virus passes from an infected mother to 
her baby
 By having sex with an infected person
 By injecting illegal drugs
 By being stuck with a used needle on the job
 By sharing personal items, such as a razor or toothbrush with 
an infected person

    People can get hepatitis B infection without knowing how they got 
it. About \1/3\ of hepatitis B cases in the United States have an 
unknown source.

3. Who Should Get Hepatitis B Vaccine and When?

(1) Everyone 18 years of age and younger
(2) Adults over 18 who are at risk

    Adults at risk for hepatitis B infection include people who have 
more than one sex partner, men who have sex with other men, injection 
drug users, health care workers, and others who might be exposed to 
infected blood or body fluids.
    If you are not sure whether you are at risk, ask your doctor or 
nurse.
    People should get 3 doses of hepatitis B vaccine according to the 
following schedule. If you miss a dose or get behind schedule, get the 
next dose as soon as you can. There is no need to start over.

                                        Hepatitis B Vaccination Schedule
----------------------------------------------------------------------------------------------------------------
                                                                          Who?
                                      --------------------------------------------------------------------------
                When?                   Infant whose mother is   Infant whose mother is
                                       infected with hepatitis     not  infected with          Older child,
                                               B virus             hepatitis B virus       adolescent, or adult
----------------------------------------------------------------------------------------------------------------
First Dose...........................  Within 12 hours of       Birth-2 months of age..  Any time.
                                        birth.
Second Dose..........................  1-2 months of age......  1-4 months of age (At    1-2 months after first
                                                                 least 1 month after      dose.
                                                                 first dose).
Third Dose...........................  6 months of age........  6-18 months of age.....  4-6 months after first
                                                                                          dose.
----------------------------------------------------------------------------------------------------------------
The second dose must be given at least 1 month after the first dose.
The third dose must be given at least 2 months after the second dose and at least 4 months after the first.
The third dose should not be given to infants younger than 6 months of age.

    Adolescents 11 to 15 years of age may need only two doses of 
hepatitis B vaccine, separated by 4-6 months. Ask your health care 
provider for details.
    Hepatitis B vaccine may be given at the same time as other 
vaccines.

4. Some People Should Not Get Hepatitis B Vaccine or Should Wait

    People should not get hepatitis B vaccine if they have ever had a 
life-threatening allergic reaction to baker's yeast (the kind used for 
making bread) or to a previous dose of hepatitis B vaccine.
    People who are moderately or severely ill at the time the shot is 
scheduled should usually wait until they recover before getting 
hepatitis B vaccine.
    Ask your doctor or nurse for more information.

5. What Are the Risks From Hepatitis B Vaccine?

    A vaccine, like any medicine, is capable of causing serious 
problems, such as severe allergic reactions. The risk of a vaccine 
causing serious harm, or death, is extremely small.
    Getting hepatitis B vaccine is much safer than getting hepatitis B 
disease.
    Most people who get hepatitis B vaccine do not have any problems 
with it.
Mild Problems
 Soreness where the shot was given, lasting a day or two (up to 
1 out of 11 children and adolescents, and about 1 out of 4 adults)
 Mild to moderate fever (up to 1 out of 14 children and 
adolescents and 1 out of 100 adults)

[[Page 13544]]

Severe Problems
 Serious allergic reaction (very rare)

6. What If There Is a Moderate or Severe Reaction?

What Should I Look For?
    Any unusual condition, such as a serious allergic reaction, 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. If such a reaction were to 
occur, it would be within a few minutes to a few hours after the shot.
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 file a 
Vaccine Adverse Event Reporting System (VAERS) form, or call VAERS 
yourself at 1-800-822-7967.

7. 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 website at http://www.hrsa.gov/bhpr/vicp

8. 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's immunization 
program.
     Contact the Centers for Disease Control and Prevention 
(CDC):
--Call 1-800-232-2522 or 1-888-443-7232 (English)
--Call 1-800-232-0233 (Espanol)
--Visit the National Immunization Program's website at http://www.cdc.gov/nip or CDC's Hepatitis Branch website at http://www.cdc.gov/ncidod/diseases/hepatitis
Department of Health & Human Services, Centers for Disease Control and 
Prevention, National Immunization Program
Vaccine Information Statement
Hepatitis B
(00/00/0000) (Proposed)
42 U.S.C. 300aa-26

    Dated: February 28, 2001.
Joseph R. Carter,
Associate Director for Management and Operations, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 01-5377 Filed 3-5-01; 8:45 am]
BILLING CODE 4163-18-P